(142 days)
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The FemRx Focused Monopolar (FMP) 07584STAR™ System is identical to FemRx's currently marketed of ERASTARTM System resectoscope in terms of outward appearance and basic tissue cutting, ablating and morcellating mechanism (electrocautery wire / Star loop and morcellator internal to the fluid return path). That is, high frequency current is applied to a single active electrode to either cut or coagulate tissue which is subsequently chopped up and aspirated via a morcellator internal to the fluid return path.
The FMP offers TAR System differs from our previously cleared device in that the return electrode has been moved from outside of the patient body (dispersive electrode pad attached to the patients back or leg) to the metallic body of the device (outer tube/housing the morcellator). (Reference the Device Description section of this submission for an "insulation diagram" and schematic drawing providing a diagrammatic representation of the electrical circuit effect of moving the return electrode.) This change in return electrode location makes it possible to use (indeed requires the use of) a conductive irrigant solution such as normal saline (0.9% NaCl). The use of an isotonic solution eliminates significant potential complications associated with non-isotonic solutions (e.g., Mannitol, Sorbitol, Glycine).
The FMP offers TAR System differs from currently marketed bi-polar devices in that it continues to have a single active electrode (wire loop or Star loop) as opposed to two active electrodes. The return electrode (the metallic outer Morcellator housing of the device) has such a large surface area relative to the active electrode that there can be no tissue coagulating (much less cutting or ablating) effect at its surface. Current densities near the surface of the morcellator housing have been measured to verify this physical impossibility.
The provided text does not contain information about acceptance criteria or a study designed to prove a medical device meets specific performance criteria. Instead, it is a 510(k) summary for a medical device called the FemRx Focused Monopolar (FMP) 07584STAR™ System.
This summary primarily focuses on:
- Device Description and Comparison: Explaining how the FMP system is similar to and different from a previously cleared device (ERASTARTM System resectoscope) and other bipolar devices.
- Key Technological Change: Highlighting the move of the return electrode from outside the patient to the device body, enabling the use of isotonic saline.
- Safety Rationale: Emphasizing how the large surface area of the new return electrode prevents tissue damage at that site.
- Substantial Equivalence Claim: Stating that "in vitro and extirpated uteri studies comparing the resection and ablation performance of the Focused Monopolar device with the predicate confirmed that resection and ablation characteristics are substantially equivalent to currently marketed devices."
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth information, expert qualifications, adjudication methods, or MRMC study results) from the given text.
To provide the requested details, I would need a different type of document, such as a clinical study report, a regulatory submission with detailed performance data, or a scientific publication.
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).