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The ROTOCUT G1 Electromechanical Morcellator in conjunction with the UNIDRIVE GYN Control unit is a motorized unit for morcellating and extracting tissue during laparoscopic procedures in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.

The KSEA ROTOCUT G1 Electronechanical Morcellator in conjunction with the UNIDRIVE GYN control unit is a motorized, reusable surgical device system, intended for the morcellation and extracting tissue during laparoscopic procedures in general surgery, gynecology, and urology by qualified surgeons.

This document is a 510(k) summary for the KSEA ROTOCUT G1 Electromechanical Morcellator. It claims substantial equivalence to predicate devices and does not describe acceptance criteria, performance studies, or clinical trial data. Therefore, I cannot extract the requested information.

Here's why:

• 510(k) Substantial Equivalence: A 510(k) submission generally focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and performance characteristics, often through non-clinical testing (e.g., bench testing, biocompatibility).
• Lack of Clinical Study Details: The provided text is a summary of the 510(k) and the FDA's clearance letter. It does not contain details of specific clinical studies, performance criteria, sample sizes, expert qualifications, or ground truth establishment. The declaration of substantial equivalence usually implies that the performance is considered acceptable based on the predicate device's established safety and effectiveness.

To answer your request, I would need a different type of document, such as a full clinical study report, a regulatory submission with detailed performance data, or an FDA review memorandum that explicitly discusses clinical acceptance criteria and the results of a study designed to meet them.

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