(24 days)
The Applied Laparoscopic Monopolar Scissors is indicated for use in patients undergoing general, gynecologic and urologic endoscopic procedures for mobilization and transection of tissue.
The Applied Laparoscopic Disposable Monopolar Scissors consists of a ratcheting handle attached to an insulated shaft with scissor blades. The handle includes male cautery connector to be utilized for monopolar cautery when attached to standard monopolar cautery cables and their generators. The scissor blade length is 17.4mm and the blade opening is 5.59mm and will be available in working lengths of 32cm, and 45cm. The device is to be supplied sterile in single unit pouches.
This document describes the premarket notification (510(k)) for the Applied Laparoscopic Disposable Monopolar Scissors. The study conducted was a substantial equivalence comparison to a predicate device, not a multi-reader, multi-case comparative effectiveness study or a standalone algorithm performance study. Therefore, some requested information regarding AI-specific studies (e.g., effect size of human readers with AI, training set details, and ground truth establishment for training) is not applicable to this submission.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Design Input Requirements) | Reported Device Performance (functional characteristics) |
|---|---|
| Biocompatibility | Compliance with ISO 10993 |
| Sterility Assurance Level | 10⁻⁶ (validated using AAMI FDS-1 TIR 27 2001 Radiation sterilization - Substantiation of 25 kGy as sterilization dose - Method VDMax) |
| Dielectric Withstand (per ANSI/AAMI HF-18: 2001) | Met acceptance criteria during bench testing |
| Cutting Functionality | Met acceptance criteria during bench testing |
| Monopolar Functionality | Met acceptance criteria during bench testing |
| Dimensional Compatibility (with specified ranges for blade length, opening, and working lengths) | Met acceptance criteria during dimensional comparison |
| Substantial Equivalence to predicate device (functional characteristics) | Demonstrated through design analysis, comparisons, and bench testing to the Applied Laparoscopic Monopolar Scissor (K040295) |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing and design analysis for various functional characteristics and dimensional comparisons. It does not specify a "test set" in terms of patient data or clinical cases. The testing was conducted on the physical device itself. Therefore, information on sample size for a "test set" in the context of clinical data or data provenance (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The study involved engineering and performance testing of a medical device, not the interpretation of medical images or clinical data requiring expert reviewers for ground truth.
4. Adjudication Method for the Test Set:
Not applicable. As described above, this study did not involve expert review or adjudication of a test set of medical cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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 510(k) submission is for a surgical instrument, not an AI-powered diagnostic or assistive technology. Therefore, there is no discussion of human reader improvement with or without AI assistance.
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 submission pertains to a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance was established through engineering specifications, regulatory standards (e.g., ISO 10993, ANSI/AAMI HF-18, AAMI FDS-1 TIR 27 2001), and direct functional testing against these predefined criteria, as well as comparison to the predicate device's established performance. Metrics such as dielectric withstand, cutting force, monopolar energy delivery, and dimensional accuracy served as the "ground truth" for evaluating the device.
8. The Sample Size for the Training Set:
Not applicable. This submission is for a physical medical device and does not involve an AI algorithm with a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no AI algorithm with a training set, the concept of establishing ground truth for a training set is not relevant to this submission.
§ 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.