(195 days)
The ColpoWave Colpotomizer and CerviGrip Uterine Manipulator is indicated for use by a surgeon in laparoscopic procedures where uterine manipulation of the position of the vaginal fornices for colpotomy incisions is required, and for maintaining pneumoperitoneum during vaginal vault closure.
The Surgitools Pty Ltd. ColpoWave Colpotomizer and CerviGrip Uterine Manipulator consists of the ColpoWave™ Colpotomizer, CerviGrip™ Uterine Manipulator, and the ColpoWave™ Balloon accessory. All parts are made without natural latex rubber and supplied sterile to be disposed of after use.
The single-use CerviGrip™ Uterine Manipulator is designed with an integrated cervical screw, a sliding uterine tip, tail screw that can lock the uterine tip in place, and a screw to hold the colpotomizer in place. The CerviGrip™ Uterine Manipulator is manufactured with ABS polymer and 304 Stainless Steel.
The ColpoWave™ Colpotomizer is non-fenestrated and has incorporated two different sizes due to the double-ended colpotomizer design (30mm or 40mm diameter). Cup shape with one partial circumferential raised lip at each end and a second partial raised circumferential lip 20mm from each end providing the surgeon with a known distance to help gauge pelvic distances during dissection. The ColpoWave™ Colpotomizer is manufactured with green ABS polymer to provide better visualization (greater contrast than white against tissue).
The ColpoWave™ Balloon is an optional accessory, which is inflated to fit various vaginas.
The provided FDA 510(k) summary for the ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of clinical performance or diagnostic accuracy. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing, biocompatibility, sterilization validation, and shelf-life testing).
Therefore, I cannot provide the requested information regarding acceptance criteria and clinical study details (sample size, data provenance, expert ground truth establishment, adjudication, MRMC studies, standalone performance, or training set details) from the provided text.
However, I can extract the non-clinical performance data that was used to demonstrate the device's safety and effectiveness.
Non-Clinical Performance Data
The device's safety and effectiveness and substantial equivalence were demonstrated through the following non-clinical tests:
1. Table of Acceptance Criteria (Implied) and Reported Device Performance:
Since explicit acceptance criteria values are not provided, I will list the type of performance testing and the outcome, implying that the device met the internal requirements, and national/international standards for these tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance Testing | The device successfully passed bench testing to evaluate mechanical and functional properties. It was shown to be robust to withstand forces that exceed expected in-use forces, including tensile tests, manipulation, and balloon strength and stability. (Implied: Met internal requirements, national, and international standards for mechanical and functional properties.) A specific acceptance value is not provided. |
| Biocompatibility Testing | Test Performed: Cytotoxicity, Intracutaneous Reactivity, Sensitization, and Acute Systemic Toxicity testing per ISO 10993-1, ISO 10993-10, and ISO 10993-11. Tests were conducted on finished, packaged, and sterilized devices. |
| Reported Performance: All patient-contacting device components passed biocompatibility testing required by ISO 10993-1 and FDA General Program Memorandum G95-1. (Implied: Met specified limits for these tests.) | |
| Sterilization Validation | Standard: ISO 11135-1. |
| Reported Performance: Validation results met the acceptance criteria defined in the standard. Demonstrated ability of the process to deliver a Sterility Assurance Level (SAL) of $10^{-6}$. | |
| EtO Residuals: Conducted in accordance with ISO 10993-7. Validated a minimum release period of 7 days. (Implied: Residuals were within acceptable limits.) | |
| Shelf Life Testing | Method: Accelerated aging post-sterilization. |
| Reported Performance: Demonstrated no degradation in strength or functionality over the anticipated shelf life period of three (3) years. (Implied: Maintained specified strength and functionality after accelerated aging.) |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. The document explicitly states: "There was no human clinical testing required to support the substantial equivalence of the subject device." The tests performed were laboratory-based (bench testing, biocompatibility, sterilization, shelf-life).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. No clinical test set with corresponding expert ground truth was utilized.
4. Adjudication Method for the Test Set:
Not applicable. No clinical test set or adjudication method was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. As no human clinical testing was performed, no clinical ground truth (expert consensus, pathology, outcomes data) was established for the device. The "ground truth" for the non-clinical tests would have been the established performance specifications and regulatory standards for mechanical properties, biocompatibility, sterilization, and shelf life.
8. The sample size for the training set:
Not applicable. This device is a surgical instrument, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As no training set was used, no ground truth for a training set was established.
§ 884.1640 Culdoscope and accessories.
(a)
Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.