(273 days)
The primary indications for use are abnormal uterine bleeding with or without pain, and infertility. Vaporization electrodes intended uses in gynecology, along with other resectoscopic electrodes and instruments, are: transuterine resection of fibroids, endometrial ablation, resectoscopic management of Müllerian fusion defects, resectoscopic management of intrauterine lesions, resectoscopic management of intractable uterine bleeding.
VaporTrode™ Vaporization Electrodes in Gynecology
This document is a 510(k) clearance letter from the FDA, and it does not contain the detailed information about acceptance criteria or a study proving device performance as requested. The letter confirms that Circon Corporation's VaporTrode™ Vaporization Electrodes in Gynecology are "substantially equivalent" to legally marketed predicate devices, allowing them to be marketed.
Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from the provided text. The document is primarily a regulatory approval notification and does not delve into the technical study details.
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Food and Drug Administration 9200 Corporate Boulevard kville MD 20850
Mr. Ervin F. Taylor, P.E. Director, Regulatory Affairs and Quality Assurance Circon Corporation 300 Stillwater Avenue P.O. Box 1971 Stamford, Connecticut 06904
Re: K964594
VaporTrode™ Vaporization Electrodes in Gynecology Dated: July 8, 1997 Received: July 10, 1997 Regulatory class: II 21 CFR §884.4160/Product code: 85 KNF 21 CFR §884.1690/Product code: 85 HIH
Dear Mr. Taylor:
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, 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 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 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 requlation 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 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/odriddsmamain.html".
Sincerely vours
William Yim
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
Enclosure
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510(k) Number (if known): Kaeyesta
VaporTrode™ Vaporization Electrodes in Gynecology Device Name:
Indications For Use:
The primary indications for use are abnormal uterine bleeding with or without pain, and infertility.
Vaporization electrodes intended uses in gynecology, along with other resectoscopic electrodes and instruments, are: transuterine resection of fibroids, endometrial ablation, resectoscopic management of Müllerian fusion defects, resectoscopic management of intrauterine lesions, resectoscopic management of intractable uterine bleeding.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDEDI
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rober R. Nothing
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K964571
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).