(42 days)
The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are designed to transilluminate sinus tissue during ENT procedures.
The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are manual, reusable, nonsterile medical devices. The body contact materials of these devices have a long history of biocompatibility with medical devices.
I am sorry, but the provided text is a 510(k) summary for a medical device called "Karl Storz Universal Twin Transilluminator". This document describes the device, its intended use, and claims substantial equivalence to predicate devices.
However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to a performance study as requested in your prompt.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
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Image /page/0/Picture/1 description: The image shows a circular shape with a grainy texture. The circle is not solid but rather composed of many small, irregularly shaped dark spots against a white background. The distribution of these spots is uneven, with some areas appearing denser than others, giving the circle a somewhat blurred or faded appearance.
600 Ceroorako Pente Culver City, Culdiana 90230-7600 Phone 310 558 1500
Rolling Meadows, IL 60008-3137
Fax 847-818-4877
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 document 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 Transilluminator
Trade Name Karl Storz Universal Twin Transilluminator Karl Storz Universal Fiber Optic Twin Transilluminator
Indication: The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are designed to transilluminate sinus tissue during ENT procedures.
Device Description: The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are manual, reusable, nonsterile medical devices. The body contact materials of these devices have a long history of biocompatibility with medical devices.
Substantial Equivalence: The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between the Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
Signed: Marika Anderson
Marika Anderson
Marika Anderson Regulatory Affairs Specialist
§ 874.4350 Ear, nose, and throat fiberoptic light source and carrier.
(a)
Identification. An ear, nose, and throat fiberoptic light source and carrier is an AC-powered device that generates and transmits light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-bronchial telescope, and nasopharyngoscope.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.