(87 days)
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.
Tissue Fixation System (TFS Device)
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, data provenance, ground truth establishment, or expert involvement for a medical device. The document is an FDA 510(k) clearance letter for a "Tissue Fixation System (TFS Device)," acknowledging its substantial equivalence to legally marketed predicate devices for specific indications for use. It outlines regulatory requirements but does not contain the detailed study information you've requested.
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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 (240) 276-0115 . 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 (800) 638-2041 or (301) 443-6597 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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§ 878.3300 Surgical mesh.
(a)
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.(b)
Classification. Class II.