(89 days)
The Lumenon™ Xenon Light Source is intended to supply adjustable high intensity illumination for accessories such as headlights and endoscopes.
The Lumenon™ Xenon Light Source is a fiberoptic illuminator for supplying high intensity illumination for accessories such as headlights and endoscopes. The device has a universal turret with four (4) receptacles to accept various light cables. It features a quick-change lamp module and two (2) lamp life indicators. The device incorporates a graduated shutter to attenuate the intensity of the light output, adjustable from 0 to 100 percent. The intensity control is adjusted by turning the attenuater knob located on the front panel The Lumenon™ Light Source utilizes a Plano Convex Lens for focusing light down to the diameter of the fiber optic cable. The 5600°K, light is produced by a Xenon Ceramic Short Arc Lamp. The visible output is 515 X 10(3) Candelas. The equivalent visible output in terms of Lux is 47,862 Lux. ORC coats the glass window of the xenon lamp in order to reduce UV output. The IR is reduced by a glass filter with an IR coating which blocks IR transmissions. UV output is 2.6 watts.
The provided text describes a medical device, the Lumenon™ Xenon Light Source, and its regulatory clearance (510(k) K992050) by the FDA. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria as typically outlined in an AI/software medical device submission.
The document provided is a summary of safety and effectiveness for a conventional hardware medical device (a light source), not an AI/software-based device. Therefore, the requested information about acceptance criteria, study details, ground truth, expert adjudication, MRMC studies, or training sets is not present in this type of submission.
The "Summary of Safety and Effectiveness" for this device focuses on:
- Intended Use: To supply adjustable high-intensity illumination for accessories such as headlights and endoscopes.
- Device Description: Specifics about its components, light output, and safety features (e.g., UV/IR reduction).
- Potential Risks: Hazards associated with its use (flammable gases, high temperatures, radiation, electrical safety).
- Substantial Equivalence: Comparison to existing legally marketed predicate devices (Welch Allyn Xenon 300 Light Source, Xenon Light Source Model LS 6035). The argument for clearance is that its operational principles and technological characteristics are substantially equivalent, and any differences are minor and do not raise new safety or effectiveness issues.
Therefore, I cannot populate the table or answer the specific questions because the provided text does not contain the information requested for AI/software device evaluation.
§ 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.