Rule2022-12364
Medical Devices; Cardiovascular Devices; Classification of the Intravascular Bleed Monitor
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 8, 2022
Effective
June 8, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 110 (Wednesday, June 8, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#df8cabbaafb7bab1f19dadb0a8b1b6b1b89fb9bbbef1b7b7acf1b8b0a9"><span class="__cf_email__" data-cfemail="fba88f9e8b939e95d5b989948c9592959cbb9d9f9ad5939388d59c948d">[email protected]</span></a>.
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.
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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. 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
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