(41 days)
RF 2000T-K981672
No
The document describes a standard radiofrequency generator with controls for power, time, and safety features. There is no mention of AI, ML, image processing, or data sets for training or testing, which are typical indicators of AI/ML integration in medical devices.
No
The device is used for surgical procedures like cutting and coagulating tissues, not for treating a disease or condition in a therapeutic manner.
No
The device is described as a radiofrequency generator used for general surgical procedures to coagulate and cut soft tissues, and to produce hemostasis. Its function is to deliver energy for treatment, not to diagnose conditions.
No
The device description explicitly states it is a "Radiofrequency Generator" and details hardware components and electrical testing, indicating it is a physical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Stellartech Radiofrequency Generator is used in general surgical procedures to cut and coagulate soft tissues and coagulate blood and soft tissues to produce hemostasis. This is a direct intervention on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly describes a surgical procedure, not a diagnostic test.
- Device Description: The description focuses on the delivery of radiofrequency energy to tissue, not on analyzing biological samples.
Therefore, based on the provided information, the Stellartech Radiofrequency Generator is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stellartech Radiofrequency Generator is indicated for use in general surgical procedures to coagulate soft tissues. The Stellartech Radiofrequency Generator may also be used to coagulate blood and soft tissues to produce hemostasis.
The Stellartech Radio Frequency Generator (Model 1025A-115 and Model 1025A-230) is indicated for use in general surgical procedures to cut and coagulate soft tissue.
Product codes
GEI
Device Description
The Stellartech Radiofrequency Generator is capable of supplying up to 25 watts of radiofrequency energy in unipolar mode to an electrode or electrodes in contact with tissue while continuously monitoring and displaying actual power delivered, tissue impedance, and time of power duration. User controls are provided for setting desired power and maximum time of power duration. Safety features include overvoltage, overcurrent, and overpower shutdowns. Each generator is tested for leakage current, dielectric withstand, and control of power delivery prior to quality control release.
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
The technical characteristics of the Stellartech Radiofrequency Generator are substantially equivalent to those of the previously identified predicate device. as demonstrated by a series of physical, electrical, and functional tests. The device is designed to comply with the requirements of :
- EN 60601-1, " Medical Electrical Equipment, General Requirements for . Safety"
- EN 60601-1-1, "Medical Electrical Equipment, General Requirements for . Safety - Safety Requirements for Medical Electrical Systems"
- EN 60606-1-1-2, "Medical Electrical Equipment, General Requirements . for Safety - Electromagnetic Compatibility - Requirements and Tests"
- EN 60601-1-4, "Medical Electrical Equipment-Part 1 General . Requirements for Safety; 4. Collateral Standard: Programmable Electrical Medical Devices"
- EN 60601-2-2, "Medical Electrical Equipment, Particular Requirements . for the Safety of High Frequency Surgical Equipment"
Key Metrics
Not Found
Predicate Device(s)
RadioTherapeutics Radiofrequency Generator, Model RF 2000T-K981672
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 contains a sequence of alphanumeric characters that appear to be handwritten. The characters are K994173, with each digit and letter distinct and legible. The writing style suggests a casual or informal script, possibly a serial number or identification code.
Stellartech Radiofrequency Generator 510(k) Safety Summary
| Date Prepared: | December 7, 1999 |
|---|---|
| Applicant: | Stellartech Research Corporation |
| 1346 Bordeaux Drive | |
| Sunnyvale, CA 94089 | |
| Telephone (408) 331-3000 | |
| Facsimile (408) 331-3101 | |
| Sponsor: | Stellartech Research Corporation |
| 1346 Bordeaux Drive | |
| Sunnyvale, CA 94089 | |
| Telephone (408) 331-3000 | |
| Facsimile (408) 331-3101 | |
| Contact: | James R. Santos |
| Senior Quality Engineer | |
| Trade Name: | Stellartech Radiofrequency Generator, Model 1025-115 |
| Stellartech Radiofrequency Generator, Model 1025-230 | |
| Common Name: | Electrosurgical Generator |
| Classification Name: | Electrosurgical Cutting and Coagulating Device |
| Classification: | Class II - 21 CFR 882.4400 |
| Predicate Device: | RadioTherapeutics™ Radiofrequency Generator, Model RF 2000™-K981672 |
| Device Description: | The Stellartech Radiofrequency Generator is capable of supplying up to 25 |
| watts of radiofrequency energy in unipolar mode to an electrode or electrodes | |
| in contact with tissue while continuously monitoring and displaying actual | |
| power delivered, tissue impedance, and time of power duration. | |
| User controls are provided for setting desired power and maximum time of | |
| power duration. Safety features include overvoltage, overcurrent, and | |
| overpower shutdowns. Each generator is tested for leakage current, dielectric | |
| withstand, and control of power delivery prior to quality control release. | |
| Intended Use: | The Stellartech Radiofrequency Generator is indicated for use in general |
| surgical procedures to coagulate soft tissues. The Stellartech Radiofrequency | |
| Generator may also be used to coagulate blood and soft tissues to produce | |
| hemostasis. |
1
Technical Features: The technical characteristics of the Stellartech Radiofrequency Generator are substantially equivalent to those of the previously identified predicate device. as demonstrated by a series of physical, electrical, and functional tests. The device is designed to comply with the requirements of :
- EN 60601-1, " Medical Electrical Equipment, General Requirements for . Safety"
- EN 60601-1-1, "Medical Electrical Equipment, General Requirements for . Safety - Safety Requirements for Medical Electrical Systems"
- EN 60606-1-1-2, "Medical Electrical Equipment, General Requirements . for Safety - Electromagnetic Compatibility - Requirements and Tests"
- EN 60601-1-4, "Medical Electrical Equipment-Part 1 General . Requirements for Safety; 4. Collateral Standard: Programmable Electrical Medical Devices"
- EN 60601-2-2, "Medical Electrical Equipment, Particular Requirements . for the Safety of High Frequency Surgical Equipment"
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 2000
Mr. James R. Santos Senior Quality Engineer Stellartech Research Corporation 1346 Bordeaux Drive Sunnyvale, California 94089
K994173 Re:
Trade Name: Stellartech Radiofrequency Generator, Model 1025A-115 and Model 1025A-230 Regulatory Class: II
Product Code: GEI Dated: December 7, 1999 Received: December 10, 1999
Dear Mr. Santos:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices 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 Devices 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 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 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 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 devices 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 devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed
3
Page 2 - Mr. James R. Santos
predicate devices 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,
Stypt Rhodes
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Devices Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) NUMBER (IF KNOWN):
K994173 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------
DEVICE NAME:
Stellartech Radio Frequency Generator, Model 1025A-115 and Model 1025A-230
INDICATIONS FOR USE:
The Stellartech Radio Frequency Generator (Model 1025A-115 and Model 1025A-230) is indicated for use in general surgical procedures to cut and coagulate soft tissue.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K994173 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter-Use |
|---|---|---|
| --------------------------------------- | --------------- | ---------------------- |
25W SRG 510K 991207.doc