80 FR 30931 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Rectal Control System

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 104 (June 1, 2015)

Page Range		30931-30933
FR Document		2015-13067

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.

Federal Register, Volume 80 Issue 104 (Monday, June 1, 2015)

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


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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, 
purva.pandya@fda.hhs.gov.

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

Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Rules and Regulations 30931

(1) Airplanes identified in Boeing Service (j) Alternative Methods of Compliance (2) You must use this service information
Bulletin 747–21–2550, dated December 6, (AMOCs) as applicable to do the actions required by
2013. (1) The Manager, Seattle Aircraft this AD, unless the AD specifies otherwise.
(2) Airplanes identified in paragraph (h)(2) Certification Office (ACO), FAA, has the (i) Boeing Special Attention Service
of this AD. authority to approve AMOCs for this AD, if Bulletin 747–21–2544, Revision 2, dated
requested using the procedures found in 14 December 11, 2014.
(d) Subject
CFR 39.19. In accordance with 14 CFR 39.19, (ii) Boeing Special Attention Service
Air Transport Association (ATA) of Bulletin 747–21–2550, dated December 6,
send your request to your principal inspector
America Code 21, Air conditioning. 2013.
or local Flight Standards District Office, as
(e) Unsafe Condition appropriate. If sending information directly (3) For service information identified in
to the manager of the ACO, send it to the this AD, contact Boeing Commercial
This AD was prompted by reports of very Airplanes, Attention: Data & Services
high temperatures, near the floor in the aft attention of the person identified in
paragraph (k)(1) of this AD. Information may Management, P.O. Box 3707, MC 2H–65,
lower lobe cargo compartment. We are Seattle, WA 98124–2207; telephone 206–
issuing this AD to prevent overheating of the be emailed to: 9-ANM-Seattle-ACO-AMOC-
Requests@faa.gov. 544–5000, extension 1; fax 206–766–5680;
aft lower lobe cargo compartment, where, if Internet https://www.myboeingfleet.com.
temperature sensitive cargo is present, the (2) Before using any approved AMOC,
notify your appropriate principal inspector, (4) You may view this service information
release of flammable vapors could result in
or lacking a principal inspector, the manager at the FAA, Transport Airplane Directorate,
a fire or explosion if exposed to an ignition
of the local flight standards district office/ 1601 Lind Avenue SW., Renton, WA. For
source.
certificate holding district office. information on the availability of this
(f) Compliance (3) An AMOC that provides an acceptable material at the FAA, call 425–227–1221.
Comply with this AD within the level of safety may be used for any repair (5) You may view this service information
compliance times specified, unless already required by this AD if it is approved by the that is incorporated by reference at the
done. Boeing Commercial Airplanes Organization National Archives and Records
Designation Authorization (ODA) that has Administration (NARA). For information on
(g) Installation for Certain Airplanes been authorized by the Manager, Seattle the availability of this material at NARA, call
(Interim Action) ACO, to make those findings. For a repair 202–741–6030, or go to: http://
Within 12 months after the effective date method to be approved, the repair must meet www.archives.gov/federal-register/cfr/ibr-
of this AD, remove the existing markers and the certification basis of the airplane, and the locations.html.
install tape and new markers in the bulk approval must specifically refer to this AD. Issued in Renton, Washington, on May 21,
cargo compartment, in accordance with the (4) If the service information contains steps 2015.
Accomplishment Instructions of Boeing that are labeled as Required for Compliance
Special Attention Service Bulletin 747–21– (RC), the provisions of paragraphs (j)(4)(i) John P. Piccola, Jr.,
2544, Revision 2, dated December 11, 2014; and (j)(4)(ii) apply. Acting Manager, Transport Airplane
or using a method approved in accordance (i) The steps labeled as RC, including Directorate, Aircraft Certification Service.
with the procedures specified in paragraph (j) substeps under an RC step and any figures [FR Doc. 2015–13018 Filed 5–29–15; 8:45 am]
of this AD, as applicable. Accomplishing the identified in an RC step, must be done to BILLING CODE 4910–13–P
actions specified in paragraph (h) of this AD comply with the AD. An AMOC is required
within 12 months after the effective date of for any deviations to RC steps, including
this AD terminates the requirements of this substeps and identified figures.
paragraph. (ii) Steps not labeled as RC may be DEPARTMENT OF HEALTH AND
(h) Installation for All Airplanes deviated from using accepted methods in HUMAN SERVICES
(Terminating Action) accordance with the operator’s maintenance
or inspection program without obtaining Food and Drug Administration
Within 60 months after the effective date approval of an AMOC, provided the RC steps,
of this AD, install an additional zone
temperature sensor assembly in the aft cargo
including substeps and identified figures, can 21 CFR Part 876
still be done as specified, and the airplane
compartment, as specified in paragraph (h)(1) [Docket No. FDA–2015–N–1338]
can be put back in an airworthy condition.
or (h)(2) of this AD, as applicable. Doing this
action within 12 months after the effective (k) Related Information Medical Devices; Gastroenterology-
date of this AD terminates the requirements (1) For more information about this AD Urology Devices; Classification of the
of paragraph (g) of this AD. Rectal Control System
that is not incorporated by reference, contact
(1) For airplanes identified in Boeing
Susan Monroe, Aerospace Engineer, Cabin
Service Bulletin 747–21–2550, dated AGENCY: Food and Drug Administration,
Safety and Environmental Systems Branch,
December 6, 2013: Do the actions in HHS.
ANM–150S, FAA, 1601 Lind Avenue SW.,
accordance with the Accomplishment
Instructions of Boeing Service Bulletin 747– Renton, WA; phone: 425–917–6457; fax: 425– ACTION: Final order.
21–2550, dated December 6, 2013. 917–6590; email: susan.l.monroe@faa.gov.
(2) For service information identified in SUMMARY: The Food and Drug
(2) For airplanes having variable numbers
RC021 and RC573: Do the actions using a this AD, contact Boeing Commercial Administration (FDA) is classifying the
method approved in accordance with the Airplanes, Attention: Data & Services rectal control system into class II
procedures specified in paragraph (j) of this Management, P.O. Box 3707, MC 2H–65, (special controls). The special controls
AD. Seattle, WA 98124–2207; telephone 206– that will apply to the device are
544–5000, extension 1; fax 206–766–5680; identified in this order and will be part
(i) Credit for Previous Actions Internet https://www.myboeingfleet.com. You
may view this referenced service information
of the codified language for the rectal
This paragraph provides credit for
removing the existing markers and installing at the FAA, Transport Airplane Directorate, control system’s classification. The
tape and new markers in the bulk cargo 1601 Lind Avenue SW., Renton, WA. For Agency is classifying the device into
compartment, as required by paragraph (g) of information on the availability of this class II (special controls) in order to
this AD, if those actions were performed material at the FAA, call 425–227–1221. provide a reasonable assurance of safety
Lhorne on DSK2VPTVN1PROD with RULES

before the effective date of this AD using
(l) Material Incorporated by Reference
and effectiveness of the device.
Boeing Service Bulletin 747–21–2544, dated DATES: This order is effective June 1,
January 15, 2013; or Boeing Special Attention (1) The Director of the Federal Register
approved the incorporation by reference
2015. The classification was applicable
Service Bulletin 747–21–2544, Revision 1,
dated September 30, 2013. This service (IBR) of the service information listed in this on February 12, 2015.
information is not incorporated by reference paragraph under 5 U.S.C. 552(a) and 1 CFR FOR FURTHER INFORMATION CONTACT:
in this AD. part 51. Purva Pandya, Center for Devices and

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Document Created: 2015-12-15 15:18:44
Document Modified: 2015-12-15 15:18:44

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final order.
Dates		This order is effective June 1, 2015. The classification was applicable on February 12, 2015.
Contact		Purva Pandya, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G223, Silver Spring, MD 20993-0002, 240-402-9979, [email protected]
FR Citation		80 FR 30931

80 FR 30931 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Rectal Control System

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 104 (June 1, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration