(141 days)
Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation.
Excision of intrauterine myomas
Excision of intrauterine polyps
Lysis of intrauterine adhesions
Incision of uterine septa
Endometrial ablation
The G-VAP Electrode is an Bipolar Electrosurgical Electrode. It is used in conjunction with the Scuba Electrosurgical Generator.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Versapoint Electrosurgery G-VAP Electrode Accessory:
Summary of Device Performance and Acceptance Criteria
Based on the provided documents, limited specific details are given regarding explicit acceptance criteria and corresponding reported device performance values in a quantitative manner. The submission primarily relies on a qualitative statement of performance verification.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | Device performs safely and effectively. | "It was determined that the device performs safely and effectively." |
| Performance Requirements | Meets all described performance requirements. | "product meets the performance requirements described." |
| Substantial Equivalence | Similar technological characteristics to predicate device (form, fit, function, method of operation). | "The modified device has the same technological characteristics as the predicate devices. The form, fit, function and method of operation are similar." |
| Intended Use | Suitable for tissue cutting, removal, and desiccation in gynecologic hysteroscopic electrosurgical procedures (myomas, polyps, adhesions, septa, endometrial ablation). | Device is intended for these uses and its performance supports them. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Pre-clinical as well as bench top testing" but does not provide details on the number of samples or tests conducted.
- Data Provenance: The nature of the testing (pre-clinical, bench top) suggests controlled laboratory environments. There is no information regarding country of origin of data or whether it was retrospective or prospective in a clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. The provided summary describes testing of an electrosurgical electrode and generator, which typically involves engineering and functional performance testing, not diagnostic accuracy requiring expert panel review for ground truth.
4. Adjudication Method for the Test Set
- Not applicable. As the testing is described as pre-clinical and bench top for an electrosurgical device, expert adjudication methods (like 2+1, 3+1) are not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. There is no mention of a multi-reader multi-case comparative effectiveness study. This type of study is typically relevant for interpretative diagnostic devices, not for an electrosurgical accessory.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is an electrosurgical electrode accessory, not a software algorithm or AI-based diagnostic tool. Therefore, a "standalone algorithm only" study is not relevant.
7. Type of Ground Truth Used
- Functional/Performance Standards: The ground truth would be established by engineering specifications, safety standards, and performance test protocols for electrosurgical devices (e.g., power output, safety cut-offs, tissue effect characteristics). The document generally states "performance requirements described," implying adherence to such standards.
8. Sample Size for the Training Set
- Not applicable. This device is a hardware accessory (electrosurgical electrode). The concept of a "training set" is typically associated with machine learning or AI models, which are not relevant here.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As mentioned above, the concept of a training set and its ground truth does not apply to this type of medical device.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope 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 hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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.