(29 days)
The camera head has been designed to be used with Olympus endoscopes, camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
Both 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB and 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA are structurally consisted of endoscopic coupler end, camera cable and video connector end.
The 4K Camera Heads function as receiving optical image from a variety of endoscopes that are attached to it via coupler and using incorporated complementary metal oxide semiconductor (CMOS) image sensor to convert optical image into electronic signal. The signal is subsequently transformed into laser by laser diodes and input to VISERA 4K UHD CAMERA CONTROL UNIT by optical fiber for further processing with other ancillary equipment on endoscopic diagnosis, treatment, and observation.
This document is a 510(k) Summary for the Olympus 4K Camera Heads. It describes their equivalence to a predicate device and does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of clinical performance or diagnostic accuracy. Instead, it focuses on non-clinical testing for design verification and validation against safety and performance standards.
Therefore, I cannot provide the requested information. The document asserts that the new devices are substantially equivalent to the predicate device due to similar indications for use, fundamental scientific technology, principle of operation, and energy source, with minor modifications (like additional sterilization methods) not raising new safety or effectiveness issues.
No information regarding acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth used (clinical), or training set details is present in the provided text.
§ 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.