(28 days)
The Smith & Nephew Illuminators are indicated for use in endoscopic surgical procedures to provide illumination of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope.
The Smith & Nephew Illuminators are indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated endoscope.
The Smith & Nephew 300 XL Illuminator - HERMES Ready is a 300 Watt Xenon Illuminator indicated for use in endoscopic surgical procedures. The Hermes-Ready™ feature will enable voice and pendant control of light intensity, manual and automatic mode control and standby and activation mode control from a central location when used in conjunction with a Hermes™ Digital O.R. Control Center.
The provided text is a 510(k) summary for the Smith & Nephew 300XL Xenon Illuminator-HERMES Ready device. It describes the device, its intended use, and its substantial equivalence to a predicate device.
However, the text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to an AI/ML medical device.
The document states: "All verification and validation data demonstrates that the device is safe and effective and performs as intended." This is a general statement about the device's performance but does not provide the specific details requested in your prompt, which are typically associated with performance studies for AI/ML-based devices.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document focuses on regulatory approval based on technological equivalence to a predicate device and adherence to safety standards for medical electrical equipment.
§ 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.