Document ID: FDA-2021-N-0600-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Cardiovascular Devices; Classification of the Intravascular Bleed Monitor
Posted Date: 2022-06-08T04:00Z

[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Rules and Regulations]
[Pages 34777-34779]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12364]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2021-N-0600]

Medical Devices; Cardiovascular Devices; Classification of the 
Intravascular Bleed Monitor

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 intravascular bleed monitor 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 intravascular 
bleed monitor'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 June 8, 2022. The classification was 
applicable on March 1, 2019.

FOR FURTHER INFORMATION CONTACT: LT Stephen Browning, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 2106, Silver Spring, MD 20993-0002, 
240-402-5241, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the intravascular bleed monitor 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 (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.
    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 21 U.S.C. 360c(f)(2)(B)(i)). 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 21 U.S.C. 360c(i), defining ``substantial equivalence''). 
Instead, sponsors can use the less-burdensome 510(k) process, when 
necessary, to market their device.

II. De Novo Classification

    On April 23, 2018, Saranas, Inc. submitted a request for De Novo 
classification of the Early Bird Bleed Monitoring 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

[[Page 34778]]

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 March 1, 2019, 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 
870.1345.\1\ We have named the generic type of device intravascular 
bleed monitor, and it is identified as a probe, catheter, or catheter 
introducer that measures changes in bioimpedance and uses an algorithm 
to detect or monitor progression of potential internal bleeding 
complications.
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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--Intravascular Bleed Monitor Risks and Mitigation Measures
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           Identified risks                   Mitigation measures
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Adverse tissue reaction..............  Biocompatibility evaluation.
Infection............................  Sterilization validation,
                                        Pyrogenicity testing, Shelf-life
                                        testing, and Labeling.
Blood loss, bleeding, hematoma.......  Human factors testing, Labeling,
                                        Animal performance testing, and
                                        Non-clinical performance
                                        testing.
Embolization (micro or macro) with     Human factors testing, Labeling,
 transient or permanent ischemia.       Animal performance testing, and
                                        Non-clinical performance
                                        testing.
Vascular trauma (i.e., dissection,     Human factors testing, Labeling,
 rupture, perforation, tear, etc.).     Animal performance testing, and
                                        Non-clinical performance
                                        testing.
Electrical shock.....................  Electrical safety testing.
Device failure due to interference     Electromagnetic compatibility
 with other devices.                    (EMC) testing, and Electrical
                                        safety testing.
Device failure due to software         Software verification,
 malfunction.                           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. 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. 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, 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.  870.1345 to subpart B to read as follows:

Sec.  870.1345   Intravascular bleed monitor.

    (a) Identification. An intravascular bleed monitor is a probe, 
catheter, or catheter introducer that measures changes in bioimpedance 
and uses an algorithm to detect or monitor progression of potential 
internal bleeding complications.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) In vivo animal performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use and 
evaluate the following:
    (i) Device performance characteristics;
    (ii) Adverse effects, including gross necropsy and histopathology; 
and
    (iii) Device usability, including device preparation, device 
handling, and user interface.
    (2) Non-clinical performance testing data must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following

[[Page 34779]]

performance characteristics must be tested:
    (i) Tensile testing of joints and materials;
    (ii) Mechanical integrity testing;
    (iii) Friction testing;
    (iv) Flush testing;
    (v) Air leakage and liquid leakage testing;
    (vi) Latching and unlatching testing;
    (vii) Kink and bend testing;
    (viii) Insertion force testing;
    (ix) Torque testing;
    (x) Corrosion testing; and
    (xi) Dimensional tolerance testing.
    (3) Performance data must support the sterility and pyrogenicity of 
the device components intended to be provided sterile.
    (4) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (5) The patient contacting components of the device must be 
demonstrated to be biocompatible.
    (6) Software verification, validation, and hazard analysis must be 
performed.
    (7) Performance data must demonstrate electromagnetic compatibility 
(EMC), electrical safety, thermal safety, and mechanical safety.
    (8) Human factors performance evaluation must demonstrate that the 
user can correctly use the device, based solely on reading the 
directions for use.
    (9) Labeling must include:
    (i) Instructions for use;
    (ii) A shelf life and storage conditions;
    (iii) Compatible procedures;
    (iv) A sizing table; and
    (v) Quantification of blood detected.

    Dated: June 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12364 Filed 6-7-22; 8:45 am]
BILLING CODE 4164-01-P