(134 days)
Not Found
Not Found
No
The summary describes a standard RF electrosurgical generator and does not mention any AI or ML capabilities.
Yes
The device is indicated for "coagulation of tissue," which is a medical procedure used to treat specific conditions (e.g., stopping bleeding, removing abnormal tissue), thus fitting the definition of a therapeutic device.
No
Explanation: The device is an RF generator indicated for the coagulation of tissue, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "Radiofrequency Electrosurgical Generator," which is a hardware device. The intended use also mentions "Conway Stuart Medical electrodes," which are also hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "coagulation of tissue." This is a therapeutic procedure performed directly on a patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information about a person's health. They are used outside the body (in vitro).
- Device Description: The device is an "RF Generator" used for electrosurgery, which is a surgical technique.
The description clearly indicates a device used for a surgical procedure on a patient, not for testing samples in a lab.
N/A
Intended Use / Indications for Use
The Conway-Stuart Medical Model C4 RF Generator, in combination with Conway Stuart Medical electrodes, is indicated for coagulation of tissue. This device is intended for use by qualified medical personnel, trained in the use of electrosurgery.
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
qualified medical personnel, trained in the use of electrosurgery.
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)
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 1999
Thomas C. Wehman, Ph.D. Regulatory Affairs Conway Stuart Medical, Inc. 735 Palomar Avenue Sunnyvale, California 94086
K983986 Re: Trade Name: Model C4 Radiofrequency Electrosurgical Generator Regulatory Class: II Product Code: GEI Dated: February 12, 1999 Received: February 23, 1999
Dear Dr. Wehman:
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 - Thomas C. Wehman, Ph.D.
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 vour 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) Premarket Notification Model C4 Radiofrequency Electrosurgical Generator
K983986
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Contraindications for Use:
Model C4 Radiofrequency Electrosurgical Generator
The Conway-Stuart Medical Model C4 RF Generator, in combination with Conway Stuart Medical electrodes, is indicated for coagulation of tissue. This device is intended for use by qualified medical personnel, trained in the use of electrosurgery.
The use of the CSM Model C4 RF generator is contraindicated when, in the judgment of the physician, electrosurgical procedures would be contrary to the best interest of the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (per 21 CFR 801.109) | |
|---|---|
| OR Over-the-Counter Use | |
| (Optional format 1-2-06) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K983986 |
|---|---|
| --------------- | --------- |
Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Conway Stuart Medical, Inc.