(64 days)
This device is designed to supply light for endoscopic diagnostic and surgical procedures.
This light source is a 300W xenon light source with manually or automatically controlled brightness. This device is not for use with flash photography.
The provided text is a 510(k) summary for a medical device: the Karl Storz Xenon 300 Light Source for Non-Flash Applications. This document is a regulatory submission for premarket notification and does not contain information related to software performance, clinical studies, or AI/ML-driven device evaluation.
Therefore, I cannot extract any information regarding:
- Acceptance criteria and reported device performance: This device is a light source, not a diagnostic or AI-driven tool for which performance metrics like sensitivity, specificity, or F1-score would be applicable.
- Sample size, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth, training set sample size, or how ground truth was established. These are all concepts relevant to the evaluation of AI/ML algorithms or diagnostic tools, which are not present in this document.
The document discusses "substantial equivalence" to a predicate device, meaning its safety and effectiveness are established by demonstrating similarity to an already legally marketed device. It does not involve a study proving performance against acceptance criteria in the way a diagnostic or AI device would.
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SEP - 4 1996
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this documents are accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc. |
|---|---|
| 600 Corporate Pointe | |
| Culver City, CA 90230 | |
| (310) 558-1500 | |
| Contact: | Betty M. Johnson |
| Manager, Regulatory Affairs | |
| Device Identification: | |
| Common Name | |
| 300W Xenon Light Source |
Trade Name Karl Storz Xenon 300 Light Source for Non-Flash Applications
Indication:
This device is designed to supply light for endoscopic diagnostic and surgical procedures.
Device Description:
This light source is a 300W xenon light source with manually or automatically controlled brightness. This device is not for use with flash photography.
Substantial Equivalence:
The KSEA light source is substantially equivalent to the predicate device, since the basic features, design and intended uses are the same. The minor differences between the Xenon light source and the predicate device raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices.
Signed: Betty M. Johnson
Manager, Regulatory Affairs
0000995
§ 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.