The FemRx™ Focused Monopolar (FMP) offersTAR™ System is intended for gynecologic hysteroscopic / electro-surgical use by trained professional gynecologists in hospital or office environments. It is used to resect and / or ablate endometrial tissue.

INDICATIONS: Abnormal Uterine Bleeding, Submucous Fibroids, Endometrial Polyps

Device Description

The FemRx Focused Monopolar (FMP) @ERASTAR™ System [with Dispersive Electrode Option] is identical to FemRx's currently cleared FMP offRASTAR™ System with the exception that it includes the option of using a standard dispersive skin electrode. When used in this way it is basically identical to our original oreRASTAR™ System except that it incorporates a PEARL electrode (Physiologic endometrial ablation / resection loop). This loop is partially insulated to "focus" the current toward the tissue and avoid the reduction in effect associated with conventional devices. The use of isotonic solutions (e.g., NaCl or Ringers Lactate) is strongly recommended in order to reduce the risks associated with fluid overload.

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 OR a standard dispersive pad located on the patients skin) 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.

AI/ML Overview

This 510(k) summary (from 1997) for the FemRx Focused Monopolar (FMP) OPERASTAR™ System with Dispersive Electrode Option provides limited information regarding formal acceptance criteria or detailed study methodologies as would be expected from more recent submissions. Based on the provided text, here's what can be extracted and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence in resection and ablation performance compared to predicate devices.	"In vitro extirpated uteri studies comparing the resection and ablation performance of the Focused Monopolar device with the predicates confirm that tissue effects are substantially equivalent to currently marketed devices."
Equivalent performance between the FMP OPERASTAR™ System (cleared via K964441) and the FMP OPERASTAR™ System [with Dispersive Electrode Option].	"clinical testing has demonstrated equivalent performance between the FMP offersTAR™ System (recently cleared via K964441) and the FMP operaSTARTM System [with Dispersive Electrode Option]."
The return electrode (metallic outer Morcellator housing or standard dispersive pad) should not cause tissue coagulating, cutting, or ablating effect.	"The return electrode... 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."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified for any study mentioned.
Data Provenance:
- "In vitro extirpated uteri studies" - suggests laboratory studies using excised human or animal uteri. No country of origin is mentioned.
- "clinical testing" - prospective vs. retrospective is not specified. No country of origin is mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided. The summary mentions "in vitro extirpated uteri studies" and "clinical testing" but does not detail how ground truth was established for these studies, nor the number or qualifications of experts involved.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC study is explicitly mentioned. The studies focus on device performance equivalence rather than human reader improvement with AI assistance (as this is a medical device, not an AI/imaging device).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a surgical instrument, not an algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable here. The performance described is that of the physical device itself.

7. The Type of Ground Truth Used

For the "in vitro extirpated uteri studies," the ground truth likely involved direct observation, measurement, and histological analysis of tissue effects (resection depth, ablation depth, coagulation patterns).
For the "clinical testing," the ground truth for "equivalent performance" would likely have been based on clinical outcomes, such as efficacy of endometrial ablation/resection, safety profiles, and possibly physician reports of ease of use or tissue manipulation.

8. The Sample Size for the Training Set

This concept is not applicable as this is a physical medical device, not a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

This concept is not applicable as this is a physical medical device, not a machine learning algorithm.

Summary

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510(k) SUMMARY

AUG | | 1997

In vitro extirpated uteri studies comparing the resection and ablation performance of the Focused Monopolar device with the predicates confirm that tissue effects are substantially equivalent to currently marketed devices. In addition, clinical testing has demonstrated equivalent performance between the FMP offersTAR™ System (recently cleared via K964441) and the FMP operaSTARTM System [with Dispersive Electrode Option].

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird with three human profiles incorporated into its design. The profiles are facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

George M. Savage, M.D. Senior Vice President FemRx 1221 Innsbruck Drive Sunnyvale, California 94089

AUG 11 1997

1 1997

Re: K971305 Focused Monopolar (FMP) OPERASTAR™ System with Dispersive Electrode Option Dated: July 3, 1997 Received: July 11, 1997 Regulatory class: II 21 CFR §884.4160 and §884.1690 Product code: 85 HIH & KNF

Dear Dr. Savage:

We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

h. Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

Device Name: FemRxTM FMP OERASTAR™ (with Dispersive Electrode Option)

Indications For Use:

INDICATIONS: -----------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTRAINDICATIONS: CONTRAND

Abnormal Uterine Bleeding Submucous Fibroids Endometrial Polyps

Pregnancy Pelvic Infection Cervical Malignancy Previously diagnosed Endometrial cancer

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Colin m. Pollard

Division Sion-l Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K971305

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

000009 000009

Regulation Number and Section

§ 884.1690 Hysteroscope and accessories.

(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.