
[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Rules and Regulations]
[Pages 18307-18310]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07815]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2015-N-0804]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Urethral Insert With Pump for Bladder Drainage

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
urethral insert with pump for bladder drainage 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 urethral insert with pump for bladder drainage'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 April 6, 2015. The classification was 
applicable on October 14, 2014.

FOR FURTHER INFORMATION CONTACT: John Baxley, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G210, Silver Spring, MD 20993-0002, 301-796-6549.

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.

[[Page 18308]]

    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 October 25, 2013, Vesiflo, Inc., submitted a request for 
classification of the inFlowTM Intraurethral Valve-Pump and 
Activator 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 October 14, 2014, FDA issued an order to the 
requestor classifying the device into class II. FDA is codifying the 
classification of the device by adding Sec.  876.5140.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a urethral 
insert with pump for bladder drainage will need to comply with the 
special controls named in this final order. The device is assigned the 
generic name urethral insert with pump for bladder drainage, and it is 
identified as a catheter-like device with internal pump mechanism that 
is placed in the urethra. Under patient control the internal pump draws 
urine out of the bladder when voiding is desired, and blocks urine flow 
when continence is desired. The device is intended for use by women who 
cannot empty their bladder due to impaired detrusor contractility.
    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--Urethral Insert With Pump for Bladder Drainage Risks and Mitigation Measures
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               Identified risk                                        Mitigation measure
----------------------------------------------------------------------------------------------------------------
Adverse Tissue Reaction.....................  Biocompatibility Testing.
Infection...................................  Sterilization Validation.
                                              Clinical Testing.
                                              Labeling.
Reflux or Renal Damage......................  Non-Clinical (Bench) Testing.
                                              Clinical Testing.
                                              Labeling.
Urethral/Bladder Wall Trauma................  Clinical Testing.
                                              Labeling.
Urinary Frequency/Urgency...................  Clinical Testing.
                                              Labeling.
Device Encrustation.........................  Non-Clinical (Bench) Testing.
                                              Labeling.
Device Migration............................  Non-Clinical (Bench) Testing.
                                              Clinical Testing.
Device Malfunction..........................  Non-Clinical (Bench) Testing.
                                              Labeling.
Urine Leakage...............................  Non-Clinical (Bench) Testing.
                                              Labeling.
Discomfort..................................  Clinical Testing.
                                              Labeling.
----------------------------------------------------------------------------------------------------------------

    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:
     The elements of the device that may contact the urinary 
tract must be demonstrated to be biocompatible.
     Performance data must demonstrate the sterility of the 
device components that contact the urinary tract.
     Performance data must support shelf life by demonstrating 
continued sterility of the device (or the sterile components), package 
integrity, and device functionality over the requested shelf life.

[[Page 18309]]

     Non-clinical testing data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    [cir] Urine flow rate testing.
    [cir] Valve integrity testing.
    [cir] Bladder neck retention force testing.
    [cir] Pump/valve endurance testing.
    [cir] Encrustation testing.
    [cir] Remote control reliability, mechanical integrity, and battery 
life testing.
     Clinical testing must demonstrate safe and effective use, 
document the device acceptance rate and the adverse event profile 
associated with clinical use, and demonstrate that the device performs 
as intended under anticipated conditions of use.
     Labeling must include:
    [cir] Specific instructions, contraindications, warnings, cautions, 
limitations, and the clinical training needed for the safe use of the 
device.
    [cir] Statement of the maximum insert indwelling period.
    [cir] Information on the patient education and support program 
prior to and during initial device use.
    [cir] Information on the patient population for which the device 
has been demonstrated to be safe and effective.
    [cir] Information on how the device operates and the recommended 
treatment regimen.
    [cir] A detailed summary of the device- and procedure-related 
complications or adverse events pertinent to use of the device.
    [cir] An expiration date/shelf life.
     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 
treatment regimen.
    [cir] Information on the patient education and support program 
prior to and during initial device use.
    [cir] Information on the patient population for which there is 
clinical evidence of safety and effectiveness.
    [cir] The potential risks and benefits associated with the use of 
the device.
    [cir] Post-insertion care instructions.
    [cir] Alternative treatments.
    Urethral inserts with pump for bladder drainage are prescription 
devices restricted to patient use only upon the authorization of a 
practitioner licensed by law to administer or use the device; see 
section 520(e) of the FD&C Act (21 U.S.C. 360j(e)) and 21 CFR 801.109 
(Prescription devices). Prescription-use restrictions are a type of 
general controls as defined in section 513(a)(1)(A)(i) of the FD&C Act.
    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 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 
urethral inserts with pump for bladder drainage 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 21 
CFR 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. DEN130044: De Novo Request per 513(f)(2) from Vesiflo, Inc., 
dated October 25, 2013.

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.  876.5140 to subpart F to read as follows:


Sec.  876.5140  Urethral insert with pump for bladder drainage.

    (a) Identification. A urethral insert with pump for bladder 
drainage is a catheter-like device with internal pump mechanism that is 
placed in the urethra. Under patient control the internal pump draws 
urine out of the bladder when voiding is desired, and blocks urine flow 
when continence is desired. The device is intended for use by women who 
cannot empty their bladder due to impaired detrusor contractility.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The elements of the device that may contact the urinary tract 
must be demonstrated to be biocompatible.
    (2) Performance data must demonstrate the sterility of the device 
components that contact the urinary tract.
    (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 requested shelf life.
    (4) Non-clinical testing data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Urine flow rate testing.
    (ii) Valve integrity testing.
    (iii) Bladder neck retention force testing.
    (iv) Pump/valve endurance testing.
    (v) Encrustation testing.
    (vi) Remote control reliability, mechanical integrity, and battery 
life testing.
    (5) Clinical testing must demonstrate safe and effective use, 
document the device acceptance rate and the adverse event profile 
associated with clinical use, and demonstrate that the device performs 
as intended under anticipated conditions of use.

[[Page 18310]]

    (6) Labeling must include:
    (i) Specific instructions, contraindications, warnings, cautions, 
limitations, and the clinical training needed for the safe use of the 
device.
    (ii) Statement of the maximum insert indwelling period.
    (iii) Information on the patient education and support program 
prior to and during initial device use.
    (iv) Information on the patient population for which the device has 
been demonstrated to be safe and effective.
    (v) Information on how the device operates and the recommended 
treatment regimen.
    (vi) A detailed summary of the device- and procedure-related 
complications or adverse events pertinent to use of the device.
    (vii) An expiration date/shelf life.
    (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 
treatment regimen.
    (iii) Information on the patient education and support program 
prior to and during initial device use.
    (iv) Information on the patient population for which there is 
clinical evidence of safety and effectiveness.
    (v) The potential risks and benefits associated with the use of the 
device.
    (vi) Post-insertion care instructions.
    (vii) Alternative treatments.

    Dated: March 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07815 Filed 4-3-15; 8:45 am]
 BILLING CODE 4164-01-P


