(86 days)
This light source has been designed to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
The Olympus CLL-V1 is a desk top device which consists of a LED light source designed and intended to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
The provided 510(k) summary (K130819) describes an LED light source, the Olympus CLL-V1, and its substantial equivalence to predicate devices. However, this document does not contain acceptance criteria, device performance data, details of a clinical study, or information about ground truth establishment.
The summary focuses on:
- Technological characteristics: States the CLL-V1 uses LED technology, offering a long-lasting LED "bulb," reduced energy consumption, no need for additional fan cooling (making it silent), and optimized light intensity for higher contrast and brightness compared to existing Halogen bulbs.
- Non-clinical testing: Mentions risk analysis per ISO-14971:2007, and software validation per FDA guidance for a "Minor Level of Concern" device. It also lists several applied standards (ISO 14971:2007, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-1-6).
- Conclusion: States that the CLL-V1 is substantially equivalent to predicate devices with respect to general design, function, and indications for use, and raises no new concerns regarding safety or efficacy.
Therefore, based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them because this information is not present in the document.
The document addresses compliance with standards and non-clinical aspects for regulatory clearance, but it does not detail a clinical study with performance metrics as typically expected for algorithms, diagnostics, or other devices requiring specific sensitivity/specificity, accuracy, or other outcome-based performance criteria. This device (a light source for endoscopy) would typically focus on electrical safety, EMC, light output specifications, and biocompatibility rather than a clinical performance study with human readers or ground truth analysis as might be done for an AI diagnostic device.
§ 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.