(178 days)
This device is restricted to use by authorized expert personnel/physicians.
The WISAP Aqua-Purator Biotherm 1608 is solely destined for operative therapeutical Pelviscopy/Laparoscopy for lavage of the abdominal cavity with physiological saline solution coming from plastic bags up to 5 1 volume. The irrigation pressure can be preselected; the preheated liquid in the bag is kept at body temperature.
Aqua-Purator Biotherme 1608
The provided text is a 510(k) clearance letter for the WISAP Aqua-Purator Biotherm 1608 device, indicating it has been found substantially equivalent to a predicate device. However, this type of regulatory document typically does not contain the detailed study information required to fill out the requested table for acceptance criteria and device performance.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...". This means the submission primarily focused on demonstrating equivalence to an existing device, rather than providing new clinical study data with detailed performance metrics and ground truth analysis as would be found in a new PMA (Premarket Approval) application or a more extensive de novo submission.
Therefore, the following information is not available in the provided document:
- A table of acceptance criteria and the reported device performance: No specific performance criteria or results of a study demonstrating these are mentioned.
- Sample size used for the test set and the data provenance: Not applicable as a formal test set with performance metrics is not described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is an Aqua-Purator, not an AI or imaging device, so MRMC studies are not relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document only provides:
- Device Name: Aqua-Purator Biotherm 1608
- Intended Use: "This device is restricted to use by authorized expert personnel/physicians. The WISAP Aqua-Purator Biotherm 1608 is solely destined for operative therapeutical Pelviscopy/Laparoscopy for lavage of the abdominal cavity with physiological saline solution coming from plastic bags up to 5 l volume. The irrigation pressure can be preselected; the preheated liquid in the bag is kept at body temperature."
To obtain the detailed study information, one would typically need to review the full 510(k) submission, which is not publicly available in its entirety in this format, or look for predicate device information if specific performance claims were being made in comparison.
§ 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.