[Federal Register Volume 86, Number 223 (Tuesday, November 23, 2021)]
[Rules and Regulations]
[Pages 66456-66458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25585]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2018-N-1913]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the General Laparoscopic Power Morcellation 
Containment System

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 general laparoscopic power morcellation containment system 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 general laparoscopic power morcellation 
containment system'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 November 23, 2021. The classification 
was applicable on December 19, 2017.

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 general laparoscopic power 
morcellation containment system 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 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

[[Page 66457]]

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 September 29, 2017, FDA received Advanced Surgical Concepts 
Ltd.'s request for De Novo classification of the ContainOR. 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 section 513(a)(1)(B) of the FD&C Act). 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 December 19, 2017, 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 
878.4825.\1\ We have named the generic type of device general 
laparoscopic power morcellation containment system, and it is 
identified as a prescription device consisting of an instrument port 
and tissue containment method that creates a working space allowing for 
direct visualization during a power morcellation procedure following a 
laparoscopic procedure for the excision of benign tissue that is not 
suspected to contain malignancy.
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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--General Laparoscopic Power Morcellation Containment System
                      Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Sterilization validation, Shelf
                                          life testing, and Labeling.
Intraperitoneal tissue dissemination...  Non-clinical performance
                                          testing, Animal performance
                                          testing, Shelf life
     Material permeability.       testing, Labeling, and
                                          Training.
     Improper function of
     containment device.
     Inadequate material
     strength.
     Physical trauma to liner
     caused by contact with morcellator
     or grasper/tenaculum.
     Damage to liner
     (intentional or accidental) from
     instrument inserted through
     secondary port.
     Tearing during removal
     with loss of contents into
     abdominal cavity.
     Tearing of the bag due to
     stones contained in tissue.
     Use error.
Traumatic injury to non-target tissue/   Non-clinical performance
 organ.                                   testing, Animal performance
                                          testing, Labeling,
     Active end of morcellator    and Training.
     or grasper/tenaculum breaches
     liner.
     Loss of insufflation.
     Inadequate space to
     perform morcellation.
     Inadequate visualization
     of the laparoscopic instruments
     and tissue specimen relative to
     the external viscera.
     Use error.
Hernia through abdominal wall incision.  Labeling and Training.
Prolongation of procedure and exposure   Labeling and Training.
 to anesthesia.
------------------------------------------------------------------------

    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.

[[Page 66458]]

    At the time of classification, general laparoscopic power 
morcellation containment systems 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 regulations, 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.  878.4825 to subpart E to read as follows:


Sec.  878.4825  General laparoscopic power morcellation containment 
system.

    (a) Identification. A general laparoscopic power morcellation 
containment system is a prescription device consisting of an instrument 
port and tissue containment method that creates a working space 
allowing for direct visualization during a power morcellation procedure 
following a laparoscopic procedure for the excision of benign tissue 
that is not suspected to contain malignancy.
    (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 testing 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 intended shelf life.
    (4) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Demonstration of the device impermeability to tissue, cells, 
and fluids;
    (ii) Demonstration that the device allows for the insertion/
withdrawal of laparoscopic instruments while maintaining 
pneumoperitoneum;
    (iii) Demonstration that the containment system provides adequate 
space to perform morcellation and adequate visualization of the 
laparoscopic instruments and tissue specimen relative to the external 
viscera;
    (iv) Demonstration that compatible laparoscopic instruments and 
morcellators do not compromise the integrity of the containment system; 
and
    (v) Demonstration that users can adequately deploy the device, 
morcellate a specimen without compromising the integrity of the device, 
and remove the device without spillage of contents.
    (5) Training must be developed and validated to ensure users can 
follow the instructions for use.
    (6) Labeling must include:
    (i) A contraindication for use in gynecological procedures;
    (ii) A contraindication against use of tissue that is known or 
suspected to contain malignancy;
    (iii) The following boxed warning: ``Warning: Information regarding 
the potential risks of a procedure with this device should be shared 
with patients. The use of laparoscopic power morcellators may spread 
cancer. The use of this containment system has not been clinically 
demonstrated to reduce this risk;''
    (iv) A statement limiting use of device to physicians who have 
completed the training program; and
    (v) A shelf life.

    Dated: November 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25585 Filed 11-22-21; 8:45 am]
BILLING CODE 4164-01-P