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The S-52 Electronic Video Laparossope
This document does not contain the information required to populate the fields of the request. The text describes a submission for substantial equivalence for a medical device (S-52 Electronic Video Laparoscope) by Del Medical Systems, comparing it to existing predicate devices (e.g., Fujinon's EVL-R, Smith & Nephew devices).
The document focuses on:
- Claim of Substantial Equivalence: Stating that the S-52 is substantially equivalent in technology and intended use to predicate devices.
- Comparison of Design and Technology: Highlighting similarities in design, technology, specifications (with a noted difference in flexibility not affecting use), and intended use.
- Predicate Devices: Listing specific predicate devices and their K-numbers (e.g., Fujinon under K-902197/B and K912859/A, and generally "Smith & Nephew and Welch Allyn as makers/marketers of 'distal end CCD devices'").
However, it does not provide any information on:
- Acceptance criteria: No specific performance metrics or thresholds are mentioned.
- Reported device performance: No data on the S-52's performance against any criteria are presented.
- Study details: No mention of any clinical or technical study, sample sizes, data provenance, ground truth establishment, expert involvement, adjudication methods, or effects of AI assistance.
- Standalone algorithm performance: This is not an AI/algorithm-based device in the context of the document.
- Training set information: Not applicable as no machine learning algorithm is discussed.
Therefore, the requested tables and details cannot be extracted from this provided input. This document is a regulatory submission arguing for substantial equivalence based on design and intended use, not a performance study report.
§ 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.