(90 days)
Indicated for coagulation of tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
Conway Stuart Medical Model C8 Needle Inflatable Basket Catheter Electrode with Aspiration
I'm sorry, but without further input, I cannot furnish an answer. The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called the "Stretta Model C8 Needle Inflatable Basket Catheter Electrode with Aspiration." This letter confirms the device's substantial equivalence to previously marketed devices and outlines regulatory responsibilities. However, it does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. Therefore, I cannot construct an answer based on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 14 1999
Thomas C. Wehman, Ph.D. Regulatory Affairs Conway Stuart Medical, Inc. 735 Palomar Avenue Sunnyvale, California 94086
K991291 Re:
Trade Name: Stretta Model C8 Needle Inflatable Basket Catheter Electrode with Aspiration Regulatory Class: II Product Code: GEI Dated: April 5, 1999 Received: April 15, 1999
Dear Dr. Wehman:
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 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 (Special Controls) or 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
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Page 2- Thomas C. Wehman, Ph.D.
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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 10.3
Indications for Use
510(k) Number (if known):
Device Name:
Conway Stuart Medical Model C8 Needle Inflatable Basket Catheter Electrode with Aspiration
Indications for Use:
Indicated for coagulation of tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109) OR
Over-the-Counter Use (Optional format 1-2-06)
(Division) Sign-Off Division of General Restorative D 510(k) Number
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.