(63 days)
Sovis Optique's endoscopic light cable is designed to transmit light for illumination purposes from a remote source to an endoscope or similar surgical instrument. It can be adjusted to be compatible with major manufacturers' equipment.
Sovis Optique's endoscopic light cable consists of two metal end fittings connected by a glass fiber bundle and a silicone sheath covering. The sheath is reinforced with a stainless steel spring. The protruding optical end is made from an independent piece of glass bonded to a stainless steel support for ease of replacement.
The provided text is a 510(k) summary for a medical device (endoscopic light cable). It asserts substantial equivalence to a predicate device based on similar intended use, target population, environment of use, design, and materials.
However, the provided document does not contain information about:
- Specific acceptance criteria, performance metrics, or a formal study proving the device meets those criteria.
- Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for a study.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- The type of ground truth used in such studies.
- Sample size for training sets or how ground truth for training sets was established.
The summary discusses two minor differences between the proposed and predicate device:
- Reinforced sheath: The summary claims the reinforcement is molded into the silicone and does not contact human tissues. It also states that "biocompatibility tests performed on the material, the silicone that may potentially contact patients poses no additional safety issues."
- Independent glass rod at the source end: The summary states "The rod is made from the same components as CUDA or UFR product (i.e., glass, epoxy glue and stainless steel). There is thus no significant adverse effect on safety."
These statements suggest that some form of testing or evaluation was performed for biocompatibility, but details of these tests, their acceptance criteria, or their results are not explicitly provided in the text you've given.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving their fulfillment as the necessary information is not present in the provided 510(k) summary. This document focuses on demonstrating substantial equivalence, not on detailed performance study results against specific 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.