Document ID: FDA-2017-N-1916-0001
Agency: fda
Document Type: Rule
Title: Medical Devices: Cardiovascular Devices; Classification of Balloon Aortic Valvuloplasty Catheter
Posted Date: 2017-07-27T04:00Z

[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)]
[Rules and Regulations]
[Pages 34850-34852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15786]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2017-N-1916]

Medical Devices; Cardiovascular Devices; Classification of the 
Balloon Aortic Valvuloplasty Catheter

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
classifying the balloon aortic valvuloplasty catheter 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 balloon aortic valvuloplasty catheter's classification. The 
Agency is classifying the device into class II (special controls) to 
provide a reasonable assurance of safety and effectiveness of the 
device.

DATES: This order is effective July 27, 2017. The classification was 
applicable on June 11, 2012.

FOR FURTHER INFORMATION CONTACT: Nicole Ibrahim, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1232, Silver Spring, MD, 20993-0002, 301-796-5171, 
nicole.ibrahim@fda.hhs.gov.

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

[[Page 34851]]

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 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. In 
accordance with section 513(f)(1) of the FD&C Act, FDA issued an order 
on December 3, 2008, classifying the NuCLEUS-X Percutaneous 
Transluminal Valvuloplasty Catheter 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 December 23, 2008, NuMED, Inc. submitted a request for 
classification of the NuCLEUS-X Percutaneous Transluminal Valvuloplasty 
Catheter 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 June 11, 2012, 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 870.1255.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a balloon 
aortic valvuloplasty catheter will need to comply with the special 
controls named in this 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 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 balloon aortic 
valvuloplasty catheter, and it is identified as a catheter with a 
balloon at the distal end of the shaft that is intended to treat 
stenosis in the aortic valve when the balloon is expanded.
    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--Balloon Aortic Valvuloplasty Catheter Risks and Mitigation Measures
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              Identified risks                                       Mitigation measures
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Adverse tissue reaction....................  Biocompatibility testing.
                                             Labeling.
Infection..................................  Sterility.
                                             Shelf life testing.
User error.................................  Labeling.
Valve leaflet perforation..................  Non-clinical performance evaluation.
                                             In Vivo evaluation.
                                             Labeling.
Perforation of vascular or cardiac tissue..  Non-clinical performance evaluation.
                                             In Vivo evaluation.
                                             Labeling.
Procedural complications, including          Non-clinical performance evaluation.
 bleeding, cardiac tamponade, calcium        In Vivo evaluation.
 embolic events, valvular regurgitation,     Labeling.
 and death.
Balloon burst..............................  Non-clinical performance evaluation.
                                             In Vivo evaluation.
                                             Labeling.

[[Page 34852]]

 
Inability for balloon deflation............  Non-clinical performance evaluation.
                                             In Vivo evaluation.
Increased balloon inflation and deflation    Non-clinical performance evaluation.
 times.                                      In Vivo evaluation.
                                             Labeling.
Inability to steer towards valve of          Non-clinical performance evaluation.
 interest.                                   In Vivo evaluation.
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    FDA believes that special controls, in combination with the general 
controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness.
    Balloon aortic valvuloplasty catheters are not safe for use except 
under the supervision of a practitioner licensed by law to direct the 
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 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 
about the balloon aortic valvuloplasty catheter 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 21 CFR part 801, regarding labeling have been 
approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 870

    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 
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

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

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

0
2. Add Sec.  870.1255 to subpart B to read as follows:

Sec.  870.1255   Balloon aortic valvuloplasty catheter.

    (a) Identification. A balloon aortic valvuloplasty catheter is a 
catheter with a balloon at the distal end of the shaft, which is 
intended to treat stenosis in the aortic valve when the balloon is 
expanded.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device must be demonstrated to be biocompatible.
    (2) Sterility and shelf life testing must demonstrate the sterility 
of patient-contacting components and the shelf life of these 
components.
    (3) Non-clinical performance evaluation must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including device delivery, inflation, deflation, and removal.
    (4) In vivo evaluation of the device must demonstrate device 
performance, including the ability of the device to treat aortic 
stenosis.
    (5) Labeling must include a detailed summary of the device-related 
and procedure-related complications pertinent to the use of the device.

    Dated: July 21, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15786 Filed 7-26-17; 8:45 am]
BILLING CODE 4164-01-P