(183 days)
This device is restricted to use by authorized expert personnel/physicians. The WISAP POWER-DRIVE is a laparoscopic accessory to be used in connection with the SEMM-Set. It allows cutting of tissue cylinders out of myoma and uterion. It allows cutting of Cissue cyrinkers out intermittent manual rocation. rotation of the motor drive or additional interest manual rocation. The POWER-DRIVE may only be used for horizontal morcellation.
The WISAP POWER-DRIVE is a laparoscopic accessory to be used in connection with the SEMM-Set. It allows cutting of tissue cylinders out of myoma and uterion. It allows cutting of Cissue cyrinkers out intermittent manual rocation. rotation of the motor drive or additional interest manual rocation. The POWER-DRIVE may only be used for horizontal morcellation.
This is a 510(k) premarket notification for a medical device (WISAP Power-Drive, Model #7688PD/7688PD1), which is a regulatory submission to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of document does not typically include detailed clinical study data or acceptance criteria in the way a clinical trial report or a PMA (Premarket Approval) submission would.
The document states that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided by the manufacturer, which would typically include technical specifications, performance testing (bench testing), and sometimes a comparison to the predicate device's features.
Therefore, most of the information requested in your prompt regarding acceptance criteria and studies proving the device meets them will not be explicitly present in this particular FDA letter or the accompanying "Indications for Use" statement. This letter is the FDA's response to the 510(k) application, not the application itself.
However, based on the nature of a 510(k) and the information provided, we can infer some details and state what is not present:
Inferred or Not Applicable Information:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in this document. For a 510(k), acceptance criteria would typically relate to demonstrating performance consistent with the predicate device, often through bench testing (e.g., cutting efficacy, torque, durability, safety features).
- Reported Device Performance: Not detailed in this document. The manufacturer would have submitted this in their 510(k) application (e.g., results of bench tests demonstrating appropriate cutting capacity for tissue cylinders, safety features, and mechanical performance).
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not present in these documents. Given it's a laparoscopic accessory for cutting tissue, any "test set" would likely refer to engineering or bench testing, not a patient cohort in a clinical study.
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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/present. This device is a surgical instrument. "Ground truth" in this context would likely be established through engineering specifications and the physical properties of cut tissue, not expert medical interpretation of images or observations.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/present. Adjudication is typically associated with clinical studies involving interpretation, not mechanical device performance.
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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:
- Definitely not applicable. This device is a surgical tool, not an AI-powered diagnostic or interpretive system. MRMC studies are for evaluating diagnostic accuracy, especially with imaging.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Definitely not applicable. This is a mechanical surgical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated. For a mechanical device, ground truth would likely involve measuring physical parameters (e.g., dimensions of cut tissue cylinders, precision of rotation, material properties) against engineering specifications and predicate device performance.
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The sample size for the training set:
- Not applicable. This device does not use machine learning or AI that would require a "training set."
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How the ground truth for the training set was established:
- Not applicable. As above.
Summary based on the provided documents:
The FDA letter indicates that the WISAP Power-Drive (Model #7688PD/7688PD1) was deemed substantially equivalent to a predicate device. This implies that the manufacturer provided sufficient evidence (likely through engineering and performance testing, and a comparison to the predicate) to satisfy the FDA that it performs as intended and is as safe and effective as the already-marketed predicate. The specific details of that evidence, including acceptance criteria and study results, are contained within the full 510(k) submission, not in this response letter or the indications for use.
§ 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.