(97 days)
The design of the S-357 is virtually identical to the comparative device as slisted in the above paragraph.. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the same as those above listed devices, DMS feels that these minor differences have no impact on the safe use and/or effectiveness of the device.
The design of the S-357 is virtually identical to the comparative device as slisted in the above paragraph.. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the same as those above listed devices, DMS feels that these minor differences have no impact on the safe use and/or effectiveness of the device.
This document does not contain the requested information regarding acceptance criteria or a study proving device performance. The provided text is a 510(k) summary (revision 1) for the Del Medical Systems S-357 Video Imaging System, dated October 15, 1996.
The summary primarily focuses on demonstrating substantial equivalence to already marketed devices. It argues that the S-357 is "virtually identical" in design and technology to comparative devices like those from Circon/ACMI, Storz, Stryker, Smith & Nephew, and Olympus. The argument for substantial equivalence is based on:
- Identical design: "The design of the S-357 is virtually identical to the comparative device..."
- Comparable technology: "...technology virtually identical..."
- Similar specifications: "...the specifications very similar..."
- Same intended use: "...and the intended use the same as those above listed devices..."
The document asserts that "these minor differences have no impact on the safe use and/or effectiveness of the device." It also mentions incorporating other legally marketed devices to "illustrate the wide, general use of similar other devices," implying that widespread historical use of similar devices suggests the S-357's safety.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because this information is not present in the provided text. The document is a regulatory submission for substantial equivalence, 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.