[Federal Register Volume 87, Number 34 (Friday, February 18, 2022)]
[Rules and Regulations]
[Pages 9240-9242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03496]



[[Page 9240]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2021-N-1029]


Medical Devices; Cardiovascular Devices; Classification of the 
Percutaneous Catheter for Creation of an Arteriovenous Fistula for 
Hemodialysis Access

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the percutaneous catheter for creation of an arteriovenous fistula for 
hemodialysis access 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 percutaneous catheter for 
creation of an arteriovenous fistula for hemodialysis access' 
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.

DATES: This order is effective February 18, 2022. The classification 
was applicable on June 22, 2018.

FOR FURTHER INFORMATION CONTACT: Carmen Gacchina Johnson, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 2120, Silver Spring, MD 20993-0002, 
240-402-5244, <a href="/cdn-cgi/l/email-protection#9fdcfeedf2faf1b1d8fefcfcf7f6f1fedff9fbfeb1f7f7ecb1f8f0e9"><span class="__cf_email__" data-cfemail="b1f2d0c3dcd4df9ff6d0d2d2d9d8dfd0f1d7d5d09fd9d9c29fd6dec7">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the percutaneous catheter for 
creation of an arteriovenous fistula for hemodialysis access 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, 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 (see 21 U.S.C. 360c(i)) to a predicate device 
that does not require premarket approval. We determine whether a new 
device is substantially equivalent to a predicate device 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. 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 is required 
to 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 placed 
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. 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 
section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device 
sponsors do not have to submit a De Novo request or premarket approval 
application to market a substantially equivalent device (see section 
513(i) of the FD&C Act, defining ``substantial equivalence''). Instead, 
sponsors can use the less-burdensome 510(k) process, when necessary, to 
market their device.

II. De Novo Classification

    On February 3, 2016, FDA received TVA Medical, Inc.'s request for 
De Novo classification of the everlinQ endoAVF System. Subsequently, on 
January 10, 2017, FDA received Avenu Medical, Inc.'s similar request 
for De Novo classification of the Ellipsys Vascular Access System. FDA 
reviewed both requests in order to classify the devices 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 requests, we determined that the devices 
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 devices.
    Therefore, on June 22, 2018, FDA issued orders to both requesters 
classifying their devices into class II. In this final order, FDA is 
codifying the classification of the devices by adding 21 CFR 
870.1252.\1\ We have named the generic type of device percutaneous 
catheter for creation of an arteriovenous

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fistula for hemodialysis access, and it is identified as a single use 
percutaneous catheter system that creates an arteriovenous fistula in 
the arm of patients with chronic kidney disease who need hemodialysis.
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    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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    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--Percutaneous Catheter for Creation of an Arteriovenous Fistula
          for Hemodialysis Access Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Unintended vascular or tissue injury...  Non-clinical performance
                                          testing, Animal testing,
                                          Clinical performance testing,
                                          and Labeling.
Adverse hemodynamic effects............  Non-clinical performance
                                          testing, Animal testing,
                                          Clinical performance testing,
                                          and Labeling.
Failure to create a durable fistula      Animal testing and Clinical
 that is usable for hemodialysis.         performance testing.
Use of the device adversely impacts      Clinical performance testing
 future vascular access sites.            and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation and
                                          Labeling.
Infection..............................  Sterilization validation, Shelf
                                          life testing, and Labeling.
Electrical malfunction or interference   Non-clinical performance
 leading to electrical shock, device      testing, Electrical safety
 failure, or inappropriate activation.    testing, and Electromagnetic
                                          compatibility (EMC) testing.
Software malfunction leading to device   Software verification,
 failure or inappropriate activation.     validation, and hazard
                                          analysis.
------------------------------------------------------------------------

    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. 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.

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. 3501-3521). 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; the collections of information in 21 CFR part 
820, regarding quality system regulation, have been approved under OMB 
control number 0910-0073; 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.  870.1252 to subpart B to read as follows:


Sec.  870.1252   Percutaneous catheter for creation of an arteriovenous 
fistula for hemodialysis access.

    (a) Identification. This device is a single use percutaneous 
catheter system that creates an arteriovenous fistula in the arm of 
patients with chronic kidney disease who need hemodialysis.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must evaluate:
    (i) The ability to safely deliver, deploy, and remove the device;
    (ii) The ability of the device to create an arteriovenous fistula;
    (iii) The ability of the arteriovenous fistula to attain a blood 
flow rate and diameter suitable for hemodialysis;
    (iv) The ability of the fistula to be used for vascular access for 
hemodialysis;
    (v) The patency of the fistula; and
    (vi) The rates and types of all adverse events.
    (2) Animal testing must demonstrate that the device performs as 
intended under anticipated conditions of use. The following performance 
characteristics must be assessed:
    (i) Delivery, deployment, and retrieval of the device;
    (ii) Compatibility with other devices labeled for use with the 
device;
    (iii) Patency of the fistula;
    (iv) Characterization of blood flow at the time of the fistula 
creation procedure and at chronic followup; and
    (v) Gross pathology and histopathology assessing vascular injury 
and downstream embolization.
    (3) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Simulated-use testing in a clinically relevant bench anatomic 
model to assess the delivery, deployment, activation, and retrieval of 
the device;
    (ii) Tensile strengths of joints and components;

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    (iii) Accurate positioning and alignment of the device to achieve 
fistula creation; and
    (iv) Characterization and verification of all dimensions.
    (4) Electrical performance, electrical safety, and electromagnetic 
compatibility (EMC) testing must be performed for devices with 
electrical components.
    (5) Software verification, validation, and hazard analysis must be 
performed for devices that use software.
    (6) All patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (7) Performance data must demonstrate the sterility of the device 
components intended to be provided sterile.
    (8) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (9) Labeling for the device must include:
    (i) Instructions for use;
    (ii) Identification of system components and compatible devices;
    (iii) Expertise needed for the safe use of the device;
    (iv) A detailed summary of the clinical testing conducted and the 
patient population studied; and
    (v) A shelf life and storage conditions.

    Dated: February 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03496 Filed 2-17-22; 8:45 am]
BILLING CODE 4164-01-P


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