[Federal Register Volume 87, Number 88 (Friday, May 6, 2022)]
[Rules and Regulations]
[Pages 26993-26996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09749]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2022-N-0175]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Mountable Electromechanical Surgical System for 
Transluminal Approaches

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 mountable electromechanical surgical system for 
transluminal approaches 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 mountable 
electromechanical surgical system for transluminal approaches'

[[Page 26994]]

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 May 6, 2022. The classification was 
applicable on February 26, 2021.

FOR FURTHER INFORMATION CONTACT: Virag Patel, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4609, Silver Spring, MD 20993-0002, 301-796-0452, 
<a href="/cdn-cgi/l/email-protection#03556a7162642d536277666f436567622d6b6b702d646c75"><span class="__cf_email__" data-cfemail="b3e5dac1d2d49de3d2c7d6dff3d5d7d29ddbdbc09dd4dcc5">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the mountable electromechanical 
surgical system for transluminal approaches 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 (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 April 17, 2019, FDA received Memic Innovative Surgery Ltd.'s 
request for De Novo classification of the Hominis Surgical 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 February 26, 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 
878.4961.\1\ We have named the generic type of device mountable 
electromechanical surgical system for transluminal approaches, and it 
is identified as a software-controlled, patient bed- and/or operating 
table-mounted electromechanical surgical system with human/device 
interfaces that allows a qualified user to perform transluminal 
endoscopic or laparoscopic surgical procedures using surgical 
instruments attached to an electromechanical arm.
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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.

[[Page 26995]]



  Table 1--Mountable Electromechanical Surgical System for Transluminal
                Approaches Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Thermal, electrical, or mechanical       Non-clinical performance
 fault, or system malfunction resulting   testing; Electrical safety
 in tissue perforation or injury to       testing; Electromagnetic
 patient or user.                         compatibility (EMC) testing;
                                          Software verification,
                                          validation, and hazard
                                          analysis; Human factors
                                          assessment; Clinical
                                          performance testing; Annual
                                          reporting; and Labeling.
Use error resulting in patient injury:.  Non-clinical performance
<bullet> Dehiscence or delayed healing    testing; Human factors
 at the device access site..              assessment; Training; Clinical
<bullet> Hemorrhage....................   performance testing; Post-
<bullet> Thromboembolism...............   market surveillance; Annual
<bullet> Transluminal risks............   reporting; Control on
                                          distribution; and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation,
                                          and Pyrogenicity testing.
Infection..............................  Biocompatibility evaluation;
                                          Pyrogenicity testing;
                                          Sterilization validation;
                                          Reprocessing validation; Shelf-
                                          life testing; Clinical
                                          performance 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.

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

    While this final order contains no collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this final order. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 822, regarding postmarket surveillance of 
medical devices, have been approved under OMB control number 0910-0449; 
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 878

    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 
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

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


0
2. Add Sec.  878.4961 to subpart E to read as follows:


Sec.  878.4961   Mountable electromechanical surgical system for 
transluminal approaches.

    (a) Identification. A mountable electromechanical surgical system 
for transluminal approaches is a software-controlled, patient bed- and/
or operating table-mounted electromechanical surgical system with 
human/device interfaces that allows a qualified user to perform 
transluminal endoscopic or laparoscopic surgical procedures using 
surgical instruments attached to an electromechanical arm.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device manufacturer must develop, and update as necessary, 
a device-specific use training program that ensures proper device 
setup/use/shutdown, accurate control of instruments to perform the 
intended surgical procedures, troubleshooting and handling during 
unexpected events or emergencies, and safe practices to mitigate use 
error.
    (2) The device manufacturer may only distribute the device to 
facilities that implement and maintain the device-specific use training 
program and ensure that users of the device have completed the device-
specific use training program.
    (3) The device manufacturer must conduct and complete post-market 
surveillance, including an impact of the training program on user 
learning, behavior, and performance, in accordance with an FDA-agreed-
upon protocol. The device manufacturer must submit post-market 
surveillance reports that contain current data and findings in 
accordance with the FDA-agreed-upon protocol.
    (4) The device manufacturer must submit a report to FDA annually on 
the anniversary of initial marketing authorization for the device, 
until such time as FDA may terminate such reporting, which comprises 
the following information:
    (i) Cumulative summary, by year, of complaints and adverse events 
since date of initial marketing authorization; and
    (ii) Identification and rationale for changes made to the device, 
labeling or device-specific use training program, which did not require 
submission of a premarket notification during the reporting period.
    (5) Labeling must include:
    (i) A detailed summary of clinical performance testing conducted 
with the device, including study population, results, adverse events, 
and comparisons to any comparator groups identified;

[[Page 26996]]

    (ii) A statement in the labeling that the safety and effectiveness 
of the device has not been evaluated for outcomes related to the 
treatment or prevention of cancer, including but not limited to risk 
reduction, overall survival, disease-free survival and local 
recurrence, unless FDA determines that it can be removed or modified 
based on clinical performance data submitted to FDA;
    (iii) Identification of compatible devices;
    (iv) The list of surgical procedures for which the device has been 
determined to be safe with clinical justification;
    (v) Reprocessing instructions for reusable components;
    (vi) A shelf life for any sterile components;
    (vii) A description of the device-specific use training program;
    (viii) A statement that the device is only for distribution to 
facilities that implement and maintain the device-specific use training 
program and ensure that users of the device have completed the device-
specific use training program; and
    (ix) A detailed summary of the post-market surveillance data 
collected under paragraph (b)(3) of this section and any necessary 
modifications to the labeling to accurately reflect outcomes based upon 
the post-market surveillance data collected under paragraph (b)(3) of 
this section.
    (6) Clinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use.
    (7) Human factors validation testing must be performed and must 
demonstrate that the user interfaces of the system support safe use in 
an operating room environment.
    (8) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use and 
must include:
    (i) Device motion accuracy and precision;
    (ii) System testing;
    (iii) Instrument reliability;
    (iv) Thermal effects on tissue;
    (v) Human-device interface;
    (vi) Mounting hardware testing;
    (vii) Workspace access testing; and
    (viii) Performance testing with compatible devices.
    (9) Software verification, validation, and hazard analysis must be 
performed. Software documentation must include an assessment of the 
impact of threats and vulnerabilities on device functionality and end 
users/patients as part of cybersecurity review.
    (10) Electromagnetic compatibility and electrical, thermal, and 
mechanical safety testing must be performed.
    (11) Performance data must demonstrate the sterility of all 
patient-contacting device components.
    (12) Performance data must support the shelf life of the device 
components provided sterile by demonstrating continued sterility and 
package integrity over the labeled shelf life.
    (13) Performance data must validate the reprocessing instructions 
for the reusable components of the device.
    (14) Performance data must demonstrate that all patient-contacting 
components of the device are biocompatible.
    (15) Performance data must demonstrate that all patient-contacting 
components of the device are non-pyrogenic.

    Dated: April 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09749 Filed 5-5-22; 8:45 am]
BILLING CODE 4164-01-P


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