Source: https://www.federalregister.gov/documents/2014/07/25/2014-17542/medical-devices-gastroenterology-urology-devices-classification-of-the-implantable-transprostatic
Timestamp: 2017-08-21 03:07:06
Document Index: 526446658

Matched Legal Cases: ['ART 876', '§\u2009876', '§\u2009876', '§\u2009801', 'art 807', 'art 801', '§\u2009876', '§\u2009876']

Federal Register :: Medical Devices; Gastroenterology-Urology Devices; Classification of the Implantable Transprostatic Tissue Retractor System
Medical Devices; Gastroenterology-Urology Devices; Classification of the Implantable Transprostatic Tissue Retractor System
A Rule by the Food and Drug Administration on 07/25/2014
FDA-2014-M-0966
PART 876—GASTOENTEROLOGY-UROLOGY DEVICES
https://www.federalregister.gov/d/2014-17542 https://www.federalregister.gov/d/2014-17542
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.
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 Start Printed Page 43248undertake 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.
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).
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 § 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.
Table 1—Implantable Tranprostatic Tissue Retractor System Risks and Mitigation Measures
Adverse Tissue Reaction to the Device Biocompatibility Testing. In Vivo Testing.
Infection Due to Presence of Foreign Body Sterilization Validation. Labeling (including expiration dating). Shelf Life Testing.
Mitigation of Implanted Device In Vivo Testing. Magnetic Resonance Compatibility Testing.
Failure to Deploy Device or Misdeployment Non-clinical Testing. 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 Events In Vivo Testing. Labeling.
Presence of Implants Adversly Affects Subsequent Interventions Non-clinical Testing In Vivo Testing. Labeling.
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.
○ Deployment testing must be conducted;
○ mechanical strength must be conducted; and
○ 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:Start Printed Page 43249
○ Deployment testing must be conducted and
○ implant migration must be conducted.
Labeling must bear all information required for safe and effective use of the device, and must include:
○ Specific instructions, warnings, cautions, limitations, and the clinical training needed for the safe use of the device;
○ information on the patient population for which the device has been demonstrated to be effective;
○ information on how the device operates and the typical course of treatment;
○ an expiration date/shelf life; and
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 § 876.5530(a); see section 520(e) of the FD&C Act (21 U.S.C. 360j(e)) and § 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.
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.
1. K130651: De Novo Request per 513(f)(2) of the Federal Food, Drug, and Cosmetic Act From NeoTract, Inc., dated March 7, 2013.
2. Add § 876.5530 to subpart F to read as follows:
§ 876.5530
Implantable transprostatic tissue retractor system.
[FR Doc. 2014-17542 Filed 7-24-14; 8:45 am]