Rule2021-27317
Medical Devices; General and Plastic Surgery Devices; Classification of the Manual Percutaneous Surgical Set Assembled in the Abdomen
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 17, 2021
Effective
December 17, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is classifying the manual percutaneous surgical set assembled in the abdomen 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 manual percutaneous surgical set assembled in the abdomen'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 86 Issue 240 (Friday, December 17, 2021)</title>
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[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Rules and Regulations]
[Pages 71568-71570]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27317]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2021-N-0857]
Medical Devices; General and Plastic Surgery Devices;
Classification of the Manual Percutaneous Surgical Set Assembled in the
Abdomen
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the manual percutaneous surgical set assembled in the abdomen 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 manual percutaneous surgical set assembled in
the abdomen'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 December 17, 2021. The classification
was applicable on April 30, 2012.
FOR FURTHER INFORMATION CONTACT: Cal Rabang, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4633, Silver Spring, MD 20993-0002, 301-796-6412,
<a href="/cdn-cgi/l/email-protection#fcbf9d90d2ae9d9e9d929bbc9a989dd294948fd29b938a"><span class="__cf_email__" data-cfemail="1655777a3844777477787156707277387e7e6538717960">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the manual percutaneous surgical
set assembled in the abdomen 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.
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 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). 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.
We believe this De Novo classification will enhance patients'
access to beneficial innovation. 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
21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not
have to submit a De Novo request or premarket approval application
(PMA) to market a substantially equivalent device (see 21 U.S.C.
360c(i), defining ``substantial equivalence''). Instead, sponsors can
use the less-burdensome 510(k) process, when necessary, to market their
device.
II. De Novo Classification
For this device, FDA issued an order on August 26, 2011, finding
the Percutaneous Surgical Set with 5mm or 10mm Attachments not
substantially equivalent to a predicate not subject to PMA. Thus, the
device remained in class III in accordance with section 513(f)(1) of
the FD&C Act when we issued the order.
On September 21, 2011, FDA received Ethicon Endo-Surgery, Inc.'s
request for De Novo classification of the Percutaneous Surgical Set
with 5mm or 10mm Attachments. 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 April 30, 2012, 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
878.4805.\1\ We have named the
[[Page 71569]]
generic type of device manual percutaneous surgical set assembled in
the abdomen, and it is identified as a prescription device consisting
of a percutaneous surgical set used as a means to penetrate soft tissue
to access certain areas of the abdomen. The device's effectors or
attachments are provided separately from the percutaneous shaft and are
introduced to the site via a traditional conduit such as a trocar. The
attachment or effectors are connected to the shaft once the tip of the
shaft is inside the abdomen. Once inside the abdomen, the surgical set
is used to grasp, hold, and manipulate soft tissues. A surgical
instrument that has specialized uses in a specific medical specialty is
classified in separate regulations in 21 CFR parts 868 through 892.
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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--Manual Percutaneous Surgical Set Assembled in the Abdomen Risks
and Mitigation Measures
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Identified risks Mitigation measures
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Adverse tissue reaction.............. Biocompatibility evaluation.
Device failure....................... Non-clinical performance testing,
Sterilization validation, and
Shelf life testing.
User error........................... Non-clinical performance testing,
Simulated use testing, and
Labeling.
Abdominal cavity damage.............. Non-clinical performance testing,
Simulated use testing, and
Labeling.
Infection............................ Sterilization validation and
Shelf life testing.
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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. We encourage sponsors to consult with us if they wish to
use a non-animal testing method they believe is suitable, adequate,
validated, and feasible. We will consider if such an alternative method
could be assessed for equivalency to an animal test method. This device
is subject to premarket notification requirements under section 510(k)
of the FD&C Act.
At the time of classification, manual percutaneous surgical sets
assembled in the abdomen 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 the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' 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. 878.4805 to subpart E to read as follows:
Sec. 878.4805 Manual percutaneous surgical set assembled in the
abdomen.
(a) Identification. A manual percutaneous surgical set assembled in
the abdomen is a prescription device consisting of a percutaneous
surgical set used as a means to penetrate soft tissue to access certain
areas of the abdomen. The device's effectors or attachments are
provided separately from the percutaneous shaft and are introduced to
the site via a traditional conduit such as a trocar. The attachment or
effectors are connected to the shaft once the tip of the shaft is
inside the abdomen. Once inside the abdomen, the surgical set is used
to grasp, hold, and manipulate soft tissues. A surgical instrument that
has specialized uses in a specific medical specialty is classified in
separate regulations in parts 868 through 892 of this chapter.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(2) Performance data must demonstrate the sterility of patient-
contacting components of the device.
(3) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the requested shelf life.
(4) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following
[[Page 71570]]
performance characteristics must be tested:
(i) Dimensional verification testing must be conducted.
(ii) Force verification testing must be conducted. The force
testing must demonstrate the forces necessary to insert and operate
each component of the device during use as intended.
(iii) Functional verification testing of the device components must
be conducted.
(5) Simulated use testing in an anatomically relevant animal model
must demonstrate the device's ability to penetrate soft tissue, be
assembled in situ, and to grasp, hold and manipulate soft tissues in
the intended treatment area.
(6) The labeling must include the following:
(i) Instructions for use, including detailed instructions for
instrument assembly, disassembly, and removal; and
(ii) A shelf life.
Dated: December 10, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27317 Filed 12-16-21; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on December 17, 2021.
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