Medical Devices; Cardiovascular Devices; Classification of Implantable Intra-Aneurysm Pressure Measurement System, 7869-7871 [06-1417]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 31 (Wednesday, February 15, 2006)]
[Rules and Regulations]
[Pages 7869-7871]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-1417]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR 870

[Docket No. 2005N-0506]


Medical Devices; Cardiovascular Devices; Classification of 
Implantable Intra-Aneurysm Pressure Measurement System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
implantable intra-aneurysm pressure measurement system into class II 
(special controls). The special control that will apply to the device 
is the guidance document entitled ``Class II Special Controls Guidance 
Document: Implantable Intra-Aneurysm Pressure Measurement System.'' 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. Elsewhere in this issue of the Federal Register, FDA is 
announcing the availability of a guidance document that will serve as 
the special control for the device.

DATES: This rule is effective March 17, 2006.

FOR FURTHER INFORMATION CONTACT: Nelson Anderson, Center for Devices 
and Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8282, ext. 171.

SUPPLEMENTARY INFORMATION:

[[Page 7870]]

I. What Is the Background of This Rulemaking?

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the 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 (the amendments), 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 act, to a predicate device 
that does not require premarket approval. The agency determines whether 
new devices are substantially equivalent to previously marketed devices 
by means of the premarket notification procedures in section 510(k) of 
the act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of FDA 
regulations.
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act for a device 
that has not previously been classified may, within 30 days after 
receiving an order classifying the device in class III under section 
513(f)(1) of the act, request FDA to classify the device under the 
criteria set forth in section 513(a)(1) of the act. FDA shall, within 
60 days of receiving such a request, classify the device by written 
order. This classification shall be the initial classification of the 
device. Within 30 days after the issuance of an order classifying the 
device, FDA must publish a notice in the Federal Register announcing 
such classification (section 513(f)(2) of the act).
    In accordance with section 513(f)(1) of the act, FDA issued an 
order on August 4, 2005, classifying the CardioMEMS EndoSensor System 
into class III, because it was not substantially equivalent to a device 
that was introduced or delivered for introduction into interstate 
commerce for commercial distribution before May 28, 1976, or a device 
which was subsequently reclassified into class I or class II. On August 
9, 2005, CardioMEMS, Inc., submitted a petition requesting 
classification of the CardioMEMS EndoSensor System under section 
513(f)(2) of the act. The manufacturer recommended that the device be 
classified into class II.
    In accordance with 513(f)(2) of the act, FDA reviewed the petition 
in order to classify the device under the criteria for classification 
set forth in 513 (a)(1) of the act. Devices are to be classified 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 
petition, FDA determined that the CardioMEMS EndoSensor System can be 
classified into class II with the establishment of special controls. 
FDA believes these special controls will provide reasonable assurance 
of the safety and effectiveness of the device type.
    The device type is assigned the generic name Implantable Intra-
Aneurysm Pressure Measurement System, and it is identified as a device 
intended to measure the intra-sac pressure in a vascular aneurysm. The 
device consists of a pressure transducer that is implanted into the 
aneurysm and a monitor that reads the pressure from the transducer.
    FDA has identified the following risks to health associated 
specifically with this type of device: (1) Adverse tissue reaction, (2) 
the migration of implanted sensor, (3) inaccurate sensor information, 
(3) failure of implanted sensor, (4) failure of delivery system, (5) 
failure of electronic monitor, (6) electromagnetic interference, (7) 
electrical hazards, (8) magnetic resonance imaging incompatibility, (9) 
ultrasound incompatibility, (10) external defibrillation 
incompatibility, and (11) failure to detect and/or diagnose an endoleak 
that requires intervention.
    FDA believes that the class II special controls guidance document 
entitled, ``Implantable Intra-Aneurysm Pressure Measurement System'' 
will aid in mitigating the potential risks to health by providing 
recommendations on biocompatibility testing, bench testing, software 
validation, electromagnetic compatibility testing, electrical safety 
testing, sterility of the device, magnetic resonance imaging 
compatibility, labeling, ultrasound compatibility, defibrillator 
compatibility, animal testing, and clinical testing. The guidance 
document also provides information on how to meet premarket (510(k)) 
submission requirements for the device. FDA believes that the special 
controls guidance document, in addition to general controls, addresses 
the risks to health identified previously and provides reasonable 
assurance of the safety and effectiveness of the device. Therefore, on 
October 28, 2005, FDA issued an order to the petitioner classifying the 
device into class II. FDA is codifying this classification by adding 
Sec.  870.2855 to its classification regulations.
    Following the effective date of this final classification rule, any 
firm submitting a 510(k) premarket notification for an implantable 
intra-aneurysm pressure measurement system will need to address the 
issues covered in the special controls guidance. However, the firm need 
only show that its device meets the recommendations of the guidance, or 
in some other way provides equivalent assurances of safety and 
effectiveness.
    Section 510(m) of the act provides that FDA may exempt a class II 
device from the premarket notification requirement under 510(k) of the 
act if 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 and, therefore, the type of device is 
not exempt from premarket notification requirements. Persons who intend 
to market this type of device must submit to FDA a premarket 
notification, prior to marketing the device, which contains information 
about the implantable intra-aneurysm pressure measurement system they 
intend to market.

II. What Is the Environmental Impact of This Rule?

    The agency has determined under 21 CFR 25.34(b) that this action is 
of 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. What Is the Economic Impact of This Rule?

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is not a significant regulatory action as defined by 
the Executive order and so it is not

[[Page 7871]]

subject to review under the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because classification of this device in class II 
will relieve manufacturers of the device of the cost of complying with 
the premarket approval requirements of section 515 of the act (21 
U.S.C. 360e), and may permit small potential competitors to enter the 
marketplace by lowering their costs, the agency certifies that the 
final rule will not have a significant economic impact on a substantial 
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or the private 
sector, of $100,000,000 or more (adjusted annually for inflation) in 
any one year.''
    The current threshold after adjustment for inflation is $115 
million, using the most current (2003) Implicit Price Deflator for the 
Gross Domestic Product. FDA does not expect this final rule to result 
in any 1-year expenditure that would meet or exceed this amount.

IV. Does This Rule Have Federalism Implications?

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

V. How Does This Rule Comply With the Paperwork Reduction Act of 1995?

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520) is not 
required.
    FDA also concludes that the special controls guidance document does 
not contain new information collection provisions that are subject to 
review and clearance by OMB under the PRA.

VI. What References are on Display?

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition from CardioMEMS, Inc., dated August 9, 2005.

List of Subjects in 21 CFR Part 870

    Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for 21 CFR part 870 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 870.2855 is added to subpart C to read as follows:


Sec.  870.2855  Implantable Intra-aneurysm Pressure Measurement System.

    (a) Identification. Implantable intra-aneurysm pressure measurement 
system is a device used to measure the intra-sac pressure in a vascular 
aneurysm. The device consists of a pressure transducer that is 
implanted into the aneurysm and a monitor that reads the pressure from 
the transducer.
    (b) Classification. Class II (special controls). The special 
control is FDA's guidance document entitled ``Class II Special Controls 
Guidance Document: Implantable Intra-Aneurysm Pressure Measurement 
System.'' See Sec.  870.1 (e) for the availability of this guidance 
document.

    Dated: February 6, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 06-1417 Filed 2-14-06; 8:45 am]
BILLING CODE 4160-01-S