MINITAPE URETHRAL SLING

K073646 · Mpathy Medical Devices, Ltd. · PAH · Feb 25, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073646
• Device Name: MINITAPE URETHRAL SLING
• Applicant: Mpathy Medical Devices, Ltd.
• Product Code: PAH · General, Plastic Surgery
• Decision Date: Feb 25, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Minitape* Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Story

Modified Minitape Urethral Sling is a totally disposable polypropylene tape mesh; used as a pubourethral sling for female urinary stress incontinence treatment. Device features central mesh sling with integral fixation zones on both sides to anchor to surrounding soft tissues. Used by surgeons in clinical settings to provide urethral support. Device functions by restraining urethral tissue to correct hypermobility or intrinsic sphincter deficiency. Benefits include restoration of continence through mechanical support.

Clinical Evidence

Bench testing only. In-vitro and in-vivo testing demonstrated the device's ability to adequately restrain urethral tissue under conditions in excess of those encountered during normal clinical use.

Technological Characteristics

Polypropylene tape mesh with integral fixation zones. Designed for surgical implantation as a pubourethral sling. Mechanical fixation principle. Class II surgical mesh.

Indications for Use

Indicated for female patients with urodynamically proven urinary stress incontinence caused by urethral hypermobility and/or intrinsic sphincter deficiency.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• Minitape RPTM Urethral Sling (K023898)
• SAFYRE Sling (K020007)
• SPARC Sling System (K021263)

Submission Summary (Full Text)

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K073646

MPATHY MEDICAL. DEVICES. LTD. MODIFIED MINITAPE* URETHRAI . SLING ·SPECIAL 510(K) NOTIFICATION

## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

FEE 25 20CC

| SUBMITTER | Mpathy Medical Devices Ltd.<br>Glasgow - United Kingdom |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Louis J. Mazzarese<br>U.S. Agent for Mpathy Medical Devices Ltd |
| DATE PREPARED | December 18, 2007 |
| CLASSIFICATION | Surgical Mesh; ref. 21 CFR 878.3300<br>Class II |
| COMMON NAME | Urethral Sling |
| PROPRIETARY<br>NAME | Modified Minitape* Urethral Sling |
| PREDICATE DEVICE | K023898 - Minitape RPTM Urethral Sling (Mpathy Medical<br>Devices)<br>K020007 - SAFYRE Sling (Corniche, LLC)<br>K021263 - SPARC Sling System (American Medical<br>Systems) |
| DEVICE<br>DESCRIPTION | The subject device is a totally disposable tape mesh intended<br>to be used as a pubourethral sling for the treatment of female<br>urinary incontinence resulting from urethral hypermobility<br>and/or intrinsic sphincter deficiency. It consists of a<br>polypropylene tape with integral fixation zones on either side<br>of a central mesh sling. These fixation zones at the ends of<br>the tape anchor the sling to surrounding soft tissues. |
| TESTING | The device has been subjected to in-vitro and in-vivo testing<br>which demonstrate the ability of the device to adequately<br>restrain urethral tissue under conditions in excess of those<br>encountered during normal clinical use. |

* FINAL TRADEMARK NAME TO BE DETERMINED

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mpathy Medical Devices, Ltd. % Mr. Louis J. Mazzarese 24 Barberry Lane MADISON CT 06443

SEP 2 8 2012

K073646 Re: Trade/Device Name: Modified Minitape* Urethral Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: February 11, 2008 Received: February 13, 2008

Dear Mr. Mazzarese:

This letter corrects our substantially equivalent letter of February 25, 2008.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Benjamin R. Perkins

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## MPATHY MEDICAL DEVICES, LTD. Modified Minitape* Urethral Sling SPECIAL 510(K) NOTIFICATION

## STATEMENT FOR INDICATIONS FOR USE

K073646 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Modified Minitape* Urethral Sling

Indications for Use: The Minitape* Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Prescription Use: Yes

DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** 11073642