(89 days)
Not Found
Not Found
No
The summary describes a needle electrode for thermal coagulation, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is described as being used for "thermal coagulation necrosis of soft tissues," which is a medical procedure aimed at treating or alleviating a condition, thus making it a therapeutic device.
No
The device is described as an electrode for thermal coagulation necrosis of soft tissues, which is a treatment modality, not a diagnostic one.
No
The device description explicitly states "MR Compatible LeVeen Needle Electrode," which is a physical hardware component (a needle electrode). The summary does not mention any software component as the primary or sole function of the 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 necrosis of soft tissues" using an RF Generator. This is a therapeutic procedure performed directly on the patient's body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "Needle Electrode," which is a tool used for delivering energy to tissue, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, the MR Compatible LeVeen Needle Electrode is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MR Compatible LeVeen Needle Electrode is intended to be used in conjunction with separately approved RF Generators such as the RadioTherapeutics RF-2000, for the thermal coagulation necrosis of soft tissues.
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
soft tissues
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
Not Found
Key Metrics
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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three heads, depicted in a simple, black line drawing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 1998
Radiotherapeutics, Corp. c/o Mr. Robert Behl Official Correspondent 2685 Marine Way Suite 1408 Mountain View, California 94043-1115
K982854 Re: MR Compatible LeVeen Needle Electrode Trade Name: Requlatory Class: II Product Code: GEI Dated: August 12, 1998 August 13, 1998 Received:
Dear Mr. Behl:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 - Mr. Robert Behl
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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
MR Compatible LeVeen Needle Electrode™
Indications for Use Statement
510(k) Number: Unknown K982854
MR Compatible LeVeen Needle Electode Device Name:
Indications For Use:
The MR Compatible LeVeen Needle Electrode is intended to be used in conjunction with separately approved RF Generators such as the RadioTherapeutics RF-2000, for the thermal coagulation necrosis of soft tissues..
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | 11/10/98 |
| Prescription Use | X | OR | Over-The-Counter Use | ______ |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
510(k) Submission APPENDIX III