(563 days)
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No
The 510(k) summary describes a standard electrosurgical electrode and makes no mention of AI, ML, image processing, or any related concepts.
Yes
The device, an electrosurgery electrode, is intended for use in electrosurgery to perform medical procedures such as cutting, coagulation, desiccation, and fulguration, which are therapeutic interventions.
No
The device is used to perform surgical functions (cutting, coagulation, desiccation, and fulguration), not to diagnose conditions.
No
The device description clearly states "CleanCut Electrosurgery Electrode," indicating a physical electrode, which is a hardware component. The intended use also describes physical actions like cutting and coagulation performed by the electrode.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the electrodes are for use in electrosurgery to perform procedures like cutting, coagulation, dessication, and fulguration. These are surgical procedures performed directly on a patient's tissue.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples.
The device is an electrosurgical electrode, which is a surgical instrument used during procedures.
N/A
Intended Use / Indications for Use
MedQuest Products Inc.'s Clean-Cut™ electrodes are intended for use in electrosurgery to perform cutting, coagulation, dessication, and fulguration. Each electrode is intended to be a disposable electrode, designed to fit standard electrosurgical pencils, and to be powered by standard electrosurgical generators.
Product codes
GEI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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 seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which is the department's symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 7 1999
Mr. Pratap S. Khanwilkar President MedQuest Products, Inc. N143, 825 North 300 West Salt Lake City, Utah 84103-1414
K972335 Trade Name: CleanCut Electrosurgery Electrode Regulatory Class: II Product Code: GEI Dated: November 25, 1998 Received: December 1, 1998
Dear Mr. Khanwilkar:
Re:
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. Pratap S. Khanwilkar
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
- Indications for Use
510(k) Number (if known):_KG2235
Device Name: Clean-Cut Electrosurgery Electrode
Indications for Use:
ﺪ ﺍﻟﻤﺮﺍﺟﻊ
MedQuest Products Inc.'s Clean-Cut™ electrodes are intended for use in electrosurgery to perform cutting, coagulation, dessication, and fulguration. Each electrode is intended to be a disposable electrode, designed to fit standard electrosurgical pencils, and to be powered by standard electrosurgical generators.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | IC972335 |
MedQuest Products Inc., June 1997
CONFIDENTIAL AND PROPRIETARY