(89 days)
Indicated for coagulation of tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
Model A 4000 Tubular Electrode, 4 Needle, No Irrigation or Aspiration
Model A 4000 Tubular Electrode, 4 Needle, With Irrigation or Aspiration
Model A 4400 Tubular Electrode, 8 Needle (2 rows of 4), No Irrigation or Aspiration
Model A 4400 Tubular Electrode, 8 Needle (2 rows of 4), With Irrigation or Aspiration
Model A 8000 Tubular Electrode, 8 Needle, No Irrigation or Aspiration
Model A 8000 Tubular Electrode, 8 Needle, With Irrigation or Aspiration
I apologize, but the provided text from the FDA 510(k) premarket notification for the Conway Stuart Medical Tubular Electrode series (Model A 4000, A 4400, A 8000) does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any details typically found in such studies.
The document is a letter from the FDA acknowledging the review of the 510(k) submission and determining substantial equivalence for the device. It focuses on regulatory aspects such as:
- Trade Names and Regulatory Class: Listing the different models and their classification.
- Substantial Equivalence Determination: Stating that the device is substantially equivalent to predicate devices marketed before May 28, 1976.
- Regulatory Compliance: Reminding the applicant of general controls, Good Manufacturing Practice (GMP) requirements, and other federal laws.
- Marketing Authorization: Allowing the device to be marketed.
- Indications for Use: Stating that the devices are "Indicated for coagulation of tissue" and "intended for use by qualified medical personnel trained in the use of electrosurgery."
Therefore, I cannot provide the requested table or information because the document does not contain the study details.
{0}------------------------------------------------
Public Health Service
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is facing left and has three lines extending from its body, possibly representing feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 1999
Thomas C. Wehman, Ph.D. Regulatory Affairs Conway Stuart Medical, Inc. 735 Palomar Avenue Sunnyvale, California 94086
K992542 Re:
Trade Name: Model A 4000 Tubular Electrode, 4 Needle, No Irrigation or Aspiration Model A 4000 Tubular Electrode, 4 Needle, With Irrigation or Aspiration Model A 4400 Tubular Electrode, 8 Needle (2 rows of 4), No Irrigation or Aspiration Model A 4400 Tubular Electrode, 8 Needle (2 rows of 4), With Irrigation or Aspiration Model A 8000 Tubular Electrode, 8 Needle, No Irrigation or Aspiration Model A 8000 Tubular Electrode, 8 Needle, With Irrigation or Aspiration Regulatory Class: II Product Code: GEI Dated: July 27, 1999 Received: July 30, 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 endednent and 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, eond manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see ahove) into cither class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( Fenance . Ipple day) . The Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially cquivalent 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)
{1}------------------------------------------------
Page 2 - Thomas C. Wehman, Ph.D.
inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure mispections, the Food and Drag Hanmay result in regulatory action. In addition, FDA may to comply with the GMT Tegulation may result in regarity of the Federal Register. Please note:
publish further announcements concerning your device in the Federal Register. publish further anilouncements concerning , when ission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic might have under books on other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow you to begal finding of substantial equivalence of your device to a premarket notification. The PDF Imaling or volusion for your device and thus, permits your device to proceed to the market.
If you desire spccific 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 and additionally 6071594-4595. Additionally, for questions on the promotion and Compliance at (301) 571-1595. Pradition of Compliance at (301) 594-4639. advertising of your dovies, prome entitled, "Misbranding by reference to prematicet Also, prease note the regulation email.org.neral information on your responsibilities under the montheation (21 CF (21 CF (007.97). Outler got 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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use 9.3
Indications for Use
MA
510(k) Number (if known):
992542
Device Name:
Indications for Use:
Conway Stuart Medical Tubular Electrode Conway Bidal A4000, A4400, A8000
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) Over-the-Counter Use OR Prescription Use (Optional format 1-2-06) (per 21 CFR 801.109)
Proprietary Data: This document and the information contined herein may not be reproduced, used or disclosed without prior written consent of Comway Stuart Medical, Inc.
§ 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.