GYNE IDEAS MINITAPE RP DEVICE

K023898 · Gyne Ideas , Ltd. · PAH · Jun 18, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023898
• Device Name: GYNE IDEAS MINITAPE RP DEVICE
• Applicant: Gyne Ideas , Ltd.
• Product Code: PAH · General, Plastic Surgery
• Decision Date: Jun 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Story

Polypropylene sling with integral serrated anchoring arms; 14cm length. Supplied with two metal needles for surgical placement. Used by surgeons in clinical settings to treat female urinary incontinence. Device provides mechanical support to the urethra to restore continence. Sterile, single-use implant.

Clinical Evidence

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

Technological Characteristics

Polypropylene sling with integral serrated anchoring arms; 14cm length. Supplied with two metal needles. Sterile. Class II surgical mesh (Product Code: PAH).

Indications for Use

Indicated for female patients with urinary 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

• Tension Free Vaginal Tape (TVT) System (K974098)
• Biosling (K010553)
• SAFYRE Sling (K020007)
• Surgical Mesh (K020110)
• T-Sling (K020652)
• SiiS#1 Tissue Suspension System (K020705)
• SPARC Sling System (K021263)

Submission Summary (Full Text)

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JUN 1 8 2003

Gyne Ideas Ltd. 510(k) Notification

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## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

| SUBMITTER | Gyne Ideas, Ltd.<br>West of Scotland Science Park<br>Glasgow, U.K. |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Louis J. Mazzarese<br>(U.S. Agent for GyneIdeas, Ltd.) |
| DATE PREPARED | November 20, 2002 |
| CLASSIFICATION | Polymeric Surgical Mesh |
| COMMON NAME | Urethral Sling |
| PROPRIETARY NAME | Gyne Ideas Minitape RP™ |
| PREDICATE DEVICES | K974098 - Tension Free Vaginal Tape (TVT) System<br>(Ethicon, Inc.)<br>K010553 - Biosling (Injetx, Inc.)<br>K020007 - SAFYRE Sling (Corniche, LLC)<br>K020110 - Surgical Mesh (Boston Scientific)<br>K020652 - T-Sling (Herniamesh USA, Inc.)<br>K020705 - SiiS#1 Tissue Suspension System (T.A.G.<br>Medical Products, Ltd.)<br>K021263 - SPARC Sling System (American Medical Systems) |
| DEVICE<br>DESCRIPTION | The device consists of a polypropylene sling with integral<br>serrated anchoring arms. The sling has an overall length of<br>14cm. It is supplied with two metal needles to aid in surgical<br>placement of the device. The device is supplied sterile. |
| INTENDED USE | To be used as a pubourethral sling for the treatment of<br>female urinary incontinence resulting from urethral<br>hypermobility and/or intrinsic sphincter deficiency. |
| 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. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure composed of three human profiles facing to the right. The profiles are stacked on top of each other, creating the shape of the bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

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

Mr. Louis J. Mazzarese Gyne Ideas, Ltd. 150 Aran Hill Road FAIRFIELD CT 06824-1712

SEP 28 2012

Re: K023898 Trade/Device Name: Gyne Ideas Minitape RPTM Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: April 4, 2003 Received: April 7, 2003

Dear Mr. Mazzarese:

This letter corrects our substantially equivalent letter of June 18, 2003.

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 (QS) 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/ReportalProblem/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. Krebs

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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ψ23898

## Gyne Ideas Ltd. 510(k) Notification

## STATEMENT FOR INDICATIONS FOR USE

The subject device is intended to be used as a pubourethral sling for the treatment
and the subject the first for the blogs and chility and/or intrinsin of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Muriam C. Provost
Division Sign-Off

vision of General, Restorative and Neurological Devices

510(k) Number K023898

Gyne Ideas Minitape RP™