(125 days)
No
The summary describes an electrosurgical system for gynecological procedures, focusing on the electrode design and current delivery. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is intended to resect and/or ablate endometrial tissue, which indicates a direct therapeutic action on the body to treat medical conditions (abnormal uterine bleeding, submucous fibroids, endometrial polyps).
No
This device is intended for the resection and/or ablation of endometrial tissue, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines hardware components such as an active electrode (wire loop or Star loop), a return electrode (metallic outer Morcellator housing or dispersive pad), and mentions the use of isotonic solutions. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for gynecologic hysteroscopic / electro-surgical use to resect and/or ablate endometrial tissue. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical instrument (an electro-surgical system with an electrode) used for tissue manipulation within the uterus.
- Anatomical Site: The device is used on endometrial tissue within the uterus.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue samples) to provide information about a person's health. This device does not perform such tests on samples.
The device is a surgical tool used for treatment, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
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
Product codes
85 HIH, KNF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gynecologic, endometrial tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professional gynecologists in hospital or office environments.
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
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].
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) SUMMARY
AUG | | 1997
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.
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].
1
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
2
510(k) Number (if known):
Device Name: FemRxTM FMP OERASTAR™ (with Dispersive Electrode Option)
Indications For Use:
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: -----------------------------------------------------------------------------------------------------------------------------------------------------------------
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)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
000009 000009