(42 days)
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No
The summary describes a manual, reusable transilluminator for ENT procedures and makes no mention of AI, ML, image processing, or any related concepts.
No.
The device is used to illuminate sinus tissue during ENT procedures, which is a diagnostic or procedural aid rather than directly treating a medical condition or restoring function.
No
Explanation: The device is described as transilluminating sinus tissue during procedures, which is a therapeutic or assistive function, not a diagnostic one. It helps illuminate an area for a medical procedure, but it does not analyze or interpret data to diagnose a condition.
No
The device description explicitly states it is a "manual, reusable, nonsterile medical device" and mentions "body contact materials," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "transilluminate sinus tissue during ENT procedures." This describes a procedure performed directly on the patient's body, not on a sample taken from the body.
- Device Description: The description mentions it's a "manual, reusable, nonsterile medical device" used for transillumination. This aligns with a surgical or procedural device, not a device used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to illuminate tissue in situ during a procedure.
N/A
Intended Use / Indications for Use
The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are designed to transilluminate sinus tissue during ENT procedures.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
sinus tissue (during ENT procedures)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers 9, 6, 2, 0, 3, and 2. The numbers are written in a connected manner, resembling cursive handwriting. The image has a clean, white background, which makes the dark, bold characters stand out.
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