(272 days)
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™ Reusable Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT™ device retropubically.
The GYNECARE TVT™ Reusable Rigid Catheter Guide is a reusable device intended to facilitation of the urethra and bladder neck during the placement of the GYNECARE TVT™ device.
The subject devices included the following components:
GYNECARE TVT™ Reusable Introducer
GYNECARE TVT™ Reusable Rigid Catheter Guide
GYNECARE TVT™ Abdominal Guides and Couplers
The subject devices are intended to be used with the GYNECARE TVT™ sling intended to treat stress urinary incontinence.
GYNECARE TVT™ Reusable Introducer: The GYNECARE TVT Introducer is provided non-sterile and is reusable. The Introducer is made of stainless steel. It consists of two parts, a handle and an inserted threaded metal shaft. The Introducer is intended to facilitate the passage of the GYNECARE TVT Device from the vagina to the abdominal skin. It is connected and fixed to the needle, via the threaded end of the shaft, prior to inserting the needle with the tape.
GYNECARE TVT™ Reusable Rigid Catheter Guide: The GYNECARE TVT Rigid Catheter Guide is a non-sterile reusable instrument intended to facilitate the identification of the urethra and the bladder neck during the surgical procedure. It is inserted into a Foley catheter (recommended size 18 French) positioned in the bladder via the urethra. To facilitate insertion, it can be lubricated with gel.
GYNECARE TVT™ Abdominal Guide: The GYNECARE TVT abdominal guide is a sterile disposable instrument intended to facilitate passage of the GYNECARE TVT device. Two abdominal guides are included in each kit with the GYNECARE TVT couplers.
GYNECARE TVT™ Coupler: The GYNECARE TVT coupler is a sterile disposable polypropylene connector used to connect the GYNECARE TVT abdominal quide to the GYNECARE TVT needle. Two couplers are included in each kit with abdominal quides.
The provided text is a 510(k) summary for medical devices, specifically instrumental accessories for urogynecologic surgical mesh. It does not describe an AI device or a study involving AI performance. Therefore, I cannot extract the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or human reader effectiveness with AI.
The document discusses the following:
- Device Names: GYNECARE TVT™ Abdominal Guides and Couplers, GYNECARE TVT™ Reusable Introducer, GYNECARE TVT™ Reusable Rigid Catheter Guide.
- Intended Use: These are instrumental accessories used to facilitate the placement of the GYNECARE TVT™ device (a surgical mesh for stress urinary incontinence).
- Predicate Device: GYNECARE TVT™ (K012628), which is the surgical mesh system itself.
- Performance Testing: Sterilization validation, reprocessing validation, package integrity, dimensional and mechanical performance, biocompatibility (cytotoxicity, sensitization, irritation), and shelf life.
- Conclusion: The subject devices are substantially equivalent to the predicate device and meet special controls for urogynecologic surgical mesh instrumentation.
This document clearly focuses on the safety and effectiveness of conventional surgical instruments, not on the performance of an AI-powered diagnostic or assistive tool.
§ 884.4910 Specialized surgical instrumentation for use with urogynecologic surgical mesh.
(a)
Identification. Specialized surgical instrumentation for use with urogynecologic surgical mesh is a prescription device specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures. These procedures include transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), and treatment of female stress urinary incontinence. Examples of specialized surgical instrumentation include needle passers and trocars, needle guides, fixation tools, and tissue anchors. This device is not a manual gastroenterology-urology surgical instrument and accessories (§ 876.4730) or a manual surgical instrument for general use (§ 878.4800).(b)
Classification. Class II (special controls). The special controls for specialized surgical instrumentation for use with urogynecologic surgical mesh are:(1) The device must be demonstrated to be biocompatible;
(2) The device must be demonstrated to be sterile and, if reusable, it must be demonstrated that the device can be adequately reprocessed;
(3) Performance data must support the shelf life of the device by demonstrating package integrity and device functionality over the requested shelf life;
(4) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use; and
(5) Labeling must include:
(i) Information regarding the mesh design that may be used with the device;
(ii) Detailed summary of the clinical evaluations pertinent to use of the device;
(iii) Expiration date; and
(iv) Where components are intended to be sterilized by the user prior to initial use and/or are reusable, validated methods and instructions for sterilization and/or reprocessing of any reusable components.