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The intended use of the device is to electrosurgically cut and coagulate soft tissue during the performance of arthroscopic procedures.

The devices are tubular instruments, either 3mm or 5mm in diameter, with shaft lengths of 15cm. The intended use of the device is to electrosurgically cut and coagulate soft tissue during the performance of arthroscopic procedures. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the previously cleared laparoscopic and thorascopic devices. The devices are constructed from the same materials and are processed similarly to the predicate devices. The device incorporates a return electrode on the distal end of the shaft eliminating the need for a return pad.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a 510(k) summary and an FDA clearance letter for the BiTx Probe, which focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting performance data against specific acceptance criteria.

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Electrosurgical Coagulation of soft tissue during ENT procedures.

The devices are Class II medical devices are similar in design to the referenced predicate devices. The BiTx devices are similar in construction and in component materials as compared to laparoscopic devices (Ref. BiLAP Probes submitted in 510(k) no's. K904993 and K945975). The devices are tubular instruments, either 3mm or 5mm in diameter, with shaft lengths of 12-15cm. The intended use of the device is to electrosurgically coagulate soft tissue during the performance of ENT procedures. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices with indications for ENT procedures. The device incorporates a return electrode on it's distal end, eliminating the need for a return pad.

The provided text describes a 510(k) submission for a medical device (BiTx Probe) and the FDA's "Substantially Equivalent" determination. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any other details related to a performance evaluation of the device against specific criteria.

The document is a regulatory submission for pre-market notification, focusing on demonstrating substantial equivalence to existing predicate devices, rather than presenting a detailed performance study with quantitative results.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details. The input document simply does not contain this type of data.

Here's what the document does state, which is relevant to a 510(k) submission but not to a performance study:

• Device Name: BiTx Probe
• Intended Use: Electrosurgically coagulate soft tissue during the performance of ENT procedures.
• Mechanism of Action: Bipolar Electrosurgical Energy, similar to predicate devices.
• Comparison to Predicate Devices: The submission asserts that the device is similar in design, construction, component materials, function, and intended use as compared to predicate devices (BiLAP Probes and devices marketed by Elmed Incorporated and Ellman International).
• Conclusion for 510(k): "Everest Medical believes that no new issues of safety and effectiveness are raised and that this device is substantially equivalent."
• FDA Determination: The FDA found the device "substantially equivalent" to predicate devices, allowing it to be marketed.

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