(87 days)
The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and are intended to facilitate in the placement of the GYNECARE TVT Device.
The GYNECARE TVT Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.
The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT Device.
The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and GYNECARE TVT Abdominal Guides and Couplers are included in each kit.
The GYNECARE TVT Abdominal Guides and Couplers are single use devices used to facilitate placement of the GYNECARE TVT Device when placed in a top-down retropubic fashion (also known as an abdominal approach).
The GYNECARE TVT EXACT Continence System is intended to be used as a pubo-urethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The GYNECARE TVT EXACT Continence System Trocar is a single use device intended to aid in the placement of the GYNECARE TVT EXACT Continence System retropubically.
The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT EXACT Continence System.
The GYNECARE TVT Obturator Device is intended to be used in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The GYNECARE TVT Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT Obturator Device.
The GYNECARE TVT ABBREVO Continence System is intended for use in women as a suburethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The GYNECARE TVT ABBREVO Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO Device.
GYNECARE TVT™ Tension-free Vaginal Tape System: Consists of PROLENE™ Polypropylene Mesh (tape) with clear plastic Sheaths and stainless steel needles. The mesh is knitted filaments of extruded polypropylene strands. GYNECARE TVT™ Reusable Introducer (available separately) is a reusable stainless steel instrument. GYNECARE TVT™ Rigid Catheter Guide (available separately) is a non-sterile reusable stainless-steel instrument.
GYNECARE TVT™ with Abdominal Guides Tension-free Support for Incontinence System: Includes GYNECARE TVT™ Abdominal Guide, a sterile disposable instrument, and GYNECARE TVT™ Coupler, a sterile disposable polypropylene connector.
GYNECARE TVT EXACT™ Continence System: A sterile, single patient use procedure kit consisting of the GYNECARE TVT EXACT Continence System Trocar Sheath / Implant Assembly (blue PROLENE™ Polypropylene Mesh with clear plastic Sheaths and white Trocar Sheaths) and the GYNECARE TVT EXACT Continence System Trocar (stainless-steel Trocar Shaft and plastic Trocar Handle).
GYNECARE TVT™ Obturator System: A sterile, single patient use procedure kit consisting of the GYNECARE TV Obturator Device (undyed or blue PROLENE™ polypropylene mesh with clear plastic sheath and plastic tube receptacles) and the GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide (two stainless steel, curved wire helical passers with plastic handles and a stainless steel accessory instrument).
GYNECARE TVT ABBREVO™ Continence System: A sterile, single-patient use procedure kit consisting of the GYNECARE TVT ABBREVO Implant Assembly (blue PROLENE™ Polypropylene Mesh with clear plastic Sheaths and Helical Passer Sheaths, and Positioning Lines) and the GYNECARE TVT ABBREVO Placement Loop (PROLENE Polypropylene Monofilament loop with an attached polypropylene button). Also includes GYNECARE TVT ABBREVO™ Helical Passers and Atraumatic Winged Guide (two stainless steel, curved wire helical passers with plastic handles and a stainless steel accessory instrument).
The provided document is a 510(k) summary for the GYNECARE TVT™ System and related devices. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and efficacy through new clinical studies against specific acceptance criteria.
Therefore, the document does not contain information about:
- Clearly defined acceptance criteria for device performance.
- A standalone study proving the device meets specific acceptance criteria.
- Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for test and training sets.
Instead, the document states:
- Substantial Equivalence: The primary assertion is that "the subject devices are substantially equivalent to their respective predicate devices."
- Technological Characteristics: "The subject devices and their respective predicate devices are identical and therefore have the same technological characteristics."
- Differences from Predicates: The only stated differences are in "labeling (Instructions for Use)" which have been "revised to meet the new European Union (EU) Medical Device Regulation (MDR) requirements" and include additional information such as warnings, adverse events, safety information, and information for patients. Minor clarifications to "Indications and Contraindications statements" were also made.
- Performance Data: "No performance data are needed to evaluate these labeling changes." This explicitly states that no new performance studies were conducted or required for this particular submission.
In summary, there is no study described in this document that proves acceptance criteria because the submission's purpose is to demonstrate substantial equivalence based on identical technological characteristics and updated labeling, not new performance data.
§ 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.