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K Number
K050418
Device Name
TISSUE FIXATION SYSTEM
Manufacturer
TFS MANUFACTURING PTY LTD
Date Cleared
2005-05-16

(87 days)

Product Code
FTL
Regulation Number
878.3300
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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 Description

Tissue Fixation System (TFS Device)

AI/ML Overview

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.

§ 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.