K Number
K964441
Device Name
FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
Date Cleared
1997-03-28

(142 days)

Product Code
Regulation Number
884.4160
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
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.
More Information

Not Found

Not Found

No
The device description focuses on the electrical and mechanical aspects of tissue cutting, ablation, and morcellation using electrocautery and a modified return electrode location. There is no mention of AI, ML, image processing, or any data-driven algorithms.

Yes
The device applies high-frequency electrical current to cut, coagulate, ablate, and morcellate tissue, indicating a direct therapeutic effect on the body.

No
The device description indicates it is used for cutting, ablating, and morcellating tissue, and compares its performance in "resection and ablation." These are therapeutic or surgical functions, not diagnostic ones.

No

The device description clearly describes a physical medical device with hardware components (resectoscope, electrocautery wire, morcellator, metallic body, outer tube/housing). It discusses the mechanism of action involving high-frequency current and physical tissue manipulation. There is no mention of software being the primary or sole component.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • No mention of in vitro testing: The description focuses entirely on a surgical device used for tissue cutting, ablation, and morcellation within the body. There is no indication that this device is used to examine specimens outside of the body (in vitro).
  • Surgical procedure: The device is described as a resectoscope used for a surgical procedure involving electrocautery and tissue removal. This is a direct medical intervention, not a diagnostic test performed on samples.
  • Intended Use/Indications for Use is "Not Found": While this section is missing, the detailed device description clearly points to a surgical application.

Therefore, based on the information provided, the FemRx Focused Monopolar (FMP) 07584STAR™ System is a surgical device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

Not Found

Product codes (comma separated list FDA assigned to the subject device)

Not Found

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

510(k) SUMMARY

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.

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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