(44 days)
Not Found
Not Found
No
The summary describes a passive dispersive electrode for electrosurgery and explicitly states that AI, DNN, or ML are "Not Found".
No
The device is a dispersive electrode used to return RF energy to an electrosurgical generator, which is a component of a therapeutic procedure, but the electrode itself does not introduce therapeutic energy to the patient or perform a therapeutic function directly.
No
The device is described as a dispersive electrode used for electrosurgical procedures, which involves the return of therapeutic energy, not the detection or analysis of medical conditions.
No
The device description explicitly states "Dispersive Electrodes," which are hardware components used in electrosurgery. The summary does not mention any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for the dispersion and return of therapeutic energy introduced to the patient. This describes a device used on the patient during a medical procedure, not a device used to test samples from the patient in a laboratory setting.
- Device Description: The description "dispersive electrodes" further supports its use in direct patient contact during electrosurgery.
- Lack of IVD Characteristics: The information provided does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Use in a laboratory or clinical setting for testing purposes
Therefore, this device falls under the category of a medical device used for therapeutic purposes during a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
...dispersive electrode used for the dispersion and return to the electrosurgical generator of therapeutic (RF) energy introduced to the patient at the active --------electrode during electrosurgical procedures.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ira D. Duesler, Jr. Quality Engineer ConMed® Corporation . 310 Broad Street Utica, New York 13501
AUG 27 1997
Re: K972628
Trade Name: ConMed ThermoGard™ & ThermoGard™ Plus ABC Dispersive Electrodes Regulatory Class: II Product Code: GEI Dated: July 11, 1997 Received: July 14, 1997
Dear Mr. Duesler:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirements , as set forth in the Quality Svstem Kegulation (QS) for Medica! 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 devices in the Federal Register. Please note: this response to your premarket notification submissions 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
1
Page 2 - Mr. Ira D. Duesler, Jr.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market. . . . . . . . . . . .
If you desire specific advice for your devices 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 devices, 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,
focollaz
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):
ConMed ThermoGard" & ThermoGard" Plus abc Device Name: ___ Dispersive Electrode
Indications For Use:
......dispersive electrode used for the dispersion and return to the electrosurgical generator of therapeutic (RF) energy introduced to the patient at the active --------electrode during electrosurgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE) n Sign-Off) n of Goneral Restorative Davices 972228 OR
Prescription Use J (Per 21 CFR 801.109
Over-The-Counter Use
$\frac{SU}{II}$
1 1 1 1 1 1 1 1 1 1
Revised December 17. 1996