(79 days)
Verres Needle and Cannula is intended for use in multiple surgical specialties that utilize minimally invasive surgical procedures to establish pneumoperitoneum and to provide access for operative and diagnostic instrumentation.
Verres Needle and Cannula
The provided text is a 510(k) Summary of Safety and Effectiveness for a Verres Needle and Cannula, which is a medical device for establishing pneumoperitoneum and providing access in laparoscopic surgery. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed results from a clinical study with specific acceptance criteria and performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (especially those related to AI or human reader improvement) are not applicable or not present in this type of regulatory submission. The document relies on the equivalence of material and design to established devices rather than new performance data.
Here's an analysis based on the provided text, addressing the points where information is available or relevant:
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
The acceptance criteria for the Verres Needle and Cannula are implicitly based on its substantial equivalence to predicate devices, namely the Gynescope Trocar and Sleeves and the Marlow Verres Needle. The study described is a comparison of technological characteristics and intended use to these predicate devices.
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" here are defined by the comparable characteristics of the predicate devices. The "reported device performance" is the Verres Needle and Cannula's characteristics, which are shown to be similar.
| Feature / Acceptance Criteria (based on predicate) | Verres Needle and Cannula Performance (reported) |
|---|---|
| Material: Stainless Steel (like predicate) | Stainless Steel |
| Needle Type: Spring-Loaded (like Marlow Verres Needle) | Spring-Loaded |
| Diameter Range: Comparable to predicate devices (2.0mm to 11.5mm) | 2.0 - 5.0mm (within the range of predicate devices) |
| Intended Use: Establish pneumoperitoneum and provide access in minimally invasive surgical procedures | Intended for use in multiple surgical specialties that utilize minimally invasive surgical procedures to establish pneumoperitoneum and to provide access for operative and diagnostic instrumentation. |
| Safety and Effectiveness: Comparable to predicate devices | Stated as comparable to the Gynescope Trocar and Sleeves and the Marlow Verres Needle. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is not a clinical study involving a test set of patient data. The comparison is based on the design and material specifications of the device itself against established predicate devices.
- Data Provenance: Not applicable. The "data" are the specifications of the device and its predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "test set" and no "ground truth" in the sense of expert assessment of clinical data for this type of submission. The ground truth for substantial equivalence is the established safety and effectiveness of the predicate devices based on their historical use and regulatory clearances.
4. Adjudication method for the test set
- Not applicable. No test set requiring adjudication was used. The regulatory body (FDA) makes the final determination of substantial equivalence based on the submitted comparison.
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
- No, an MRMC comparative effectiveness study was not done. 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
- No, a standalone algorithm performance study was not done. This device does not involve algorithms or AI.
7. The type of ground truth used
- The "ground truth" implicit in a 510(k) substantial equivalence submission is the established safety and effectiveness of legally marketed predicate devices. The new device is compared against these established devices to demonstrate it raises no new questions of safety or effectiveness.
8. The sample size for the training set
- Not applicable. This device does not involve algorithms or machine learning, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. 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 preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the 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.