(41 days)
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.
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.
This document is a 510(k) Safety Summary for a medical device, the Stellartech Radiofrequency Generator. It is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria in the context of an AI/human performance study.
Specifically, the document does not contain the following:
- A table of acceptance criteria and the reported device performance in the context of AI/human performance. The document lists technical features and compliance with safety standards, but these are general engineering and safety requirements, not performance metrics for an AI medical device.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, or its effect size.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) in the context of AI.
- The sample size for the training set.
- How the ground truth for the training set was established.
The provided document describes a traditional medical device (Radiofrequency Generator) and its submission for regulatory clearance based on substantial equivalence to a predicate device, not an AI or software-as-a-medical-device (SaMD) product. The "study" mentioned in the document refers to "a series of physical, electrical, and functional tests" to demonstrate technical equivalence and compliance with safety standards, not a clinical or AI performance study.
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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 Corporation1346 Bordeaux DriveSunnyvale, CA 94089Telephone (408) 331-3000Facsimile (408) 331-3101 |
| Sponsor: | Stellartech Research Corporation1346 Bordeaux DriveSunnyvale, CA 94089Telephone (408) 331-3000Facsimile (408) 331-3101 |
| Contact: | James R. SantosSenior Quality Engineer |
| Trade Name: | Stellartech Radiofrequency Generator, Model 1025-115Stellartech 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 25watts of radiofrequency energy in unipolar mode to an electrode or electrodesin contact with tissue while continuously monitoring and displaying actualpower delivered, tissue impedance, and time of power duration.User controls are provided for setting desired power and maximum time ofpower duration. Safety features include overvoltage, overcurrent, andoverpower shutdowns. Each generator is tested for leakage current, dielectricwithstand, and control of power delivery prior to quality control release. |
| Intended Use: | The Stellartech Radiofrequency Generator is indicated for use in generalsurgical procedures to coagulate soft tissues. The Stellartech RadiofrequencyGenerator may also be used to coagulate blood and soft tissues to producehemostasis. |
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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"
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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
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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
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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
§ 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.