Rule2022-03496
Medical Devices; Cardiovascular Devices; Classification of the Percutaneous Catheter for Creation of an Arteriovenous Fistula for Hemodialysis Access
Primary source
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Published
February 18, 2022
Effective
February 18, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 34 (Friday, February 18, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03496]
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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
[[Page 9241]]
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.
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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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