(90 days)
Not Found
No Reference Devices with K/DEN numbers were found in the text.
No
The summary describes a simple coagulator device with no mention of AI, ML, image processing, or data-driven performance metrics.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. While the C-300 Coagulator is used in surgical procedures to close wounds by coagulation (burning), its primary function is to facilitate a surgical step rather than to directly treat a disease or condition as a standalone therapy. It's a surgical tool used for a specific purpose within a procedure, which distinguishes it from devices that directly aim to cure, mitigate, treat, or prevent a disease or condition.
No
The device's intended use is to coagulate (burn) open wounds or skin lesions in surgical procedures, which is a therapeutic function, not a diagnostic one. It describes how it "closes" wounds, not how it identifies or analyzes conditions.
No
The description clearly states "Coagulator Device Name: C-300" and describes a physical action ("coagulate (burn) an open wound or skin lesions"), implying a hardware component is necessary to perform this function. There is no mention of software as the primary or sole component.
Based on the provided information, the C-300 Coagulator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The C-300 Coagulator is used directly on the patient's skin to coagulate (burn) open wounds or skin lesions during surgical procedures. It does not analyze any bodily fluids or tissues in vitro (outside the body).
The device's function is a therapeutic/surgical intervention performed in vivo (within the body), not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
C-300 Coagulator is used in small surgical procedures in The dermatology, plastic surgery and general surgery in order to only coagulate (burn) an open wound or skin lesions. This device does cut the skin, it only closes open wounds or lesions by not coagulating (burning) the skin in any of the small surgical procedures mentioned above.
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
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified physician, dermatology, plastic surgery, general surgery
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 is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0 1698 JUL
Ms. Annie Velez · Directory of Regulatory Affairs Magna Advanced Technologies, Inc. 7200 N.W. Seventh Street Miami, Florida 33126
Re: K981310 Trade Name: MagnaTek C-300 Regulatory Class: II Product Code: GEI Dated: March 4, 1998 Received: April 10, 1998
Dear Ms. Velez:
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 (OS) 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.
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.
1
Page 2 - Ms. Annie Velez
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
305 261 4492
INDICATION FOR USE STATEMENT
510(k) Number: Not yet available (9)3\D
Coagulator Device Name:
Device Model: C-300
Indications for Use:
C-300 Coagulator is used in small surgical procedures in The dermatology, plastic surgery and general surgery in order to only coagulate (burn) an open wound or skin lesions. This device does cut the skin, it only closes open wounds or lesions by not coagulating (burning) the skin in any of the small surgical procedures mentioned above.
Federal Law restricts the use of this device by or on the order of a qualified physician only.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K981310 |