[Federal Register Volume 88, Number 3 (Thursday, January 5, 2023)]
[Rules and Regulations]
[Pages 751-753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28604]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2022-N-3239]


Medical Devices; Orthopedic Devices; Classification of the 
Implantable Post-Surgical Kinematic Measurement Knee Device

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 implantable post-surgical kinematic measurement knee 
device 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 implantable post-surgical kinematic 
measurement knee device'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 January 5, 2023. The classification was 
applicable on August 27, 2021.

FOR FURTHER INFORMATION CONTACT: Patrick Macatangga, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1567, Silver Spring, MD 20993-0002, 301-
796-4369, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the implantable post-surgical 
kinematic measurement knee device 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).
    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

[[Page 752]]

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 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 October 19, 2020, FDA received Canary Medical, Inc.'s request 
for De Novo classification of the Canary Tibial Extension with Canary 
Health Implanted Reporting Processor (CHIRP) 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 August 27, 2021, 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 
888.3600.\1\ We have named the generic type of device implantable post-
surgical kinematic measurement knee device, and it is identified as a 
device that provides objective kinematic data after total knee 
arthroplasty surgery. The kinematic data provided by the device are 
used as an adjunct to other physiological parameter measurement tools 
utilized during the course of patient monitoring and treatment post 
surgery.
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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--Implantable Post-Surgical Kinematic Measurement Knee Device
                      Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Tissue injury, thermal injury, or        Thermal safety testing,
 electric shock due to device failure     Electrical safety testing,
 including:                               Battery safety testing, and
 Loss of hermeticity.             Non-clinical performance
 Battery failure.                 testing.
Loosening/migration due to device        Non-clinical performance
 failure at the bone/implant interface.   testing, and Labeling.
Inaccurate, unreliable, and              Non-clinical performance
 irreproducible kinematic data leading    testing.
 to improper post-surgical patient
 management.
Interference with imaging modalities...  Non-clinical performance
                                          testing, and Magnetic
                                          resonance compatibility
                                          testing.
Data access failure and delayed access   Software verification,
 to kinematic data due to:                validation, and hazard
 Software failure.                analysis, Electromagnetic
 Interference with other          compatibility testing, Human
 devices.                                 factors testing, and Labeling.
 Use error.
Infection..............................  Sterilization validation,
                                          Reprocessing validation,
                                          Biocompatibility evaluation,
                                          and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
------------------------------------------------------------------------

    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. 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 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 parts 801, regarding labeling, have been

[[Page 753]]

approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 888

    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 
888 is amended as follows:

PART 888--ORTHOPEDIC DEVICES

0
1. The authority citation for part 888 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  888.3600 to subpart D to read as follows:


Sec.  888.3600  Implantable post-surgical kinematic measurement knee 
device.

    (a) Identification. An implantable post-surgical kinematic 
measurement knee device is a device that provides objective kinematic 
data after total knee arthroplasty surgery. The kinematic data provided 
by the device are used as an adjunct to other physiological parameter 
measurement tools utilized during the course of patient monitoring and 
treatment post surgery.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following tests must be conducted:
    (i) Mechanical testing must evaluate the mechanical function 
(mechanical fatigue, static mechanical strength) and durability of the 
implant.
    (ii) Simulated use testing must evaluate the ability of the device 
to be sized, inserted, and sufficiently secured to any compatible 
components.
    (iii) Testing must demonstrate the accuracy, reliability, and 
reproducibility of kinematic measurements.
    (iv) Testing must demonstrate diagnostic and therapeutic ultrasound 
conditions for safe use.
    (v) Testing must demonstrate that the device performs as intended 
under anticipated conditions of use demonstrating the following 
performance characteristics, if applicable:
    (A) Magnetic pulse output testing;
    (B) Magnetic and electrical field testing; and
    (C) Testing of the safety features built into the device.
    (vi) Testing must demonstrate hermeticity of any electronic 
component enclosures.
    (2) Performance testing must evaluate the compatibility of the 
device in a magnetic resonance (MR) environment.
    (3) Human factors testing must demonstrate that the intended 
user(s) can correctly use the device for its intended use, including 
for implantation and post-procedure data access.
    (4) Performance data must demonstrate the sterility of the device 
implant and patient-contacting components.
    (5) Performance data must validate the reprocessing instructions 
for the reusable components of the device.
    (6) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (7) Design characteristics of the device, including engineering 
schematics, must ensure that the geometry and material composition are 
consistent with the intended use.
    (8) Performance testing must demonstrate the electromagnetic 
compatibility/interference, (EMC/EMI), electrical safety, thermal 
safety, battery safety, and wireless performance of the device.
    (9) Software verification, validation, and hazard analysis must be 
performed.
    (10) The labeling must include the following:
    (i) A shelf life;
    (ii) Physician and patient instructions for use, including images 
that demonstrate how to interact with the device;
    (iii) Detailed instruction of the surgical technique;
    (iv) Hardware and software requirements for interacting with the 
device;
    (v) A clear description of the technological features of the device 
including identification of the device materials, compatible 
components, and the principles of operation;
    (vi) Identification of magnetic resonance (MR) compatibility 
status;
    (vii) Validated methods and instructions for reprocessing of any 
reusable components; and
    (viii) A statement regarding the limitations of the clinical 
significance of the kinematic data.

    Dated: December 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28604 Filed 1-4-23; 8:45 am]
BILLING CODE 4164-01-P