[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Rules and Regulations]
[Pages 40181-40183]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14627]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2016-N-1318]


Medical Devices; Obstetrical and Gynecological Devices; 
Classification of the Gynecologic Laparoscopic Power Morcellation 
Containment System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
gynecologic laparoscopic power morcellation containment system into 
class II (special controls). The special controls that will apply to 
the device are identified in this order and will be part of the 
codified language for the gynecologic laparoscopic power morcellation 
containment system's classification. The Agency is classifying the 
device into class II (special controls) in order to provide a 
reasonable assurance of safety and effectiveness of the device.

DATES: This order is effective June 21, 2016. The classification was 
applicable on April 7, 2016.

FOR FURTHER INFORMATION CONTACT: Veronica Price, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G116, Silver Spring, MD 20993-0002, 301-796-6538, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval, unless and until the 
device is classified or reclassified into class I or II, or FDA issues 
an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the FD&C Act, to a predicate device 
that does not require premarket approval. The Agency determines whether 
new devices are substantially equivalent to predicate devices by means 
of premarket notification procedures in section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to 
classify a device under the criteria set forth in section 513(a)(1). 
Under the first procedure, the person submits a premarket notification 
under section 510(k) of the FD&C Act for a device that has not 
previously been classified and, within 30 days of receiving an order 
classifying the device into class III under section 513(f)(1) of the 
FD&C Act, the person requests a classification under section 513(f)(2). 
Under the second procedure, rather than first submitting a premarket 
notification under section 510(k) of the FD&C Act and then a request 
for classification under the first procedure, the person determines 
that there is no legally marketed device upon which to base a 
determination of substantial equivalence and requests a classification 
under section 513(f)(2) of the FD&C Act. If the person submits a 
request to classify the device under this second procedure, FDA may 
decline to undertake the classification request if FDA identifies a 
legally marketed device that could provide a reasonable basis for 
review of substantial equivalence with the device or if FDA determines 
that the device submitted is not of ``low-moderate risk'' or that 
general controls would be inadequate to control the risks and special 
controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA will 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On June 19, 2015, Advanced Surgical Concepts submitted a request 
for classification of the PneumoLiner device under section 513(f)(2) of 
the FD&C Act. The manufacturer recommended that the device be 
classified into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the request in order to classify the device under the criteria for 
classification set

[[Page 40182]]

forth in section 513(a)(1). FDA classifies 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 to provide reasonable 
assurance of the safety and effectiveness of the device for its 
intended use. After review of the information submitted in the request, 
FDA determined that the device can be classified into class II with the 
establishment of special controls. FDA believes these special controls, 
in addition to general controls, will provide reasonable assurance of 
the safety and effectiveness of the device.
    Therefore, on April 7, 2016, FDA issued an order to the requestor 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 884.4050.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a gynecologic 
laparoscopic power morcellation containment system will need to comply 
with the special controls named in this final order.
    The device is assigned the generic name gynecologic laparoscopic 
power morcellation containment system and 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 gynecologic tissue 
that is not suspected to contain malignancy.
    FDA has identified the following risks to health associated with 
this type of device and the measures required to mitigate these risks, 
in Table 1.

 Table 1--Gynecologic Laparoscopic Power Morcellation Containment System
                      Risks and Mitigation Measures
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            Identified risk                     Mitigation measure
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Adverse tissue reaction................  Biocompatibility.
Infection..............................  Sterilization validation, shelf
                                          life validation, and labeling.
Intraperitoneal tissue dissemination     Non-clinical performance
 (benign or malignant):                   testing (bench and animal),
  Material permeability;          shelf life validation,
                                          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; and
     Use error.
Traumatic injury to non-target tissue/   Non-clinical performance
 organ:                                   testing (bench and animal),
  Active end of morcellator or    labeling, and training.
 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; and
     Use error.
Hernia through abdominal wall incision.  Labeling and training.
Prolongation of procedure and exposure   Labeling and training.
 to anesthesia.
------------------------------------------------------------------------

    FDA believes that the special controls, in addition to the general 
controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness.
    A gynecologic laparoscopic power morcellation containment system is 
not safe for use except under the supervision of a practitioner 
licensed by law to direct the use of the device. As such, the device is 
a prescription device and must satisfy prescription labeling 
requirements (see 21 CFR 801.109, Prescription devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act if FDA determines that premarket notification is 
not necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, this device type is not exempt from premarket notification 
requirements. Persons who intend to market this type of device must 
submit to FDA a premarket notification, prior to marketing the device, 
which contains information about the gynecologic laparoscopic power 
morcellation containment system they intend to market.

II. 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.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations. 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. 3501-3520). The collections of information in 
part 807, subpart E, regarding premarket notification submissions have 
been approved under OMB control number 0910-0120, and the collections 
of information in 21 CFR part 801, regarding labeling, have been 
approved under OMB control number 0910-0485.

IV. Reference

    The following reference is on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, and is available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; it 
is also

[[Page 40183]]

available electronically at http://www.regulations.gov.

    1. DEN150028: De novo request from Advanced Surgical Concepts, 
dated June 19, 2015.

List of Subjects in 21 CFR Part 884

    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 
884 is amended as follows:

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
1. The authority citation for part 884 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.


0
2. Add Sec.  884.4050 to subpart E to read as follows:


Sec.  884.4050  Gynecologic laparoscopic power morcellation containment 
system.

    (a) Identification. A gynecologic 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 
gynecologic 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) Device components that are labeled sterile must be validated to 
a sterility assurance level of 10-\6\;
    (3) Performance data must support shelf life by demonstrating 
continued sterility of the device or the sterile components, package 
integrity, and device functionality over the intended shelf life;
    (4) Non-clinical performance data must demonstrate that the device 
meets all design specifications and performance requirements. 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 and 
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 intended laparoscopic instruments and 
morcellators do not compromise the integrity of the containment system; 
and
    (v) Demonstration that intended 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; and
    (6) Labeling must include the following:
    (i) A contraindication for use in gynecologic surgery in which the 
tissue to be morcellated is known or suspected to contain malignancy;
    (ii) Unless clinical performance data demonstrates that it can be 
removed or modified, a contraindication for removal of uterine tissue 
containing suspected fibroids in patients who are: Peri- or 
postmenopausal, or candidates for en bloc tissue removal, for example, 
through the vagina or via a mini-laparotomy incision;
    (iii) The following boxed warning: ``Warning: Information regarding 
the potential risks of a procedure with this device should be shared 
with patients. Uterine tissue may contain unsuspected cancer. The use 
of laparoscopic power morcellators during fibroid surgery 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) An expiration date or shelf life.

    Dated: June 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14627 Filed 6-20-16; 8:45 am]
BILLING CODE 4164-01-P