(69 days)
MEDIVISION HYSTEROSCOPE MV400/MV415/MV430/MV470 INDICATIONS for USE NOTE: Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery. Diagnostic Hysteroscopy - . Abnormal Uterine Bleeding - Infertility & Pregnancy Wastage . - Evaluation of Abnormal Hysterosalpingogram # - Intrauterine Foreign Body - . Amenontiea - Pelvic Pain . - Operative Hysteroscopy - . Directed Blopsy - Removal of Submucous Fibroids and Large Polyps . - . Submucous Myomectorny - . Transection of Intrauterine Adhesions - o Transection of Intrauterine Septa - . Endometrial Ablation Medical disease, cervical stenosis, and pelvic infection may alter the choice of location for hysteroscopy {i.e., office setting vs. Hospital),
Not Found
This document is a 510(k) clearance letter from the FDA for Medivision Hysteroscopes. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it confirms that the device is substantially equivalent to a predicate device already on the market.
Therefore, I cannot provide the requested information.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 1998
Mr. Wayne B. Sterner Medivision Scope Service Center, Inc. 1440 South State College Blvd. Suite IC Anaheim. CA 92806
Re: K982659 Medivision Hysteroscopes, Models MV400, MV415, MV430 and MV470 Dated: July 27, 1998 Received: July 27, 1998 Regulatory Class: II 21 CFR 884.1690/Procode: 85 HIH
Dear Mr. Sterner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above 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, market the device, subject to the general controls provisions of 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 II (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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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/cdrb/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ _ _ _ _ 98 2659 __________________________________________________________________________________________________________________________________
HUSTEROSCOPE Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
MEDIVISION HYSTEROSCOPE MV400/MV415/MV430/MV470
INDICATIONS for USE
NOTE:
Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery.
Diagnostic Hysteroscopy
- . Abnormal Uterine Bleeding
- Infertility & Pregnancy Wastage .
- Evaluation of Abnormal Hysterosalpingogram #
- Intrauterine Foreign Body
- . Amenontiea
- Pelvic Pain .
- Operative Hysteroscopy
- . Directed Blopsy
- Removal of Submucous Fibroids and Large Polyps .
- . Submucous Myomectorny
- . Transection of Intrauterine Adhesions
- o Transection of Intrauterine Septa
- . Endometrial Ablation
Medical disease, cervical stenosis, and pelvic infection may alter the choice of location for hysteroscopy {i.e., office setting vs. Hospital),
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEROED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K982659 |
|---|---|
| --------------- | --------- |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
EPINISTON
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§ 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.