(118 days)
The LAP-Pump PP110 is a suction and irrigation pump intended for use during diagnostic and or therapeutic laparoscopic procedures to irrigate fluid into and remove fluid from the abdominal cavity.
The LAP-Pump PP110 is a suction and irrigation pump for use during laparoscopic procedures. The irrigation and suction functions are used to facilitate the removal of debris and fluids during laparoscopy. The pump consists of the following main components: : (1) a power supply, (2) a power switch, (3), a START/STOP button for the irrigation function, (4), a START/STOP button for the suction function, (5) a roller wheel, (6) a pump head, (7) suction pump and (8) a casing. The pump is a microprocessor controlled single roller pump that functions according to the peristaltic principle and is to be used with specially designed sterile, single use irrigation tube sets with or without hand piece, a sterile outflow tube set and a vacuum tube set. The pump is designed to be mounted on a pole/tripod, or can be placed in an equipment rack.
This is a 510(k) premarket notification for the LAP-Pump PP110, a suction and irrigation pump for laparoscopic procedures. The document asserts substantial equivalence to predicate devices based on similar intended use, basic technological characteristics, and performance testing.
Here's an analysis of the provided text in relation to your request about acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a table format with specific quantitative thresholds. Instead, it states that "Test results demonstrate that the proposed device conforms to the above standards" and "Design verification testing of the LAP-Pump PP10 demonstrates that the device performs as intended and that the performance does not raise new questions of safety and effectiveness."
The "performance data" section focuses on compliance with various international standards for medical devices and sterility.
Here's a summary of the reported device performance in relation to the standards it aims to meet:
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Electrical Safety & EMC (AAMI ANSI ES60601-1, IEC60601-1-2) | Conforms to standards. |
| Software Life Cycle Processes (IEC 62304) | Developed, tested, and verified in accordance with the standard and FDA guidance. |
| Overall Performance (Design Verification) | Performs as intended; performance does not raise new questions of safety and effectiveness. |
| ETO Sterilization Validation (ISO 11135-1, ISO 14937, ISO 10993-7) | Residual EO |
§ 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.