Medical Devices; Obstetrical and Gynecological Devices; Classification of the Closed Loop Hysteroscopic Insufflator With Cutter-Coagulator, 35071-35073 [2017-15892]
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Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Rules and Regulations
effectiveness of the device. For this type
of device, FDA believes premarket
notification is not necessary to provide
reasonable assurance of the safety and
effectiveness of the device type and,
therefore, is planning to exempt the
device from the premarket notification
requirements under section 510(m) of
the FD&C Act. Once finalized, persons
who intend to market this device type
need not submit a 510(k) premarket
notification containing information on
the cranial motion measurement device
prior to marketing.
II. 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.
III. Paperwork Reduction Act of 1995
This final order establishes special
controls that refer to previously
approved collections of information
found in other FDA regulations. 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
part 807, subpart E, regarding premarket
notification submissions have been
approved under OMB control number
0910–0120, and the collections of
information in 21 CFR part 801
regarding labeling have been approved
under OMB control number 0910–0485.
List of Subjects in 21 CFR Part 882
Medical devices; Neurological
devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 882 is
amended as follows:
PART 882—NEUROLOGICAL DEVICES
1. The authority citation for part 882
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 882.1630 to subpart B to read
as follows:
asabaliauskas on DSKBBXCHB2PROD with RULES
■
§ 882.1630
device.
Cranial motion measurement
(a) Identification. A cranial motion
measurement device is a prescription
device that utilizes accelerometers to
measure the motion or acceleration of
the skull. These measurements are not
to be used for diagnostic purposes.
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(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) The technical parameters of the
device, hardware and software, must be
fully characterized and include the
following information:
(i) Hardware specifications must be
provided. Additionally, verification and
validation testing as well as a hazard
analysis must be performed.
(ii) Software must be described in
detail in the Software Requirements
Specification (SRS) and Software Design
Specification (SDS). Additionally,
software verification and validation
testing as well as a hazard analysis must
be performed.
(2) The device parts that contact the
patient must be demonstrated to be
biocompatible.
(3) The device must be designed and
tested for electrical, thermal, and
mechanical safety, and electromagnetic
compatibility (EMC).
(4) Clinical performance testing must
demonstrate the accuracy, precision,
stability, and repeatability of measuring
cranial motion per the intended use in
the intended use environment.
(5) The labeling must include:
(i) The intended use population and
the intended use environment.
(ii) Instructions for technicians to
convey to patients regarding the
collection of cranial acceleration data to
ensure device measurement accuracy,
precision, stability, and repeatability.
(iii) Information allowing clinicians to
understand potential sources of
variability in the measurement to help
recognize and identify changes in the
measurement.
Dated: July 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–15895 Filed 7–27–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 884
[Docket No. FDA–2017–N–1914]
Medical Devices; Obstetrical and
Gynecological Devices; Classification
of the Closed Loop Hysteroscopic
Insufflator With Cutter-Coagulator
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
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Fmt 4700
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35071
classifying the closed loop
hysteroscopic insufflator with cuttercoagulator into class II (special
controls). The special controls that will
apply to the device are identified in this
order, and will be part of the codified
language for the closed loop
hysteroscopic insufflator with cuttercoagulator classification. The Agency is
classifying the device into class II
(special controls) in order to provide a
reasonable assurance of safety and
effectiveness of the device.
DATES: This order is effective July 28,
2017. The classification was applicable
on March 28, 2014.
FOR FURTHER INFORMATION CONTACT:
Veronica Price, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G116, Silver Spring,
MD 20993–0002, 301–796–6538.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
360c(f)(1)), devices that were not in
commercial distribution before May 28,
1976 (the date of enactment of the
Medical Device Amendments of 1976),
generally referred to as postamendments
devices, are classified automatically by
statute into class III without any FDA
rulemaking process. These devices
remain in class III and require
premarket approval, unless and until
the device is classified or reclassified
into class I or II, or FDA issues an order
finding the device to be substantially
equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate
device that does not require premarket
approval. The Agency determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
procedures in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part
807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act,
also known as De Novo classification, as
amended by section 607 of the Food and
Drug Administration Safety and
Innovation Act (Pub. L. 112–144),
provides two procedures by which a
person may request FDA to classify a
device under the criteria set forth in
section 513(a)(1). Under the first
procedure, the person submits a
premarket notification under section
510(k) of the FD&C Act for a device that
has not previously been classified and,
within 30 days of receiving an order
classifying the device into class III
under section 513(f)(1) of the FD&C Act,
the person requests a classification
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Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Rules and Regulations
under section 513(f)(2). Under the
second procedure, rather than first
submitting a premarket notification
under section 510(k) of the FD&C Act
and then a request for classification
under the first procedure, the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence and requests a classification
under section 513(f)(2) of the FD&C Act.
If the person submits a request to
classify the device under this second
procedure, FDA may decline to
undertake the classification request if
FDA identifies a legally marketed device
that could provide a reasonable basis for
review of substantial equivalence with
the device or if FDA determines that the
device submitted is not of ‘‘lowmoderate risk’’ or that general controls
would be inadequate to control the risks
and special controls to mitigate the risks
cannot be developed.
In response to a request to classify a
device under either procedure provided
by section 513(f)(2) of the FD&C Act,
FDA shall classify the device by written
order within 120 days. This
classification will be the initial
classification of the device.
On September 5, 2013, IOGYN, Inc.,
submitted a request for classification of
the IOGYN System, Models FG–0200,
FG–0201, and FG–0202 under section
513(f)(2) of the FD&C Act.
In accordance with section 513(f)(2) of
the FD&C Act, FDA reviewed the
request in order to classify the device
under the criteria for classification set
forth in section 513(a)(1). FDA classifies
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
to provide reasonable assurance of the
safety and effectiveness of the device for
its intended use. After review of the
information submitted in the request,
FDA determined that the device can be
classified into class II with the
establishment of special controls. FDA
believes these special controls, in
addition to general controls, will
provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, on March 28, 2014, FDA
issued an order to the requestor
classifying the device into class II. FDA
is codifying the classification of the
device by adding 21 CFR 884.1710.
Following the effective date of this
final classification order, any firm
submitting a premarket notification
(510(k)) for a closed loop hysteroscopic
insufflator with cutter-coagulator will
need to comply with the special
controls named in the final order. A De
Novo classification decreases regulatory
burdens. When FDA classifies a device
type as class I or II via the De Novo
pathway, other manufacturers do not
have to submit a De Novo request or
premarket approval application in order
to market the same type of device,
unless the device has a new intended
use or technological characteristics that
raise different questions of safety or
effectiveness. Instead, manufacturers
can use the less burdensome pathway of
510(k), when necessary, to market their
device, and the device that was the
subject of the original De Novo
classification can serve as a predicate
device for additional 510(k)s from other
manufacturers.
The device is assigned the generic
name closed loop hysteroscopic
insufflator with cutter-coagulator, and it
is identified as a prescription device
configured for hysteroscopic
insufflation, resection, and coagulation.
It is used to perform diagnostic and
surgical procedures (i.e., resection and
coagulation). This device type contains
a closed loop recirculating fluid
management system for the controlled
delivery of filtered distension fluid.
This device type also contains a bipolar
radiofrequency device used in
conjunction with a hysteroscope for
resection and coagulation of intrauterine
tissues.
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—CLOSED LOOP HYSTEROSCOPIC INSUFFLATOR WITH CUTTER-COAGULATOR RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Adverse tissue reaction ............................................................................
Equipment malfunction leading to injury ..................................................
Recirculated fluid causes adverse tissue reaction ...................................
Fluid overload, embolism, perforation or other adverse events ..............
Infection ....................................................................................................
Electromagnetic interference/electrical safety issues ..............................
asabaliauskas on DSKBBXCHB2PROD with RULES
Operator error leading to patient injury ....................................................
FDA believes that special controls, in
combination with the general controls,
address these risks to health and
provide reasonable assurance of safety
and effectiveness.
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17:01 Jul 27, 2017
Jkt 241001
Biocompatibility.
Labeling.
Non-clinical Performance Testing.
Software Verification, Validation, and Hazards Analysis.
Labeling.
Training.
Biocompatibility.
Non-clinical Performance Testing.
Non-clinical Performance Testing.
Software Verification, Validation, and Hazards Analysis.
Labeling.
Training.
Sterility.
Shelf Life Testing.
Non-clinical Performance Testing.
Electromagnetic Compatibility Testing.
Electrical Safety Testing.
Labeling.
Labeling.
Training.
Closed loop hysteroscopic insufflators
with cutter-coagulator are not safe for
use except under the supervision of a
practitioner licensed by law to direct
use of the device. As such, the device
is a prescription device and must satisfy
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Fmt 4700
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prescription labeling requirements (see
21 CFR 801.109 Prescription devices).
Section 510(m) of the FD&C Act
provides that FDA may exempt a class
II device from the premarket notification
requirements under section 510(k), if
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Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Rules and Regulations
FDA determines that premarket
notification is not necessary to provide
reasonable assurance of the safety and
effectiveness of the device. For this type
of device, FDA has determined that
premarket notification is necessary to
provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, this device type is not
exempt from premarket notification
requirements. Persons who intend to
market this type of device must submit
to FDA a premarket notification
(510(k)), prior to marketing the device,
which contains information on the
closed loop hysteroscopic insufflator
with cutter-coagulator they intend to
market.
II. Analysis of Environmental Impact
We have 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.
III. Paperwork Reduction Act of 1995
This final order establishes special
controls that refer to previously
approved collections of information
found in other FDA regulations. 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
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 884
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 884 is
amended as follows:
PART 884—OBSTETRICAL AND
GYNECOLOGICAL DEVICES
1. The authority citation for part 884
is revised to read as follows:
asabaliauskas on DSKBBXCHB2PROD with RULES
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 884.1710 to subpart B to read
as follows:
■
§ 884.1710 Closed loop hysteroscopic
insufflator with cutter-coagulator.
(a) Identification. A closed loop
hysteroscopic insufflator with cutter-
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17:01 Jul 27, 2017
Jkt 241001
coagulator is a prescription device
configured for hysteroscopic
insufflation, resection, and coagulation.
It is used to perform diagnostic and
surgical procedures (i.e., resection and
coagulation). This device type contains
a closed-loop recirculating fluid
management system for the controlled
delivery of filtered distension fluid.
This device type also contains a bipolar
radiofrequency device used in
conjunction with a hysteroscope for
resection and coagulation of intrauterine
tissues.
(b) Classification. Class II (special
controls). The special control(s) for this
device are:
(1) The patient-contacting
components of the device must be
demonstrated to be biocompatible.
(2) Software validation, verification,
and hazard analysis must be provided.
(3) Electrical equipment safety,
including appropriate thermal and
mechanical safety and electromagnetic
compatibility (EMC) testing must be
performed.
(4) Device components that are
labeled sterile must be validated to a
sterility assurance level of 10¥6.
(5) Shelf-life testing that demonstrates
the device packaging maintains sterility
and the functionality of the device is
maintained following simulated
shipping and handling must be
provided to support the proposed shelf
life.
(6) Non-clinical testing data must
demonstrate the performance
characteristics of the device. Detailed
protocols and the test reports must be
provided for each test.
(i) The following tests must be
performed for the resection portion of
the device:
(A) Mechanical testing to assess
critical joint strength.
(B) Device electrode temperature
testing.
(C) Coagulation depth testing.
(D) Simulated use testing.
(E) Device durability testing.
(ii) The following tests must be
performed for the fluid management
portion of the device:
(A) Mechanical testing to assess
tensile strength of connections.
(B) Pressure testing that demonstrates
the following parameters, including
accuracy of the pressure displayed;
appropriate detection and response to
overpressure conditions; activation of a
secondary overpressure relief valve at
the maximum safe level; and all
accessories within the fluid path meet
the pressure requirements.
(C) Fluid delivery volume testing that
demonstrates that the maximum fluid
volume delivered is below a predefined
level.
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35073
(D) Flow rate testing.
(E) Simulated use testing.
(F) Filtration testing.
(G) Blood filtration capacity testing.
(H) Tissue collection capacity testing.
(I) Filtrate characterization and testing
that demonstrates that the continuous
reintroduction of filtrate into the uterus
does not pose a safety risk.
(7) Clinician labeling must include:
(i) Specific instructions and the
clinical training needed for the safe use
of the device.
(ii) Appropriate warnings,
precautions, and information related to
overpressurization.
(iii) Appropriate EMC information.
(iv) An expiration date/shelf life.
Dated: July 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–15892 Filed 7–27–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Parts 3, 20, 64, 67, 80, 82, 83,
84, 104, 105, 109, 110, 115, 117, 120,
133, 135, 136, 137, 138, 151, 155, 157,
159, 161, 162, 164, 165, 174, and 181
46 CFR Parts 4, 28, 31, 39, 44, 50, 58,
63, 69, 71, 107, 110, 111, 116, 120, 127,
153, 154, 161, 162, 170, 177, 182, and
189
[Docket No. USCG–2016–0498]
Navigation and Navigable Waters, and
Shipping; Technical, Organizational,
and Conforming Amendments
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
This final rule makes nonsubstantive technical, organizational,
and conforming amendments to existing
Coast Guard regulations. This rule will
have no substantive effect on the
regulated public.
DATES: This final rule is effective July
28, 2017.
ADDRESSES: Documents mentioned in
this preamble as being available in the
docket are part of docket USCG–2016–
0498, which is available at https://
regulations.gov.
SUMMARY:
If
you have questions on this final rule,
call or email LCDR Felicia Raybon,
Coast Guard; telephone 202–372–1499,
email Felicia.K.Raybon@uscg.mil.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\28JYR1.SGM
28JYR1
Agencies
[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Rules and Regulations]
[Pages 35071-35073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15892]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 884
[Docket No. FDA-2017-N-1914]
Medical Devices; Obstetrical and Gynecological Devices;
Classification of the Closed Loop Hysteroscopic Insufflator With
Cutter-Coagulator
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the closed loop hysteroscopic insufflator with cutter-
coagulator into class II (special controls). The special controls that
will apply to the device are identified in this order, and will be part
of the codified language for the closed loop hysteroscopic insufflator
with cutter-coagulator classification. The Agency is classifying the
device into class II (special controls) in order to provide a
reasonable assurance of safety and effectiveness of the device.
DATES: This order is effective July 28, 2017. The classification was
applicable on March 28, 2014.
FOR FURTHER INFORMATION CONTACT: Veronica Price, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G116, Silver Spring, MD 20993-0002, 301-796-6538.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, also known as De Novo
classification, as amended by section 607 of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144), provides
two procedures by which a person may request FDA to classify a device
under the criteria set forth in section 513(a)(1). Under the first
procedure, the person submits a premarket notification under section
510(k) of the FD&C Act for a device that has not previously been
classified and, within 30 days of receiving an order classifying the
device into class III under section 513(f)(1) of the FD&C Act, the
person requests a classification
[[Page 35072]]
under section 513(f)(2). Under the second procedure, rather than first
submitting a premarket notification under section 510(k) of the FD&C
Act and then a request for classification under the first procedure,
the person determines that there is no legally marketed device upon
which to base a determination of substantial equivalence and requests a
classification under section 513(f)(2) of the FD&C Act. If the person
submits a request to classify the device under this second procedure,
FDA may decline to undertake the classification request if FDA
identifies a legally marketed device that could provide a reasonable
basis for review of substantial equivalence with the device or if FDA
determines that the device submitted is not of ``low-moderate risk'' or
that general controls would be inadequate to control the risks and
special controls to mitigate the risks cannot be developed.
In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
On September 5, 2013, IOGYN, Inc., submitted a request for
classification of the IOGYN System, Models FG-0200, FG-0201, and FG-
0202 under section 513(f)(2) of the FD&C Act.
In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies 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 to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
Therefore, on March 28, 2014, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 884.1710.
Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a closed loop
hysteroscopic insufflator with cutter-coagulator will need to comply
with the special controls named in the final order. A De Novo
classification decreases regulatory burdens. When FDA classifies a
device type as class I or II via the De Novo pathway, other
manufacturers do not have to submit a De Novo request or premarket
approval application in order to market the same type of device, unless
the device has a new intended use or technological characteristics that
raise different questions of safety or effectiveness. Instead,
manufacturers can use the less burdensome pathway of 510(k), when
necessary, to market their device, and the device that was the subject
of the original De Novo classification can serve as a predicate device
for additional 510(k)s from other manufacturers.
The device is assigned the generic name closed loop hysteroscopic
insufflator with cutter-coagulator, and it is identified as a
prescription device configured for hysteroscopic insufflation,
resection, and coagulation. It is used to perform diagnostic and
surgical procedures (i.e., resection and coagulation). This device type
contains a closed loop recirculating fluid management system for the
controlled delivery of filtered distension fluid. This device type also
contains a bipolar radiofrequency device used in conjunction with a
hysteroscope for resection and coagulation of intrauterine tissues.
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--Closed Loop Hysteroscopic Insufflator With Cutter-Coagulator
Risks and Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction................ Biocompatibility.
Labeling.
Equipment malfunction leading to injury Non-clinical Performance
Testing.
Software Verification,
Validation, and Hazards
Analysis.
Labeling.
Training.
Recirculated fluid causes adverse Biocompatibility.
tissue reaction. Non-clinical Performance
Testing.
Fluid overload, embolism, perforation Non-clinical Performance
or other adverse events. Testing.
Software Verification,
Validation, and Hazards
Analysis.
Labeling.
Training.
Infection.............................. Sterility.
Shelf Life Testing.
Non-clinical Performance
Testing.
Electromagnetic interference/electrical Electromagnetic Compatibility
safety issues. Testing.
Electrical Safety Testing.
Labeling.
Operator error leading to patient Labeling.
injury. Training.
------------------------------------------------------------------------
FDA believes that special controls, in combination with the general
controls, address these risks to health and provide reasonable
assurance of safety and effectiveness.
Closed loop hysteroscopic insufflators with cutter-coagulator are
not safe for use except under the supervision of a practitioner
licensed by law to direct use of the device. As such, the device is a
prescription device and must satisfy prescription labeling requirements
(see 21 CFR 801.109 Prescription devices).
Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k), if
[[Page 35073]]
FDA determines that premarket notification is not necessary to provide
reasonable assurance of the safety and effectiveness of the device. For
this type of device, FDA has determined that premarket notification is
necessary to provide reasonable assurance of the safety and
effectiveness of the device. Therefore, this device type is not exempt
from premarket notification requirements. Persons who intend to market
this type of device must submit to FDA a premarket notification
(510(k)), prior to marketing the device, which contains information on
the closed loop hysteroscopic insufflator with cutter-coagulator they
intend to market.
II. Analysis of Environmental Impact
We have 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.
III. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. 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
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 884
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
884 is amended as follows:
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
0
1. The authority citation for part 884 is revised to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
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2. Add Sec. 884.1710 to subpart B to read as follows:
Sec. 884.1710 Closed loop hysteroscopic insufflator with cutter-
coagulator.
(a) Identification. A closed loop hysteroscopic insufflator with
cutter-coagulator is a prescription device configured for hysteroscopic
insufflation, resection, and coagulation. It is used to perform
diagnostic and surgical procedures (i.e., resection and coagulation).
This device type contains a closed-loop recirculating fluid management
system for the controlled delivery of filtered distension fluid. This
device type also contains a bipolar radiofrequency device used in
conjunction with a hysteroscope for resection and coagulation of
intrauterine tissues.
(b) Classification. Class II (special controls). The special
control(s) for this device are:
(1) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(2) Software validation, verification, and hazard analysis must be
provided.
(3) Electrical equipment safety, including appropriate thermal and
mechanical safety and electromagnetic compatibility (EMC) testing must
be performed.
(4) Device components that are labeled sterile must be validated to
a sterility assurance level of 10-\6\.
(5) Shelf-life testing that demonstrates the device packaging
maintains sterility and the functionality of the device is maintained
following simulated shipping and handling must be provided to support
the proposed shelf life.
(6) Non-clinical testing data must demonstrate the performance
characteristics of the device. Detailed protocols and the test reports
must be provided for each test.
(i) The following tests must be performed for the resection portion
of the device:
(A) Mechanical testing to assess critical joint strength.
(B) Device electrode temperature testing.
(C) Coagulation depth testing.
(D) Simulated use testing.
(E) Device durability testing.
(ii) The following tests must be performed for the fluid management
portion of the device:
(A) Mechanical testing to assess tensile strength of connections.
(B) Pressure testing that demonstrates the following parameters,
including accuracy of the pressure displayed; appropriate detection and
response to overpressure conditions; activation of a secondary
overpressure relief valve at the maximum safe level; and all
accessories within the fluid path meet the pressure requirements.
(C) Fluid delivery volume testing that demonstrates that the
maximum fluid volume delivered is below a predefined level.
(D) Flow rate testing.
(E) Simulated use testing.
(F) Filtration testing.
(G) Blood filtration capacity testing.
(H) Tissue collection capacity testing.
(I) Filtrate characterization and testing that demonstrates that
the continuous reintroduction of filtrate into the uterus does not pose
a safety risk.
(7) Clinician labeling must include:
(i) Specific instructions and the clinical training needed for the
safe use of the device.
(ii) Appropriate warnings, precautions, and information related to
overpressurization.
(iii) Appropriate EMC information.
(iv) An expiration date/shelf life.
Dated: July 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-15892 Filed 7-27-17; 8:45 am]
BILLING CODE 4164-01-P