(87 days)
Not Found
None
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the core function of an electrosurgical generator.
Yes
The device is described as an electrosurgical generator used for cutting and coagulation at an operative site, which are therapeutic medical procedures.
No
The device is described as a general-purpose electrosurgical generator used for cutting and coagulation, which are therapeutic actions, not diagnostic ones.
No
The intended use describes a hardware device (electrosurgical generator) that delivers RF current through an accessory handpiece and electrode. This is clearly not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for surgical procedures (cutting and coagulation at the operative site) by delivering radio frequency current. This is an in vivo application, meaning it's used directly on a living organism.
- IVD Definition: In vitro diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
The description clearly indicates a surgical tool used on the patient, not a device used to test samples from the patient.
N/A
Intended Use / 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.
Product codes
GEI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.
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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.
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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 _____________________________________________________________________________________________________________________________________________________________