(140 days)
The LAP-WAVE 3000 (P07) is an irrigation pump for minimally invasive surgery. It is used to facilitate the removal of debris and fluids during laparoscopic procedures by irrigation.
The LAP-WAVE 3000 (P07) (K990732) is an irrigation pump for minimally invasive surgery. It is used to facilitate the removal of debris and fluids during laparoscopic procedures by irrigation. Irrigation fluid is transported from the fluid container to the instrument inserted in the patient by means of a roller-wheel pump at the device and a disposable PVC tubing set. A trumpet valve instrument (not provided with device) is used to manipulate the flow of fluid into the patient. A pressure sensor at the device is used to regulate pressure at the instrument (trumpet valve). Irrigation is initiated by opening the instrument and discontinued by closing the instrument. Also, a tubing set for connection to a central suction system is provided with the device to allow for removal of the fluid from the patient.
The provided text describes a 510(k) premarket notification for the LAP-WAVE 3000 (P07) laparoscopic irrigation pump. It establishes substantial equivalence to a predicate device, the Surgipump (K935763). However, the document does not contain specific acceptance criteria or details of a study that proves the device meets such criteria in the way a modern medical device submission would.
Instead, the summary for this device relies on historical experience with similar devices and a literature review to assert safety and effectiveness.
Here's an attempt to answer your questions based on the provided text, highlighting what is
and isn't present:
1. A table of acceptance criteria and the reported device performance
The document does not specify formal acceptance criteria in a quantitative, measurable way that would typically be presented in a table for a performance study. It states qualitative performance characteristics.
| Acceptance Criterion (Inferred/Stated) | Reported Device Performance |
|---|---|
| Safety: | Based on extensive experience with suction/irrigation systems in operative laparoscopy, no complications have been reported during many years of use. The pressure restriction (600 mm Hg) is for protecting the tubing and instrument, not a safety feature for intra-abdominal pressure. |
| Effectiveness: | Facilitates removal of debris and fluids during laparoscopic procedures by irrigation. |
| Flow Performance: | Increased to 3 L/min (compared to its predicate, though the predicate's flow rate isn't given). |
| Pressure Regulation: | Incorporates a pressure sensor to regulate pressure at the instrument (trumpet valve), restricted to a maximum of 600 mm Hg. Irrigation is initiated/discontinued by opening/closing the instrument. |
| Compliance with Established Requirements (Literature): | "The performance specifications of the LAP-WAVE 3000 (P07) correspond with the requirements established in the literature." (This statement acts as the acceptance criteria based on broader understanding and clinical need, rather than specific numerical targets from a study). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No specific test set or clinical study data is provided for the LAP-WAVE 3000 (P07).
- The justification for safety and effectiveness is based on "extensive experience with suction/irrigation systems in operative laparoscopy without complications" and a review of medical literature. This implies a large, retrospective summation of real-world usage from various sources over many years, rather than a controlled, prospectively collected dataset for this specific device.
- The provenance would be general clinical practice of laparoscopic irrigation/suction systems, likely international, given the references include German publications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There was no specific test set requiring expert ground truth establishment for this device in the provided submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or expert adjudication process is described.
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
- Not applicable. The LAP-WAVE 3000 (P07) is a mechanical irrigation pump, not an AI-assisted diagnostic or decision-support tool. Therefore, an MRMC study and AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a hardware device; the concept of a "standalone algorithm" is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" used is essentially historical clinical outcomes data (absence of reported complications over many years of use of similar devices) combined with expert consensus/established clinical practice as documented in relevant medical literature. The document argues that the procedure (laparoscopic irrigation/suction) is safe and effective based on widespread acceptance and lack of reported complications, and since the device's performance specifications align with these established requirements, the device itself is also safe and effective.
8. The sample size for the training set
- Not applicable. This device's approval is based on substantial equivalence to a predicate and general clinical experience with the procedure, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. (See point 8).
§ 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.