(172 days)
This instrument has been designed to be used with the VISERA Video System Center OTV-S7V, light source, documentation equipment, videomonitor, endo-thrapy accessories, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.
The subject device, LAPARO-THORACO VIDEOSCOPE XLTF-VAW is designed for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. The subject device has a different lens cleaning method from the predicate Olympus LAPARO THORACO VIDEOSCOPE LTF-V. For the predicate device, air and water for lens cleaning are supplied through the sbace between the endoscope's insertion and a sheath attached to it. The subject device also uses a sheath but irrigation are performed through the inner channels of the videoscope. The basic structure of the inner channel is substantially equivalent to that of the predicate device, GIF-Q160Z.
The provided text is a 510(k) Summary for the LAPARO-THORACO VIDEOSCOPE XLTF-VAW. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through empirical testing.
Therefore, the requested information cannot be extracted from the given text. A 510(k) typically focuses on comparing the new device's technological characteristics and proposed indications for use to a legally marketed predicate device, rather than providing detailed study results for performance metrics against established acceptance criteria.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance directly addressing those criteria.
- Information on sample sizes, data provenance, expert ground truth, adjudication methods, or MRMC studies for a performance evaluation.
- Details about a standalone algorithm performance study.
- The type and method of establishing ground truth for any test or training sets, as it describes a device (endoscope), not an AI algorithm requiring such data.
The document indicates that "the XLTF-VAW does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device" when compared to the predicate device. This is the basis of its substantial equivalence claim, not a separate study proving performance against defined acceptance criteria.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.