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The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and accessories are intended for use by a physician in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Numbers: 11278ACU1 and 11278AC2) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

The provided document is an FDA 510(k) clearance letter for the KARL STORZ Ped. Cysto-Urethro-Fiberscope. This type of document declares substantial equivalence to a predicate device, meaning it is similar enough to an existing marketed device that it does not require new efficacy studies or clinical trials for approval.

Therefore, the document explicitly states:

• "Non-Clinical performance data is not provided in this submission as the majority of the technological characteristics of the subject device and predicate device are equivalent. Where differences exist, the results of testing on the reference device are leveraged in support of safety and effectiveness."
• "Clinical testing was not required to demonstrate the substantial equivalence to the predicate device."

This means that the information requested regarding acceptance criteria, performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth for the training set are not part of this 510(k) submission and are not present in the provided text. The clearance is based on the device's technological similarity to previously cleared devices, not on new performance studies as would be required for a novel device or a PMA submission.

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