Medical Devices; Gastroenterology-Urology Devices; Classification of the Fluid Jet System for Prostate Tissue Removal, 27895-27898 [2018-12829]
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Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations
CFR 10.115)). We are implementing this
guidance without prior public comment
because we have determined that prior
public participation is not feasible or
appropriate (§ 10.115(g)(2)). We made
this determination because this
guidance sets out compliance policy
that reduces burden and is consistent
with the public health. Although this
guidance document is immediately in
effect, it remains subject to comment in
accordance with FDA’s GGP regulation.
Before 2016, FDA regulations did not
define the term ‘‘dietary fiber’’ for
purposes of the Nutrition Facts and
Supplement Facts labels. In the Federal
Register of May 27, 2016 (81 FR 33742),
we published a final rule amending our
Nutrition Facts and Supplement Facts
Labels regulations (hereafter referred to
as ‘‘the final rule’’). The final rule,
among other things, defines dietary fiber
as non-digestible soluble and insoluble
carbohydrates (with 3 or more
monomeric units), and lignin that are
intrinsic and intact in plants; isolated or
synthetic non-digestible carbohydrates
(with 3 or more monomeric units)
determined by FDA to have
physiological effects that are beneficial
to human health (§ 101.9(c)(6)(i) (21
CFR 101.9(c)(6)(i))). The final rule also
identifies seven isolated or synthetic
non-digestible carbohydrates, each of
which has a physiological effect that is
beneficial to human health and that
must be declared as dietary fiber on
Nutrition and Supplement Facts labels
when present in a food.
Interested parties can ask us to list
additional isolated or synthetic nondigestible carbohydrates in the
definition of dietary fiber in
§ 101.9(c)(6)(i). For example, a
manufacturer can request FDA to
include another added isolated or
synthetic non-digestible carbohydrate in
the listing of dietary fibers by
submitting a citizen petition under 21
CFR 10.30. FDA would review the
scientific evidence to determine
whether the evidence supports the nondigestible carbohydrate as having a
physiological effect that is beneficial to
human health. If so, FDA would
propose a rule to include the nondigestible carbohydrate in the listing of
dietary fibers.
Based on our review of citizen
petitions that FDA has received
requesting that we identify additional
isolated or synthetic non-digestible
carbohydrates in the listing of dietary
fibers, and comments that we have
received on a draft guidance entitled
‘‘Scientific Evaluation of the Evidence
on the Beneficial Physiological Effects
of Isolated or Synthetic Non-Digestible
Carbohydrates Submitted as a Citizen
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Petition (21 CFR 10.30)’’ and an
accompanying document titled
‘‘Evaluation of the Beneficial
Physiological Effects of Isolated or
Synthetic Non-Digestible
Carbohydrates,’’ the availability of
which we announced in the Federal
Register of November 23, 2016 (81 FR
84516 and 81 FR 84595), in addition to
our independent evaluation of the
available scientific data, we intend to
add certain isolated or synthetic nondigestible carbohydrates to the dietary
fiber definition in § 101.9(c)(6)(i)
through our regular rulemaking process.
The eight non-digestible carbohydrates
that we intend to add are: Mixed plant
cell wall fibers; arabinoxylan; alginate,
inulin and inulin-type fructans; high
amylose starch (resistant starch 2);
galactooligosaccharide; polydextrose;
and resistant maltodextrin/dextrin. One
category of non-digestible carbohydrate
that we intend to add to § 101.9(c)(6)(i)
through our regular rulemaking
process—mixed plant cell wall fibers—
encompasses a number of fiber
ingredients, such as rice bran fibers, soy
fibers, and sugar cane fibers. We have
tentatively determined that each of
these isolated or synthetic nondigestible carbohydrates has a
physiological effect that is beneficial to
human health. Several petitions are still
pending with FDA and reviewing this
information is a very high priority for
FDA. Firms also can submit new citizen
petitions, and we will review the
petitions on a rolling basis. Firms whose
non-digestible carbohydrates do not
meet our regulatory definition of
‘‘dietary fiber’’ and are not one of the
eight non-digestible carbohydrates
identified in the guidance can still use
those non-digestible carbohydrates in
foods. Although those non-digestible
carbohydrates cannot be listed as
dietary fiber in the Nutrition Facts label,
they would still be declared as part of
the amount of total carbohydrate and
listed by name in the ingredients on the
food package. In addition, based on our
review of the scientific evidence,
including evidence we received in a
citizen petition, we intend to establish
a caloric value for polydextrose at 1
kcal/g in § 101.9(c)(1)(i)(C).
Pending completion of the rulemaking
process, we are announcing a policy for
the eight identified isolated or synthetic
non-digestible carbohydrates when one
or more are present in food and declared
in the amount of ‘‘dietary fiber’’ on
Nutrition Facts and Supplement Facts
labels and when the caloric value of 1
kcal/g is used to determine the calorie
contribution of polydextrose. Section
101.9(g) requires manufacturers to make
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27895
and keep records to verify the amount
of non-digestible carbohydrates added
to food that do not meet the definition
of dietary fiber. Under our policy, when
a mixture of dietary fiber and one or
more of these eight added non-digestible
carbohydrates (that are not currently
listed as a ‘‘dietary fiber’’ in the
definition in § 101.9(c)(6)(i)) are present
in a food, we do not expect
manufacturers to make and keep records
in accordance with § 101.9(g)(10) and
(11) to verify the declared amount of
one or more of these eight added nondigestible carbohydrates in the label and
labeling of food.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on this topic. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
II. Electronic Access
Persons with access to the internet
may obtain the document at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA website listed in the previous
sentence to find the most current
version of the guidance.
Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12867 Filed 6–14–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA–2018–N–1894]
Medical Devices; GastroenterologyUrology Devices; Classification of the
Fluid Jet System for Prostate Tissue
Removal
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the fluid jet system for
prostate tissue removal into class II
(special controls). The special controls
that apply to the device type are
identified in this order and will be part
of the codified language for the fluid jet
SUMMARY:
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system for prostate tissue removal’s
classification. We are taking this action
because we have determined that
classifying the device into class II
(special controls) will provide a
reasonable assurance of safety and
effectiveness of the device. We believe
this action will also enhance patients’
access to beneficial innovative devices,
in part by reducing regulatory burdens.
DATES: This order is effective June 15,
2018. The classification was applicable
on December 21, 2017.
FOR FURTHER INFORMATION CONTACT:
Jessica Cades, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G246, Silver Spring,
MD, 20993–0002, 240–402–3900,
Jessica.Cades@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with RULES
I. Background
Upon request, FDA has classified the
fluid jet system for prostate tissue
removal as class II (special controls),
which we have determined will provide
a reasonable assurance of safety and
effectiveness. In addition, we believe
this action will enhance patients’ access
to beneficial innovation, in part by
reducing regulatory burdens by placing
the device into a lower device class than
the automatic class III assignment.
The automatic assignment of class III
occurs by operation of law and without
any action by FDA, regardless of the
level of risk posed by the new device.
Any device that was not in commercial
distribution before May 28, 1976, is
automatically classified as, and remains
within, class III and requires premarket
approval unless and until FDA takes an
action to classify or reclassify the device
(see 21 U.S.C. 360c(f)(1)). We refer to
these devices as ‘‘postamendments
devices’’ because they were not in
commercial distribution prior to the
date of enactment of the Medical Device
Amendments of 1976, which amended
the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
FDA may take a variety of actions in
appropriate circumstances to classify or
reclassify a device into class I or II. We
may issue an order finding a new device
to be substantially equivalent under
section 513(i) of the FD&C Act to a
predicate device that does not require
premarket approval (see 21 U.S.C.
360c(i)). We determine whether a new
device is substantially equivalent to a
predicate by means of the procedures
for premarket notification under section
510(k) of the FD&C Act (21 U.S.C. 360(k)
and part 807 (21 CFR part 807).
FDA may also classify a device
through ‘‘De Novo’’ classification, a
common name for the process
authorized under section 513(f)(2) of the
FD&C Act (21 U.S.C. 360c(f)(2)). Section
207 of the Food and Drug
Administration Modernization Act of
1997 established the first procedure for
De Novo classification (Pub. L. 105–
115). Section 607 of the Food and Drug
Administration Safety and Innovation
Act modified the De Novo application
process by adding a second procedure
(Pub. L. 112–144). A device sponsor
may utilize either procedure for De
Novo classification.
Under the first procedure, the person
submits a 510(k) for a device that has
not previously been classified. After
receiving an order from FDA classifying
the device into class III under section
513(f)(1) of the FD&C Act, the person
then requests a classification under
section 513(f)(2).
Under the second procedure, rather
than first submitting a 510(k) and then
a request for classification, if the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence, that person requests a
classification under section 513(f)(2) of
the FD&C Act.
Under either procedure for De Novo
classification, FDA shall classify the
device by written order within 120 days.
The classification will be according to
the criteria under section 513(a)(1) of
the FD&C Act. Although the device was
automatically within class III, the De
Novo classification is considered to be
the initial classification of the device.
We believe this De Novo classification
will enhance patients’ access to
beneficial innovation, in part by
reducing regulatory burdens. When FDA
classifies a device into class I or II via
the De Novo process, the device can
serve as a predicate for future devices of
that type, including for 510(k)s (see 21
U.S.C. 360c(f)(2)(B)(i)). As a result, other
device sponsors do not have to submit
a De Novo request or PMA in order to
market a substantially equivalent device
(see 21 U.S.C. 360c(i), defining
‘‘substantial equivalence’’). Instead,
sponsors can use the less-burdensome
510(k) process, when necessary, to
market their device.
II. De Novo Classification
On April 17, 2017, PROCEPT
BioRobotics Inc. submitted a request for
De Novo classification of the
AQUABEAM System. FDA reviewed the
request in order to classify the device
under the criteria for classification set
forth in section 513(a)(1) of the FD&C
Act.
We classify devices into class II if
general controls by themselves are
insufficient to provide reasonable
assurance of safety and effectiveness,
but there is sufficient information to
establish special controls that, in
combination with the general controls,
provide reasonable assurance of the
safety and effectiveness of the device for
its intended use (see 21 U.S.C.
360c(a)(1)(B)). After review of the
information submitted in the request,
we determined that the device can be
classified into class II with the
establishment of special controls. FDA
has determined that these special
controls, in addition to the general
controls, will provide reasonable
assurance of the safety and effectiveness
of the device.
Therefore, on December 21, 2017,
FDA issued an order to the requester
classifying the device into class II. FDA
is codifying the classification of the
device by adding 21 CFR 876.4350. We
have named the generic type of device
fluid jet system for prostate tissue
removal, and it is identified as a
prescription device intended for the
resection and removal of prostatic tissue
for the treatment of benign prostatic
hyperplasia. The device cuts tissue by
using a pressurized jet of fluid delivered
to the prostatic urethra. The device is
able to image the treatment area, or pairs
with an imaging modality, to monitor
treatment progress.
FDA has identified the following risks
to health associated specifically with
this type of device and the measures
required to mitigate these risks in table
1.
TABLE 1—FLUID JET SYSTEM FOR PROSTATE TISSUE REMOVAL RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Injury from device operation causing one or more of the following:
Clinical performance testing, Animal testing, Labeling, and
Training.
• Bleeding
• Bruising
• Penile or pelvic pain
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27897
TABLE 1—FLUID JET SYSTEM FOR PROSTATE TISSUE REMOVAL RISKS AND MITIGATION MEASURES—Continued
Identified risks
Mitigation measures
• Dysuria
• Incontinence
• Bladder or prostate capsule perforation
• Sexual dysfunction, including ejaculatory and erectile dysfunction
• Transurethral resection syndrome
• Urethral damage causing false passage or stricture
• Rectal incontinence/perforation
• Embolism
Adverse tissue reaction .............................................................................................
Infection .....................................................................................................................
Failure to remove target tissue or removal of non-target tissue ..............................
Electrical shock or electromagnetic interference ......................................................
Biocompatibility evaluation.
Sterilization validation, Reprocessing validation, Shelf life
testing, and Labeling.
Clinical performance testing, Animal testing, Software
verification, validation, and hazard analysis, Non-clinical
performance testing, Labeling, and Training.
Electrical safety testing, Electromagnetic compatibility testing, and Labeling.
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in the
guidance document ‘‘De Novo
Classification Process (Evaluation of
Automatic Class III Designation)’’ have
been approved under OMB control
number 0910–0844; the collections of
information in 21 CFR part 814,
subparts A through E, regarding
premarket approval, have been
approved under OMB control number
0910–0231; the collections of
information in part 807, subpart E,
regarding premarket notification
submissions, have been approved under
OMB control number 0910–0120; and
the collections of information in part
801, regarding labeling, have been
approved under OMB control number
0910–0485.
III. Analysis of Environmental Impact
sradovich on DSK3GMQ082PROD with RULES
FDA has determined that special
controls, in combination with the
general controls, address these risks to
health and provide reasonable assurance
of safety and effectiveness. In order for
a device to fall within this classification,
and thus avoid automatic classification
in class III, it would have to comply
with the special controls named in this
final order. The necessary special
controls appear in the regulation
codified by this order. We encourage
sponsors to consult with us if they wish
to use a non-animal testing method they
believe is suitable, adequate, validated,
and feasible. We will consider if such an
alternative method could be assessed for
equivalency to an animal test method.
This device is subject to premarket
notification requirements under section
510(k) of the FD&C Act.
At the time of classification, fluid jet
systems for prostate tissue removal are
for prescription use only. Prescription
devices are exempt from the
requirement for adequate directions for
use for the layperson under section
502(f)(1) of the FD&C Act and 21 CFR
801.5, as long as the conditions of 21
CFR 801.109 are met (referring to 21
U.S.C. 352(f)(1)).
PART 876—GASTROENTEROLOGYUROLOGY DEVICES
The Agency has determined under 21
CFR 25.34(b) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special
controls that refer to previously
approved collections of information
found in other FDA regulations and
guidance. These collections of
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List of Subjects in 21 CFR Part 876
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 876 is
amended as follows:
1. The authority citation for part 876
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 876.4350 to subpart E to read
as follows:
■
§ 876.4350 Fluid jet system for prostate
tissue removal.
(a) Identification. A fluid jet system
for prostate tissue removal is a
prescription device intended for the
resection and removal of prostatic tissue
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for the treatment of benign prostatic
hyperplasia. The device cuts tissue by
using a pressurized jet of fluid delivered
to the prostatic urethra. The device is
able to image the treatment area, or pairs
with an imaging modality, to monitor
treatment progress.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Clinical performance testing must
evaluate the following:
(i) All adverse events associated with
the device, and
(ii) Improvement in lower urinary
tract symptoms (LUTS).
(2) Physician training must be
provided that includes:
(i) Information on key aspects and use
of the device, and
(ii) Information on how to override or
stop resection.
(3) Animal testing must demonstrate
that the device resects targeted tissue in
a controlled manner without injury to
adjacent non-target tissues.
(4) Non-clinical performance data
must demonstrate that the device
performs as intended under anticipated
conditions of use. The following
performance characteristics must be
tested:
(i) Measurement of targeting accuracy
and reproducibility of high velocity
fluid jet, and
(ii) High pressure fluid jet verification
testing at target and non-target tissues.
(5) Software verification, validation,
and hazard analysis must be performed.
(6) The patient-contacting elements of
the device must be demonstrated to be
biocompatible.
(7) Performance data must
demonstrate the electrical safety and
electromagnetic compatibility of the
device.
(8) Performance data must
demonstrate the sterility of the patientcontacting components of the device.
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(9) Performance data must support the
shelf life of the device by demonstrating
continued sterility, package integrity,
and device functionality over the
identified shelf life.
(10) Performance data must validate
the instructions for reprocessing and
reliability of reusable components.
(11) Labeling must include the
following:
(i) A section that summarizes the
clinical testing results, including the
adverse event profile and improvement
in LUTS;
(ii) A shelf life for single use
components;
(iii) A use life for reusable
components; and
(iv) Reprocessing instructions for
reusable components.
Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12829 Filed 6–14–18; 8:45 am]
BILLING CODE 4164–01–P
PENSION BENEFIT GUARANTY
CORPORATION
29 CFR Parts 4022 and 4044
Allocation of Assets in SingleEmployer Plans; Benefits Payable in
Terminated Single-Employer Plans;
Interest Assumptions for Valuing and
Paying Benefits
Pension Benefit Guaranty
Corporation.
ACTION: Final rule.
AGENCY:
This final rule amends the
Pension Benefit Guaranty Corporation’s
regulations on Benefits Payable in
Terminated Single-Employer Plans and
Allocation of Assets in Single-Employer
Plans to prescribe interest assumptions
under the benefit payments regulation
for valuation dates in July 2018 and
interest assumptions under the asset
allocation regulation for valuation dates
in the third quarter of 2018. The interest
assumptions are used for valuing and
paying benefits under terminating
single-employer plans covered by the
pension insurance system administered
by PBGC.
DATES: Effective July 1, 2018.
FOR FURTHER INFORMATION CONTACT:
Hilary Duke (duke.hilary@PBGC.gov),
Assistant General Counsel for
Regulatory Affairs, Pension Benefit
Guaranty Corporation, 1200 K Street
sradovich on DSK3GMQ082PROD with RULES
SUMMARY:
VerDate Sep<11>2014
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NW, Washington, DC 20005, 202–326–
4400, ext. 3839. (TTY users may call the
Federal relay service toll free at 1–800–
877–8339 and ask to be connected to
202–326–4400, ext. 3839.)
SUPPLEMENTARY INFORMATION: PBGC’s
regulations on Allocation of Assets in
Single-Employer Plans (29 CFR part
4044) and Benefits Payable in
Terminated Single-Employer Plans (29
CFR part 4022) prescribe actuarial
assumptions—including interest
assumptions—for valuing and paying
plan benefits under terminating singleemployer plans covered by title IV of
the Employee Retirement Income
Security Act of 1974 (ERISA). The
interest assumptions in the regulations
are also published on PBGC’s website
(https://www.pbgc.gov).
The interest assumptions in appendix
B to part 4044 are used to value benefits
for allocation purposes under ERISA
section 4044. PBGC uses the interest
assumptions in appendix B to part 4022
to determine whether a benefit is
payable as a lump sum and to determine
the amount to pay. Appendix C to part
4022 contains interest assumptions for
private-sector pension practitioners to
refer to if they wish to use lump-sum
interest rates determined using PBGC’s
historical methodology. Currently, the
rates in appendices B and C of the
benefit payment regulation are the same.
The interest assumptions are intended
to reflect current conditions in the
financial and annuity markets.
Assumptions under the asset allocation
regulation are updated quarterly;
assumptions under the benefit payments
regulation are updated monthly. This
final rule updates the benefit payments
interest assumptions for July 2018 and
updates the asset allocation interest
assumptions for the third quarter (July
through September) of 2018.
The third quarter 2018 interest
assumptions under the allocation
regulation will be 2.53 percent for the
first 25 years following the valuation
date and 2.64 percent thereafter. In
comparison with the interest
assumptions in effect for the second
quarter of 2018, these interest
assumptions represent an increase of 5
years in the select period (the period
during which the select rate (the initial
rate) applies), an increase of 0.26
percent in the select rate, and an
increase of 0.05 percent in the ultimate
rate (the final rate).
The July 2018 interest assumptions
under the benefit payments regulation
will be 1.25 percent for the period
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during which a benefit is in pay status
and 4.00 percent during any years
preceding the benefit’s placement in pay
status. In comparison with the interest
assumptions in effect for June 2018,
these interest assumptions represent no
change in the immediate rate and no
changes in i1, i2, or i3.
PBGC has determined that notice and
public comment on this amendment are
impracticable and contrary to the public
interest. This finding is based on the
need to determine and issue new
interest assumptions promptly so that
the assumptions can reflect current
market conditions as accurately as
possible.
Because of the need to provide
immediate guidance for the valuation
and payment of benefits under plans
with valuation dates during July 2018,
PBGC finds that good cause exists for
making the assumptions set forth in this
amendment effective less than 30 days
after publication.
PBGC has determined that this action
is not a ‘‘significant regulatory action’’
under the criteria set forth in Executive
Order 12866.
Because no general notice of proposed
rulemaking is required for this
amendment, the Regulatory Flexibility
Act of 1980 does not apply. See 5 U.S.C.
601(2).
List of Subjects
29 CFR Part 4022
Employee benefit plans, Pension
insurance, Pensions, Reporting and
recordkeeping requirements.
29 CFR Part 4044
Employee benefit plans, Pension
insurance, Pensions.
In consideration of the foregoing, 29
CFR parts 4022 and 4044 are amended
as follows:
PART 4022—BENEFITS PAYABLE IN
TERMINATED SINGLE–EMPLOYER
PLANS
1. The authority citation for part 4022
continues to read as follows:
■
Authority: 29 U.S.C. 1302, 1322, 1322b,
1341(c)(3)(D), and 1344.
2. In appendix B to part 4022, Rate Set
297 is added at the end of the table to
read as follows:
■
Appendix B to Part 4022—Lump Sum
Interest Rates for PBGC Payments
*
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]]>Agencies
[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Rules and Regulations]
[Pages 27895-27898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12829]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2018-N-1894]
Medical Devices; Gastroenterology-Urology Devices; Classification
of the Fluid Jet System for Prostate Tissue Removal
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the fluid jet system for prostate tissue removal into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the fluid jet
[[Page 27896]]
system for prostate tissue removal's classification. We are taking this
action because we have determined that classifying the device into
class II (special controls) will provide a reasonable assurance of
safety and effectiveness of the device. We believe this action will
also enhance patients' access to beneficial innovative devices, in part
by reducing regulatory burdens.
DATES: This order is effective June 15, 2018. The classification was
applicable on December 21, 2017.
FOR FURTHER INFORMATION CONTACT: Jessica Cades, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G246, Silver Spring, MD, 20993-0002, 240-402-3900,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the fluid jet system for prostate
tissue removal as class II (special controls), which we have determined
will provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation, in part by reducing regulatory burdens by
placing the device into a lower device class than the automatic class
III assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new
device is substantially equivalent to a predicate by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act (21 U.S.C. 360c(f)(2)). Section 207 of the Food and Drug
Administration Modernization Act of 1997 established the first
procedure for De Novo classification (Pub. L. 105-115). Section 607 of
the Food and Drug Administration Safety and Innovation Act modified the
De Novo application process by adding a second procedure (Pub. L. 112-
144). A device sponsor may utilize either procedure for De Novo
classification.
Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically within
class III, the De Novo classification is considered to be the initial
classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or PMA in order to market a substantially equivalent device (see 21
U.S.C. 360c(i), defining ``substantial equivalence''). Instead,
sponsors can use the less-burdensome 510(k) process, when necessary, to
market their device.
II. De Novo Classification
On April 17, 2017, PROCEPT BioRobotics Inc. submitted a request for
De Novo classification of the AQUABEAM System. FDA reviewed the request
in order to classify the device under the criteria for classification
set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on December 21, 2017, FDA issued an order to the
requester classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 876.4350. We have named
the generic type of device fluid jet system for prostate tissue
removal, and it is identified as a prescription device intended for the
resection and removal of prostatic tissue for the treatment of benign
prostatic hyperplasia. The device cuts tissue by using a pressurized
jet of fluid delivered to the prostatic urethra. The device is able to
image the treatment area, or pairs with an imaging modality, to monitor
treatment progress.
FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.
Table 1--Fluid Jet System for Prostate Tissue Removal Risks and
Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Injury from device operation causing one Clinical performance
or more of the following: testing, Animal testing,
Labeling, and Training.
Bleeding
Bruising
Penile or pelvic pain
[[Page 27897]]
Dysuria
Incontinence
Bladder or prostate capsule
perforation
Sexual dysfunction, including
ejaculatory and erectile dysfunction
Transurethral resection
syndrome
Urethral damage causing false
passage or stricture
Rectal incontinence/
perforation
Embolism
Adverse tissue reaction................... Biocompatibility evaluation.
Infection................................. Sterilization validation,
Reprocessing validation,
Shelf life testing, and
Labeling.
Failure to remove target tissue or removal Clinical performance
of non-target tissue. testing, Animal testing,
Software verification,
validation, and hazard
analysis, Non-clinical
performance testing,
Labeling, and Training.
Electrical shock or electromagnetic Electrical safety testing,
interference. Electromagnetic
compatibility testing, and
Labeling.
------------------------------------------------------------------------
FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. We encourage sponsors to consult
with us if they wish to use a non-animal testing method they believe is
suitable, adequate, validated, and feasible. We will consider if such
an alternative method could be assessed for equivalency to an animal
test method. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
At the time of classification, fluid jet systems for prostate
tissue removal are for prescription use only. Prescription devices are
exempt from the requirement for adequate directions for use for the
layperson under section 502(f)(1) of the FD&C Act and 21 CFR 801.5, as
long as the conditions of 21 CFR 801.109 are met (referring to 21
U.S.C. 352(f)(1)).
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; and the collections of information in part
801, regarding labeling, have been approved under OMB control number
0910-0485.
List of Subjects in 21 CFR Part 876
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
876 is amended as follows:
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
0
1. The authority citation for part 876 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 876.4350 to subpart E to read as follows:
Sec. 876.4350 Fluid jet system for prostate tissue removal.
(a) Identification. A fluid jet system for prostate tissue removal
is a prescription device intended for the resection and removal of
prostatic tissue for the treatment of benign prostatic hyperplasia. The
device cuts tissue by using a pressurized jet of fluid delivered to the
prostatic urethra. The device is able to image the treatment area, or
pairs with an imaging modality, to monitor treatment progress.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance testing must evaluate the following:
(i) All adverse events associated with the device, and
(ii) Improvement in lower urinary tract symptoms (LUTS).
(2) Physician training must be provided that includes:
(i) Information on key aspects and use of the device, and
(ii) Information on how to override or stop resection.
(3) Animal testing must demonstrate that the device resects
targeted tissue in a controlled manner without injury to adjacent non-
target tissues.
(4) Non-clinical performance data must demonstrate that the device
performs as intended under anticipated conditions of use. The following
performance characteristics must be tested:
(i) Measurement of targeting accuracy and reproducibility of high
velocity fluid jet, and
(ii) High pressure fluid jet verification testing at target and
non-target tissues.
(5) Software verification, validation, and hazard analysis must be
performed.
(6) The patient-contacting elements of the device must be
demonstrated to be biocompatible.
(7) Performance data must demonstrate the electrical safety and
electromagnetic compatibility of the device.
(8) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
[[Page 27898]]
(9) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.
(10) Performance data must validate the instructions for
reprocessing and reliability of reusable components.
(11) Labeling must include the following:
(i) A section that summarizes the clinical testing results,
including the adverse event profile and improvement in LUTS;
(ii) A shelf life for single use components;
(iii) A use life for reusable components; and
(iv) Reprocessing instructions for reusable components.
Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12829 Filed 6-14-18; 8:45 am]
BILLING CODE 4164-01-P
