(31 days)
For use in laparoscopic and open surgical procedures to provide r of ass iral cutting and electrosurgical hemostasis of tissue as well as grasping and manipulation of the tissue.
ConMED QUAD™ Bipolar Laparoscopic Coagulating and Cutting Instrument
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (ConMed QUAD Bipolar Laparoscopic Coagulating And Cutting Instrument). This document primarily focuses on regulatory approval and does not contain the detailed technical or clinical study information required to answer your specific questions about acceptance criteria, device performance, study design, or ground truth establishment.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes, data provenance, number of experts for ground truth, adjudication methods, or ground truth types for a test set.
- Details about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI.
- Information about standalone algorithm performance.
- Details on training set size or how ground truth for the training set was established.
This document confirms substantial equivalence to a predicate device based on the indications for use, but it does not provide the technical studies or clinical trial results that would typically contain the information you are requesting.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Mr. Ira D. Duesler, Jr. Quality Engineer ConMed Corporation 310 Broad Street Utica, New York 13350
K992186 Re:
Trade Name: ConMed QUAD™ Bipolar Laparoscopic Coagulating And Cutting Instrument
Regulatory Class: II Product Code: GEI Dated: June 28, 1999 Received: June 29, 1999
Dear Mr. Duesler:
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.
{1}------------------------------------------------
Page 2 - Mr. Ira D. Duesler, Jr.
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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number (if known):
Device Name:
ConMED QUAD™ Bipolar Laparoscopic Coagulating and Cutting Instrument
Indications for Use:
For use in laparoscopic and open surgical procedures to provide r of ass iral cutting and electrosurgical hemostasis of tissue as well as grasping and manipulation of the tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K992186 |
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter _____________________________________________________________________________________________________________________________________________________________
§ 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.