[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Rules and Regulations]
[Pages 35071-35073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15892]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2017-N-1914]


Medical Devices; Obstetrical and Gynecological Devices; 
Classification of the Closed Loop Hysteroscopic Insufflator With 
Cutter-Coagulator

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
classifying the closed loop hysteroscopic insufflator with cutter-
coagulator 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 closed loop hysteroscopic insufflator 
with cutter-coagulator 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 July 28, 2017. The classification was 
applicable on March 28, 2014.

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.

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, also known as De Novo 
classification, 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

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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 shall 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On September 5, 2013, IOGYN, Inc., submitted a request for 
classification of the IOGYN System, Models FG-0200, FG-0201, and FG-
0202 under section 513(f)(2) of the FD&C Act.
    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 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 March 28, 2014, 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 884.1710.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a closed loop 
hysteroscopic insufflator with cutter-coagulator will need to comply 
with the special controls named in the final order. A De Novo 
classification decreases regulatory burdens. When FDA classifies a 
device type as class I or II via the De Novo pathway, other 
manufacturers do not have to submit a De Novo request or premarket 
approval application in order to market the same type of device, unless 
the device has a new intended use or technological characteristics that 
raise different questions of safety or effectiveness. Instead, 
manufacturers can use the less burdensome pathway of 510(k), when 
necessary, to market their device, and the device that was the subject 
of the original De Novo classification can serve as a predicate device 
for additional 510(k)s from other manufacturers.
    The device is assigned the generic name closed loop hysteroscopic 
insufflator with cutter-coagulator, and it is identified as a 
prescription device configured for hysteroscopic insufflation, 
resection, and coagulation. It is used to perform diagnostic and 
surgical procedures (i.e., resection and coagulation). This device type 
contains a closed loop recirculating fluid management system for the 
controlled delivery of filtered distension fluid. This device type also 
contains a bipolar radiofrequency device used in conjunction with a 
hysteroscope for resection and coagulation of intrauterine tissues.
    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--Closed Loop Hysteroscopic Insufflator With Cutter-Coagulator
                      Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Adverse tissue reaction................  Biocompatibility.
                                         Labeling.
Equipment malfunction leading to injury  Non-clinical Performance
                                          Testing.
                                         Software Verification,
                                          Validation, and Hazards
                                          Analysis.
                                         Labeling.
                                         Training.
Recirculated fluid causes adverse        Biocompatibility.
 tissue reaction.                        Non-clinical Performance
                                          Testing.
Fluid overload, embolism, perforation    Non-clinical Performance
 or other adverse events.                 Testing.
                                         Software Verification,
                                          Validation, and Hazards
                                          Analysis.
                                         Labeling.
                                         Training.
Infection..............................  Sterility.
                                         Shelf Life Testing.
                                         Non-clinical Performance
                                          Testing.
Electromagnetic interference/electrical  Electromagnetic Compatibility
 safety issues.                           Testing.
                                         Electrical Safety Testing.
                                         Labeling.
Operator error leading to patient        Labeling.
 injury.                                 Training.
------------------------------------------------------------------------

    FDA believes that special controls, in combination with the general 
controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness.
    Closed loop hysteroscopic insufflators with cutter-coagulator are 
not safe for use except under the supervision of a practitioner 
licensed by law to direct 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), if

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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 
(510(k)), prior to marketing the device, which contains information on 
the closed loop hysteroscopic insufflator with cutter-coagulator they 
intend to market.

II. Analysis of Environmental Impact

    We have 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 part 801 regarding labeling have been approved under 
OMB control number 0910-0485.

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 is revised to read as follows:

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


0
2. Add Sec.  884.1710 to subpart B to read as follows:


Sec.  884.1710  Closed loop hysteroscopic insufflator with cutter-
coagulator.

    (a) Identification. A closed loop hysteroscopic insufflator with 
cutter-coagulator is a prescription device configured for hysteroscopic 
insufflation, resection, and coagulation. It is used to perform 
diagnostic and surgical procedures (i.e., resection and coagulation). 
This device type contains a closed-loop recirculating fluid management 
system for the controlled delivery of filtered distension fluid. This 
device type also contains a bipolar radiofrequency device used in 
conjunction with a hysteroscope for resection and coagulation of 
intrauterine tissues.
    (b) Classification. Class II (special controls). The special 
control(s) for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Software validation, verification, and hazard analysis must be 
provided.
    (3) Electrical equipment safety, including appropriate thermal and 
mechanical safety and electromagnetic compatibility (EMC) testing must 
be performed.
    (4) Device components that are labeled sterile must be validated to 
a sterility assurance level of 10-\6\.
    (5) Shelf-life testing that demonstrates the device packaging 
maintains sterility and the functionality of the device is maintained 
following simulated shipping and handling must be provided to support 
the proposed shelf life.
    (6) Non-clinical testing data must demonstrate the performance 
characteristics of the device. Detailed protocols and the test reports 
must be provided for each test.
    (i) The following tests must be performed for the resection portion 
of the device:
    (A) Mechanical testing to assess critical joint strength.
    (B) Device electrode temperature testing.
    (C) Coagulation depth testing.
    (D) Simulated use testing.
    (E) Device durability testing.
    (ii) The following tests must be performed for the fluid management 
portion of the device:
    (A) Mechanical testing to assess tensile strength of connections.
    (B) Pressure testing that demonstrates the following parameters, 
including accuracy of the pressure displayed; appropriate detection and 
response to overpressure conditions; activation of a secondary 
overpressure relief valve at the maximum safe level; and all 
accessories within the fluid path meet the pressure requirements.
    (C) Fluid delivery volume testing that demonstrates that the 
maximum fluid volume delivered is below a predefined level.
    (D) Flow rate testing.
    (E) Simulated use testing.
    (F) Filtration testing.
    (G) Blood filtration capacity testing.
    (H) Tissue collection capacity testing.
    (I) Filtrate characterization and testing that demonstrates that 
the continuous reintroduction of filtrate into the uterus does not pose 
a safety risk.
    (7) Clinician labeling must include:
    (i) Specific instructions and the clinical training needed for the 
safe use of the device.
    (ii) Appropriate warnings, precautions, and information related to 
overpressurization.
    (iii) Appropriate EMC information.
    (iv) An expiration date/shelf life.

    Dated: July 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-15892 Filed 7-27-17; 8:45 am]
BILLING CODE 4164-01-P