(281 days)
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 and GYNECARE TVT EXACT Continence System.
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 subject devices include the following components:
GYNECARE TVT™ Reusable Introducer
GYNECARE TVTTM Reusable Rigid Catheter Guide
GYNECARE TVT EXACT™ Continence System Trocar
The subject devices are intended to be used with the GYNECARE TVT™ Device and GYNECARE TVT EXACT™ Continence System 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 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 Folev catheter (recommended size 18 French) positioned in the urethra. To facilitate insertion, it can be lubricated with gel.
GYNECARE TVT EXACT™ Continence System Trocar
The GYNECARE TVT EXACT™ Continence System Trocar consists of the stainless steel Trocar Shaft and the plastic Trocar Handle. The Trocar Shaft is designed to fit inside the white Trocar Sheaths on the GYNECARE TVT EXACT™ Continence System Implant / Trocar Sheath Assembly, and is used to position the GYNECARE TVT EXACT™ Continence System Implant in the patient from a vaginal incision up through the abdominal wall.
This document describes a 510(k) premarket notification for reusable surgical instruments (GYNECARE TVT™ Reusable Introducer, GYNECARE TVT™ Reusable Rigid Catheter Guide) and a single-use instrument (GYNECARE TVT EXACT™ Continence System Trocar), which are accessories for urogynecologic surgical mesh systems. The submission asserts substantial equivalence to predicate devices (K974098 and K132054).
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail threshold manner for performance. Instead, it lists the types of performance tests conducted and concludes that the devices meet the requirements, implying that the results of these tests were considered acceptable.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Purity/Sterilization: | |
| Sterilization Validation | Sterile to an SAL for 10^-6 |
| Material/Biocompatibility: | |
| Biocompatibility | Biocompatible (Cytotoxicity, Sensitization, Irritation tests successful) |
| Functionality/Durability: | |
| Dimensional and Mechanical Performance | Sufficient mechanical performance for intended use |
| Reprocessing Validation (Reusable devices only) | Can be adequately reprocessed |
| Package Integrity | Adequate |
| Shelf Life | Validated shelf life |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the sample sizes used for any of the performance tests (e.g., how many devices were tested for mechanical performance, sterilization, or reprocessing).
The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These were likely conducted in a controlled laboratory environment by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This type of information is not applicable to the performance characteristics studied for these medical instruments. The "ground truth" for mechanical performance, sterility, or biocompatibility is established through objective laboratory testing and industry standards, not through expert consensus on interpretation, as might be the case for an AI diagnostic device.
4. Adjudication Method for the Test Set:
This is not applicable as the tests relate to objective engineering and biological performance characteristics, not subjective clinical interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. These devices are surgical instruments, not diagnostic tools that would directly assist human readers in interpreting images or data. Therefore, the concept of "effect size of how much human readers improve with AI vs. without AI assistance" is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone performance study in the context of an algorithm is not applicable. These are physical medical devices, not software algorithms.
7. The type of ground truth used:
The "ground truth" for these tests would be established by:
- Sterilization Validation: Demonstrated sterility to a specified Sterility Assurance Level (SAL) through objective microbiological testing.
- Mechanical Performance: Adherence to engineering specifications and relevant industry standards for strength, durability, and dimensional accuracy, measured objectively.
- Biocompatibility: Compliance with ISO 10993 standards, assessed through laboratory tests (e.g., cell culture for cytotoxicity, animal models for sensitization/irritation).
- Reprocessing Validation: Demonstrated effectiveness of cleaning, disinfection/sterilization, and functional integrity after multiple reprocessing cycles, verified through objective testing.
- Package Integrity: Objective tests to ensure sterile barrier integrity.
- Shelf Life: Stability and functional integrity over time, verified through accelerated aging or real-time shelf-life studies.
8. The Sample Size for the Training Set:
This concept is not applicable. These are physical medical instruments and do not involve machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set was Established:
This concept is not applicable for the same reason as above (no machine learning involved).
§ 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.