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The MINI Laparoscopes provide visualization inside the patient via natural or surgical generated access.

For examination, diagnostics, and/or therapy for use by surgeons who are trained and qualified in the use of endoscopically used accessories from various medical specialties, such as surgery, urology, gynecology, and ENT.

The PANOVIEW PLUS telescopes are part of the MICRO and MINI instrument set for laparoscopic microsurgery. They are particularly suitable for diagnostics, smaller interventions, and outpatient and pediatric laparoscopy.

The endoscopes design and biocompatability of materials is comparable to earlier Richard Wolf devices. The outer diameter of the submitted devices are smaller and provide minimally invasive laparoscopy. The smaller diameter of the lens results in a smaller endoscopic puncture.

The provided document, K973359 for the PANOVIEW PLUS telescopes 3.5 mm (MINI Laparoscopes), states that no performance data or clinical tests were performed as part of this 510(k) submission.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets those criteria because it is explicitly stated that such studies were not conducted for this submission.

The document indicates:

• 5.0 Performance Data: "No know FDA performance standards exist."
• 6.0 Clinical Tests: "No clinical tests performed."

The conclusion drawn by the manufacturer is: "The devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual." This statement is a general assertion rather than a report of specific performance data or a study demonstrating adherence to acceptance criteria.

The 510(k) clearance was based on substantial equivalence to existing predicate devices, not on a new performance study demonstrating the device meets specific acceptance criteria.

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