[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Rules and Regulations]
[Pages 977-979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00008]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. FDA-2022-N-3171]


Medical Devices; Ear, Nose, and Throat Devices; Classification of 
the Powered Insertion System for a Cochlear Implant Electrode Array

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
classifying the powered insertion system for a cochlear implant 
electrode array 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 powered insertion system for a 
cochlear implant electrode array'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 6, 2023. The classification was 
applicable on October 1, 2021.

FOR FURTHER INFORMATION CONTACT: Vasant Dasika, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1206, Silver Spring, MD, 20993-0002, 301-796-5365, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the powered insertion system for a 
cochlear implant electrode array 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 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 December 18, 2019, FDA received iotaMotion, Inc.'s request for 
De Novo classification of the iotaSOFT Insertion System--Drive Unit, 
Controller and Accessories. 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

[[Page 978]]

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 October 1, 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 
874.4450.\1\ We have named the generic type of device powered insertion 
system for a cochlear implant electrode array, and it is identified as 
a prescription device used to assist in placing an electrode array into 
the cochlea.
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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--Powered Insertion System for a Cochlear Implant Electrode Risks
                         and Mitigation Measures
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            Identified risks                   Mitigation measures
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Risks to health relating to device       Clinical performance testing,
 interface with patient anatomy,          Usability testing, Non-
 including:                               clinical performance testing,
 Damage to skull tissue.          and Labeling.
 Damage to dura mater.
 Bone damage.
 Cerebrospinal fluid leak.
 Damage to cochlea; hearing
 loss, tinnitus, vertigo.
Cochlear implant insertion failure       Clinical performance testing,
 leading to:.                             Non-clinical performance
 Trauma to cochlear structures    testing, Usability testing,
 resulting in residual hearing loss or    Cochlear implant compatibility
 nerve degeneration..                     validation, Software
 Suboptimal array placement       verification, validation, and
 (including array rotation) leading to    hazard analysis, and Labeling.
 poor hearing performance..
 Failure to disengage from
 cochlear implant at end of procedure,
 leading to manual correction and
 insertion..
Damage to cochlear implant during        Non-clinical performance
 insertion leading to poor cochlear       testing, Usability testing,
 implant performance and/or compromised   Cochlear implant compatibility
 implant reliability.                     validation, Shelf life
                                          testing, Software
                                          verification, validation, and
                                          hazard analysis, and Labeling.
Adverse tissue reaction, including       Biocompatibility evaluation.
 irritation/inflammation of surgical
 site.
Electromagnetic interference, thermal    Electrical safety testing,
 injury, or electric shock.               Electromagnetic compatibility
                                          testing, and Labeling.
Infection..............................  Sterilization validation, Shelf
                                          life testing, and Labeling.
Excessive operation time leading to      Clinical performance testing,
 increased exposure to anesthesia.        Usability testing, and
                                          Labeling.
------------------------------------------------------------------------

    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.
    At the time of classification, powered insertion systems for a 
cochlear implant electrode array 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 874

    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 
874 is amended as follows:

[[Page 979]]

PART 874--EAR, NOSE, AND THROAT DEVICES

0
1. The authority citation for part 874 continues to read as follows:

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


0
2. Add Sec.  874.4450 to subpart E to read as follows:


Sec.  874.4450   Powered insertion system for a cochlear implant 
electrode array.

    (a) Identification. A powered insertion system for a cochlear 
implant electrode array is a prescription device used to assist in 
placing an electrode array into the cochlea.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use, including 
evaluation of all adverse events.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. 
Testing must include:
    (i) Verification of cochlear implant attachment force, release 
force, and insertion speed;
    (ii) Testing to demonstrate the device does not damage or degrade 
the cochlear implant (including the lead and array portions of the 
cochlear implant); and
    (iii) Comparison testing with manual insertion to evaluate:
    (A) Differences in cochlear implant array insertion force 
associated with use of the device; and
    (B) Intracochlear placement of the cochlear implant array (intended 
scala placement and array insertion depth, together with minimal array 
tip foldover and cochlear scala translocation).
    (3) Usability testing in a simulated hospital environment with an 
anatomically relevant model (e.g., cadaver testing) that evaluates the 
following:
    (i) Successful use to aid in placement of the electrode array into 
the cochlea; and
    (ii) Harms caused by use errors observed.
    (4) Changes in cochlear implant compatibility are determined to 
significantly affect the safety or effectiveness of the device and must 
be validated through performance testing or a rationale for omission of 
any testing.
    (5) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (6) Performance testing must demonstrate the electromagnetic 
compatibility, electrical safety, and thermal safety of the device.
    (7) The patient-contacting components of the device must be 
demonstrated to be sterile and non-pyrogenic.
    (8) Performance testing must support the shelf life of device 
components provided sterile by demonstrating continued sterility, 
package integrity, and device functionality over the labeled shelf 
life.
    (9) Software verification, validation, and hazard analysis must be 
performed for any software components of the device.
    (10) Labeling must include:
    (i) The recommended training for the safe use of the device;
    (ii) Summary of the relevant clinical and non-clinical testing 
pertinent to use of the device with compatible electrode arrays; and
    (iii) A shelf life.

    Dated: January 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00008 Filed 1-5-23; 8:45 am]
BILLING CODE 4164-01-P