Rule2022-09749
Medical Devices; General and Plastic Surgery Devices; Classification of the Mountable Electromechanical Surgical System for Transluminal Approaches
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Published
May 6, 2022
Effective
May 6, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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' 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 88 (Friday, May 6, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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
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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