(81 days)
The KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting is intended for endoscopic saphenous vein harvesting procedures.
These instruments are manually operated surgical devices intended to be used in procedures for removal of the saphenous vein as a graft in coronary and vascular surgery.
The Karl Storz Instrument Set for Endoscopic Saphenous Vein Harvesting are manually operated surgical devices. The KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting is composed of Forward Oblique (30°) Endoscope, Optical Retractor and Optical Dissector, Vein Dissectors, Grasping Forceps, Dissecting and Grasping Forceps, and Hook Scissors, Take-apart™ Dissecting Forceps, Dissecting and Grasping Forceps, and Scissors, Take-apart® Bipolar Forceps, and Suction Coagulating Cannula. The body contact portions of the KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting are composed of surgical grade stainless steel, PTFE, Kynar and PEEK which are commonly used in medical devices for a wide range of applications and have a long history of biocompatibility for human use.
The provided text is a 510(k) summary for the KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting. This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics often associated with AI/ML or diagnostic devices (e.g., sensitivity, specificity, accuracy).
Instead, this document focuses on establishing substantial equivalence to existing predicate devices, which is the regulatory pathway for this type of medical instrument. Substantial equivalence relies on demonstrating that the new device has the same intended use and similar technological characteristics as an already legally marketed device, and that any differences do not raise new questions of safety or effectiveness.
Therefore, I cannot provide the requested information from the given text. The K973068 document is for a set of manually operated surgical instruments, not a device that relies on performance criteria like those described in your prompt (e.g., AI algorithms, diagnostic accuracy).
§ 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.