(66 days)
Not Found
Not Found
No
The summary describes a standard electrosurgical generator for thermal coagulation and contains no mention of AI or ML terms, image processing, or data sets typically associated with AI/ML device submissions.
Yes
The device is intended for the thermal coagulation of soft tissues, which is a therapeutic intervention.
No
The device is described as an electrosurgical generator for thermal coagulation of soft tissues, which is a therapeutic function, not a diagnostic one. It is used to treat tissues, not to identify or characterize diseases or conditions.
No
The device description explicitly states it is a "Radiofrequency Generator," which is a hardware device. The summary does not mention any software-only components or functions that constitute the primary medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "thermal coagulation of soft tissues" using an electrosurgical generator. This is a therapeutic procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue samples) taken from the human body to provide information about a person's health. This device does not involve the analysis of such specimens.
- Device Description: The description is of a "Radiofrequency Generator," which is a type of medical device used for surgical procedures, not laboratory testing.
The information provided clearly indicates a device used for a therapeutic intervention on a patient, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The RadioTherapeutics Corp. RF Generator is a medium power electrosurgical generator intended for use with separately approved electrodes for the thermal coagulation of soft tissues.
Product codes
GEI
Device Description
RadioTherapeutics RF-2000 Radiofrequency Generator
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
soft tissues
Indicated Patient Age Range
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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
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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 curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 1998
Mr. Colin J. Nichols RadioTherapeutics, Corporation 2685 Marine Way, Suite 1408 Mountain View, California 94043-1115
Re: K981672 Trade Name: RadioTherapeutics RF-2000 Radiofrequency Generator Regulatory Class: II Product Code: GEI Dated: May 8, 1998 Received: May 12, 1998
Dear Mr. Nichols:
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.
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Page 2 - Mr. Colin J. Nichols
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
RadioTherapeutics RF Generator Model RF 2000
Indications for Use Statement
510(k) Number: Unknown K981677
Device Name: RadioTherapeutics™ Corp. RF Generator Model #RF-2000
Indications For Use:
ー The RadioTherapeutics Corp. RF Generator is a medium power electrosurgical generator intended for use with separately approved electrodes for the thermal coagulation of soft tissues.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K981672 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
510(k) Submission APPENDIX X
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