LEVEEN NEEDLE ELECTRODE

K982556 · Radiotherapeutics Corp. · GEI · Apr 6, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K982556
• Device Name: LEVEEN NEEDLE ELECTRODE
• Applicant: Radiotherapeutics Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 6, 2000
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LeVeen Needle Electrode is intended to be used in conjunction with a RadioTherapeutics Corporation radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

Device Story

LeVeen Needle Electrode functions as an accessory to a RadioTherapeutics Corporation radiofrequency (RF) generator; used for thermal coagulation necrosis of soft tissues; specifically targets nonresectable liver lesions. Device delivers RF energy to tissue to induce necrosis. Used in clinical settings by physicians. Effectiveness for treatment of liver cancer or liver disease (improved clinical outcomes) not established. Labeling requires specific precaution regarding this limitation.

Clinical Evidence

No clinical data provided; effectiveness for treatment of liver cancer or liver disease has not been established.

Technological Characteristics

Needle electrode designed for use with RF generator; intended for thermal coagulation necrosis of soft tissue. No specific materials or standards provided in document.

Indications for Use

Indicated for thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

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.

Submission Summary (Full Text)

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Public Health Service

APR 6 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Colin Nichols Official Correspondent RadioTherapeutics Corporation 1308 Borregas Avenue Sunnyvale, California 94089

Re: K982556 Trade Name: Leveen Needle Electrode Regulatory Class: II Product Code: GEI Dated: January 12, 2000 Received: January 13, 2000

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 legally marketed predicate 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 and the limitations described below. 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.

Although this device is substantially equivalent to other devices used for ablation of soft tissue, we are concerned that users may overestimate the capability of the device. It is on this basis that we are requesting that you include the following statement in the precautions section of the labeling:

## The effectiveness of this device for use in the treatment of liver cancer or liver disease (i.e., improved clinical outcomes) has not been established.

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 requirements, 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.

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Page 2 - Mr. Colin Nichols

The FDA finding of substantial equivalence of your device to a legally marketed predicate I he I DA Inding of sabbianian tquir device and permits your device to proceed to the device results in a classification for your device as described in your 510(k) market notification if the limitation statement above is added to your labeling, as described.

If you desire specific information about the application of other labeling requirements to your 11 you don't 500 and additionally 809.10 for in vitro diagnostic 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, advertising or your dovice, preference to preference to premarket notification'(21 CFR please note the regaration on your responsibilities under the Act may be obtained from 001.777). Oner Echeral Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

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 IIcalth

Enclosure

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LeVeen Needle Electrode

Indications for Use Statement

The LeVeen Needle Electrode is intended to be used in conjunction with a RadioTherapeutics Corporation radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number | K982556 |
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| Prescription Use (per 21 CRF 801.109) | |
| OR Over-the-counter Use | |

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