(30 days)
The Model LS 6035/LS 6180 Xenon Light Source is intended for use in endoscopic applications.
The Xenon Light Source Model LS6035 is designed to supply light for endoscopic diagnostic observation and surgical procedures.
The Models LS 6035/LS 6180 is an electronic light source using a 300/180Watt Xenon lamp, to provide light for endoscopic procedures.
This document is a 510(k) summary for a medical device, specifically a Xenon Light Source, and not a study describing acceptance criteria and device performance. Therefore, it does not contain the information requested in the prompt.
The document primarily focuses on establishing "substantial equivalence" of the Xenon Light Source Models LS 6035/LS 6180 to already legally marketed devices. This is a regulatory pathway to market medical devices in the United States, indicating that the new device is as safe and effective as a predicate device.
Here's why the requested information cannot be extracted:
- Acceptance Criteria and Reported Device Performance: This document states that the new models "meet the same specifications" as the equivalent devices, but it does not list those specifications (acceptance criteria) or present any test results showing how the new devices performed against them.
- Study Details: There is no mention of a study to prove the device meets acceptance criteria. The 510(k) process for this type of device often relies on demonstrating similarity to existing devices rather than extensive new clinical trials or performance studies that generate quantified performance metrics.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set, and Ground Truth for Training Set: None of these details are present because the document is not an efficacy or performance study report. It's a regulatory submission to demonstrate equivalence.
In summary, the provided text is a 510(k) summary for a Xenon Light Source, which is a regulatory document, not a scientific study report describing device performance 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.