(505 days)
The KSEA C.C.L. Vaginal Extractor and accessories are intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery. The C.C.L. Vaginal Extractor is indicated for women undergoing laparoscopic surgery and intended for vaginal extraction of tissue masses as large as 6-7 cm from the peritoneal cavity, following an intra-abdominal peritoneal culdotomy at the posterior vaginal fornix.
The KSEA C.C.L. Vaginal Extractor are manual reusable surgical devices (used with the KSEA Extraction Bag and KSEA Take-apart® Rotating Claw Forceps). The KSEA C.C.L. Vaginal Extractor is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery. The body contact materials are surgical grade stainless steel, HPDE, PTFE, Ultem® and polyurethane film. The non-body contact materials of the C.C.L. Vaginal Extractor are surgical grade stainless steel.
The provided 510(k) summary is for a manual surgical device (KSEA C.C.L. Vaginal Extractor), not an AI/ML-driven device. As such, the information typically required for describing the acceptance criteria and the study proving an AI/ML device meets them (such as sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, standalone performance, etc.) is not applicable to this submission.
The 510(k) process for a device like the KSEA C.C.L. Vaginal Extractor focuses on demonstrating substantial equivalence to a predicate device based on its intended use, design, materials, and technological characteristics, rather than performance metrics derived from AI/ML algorithms.
The summary clearly states:
- Substantial Equivalence: "The KSEA C.C.L. Vaginal Extractor for tissue extraction procedures during laparoscopic surgery are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA C.C.L. Vaginal Extractor and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices."
Therefore, the study proving the device meets its acceptance criteria would typically involve:
- Bench testing: To ensure mechanical integrity, material compatibility, and functional performance (e.g., ability to grasp, extract tissue) meeting engineering specifications.
- Biocompatibility testing: To demonstrate that the materials are safe for body contact.
- Sterilization validation: To ensure the device can be effectively sterilized for repeated use.
- Usability testing: To confirm ease of use by qualified surgeons.
These types of studies are generally documented internally by the manufacturer and summarized for the FDA to support the substantial equivalence claim, but they do not involve the statistical performance metrics and expert review processes characteristic of AI/ML device validation.
None of the requested information regarding acceptance criteria for AI/ML performance, study methodology for AI, or ground truth establishment for AI models is present in the provided documents because it is not relevant to this type of device 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.