Rule2021-25585
Medical Devices; General and Plastic Surgery Devices; Classification of the General Laparoscopic Power Morcellation Containment System
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
November 23, 2021
Effective
November 23, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 223 (Tuesday, November 23, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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,
<a href="/cdn-cgi/l/email-protection#3073515c1e625152515e57705654511e5858431e575f46"><span class="__cf_email__" data-cfemail="4c0f2d20621e2d2e2d222b0c2a282d6224243f622b233a">[email protected]</span></a>.
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
<bullet> Material permeability. testing, Labeling, and
Training.
<bullet> Improper function of
containment device.
<bullet> Inadequate material
strength.
<bullet> Physical trauma to liner
caused by contact with morcellator
or grasper/tenaculum.
<bullet> Damage to liner
(intentional or accidental) from
instrument inserted through
secondary port.
<bullet> Tearing during removal
with loss of contents into
abdominal cavity.
<bullet> Tearing of the bag due to
stones contained in tissue.
<bullet> Use error.
Traumatic injury to non-target tissue/ Non-clinical performance
organ. testing, Animal performance
testing, Labeling,
<bullet> Active end of morcellator and Training.
or grasper/tenaculum breaches
liner.
<bullet> Loss of insufflation.
<bullet> Inadequate space to
perform morcellation.
<bullet> Inadequate visualization
of the laparoscopic instruments
and tissue specimen relative to
the external viscera.
<bullet> Use error.
Hernia through abdominal wall incision. Labeling and Training.
Prolongation of procedure and exposure Labeling and Training.
to anesthesia.
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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.
[[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
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