MR COMPATIBLE LEVEEN NEEDLE ELECTRODE

K982854 · Radiotherapeutics Corp. · GEI · Nov 10, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982854
• Device Name: MR COMPATIBLE LEVEEN NEEDLE ELECTRODE
• Applicant: Radiotherapeutics Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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..

Device Story

MR Compatible LeVeen Needle Electrode is a surgical accessory used with RF generators (e.g., RadioTherapeutics RF-2000) to perform thermal coagulation necrosis of soft tissues. Designed for compatibility with Magnetic Resonance (MR) imaging environments. Operated by physicians in clinical or surgical settings. Device delivers radiofrequency energy to target tissue to induce necrosis. Benefits include enabling targeted tissue ablation while maintaining compatibility with MR imaging guidance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Needle electrode designed for MR compatibility. Functions as an accessory to RF generators for thermal coagulation. No specific materials or software algorithms described.

Indications for Use

Indicated for thermal coagulation necrosis of soft tissues. Intended for prescription use only.

Regulatory Classification

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.

Reference Devices

• RadioTherapeutics RF-2000

Submission Summary (Full Text)

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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## 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 | <div style="text-decoration: overline;">X</div> | OR | Over-The-Counter Use | ______ |
|----------------------|-------------------------------------------------|----|----------------------|--------|
| (Per 21 CFR 801.109) | | | | |

510(k) Submission APPENDIX III