Search Results

The Habib Endoblate is a radiofrequency (RF) catheter which provides bipolar energy to enable the Endoscopist to cauterize and coagulate tissue in the gastrointestinal tract

The Habib Endoblate is a bipolar radiofrequency (RF) device that consists of a catheter with 3 contact electrodes and 1 ring electrode, introduced via an endoscope's biopsy channel and activated with bipolar RF energy. The Habib Endoblate has an attached cable which connects the device to an RF Generator. The catheter is inserted into the gastrointestinal tract and the tissue is coagulated using the RF power. The Habib Endoblate is designed for use in endoscopy and is a single use sterile device.

The provided text describes the Habib Endoblate device and its 510(k) clearance, but it does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria with quantitative metrics.

The document states: "Performance testing was undertaken to ensure that the Habib Endoblate functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria."

This is a general statement required for 510(k) submissions, indicating that some testing was performed to demonstrate substantial equivalence to a legally marketed predicate device (Gold Probe catheter, K970278). However, the specific results of this performance testing, the acceptance criteria used, or the study details are not included in this summary.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about sample sizes, ground truth, expert involvement, or comparative effectiveness studies, as this information is not present in the provided text.

The information that can be extracted relevant to your request is limited to:

• Predicate Device: Gold Probe catheter manufactured by Boston Scientific Inc. (K970278)
• Basis for Clearance: Substantial equivalence to the predicate device.
• Technological Characteristics: Both devices use bipolar RF energy through a number of electrodes to coagulate tissue.

To obtain the detailed performance data, acceptance criteria, and study results, one would typically need to refer to the full 510(k) submission document or supporting technical files, which are not included here.

Ask a specific question about this device