(87 days)
General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of a RF (radio frequency) electrosurgical current through an accessory electrode for . cutting and coagulation at the operative site.
Not Found
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the Conmed System 2000 ESU, an electrosurgical generator. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations. However, it does not include details on specific acceptance criteria, study designs, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for a device performance study.
Therefore, I cannot extract:
- A table of acceptance criteria and reported device performance.
- Sample sizes used, test set data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Information on MRMC comparative effectiveness studies or effect sizes.
- Information on standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
{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 emblem of three human profiles facing right, connected by a flowing ribbon-like element. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration & S 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2002
Conmed Corporation Mr. Charles M. Hart Director, RA/QA/Safety Conmed Electrosurgery 14603 Fremont Avenue Centennial, Colorado 80112
Re: K020135
Trade Name: Conmed System 2000 ESU Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 12, 2002 Received: January 15, 2002
Dear Mr. Hart:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your seemers er ermined 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 May 28, 1970, the chance with the provisions of the Federal Food, Drug, and Cosmetic Act bect reclassified in accesapproval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, manier and the Act include requirements for annual registration, listing of devices, condons provisions or use ice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
Page 2 - Mr. Charles Hart
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _____CONMED SYSTEM 2000 ESU
Indications for Use:
General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of a RF (radio frequency) electrosurgical current through an accessory electrode for . cutting and coagulation at the operative site.
| 1 - 12 - 1 | A | |
|---|---|---|
| ਾ | 43.4 | /ક્ષ્વર્ગ |
| ਾਂ ਗ੍ | entre leveloped for1 | れ |
| news in1 | 1553 | i্ਾ |
| דרן | រីវេ | િયા/ |
| ្រី | 彩ી | ાન (1C |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C Proost
(Division Sign-Off) Division of General, Restorative and Neurological De ices
Prescription Use (Per 21 CFR 801.109)
2020135 510(k) Number -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.