FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU

K964441 · Gynecare Innovation Center · KNF · Mar 28, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K964441
• Device Name: FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
• Applicant: Gynecare Innovation Center
• Product Code: KNF · Obstetrics/Gynecology
• Decision Date: Mar 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FemRx Focused Monopolar (FMP) OPERATAR™ System is identical to FemRx’s currently marketed OPERATAR™ 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 electrocautery 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.

Device Story

Electrosurgical resectoscope system; utilizes high-frequency electrocautery current applied to single active electrode (wire loop or Star loop) for tissue cutting/coagulation; integrated morcellator within fluid return path for tissue removal; operates with conductive irrigant (normal saline); return electrode integrated into metallic outer morcellator housing; used by physicians in clinical/surgical settings; enables use of isotonic saline to mitigate complications associated with non-isotonic solutions; provides equivalent resection/ablation performance to predicate.

Clinical Evidence

Bench testing and extirpated uteri studies performed. Comparison of resection and ablation performance between Focused Monopolar device and predicate confirmed substantial equivalence. No human clinical trials reported.

Technological Characteristics

Electrosurgical system; single active electrode (wire/Star loop); metallic outer morcellator housing serves as return electrode; conductive irrigant (0.9% NaCl) compatibility; high-frequency electrocautery energy source.

Indications for Use

Indicated for hysteroscopic tissue cutting, ablation, and morcellation in patients requiring uterine surgery.

Regulatory Classification

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.

Predicate Devices

• FemRx OPERATAR System resectoscope (K964441)

Submission Summary (Full Text)

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510(k) SUMMARY
MAR 28 1997
K964441

The FemRx Focused Monopolar (FMP) $^{\text{OPERATAR™}}$ System is identical to FemRx’s currently marketed $^{\text{OPERATAR™}}$ 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 electrocautery 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 $^{\text{OPERATAR}}$ 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 $^{\text{OPERATAR}}$ 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.

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.

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