[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Rules and Regulations]
[Pages 30931-30933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13067]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2015-N-1338]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Rectal Control System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
rectal control 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 rectal control 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 1, 2015. The classification was 
applicable on February 12, 2015.

FOR FURTHER INFORMATION CONTACT: Purva Pandya, Center for Devices and

[[Page 30932]]

Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G223, Silver Spring, MD 20993-0002, 240-402-9979, 
[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) of 
the FD&C Act. 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), 
the person requests a classification under section 513(f)(2) of the 
FD&C Act. Under the second procedure, rather than first submitting a 
premarket notification under section 510(k) 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 23, 2014, Pelvalon, Inc., submitted a request for classification 
of the Eclipse System 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 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 February 12, 2015, 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 876.5930.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a rectal 
control system will need to comply with the special controls named in 
this final order. The device is assigned the generic name rectal 
control system, and it is identified as a prescription device intended 
to treat fecal incontinence by controlling the size of the rectal 
lumen. The device is inserted in the vagina and includes a portion that 
expands to reduce the rectal lumen to prevent stool leakage and 
retracts to allow normal passage of stool. The device includes an 
external regulator to control the state of expansion.
    FDA has identified the following risks to health associated 
specifically with this type of device, as well as the measures required 
to mitigate these risks in table 1.

      Table 1--Rectal Control System Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                    Mitigation measures
------------------------------------------------------------------------
Vaginal Wall Trauma....................  Clinical Testing Labeling.
Adverse Tissue Reaction................  Biocompatibility Testing.
Infection..............................  Non-Clinical (Bench) Testing
                                          Cleaning and Disinfection
                                          Validation Labeling.
Device Malfunction.....................  Non-Clinical (Bench) Testing
                                          Labeling.
Urinary Urgency, Incontinence, or        Clinical Testing Labeling.
 Voiding Problems.
Fecal Urgency or Difficulty in           Clinical Testing Labeling.
 Evacuation.
Discomfort, Pain.......................  Clinical Testing Labeling.
Change in Amount, Color, or Consistency  Labeling.
 of Vaginal Discharge.
------------------------------------------------------------------------

    FDA believes that the following special controls, in combination 
with the general controls, address these risks to health and provide 
reasonable assurance of the safety and effectiveness:
     Clinical testing must document the device acceptance data 
and the adverse event profile associated with clinical use, and 
demonstrate that the device performs as intended under anticipated 
conditions of use.
     The elements of the device that contact vaginal tissue 
must be demonstrated to be biocompatible.
     The cleaning and disinfection instructions for the device 
must be validated.
     Non-clinical (bench) testing must demonstrate that the 
device performs as intended under anticipated conditions of use.

[[Page 30933]]

     Non-clinical (bench) testing must demonstrate that the 
device does not:
    [cir] Enhance the growth of Staphylococcus aureus.
    [cir] Increase production of Toxic Shock Syndrome Toxin-1 by S. 
aureus.
    [cir] Alter the growth of normal vaginal flora.
     Labeling must include:
    [cir] Specific instructions, contraindications, warnings, cautions, 
limitations, and the clinical training needed for the safe use of the 
device.
    [cir] The intended patient population and the intended use 
environment.
    [cir] Information on how the device is to be fitted, how the device 
operates, and recommendations on device maintenance.
    [cir] A detailed summary of the clinical testing pertinent to the 
use of the device, including a summary of the device- and procedure-
related complications or adverse events related to use of the device, 
as well as relevant safety and performance information.
     Patient labeling must be provided and must include:
    [cir] Relevant contraindications, warnings, precautions, and 
adverse events/complications.
    [cir] Information on how the device operates and the recommended 
device maintenance (i.e., care instructions), including cleaning and 
disinfection.
    [cir] Information on the patient population for which there was a 
favorable benefit/risk assessment.
    [cir] The potential risks and benefits associated with the use of 
the device.
    Rectal control system devices are prescription devices restricted 
to patient use only upon the authorization of a practitioner licensed 
by law to administer or use the device; 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 rectal control system they intend 
to market.

II. 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 has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and is available electronically at http://www.regulations.gov.

    1. DEN140020: De Novo Request per 513(f)(2) from Pelvalon, Inc., 
dated June 23, 2014.

List of Subjects in 21 CFR Part 876

    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 
876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for 21 CFR part 876 continues to read as 
follows:

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

0
2. Add Sec.  876.5930 to subpart F to read as follows:


Sec.  876.5930  Rectal control system.

    (a) Identification. A rectal control system is a prescription 
device intended to treat fecal incontinence by controlling the size of 
the rectal lumen. The device is inserted in the vagina and includes a 
portion that expands to reduce the rectal lumen to prevent stool 
leakage and retracts to allow normal passage of stool. The device 
includes an external regulator to control the state of expansion.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical testing must document the device acceptance data and 
the adverse event profile associated with clinical use, and demonstrate 
that the device performs as intended under anticipated conditions of 
use.
    (2) The elements of the device that contact vaginal tissue must be 
demonstrated to be biocompatible.
    (3) The cleaning and disinfection instructions for the device must 
be validated.
    (4) Non-clinical (bench) testing must demonstrate that the device 
performs as intended under anticipated conditions of use.
    (5) Non-clinical (bench) testing must demonstrate that the device 
does not:
    (i) Enhance the growth of Staphylococcus aureus.
    (ii) Increase production of Toxic Shock Syndrome Toxin-1 by S. 
aureus.
    (iii) Alter the growth of normal vaginal flora.
    (6) Labeling must include:
    (i) Specific instructions, contraindications, warnings, cautions, 
limitations, and the clinical training needed for the safe use of the 
device.
    (ii) The intended patient population and the intended use 
environment.
    (iii) Information on how the device is to be fitted, how the device 
operates, and recommendations on device maintenance.
    (iv) A detailed summary of the clinical testing pertinent to the 
use of the device, including a summary of the device- and procedure-
related complications or adverse events related to use of the device, 
as well as relevant safety and performance information.
    (7) Patient labeling must be provided and must include:
    (i) Relevant contraindications, warnings, precautions, and adverse 
events/complications.
    (ii) Information on how the device operates and the recommended 
device maintenance (i.e., care instructions), including cleaning and 
disinfection.
    (iii) Information on the patient population for which there was a 
favorable benefit/risk assessment.
    (iv) The potential risks and benefits associated with the use of 
the device.

    Dated: May 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13067 Filed 5-29-15; 8:45 am]
 BILLING CODE 4164-01-P