Rule2022-09745
Medical Devices; Cardiovascular Devices; Classification of the Reverse Central Venous Recanalization System
Primary source
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Published
May 6, 2022
Effective
May 6, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the reverse central venous recanalization system 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 reverse central venous recanalization system's 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 88 (Friday, May 6, 2022)</title>
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[Federal Register Volume 87, Number 88 (Friday, May 6, 2022)]
[Rules and Regulations]
[Pages 26989-26991]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09745]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA-2022-N-0289]
Medical Devices; Cardiovascular Devices; Classification of the
Reverse Central Venous Recanalization System
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the reverse central venous recanalization system 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 reverse central venous recanalization system's
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 May 6, 2022. The classification was
applicable on February 10, 2020.
FOR FURTHER INFORMATION CONTACT: Finn Donaldson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2568, Silver Spring, MD 20993-0002, 301-796-9579,
<a href="/cdn-cgi/l/email-protection#c583acababeb81aaaba4a9a1b6aaab85a3a1a4ebadadb6eba2aab3"><span class="__cf_email__" data-cfemail="cd8ba4a3a3e389a2a3aca1a9bea2a38daba9ace3a5a5bee3aaa2bb">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the reverse central venous
recanalization system 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, in part 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 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. 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) of the FD&C Act.
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
[[Page 26990]]
placed within class III, the De Novo classification is considered to be
the initial classification of the device.
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 (PMA) 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
For this device, FDA issued an order on March 21, 2016, finding the
Surfacer Inside-Out Access Catheter System not substantially equivalent
to a predicate not subject to PMA. Thus, the device remained in class
III in accordance with section 513(f)(1) of the FD&C Act when we issued
the order.
On August 15, 2019, FDA received Bluegrass Vascular Technologies,
Inc.'s request for De Novo classification of the Surfacer Inside-Out
Access Catheter System. FDA reviewed the request in order to classify
the device 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 request, we determined that the device 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 device.
Therefore, on February 10, 2020, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
870.1342.\1\ We have named the generic type of device reverse central
venous recanalization system, and it is identified as a prescription
device for obtaining central venous access to facilitate catheter
insertion into the central venous system. Reverse recanalization
involves the initiation of an access path from within the vein and then
progressing to the skin for patients with upper body venous occlusions
or other conditions that preclude central venous access by other
methods.
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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--Reverse Central Venous Recanalization System Risks and
Mitigation Measures
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Identified risks Mitigation measures
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Infection.............................. Sterilization validation, Shelf
life testing, and Labeling.
Adverse tissue reaction................ Biocompatibility evaluation.
Embolization caused by component Clinical performance testing,
fracture. and Non-clinical performance
testing.
Death, bleeding, damage to non-target Clinical performance testing,
tissue and organs, blood vessel Non-clinical performance
perforation or rupture, hematoma; or testing, and Labeling.
delays to therapy from failure to
achieve central venous access.
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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. In order 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. This device is subject to premarket
notification requirements under section 510(k) of the FD&C Act.
At the time of classification, reverse central venous
recanalization systems are for prescription use only. Prescription
devices are exempt from the requirement for adequate directions for use
for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C.
352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR
801.109 are met.
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 21 CFR part 860, subpart D, regarding De Novo
classification 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:
[[Page 26991]]
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. 870.1342 to subpart B to read as follows:
Sec. 870.1342 Reverse central venous recanalization system.
(a) Identification. A reverse central venous recanalization system
is a prescription device for obtaining central venous access to
facilitate catheter insertion into the central venous system. Reverse
recanalization involves the initiation of an access path from within
the vein and then progressing to the skin for patients with upper body
venous occlusions or other conditions that preclude central venous
access by other methods.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance testing must fulfill the following:
(i) Demonstrate the ability to safely deliver, deploy, and remove
the device; and
(ii) Evaluate all adverse events including death, bleeding, damage
to non-target tissue and organs, blood vessel perforation or rupture,
and hematoma.
(2) 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, and retrieval of the system;
(ii) Compatibility with other devices labeled for use with the
device;
(iii) Tensile strengths of joints and components;
(iv) Kink resistance of system components;
(v) Radiopacity of components used to monitor procedure under
fluoroscopy;
(vi) Characterization and verification of all dimensions; and
(vii) Leakage of air or fluid.
(3) All patient contacting components of the device must be
demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device
components intended to be provided sterile.
(5) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.
(6) Labeling for the device must include:
(i) Instructions for use, including a description of compatible
devices;
(ii) A detailed summary of the clinical testing conducted and;
(iii) Shelf life and storage conditions.
Dated: April 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09745 Filed 5-5-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on May 6, 2022.
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