Document ID: FDA-2022-N-0289-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Cardiovascular
Devices; Classification of the Reverse
Central Venous Recanalization System
Posted Date: 2022-05-06T04:00Z

[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 [www.gpo.gov]
[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, 
[email protected].

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