[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 [www.gpo.gov]
[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, 
[email protected].

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

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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


