Rule2022-28604
Medical Devices; Orthopedic Devices; Classification of the Implantable Post-Surgical Kinematic Measurement Knee Device
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Published
January 5, 2023
Effective
January 5, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 3 (Thursday, January 5, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#9dcdfce9eff4fef6b3d0fcfefce9fcf3fafafcddfbf9fcb3f5f5eeb3faf2eb"><span class="__cf_email__" data-cfemail="3c6c5d484e555f5712715d5f5d485d525b5b5d7c5a585d1254544f125b534a">[email protected]</span></a>.
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
<bullet> Loss of hermeticity. Non-clinical performance
<bullet> 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
<bullet> Software failure. analysis, Electromagnetic
<bullet> Interference with other compatibility testing, Human
devices. factors testing, and Labeling.
<bullet> Use error.
Infection.............................. Sterilization validation,
Reprocessing validation,
Biocompatibility evaluation,
and Labeling.
Adverse tissue reaction................ Biocompatibility evaluation.
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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. 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
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