[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Rules and Regulations]
[Pages 43247-43249]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17542]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2014-M-0966]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Implantable Transprostatic Tissue Retractor System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final Order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
implantable transprostatic tissue retractor 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. 
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 August 25, 2014. The classification was 
applicable beginning September 13, 2013.

FOR FURTHER INFORMATION CONTACT: Mark Kreitz, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G270, Silver Spring, MD 20993-0002, 301-796-7019.

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). 
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

[[Page 43248]]

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 March 7, 2013, NeoTract, Inc., submitted a request for 
classification of the UroLift 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) of the FD&C Act. 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 de novo 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 September 13, 2013, FDA issued an order to the 
requestor classifying the device into class II. FDA is codifying the 
classification of the device by adding Sec.  876.5530 (21 CFR 
876.5530).
    Following the effective date of this final classification 
administrative order, any firm submitting a premarket notification 
(510(k)) for an implantable transprostatic tissue retractor system will 
need to comply with the special controls named in the final 
administrative order.
    The device is assigned the generic name implantable transprostatic 
tissue retractor system, and it is identified as a prescription use 
device that consists of a delivery device and implant. The delivery 
device is inserted transurethrally and deploys the implant through the 
prostate. It is designed to increase prostatic urethral patency by 
providing prostate lobe tissue retraction while preserving the 
potential for future prostate procedures and is intended for the 
treatment of symptoms due to urinary outflow obstruction secondary to 
benign prostatic hyperplasia in men.
    FDA has identified the following risks to health associated with 
this type of device and the measures required to mitigate these risks:

  Table 1--Implantable Tranprostatic Tissue Retractor System Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risks                    Mitigation measure
------------------------------------------------------------------------
Adverse Tissue Reaction to the Device..  Biocompatibility Testing.
                                         In Vivo Testing.
Infection Due to Presence of Foreign     Sterilization Validation.
 Body.                                   Labeling (including expiration
                                          dating).
                                         Shelf Life Testing.
Mitigation of Implanted Device.........  In Vivo Testing.
                                         Magnetic Resonance
                                          Compatibility Testing.
Failure to Deploy Device or              Non-clinical Testing.
 Misdeployment.                          In Vivo Testing.
                                         Labeling.
Failure of Implanted Device............  Non-clinical Testing
                                          (Mechanical).
                                         Non-clinical Testing
                                          (Resistance to Degradation).
                                         Shelf Life Testing.
                                         In Vivo Testing.
                                         Labeling.
Improperly Placed Implants.............  In Vivo Testing.
                                         Labeling.
Occurrence of Genito-Urinary Adverse     In Vivo Testing.
 Events.                                 Labeling.
Presence of Implants Adversly Affects    Non-clinical Testing
 Subsequent Interventions.               In Vivo Testing.
                                         Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in addition to 
the general controls, address these risks to health and provide 
reasonable assurance of safety and effectiveness:
 The elements of the device that may contact the patient must 
be demonstrated to be biocompatible.
 Performance data must demonstrate the sterility of the 
patient-contacting components of the device.
 Performance data must support shelf life by demonstrating 
continued sterility of the device (of the patient-contacting 
components), package integrity, and device functionality over the 
requested shelf life.
 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] Deployment testing must be conducted;
    [cir] mechanical strength must be conducted; and
    [cir] resistance-to-degradation testing must be conducted.
 Non-clinical testing must evaluate the compatibility of the 
device in a magnetic resonance environment.
 In vivo testing must demonstrate safe and effective use, 
assess the impact of the implants on the ability to perform subsequent 
treatments, document the adverse event profile associated with clinical 
use, and demonstrate that the device performs as intended under 
anticipated conditions of use. The following performance 
characteristics must be tested:

[[Page 43249]]

    [cir] Deployment testing must be conducted and
    [cir] implant migration must be conducted.
 Labeling must bear all information required for safe and 
effective use of the device, and must include:
    [cir] Specific instructions, warnings, cautions, limitations, and 
the clinical training needed for the safe use of the device;
    [cir] information on the patient population for which the device 
has been demonstrated to be effective;
    [cir] a detailed summary of the device technical parameters;
    [cir] information on how the device operates and the typical course 
of treatment;
    [cir] an expiration date/shelf life; and
    [cir] a detailed summary of the device- and procedure-related 
complications or adverse events pertinent to use of the device.

    Implantable transprostatic tissue retractor systems are 
prescription devices restricted to patient use only upon the 
authorization of a practitioner licensed by law to administer or use 
the device. (Proposed Sec.  876.5530(a); see section 520(e) of the FD&C 
Act (21 U.S.C. 360j(e)) and Sec.  801.109 (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) 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 implantable transprostatic tissue 
retractor 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 administrative 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.

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. K130651: De Novo Request per 513(f)(2) of the Federal Food, Drug, 
and Cosmetic Act From NeoTract, Inc., dated March 7, 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--GASTOENTEROLOGY-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, 371.


0
2. Add Sec.  876.5530 to subpart F to read as follows:


Sec.  876.5530  Implantable transprostatic tissue retractor system.

    (a) Identification. An implantable transprostatic tissue retractor 
system is a prescription use device that consists of a delivery device 
and implant. The delivery device is inserted transurethrally and 
deploys the implant through the prostate. It is designed to increase 
prostatic urethral patency by providing prostate lobe tissue retraction 
while preserving the potential for future prostate procedures and is 
intended for the treatment of symptoms due to urinary outflow 
obstruction secondary to benign prostatic hyperplasia in men.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The elements of the device that may contact the patient must be 
demonstrated to be biocompatible.
    (2) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
    (3) Performance data must support shelf life by demonstrating 
continued sterility of the device (of the patient-contacting 
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) Deployment testing must be conducted.
    (ii) Mechanical strength must be conducted.
    (iii) Resistance-to-degradation testing must be conducted.
    (5) Non-clinical testing must evaluate the compatibility of the 
device in a magnetic resonance environment.
    (6) In vivo testing must demonstrate safe and effective use, assess 
the impact of the implants on the ability to perform subsequent 
treatments, document the adverse event profile associated with clinical 
use, and demonstrate that the device performs as intended under 
anticipated conditions of use. The following performance 
characteristics must be tested:
    (i) Deployment testing must be conducted.
    (ii) Implant migration must be conducted.
    (7) Labeling must bear all information required for safe and 
effective use of the device, and must include:
    (i) Specific instructions, warnings, cautions, limitations, and the 
clinical training needed for the safe use of the device.
    (ii) Information on the patient population for which the device has 
been demonstrated to be effective.
    (iii) A detailed summary of the device technical parameters.
    (iv) Information on how the device operates and the typical course 
of treatment.
    (v) An expiration date/shelf life.
    (vi) A detailed summary of the device- and procedure-related 
complications or adverse events pertinent to use of the device.

    Dated: July 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17542 Filed 7-24-14; 8:45 am]
BILLING CODE 4164-01-P