(24 days)
The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures.
The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures. It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids from the surgical site to aid visualization. It consists of 4.50 diameter shaft, suction/irrigation buttons and suction/irrigation tubes with hand piece. It has two types of hand piece, pistol and trumpet grip. The subject device is compatible with all suction and irrigation pumps in the market which have the connecting tubes or connectors of Ø10mm (Suction) or Ø7mm(Irrigation). All equipment conforming to this specs can be used. It is provided sterile, for Rx only and single use.
The provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML-driven medical device.
The document is a 510(k) clearance letter for a LAP-iX Suction Irrigation device. This is a conventional medical device used in laparoscopic and endoscopic procedures for surgical suction and irrigation.
The "Performance Data" section (page 4, point 7) lists general verification, validation, and testing activities, including:
- Sterilization Validation Test in accordance with ISO11737-1
- Shelf Life Validation Test in accordance with ASTM F 1980
- Biocompatibility Tests in accordance with ISO 10993 (specifically ISO 10993-5 for Cytotoxicity, and ISO 10993-7 for Ethylene Oxide Sterilization Residuals, ISO 10993-10 for Skin Sensitization and Irritation)
- Performance Tests: Air tightness, Suction and Irrigation Test
It states that "The device passed all of the tests based on pre-determined pass/fail criteria." However, it does not provide the specific acceptance criteria that were pre-determined, nor does it detail the results of these tests (e.g., specific values for air tightness, suction, or irrigation performance).
Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these are typically relevant for AI/ML device evaluations and are not present in this document for a traditional physical medical device.
§ 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.