TISSUE FIXATION SYSTEM

K050418 · Tfs Manufacturing Pty, Ltd. · FTL · May 16, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050418
• Device Name: TISSUE FIXATION SYSTEM
• Applicant: Tfs Manufacturing Pty, Ltd.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: May 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TFS Device is intended to be used in females to position a polypropylene mesh tape for the treatment of Genuine Stress Urinary Incontinence, mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse.

Device Story

The Tissue Fixation System (TFS) is a surgical device used by physicians to position polypropylene mesh tape for treating female urinary incontinence and vaginal vault prolapse. The system facilitates the placement and fixation of the mesh to support pelvic structures. It is used in a clinical/surgical setting. By providing a stable anchor for the mesh, the device aims to restore anatomical support, thereby alleviating symptoms of incontinence and prolapse.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device characteristics and intended use.

Technological Characteristics

Surgical mesh system utilizing polypropylene mesh tape. Class II device (21 CFR 878.3300).

Indications for Use

Indicated for females with Genuine Stress Urinary Incontinence, mixed incontinence due to urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse.

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.

Submission Summary (Full Text)

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MAY 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alastair Dowling QA Manager TFS Manufacturing Pty Ltd 18 Kincaid Avenue North Plympton, South Australia 5037 Australia

Re: K050418

Trade/Device Name: Tissue Fixation System (TFS Device) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 24, 2005 Received: March 28, 2005

Dear Mr. Dowling:

We have reviewed your Section 510(k) premarket notification of intent to market the device wfo nave ro rear your your be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the 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 application (PMA). and Cosmetic For (110) that 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 such additional controls. Existing major regulations affecting your device it may be second 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 – Mr. Alastair Dowling

This letter will allow you to begin marketing your device as described in your Section 510(k) This ictici will anow you to begin mailsonig of substantial equivalence of your device to a legally prematics notification: "The PDF in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acres at [phone] . Also, please note the regulation entitled, Colliaot the Office of Company of Commarket notification" (21CFR Part 807.97). You may obtain Mission of Terefonee to preneers to preneershilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## K050418

## INDICATIONS FOR USE STATEMENT

To be assigned 510(k) Number:

Tissue Fixation System (TFS Device) Device Name:

The TFS Device is intended to be used in females to Indications for Use: position a polypropylene mesh tape for the treatment of Genuine Stress Urinary Incontinence, mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse.

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Restorative

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