[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Rules and Regulations]
[Pages 22-24]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28255]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2017-N-6596]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Irrigating Wound Retractor Device

AGENCY: Food and Drug Administration, HHS.

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ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the irrigating wound retractor device 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 irrigating 
wound retractor device'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, in part by reducing 
regulatory burdens.

DATES: This order is effective January 2, 2018. The classification was 
applicable on December 16, 2016.

FOR FURTHER INFORMATION CONTACT: Terrell Cunningham, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2502, Silver Spring, MD 20993-0002, 301-
796-6299, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the irrigating wound retractor 
device 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 reducing regulatory burdens 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 by means of the procedures 
for premarket notification under section 510(k) of the FD&C Act and 
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    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 shall 
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, in part by reducing regulatory 
burdens. 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 in order 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

    On August 13, 2015, Prescient Surgical submitted a request for De 
Novo classification of the CleanCisionTM Wound Retraction 
and Protection System. 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 December 16, 2016, FDA issued an order to the 
requester classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 878.4371. We have named 
the generic type of device irrigating wound retractor device, and it is 
identified as a prescription device intended to be used by a surgeon to 
retract the surgical incision, to provide access to the surgical wound, 
to protect and irrigate the surgical wound, and to serve as a conduit 
for removal of fluid from the surgical wound.
    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--Irrigating Wound Retractor Device Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Adverse tissue reaction................  Biocompatibility evaluation.
Tissue or wound damage.................  Non-clinical performance
                                          testing, Shelf life testing,
                                          and Labeling.

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Infection..............................  Sterilization validation, Non-
                                          clinical performance testing,
                                          Shelf life testing, and
                                          Labeling.
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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. This device is subject to premarket notification 
requirements under section 510(k) of the FD&C Act.
    At the time of classification, irrigating wound retractor devices 
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 (referring 
to 21 U.S.C. 352(f)(1)).

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. 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 
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 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.

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.  878.4371 to subpart E to read as follows:


Sec.  878.4371   Irrigating wound retractor device.

    (a) Identification. An irrigating wound retractor device is a 
prescription device intended to be used by a surgeon to retract the 
surgical incision, to provide access to the surgical wound, to protect 
and irrigate the surgical wound, and to serve as a conduit for removal 
of fluid from the surgical wound.
    (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 and evaluated for particulate matter.
    (2) Performance data must demonstrate the sterility and 
pyrogenicity of the patient-contacting components of the device.
    (3) Performance data must support shelf life by demonstrating 
continued functionality and sterility of the device over the identified 
shelf life.
    (4) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. 
Performance testing must:
    (i) Characterize the tear resistance, tensile strength, and 
elongation properties of the barrier material;
    (ii) Demonstrate that the liquid barrier material is resistant to 
penetration by blood, and is non-flammable;
    (iii) Characterize the forces required to deploy the device;
    (iv) Characterize the device's ranges of operation, including flow 
rates and maximum suction pressures;
    (v) Demonstrate the ability of the device irrigation apparatus to 
maintain a user defined or preset flow rate to the surgical wound; and
    (vi) Demonstrate the ability of the device to maintain user defined 
or preset removal rates of fluid from the surgical wound.
    (5) The labeling must include or state the following information:
    (i) Device size or incision length range;
    (ii) Method of sterilization;
    (iii) Flammability classification;
    (iv) Non-pyrogenic;
    (v) Shelf life; and
    (vi) Maximum flow rate and suction pressure.

    Dated: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28255 Filed 12-29-17; 8:45 am]
BILLING CODE 4164-01-P