LEVEEN ELECTRODE

K012315 · Radiotherapeutics Corp. · GEI · Oct 11, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012315
• Device Name: LEVEEN ELECTRODE
• Applicant: Radiotherapeutics Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 11, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Device consists of preshaped, multi-armed electrode array contained within delivery cannula; attached to handle mechanism for deployment into targeted tissue. Supplied with insulated introducer sheath/stylet assembly for physician to locate target tissue. Device connects to RadioTherapeutics RF generator; RF energy passes from array to patient ground pad to heat surrounding tissue. Used in clinical setting by physicians for thermal coagulation necrosis of soft tissue; enables ablation of nonresectable liver lesions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Preshaped multi-armed electrode array; delivery cannula; insulated introducer sheath/stylet assembly; RF energy source; connects to external RF generator.

Indications for Use

Indicated for thermal coagulation necrosis of soft tissue, 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.

Predicate Devices

• LeVeen™ Electrode (K012315)

Submission Summary (Full Text)

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OCT 1 1 2001

## 510(k) Summary of Safety and Effectiveness KD12315

| Trade Name | LeVeen™ Electrode |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Classification<br>Name | Electrosurgical Electrode |
| Classification | Class II |
| Summary of Substantial<br>Equivalence | The modified LeVeen™ Electrode is substantially<br>equivalent to the previously cleared LeVeen™ Electrode |
| Device Description | The device consists of a preshaped, multi-armed electrode array which is contained within a delivery cannula. The array is attached to a handle mechanism that deploys the array into the targeted tissue. In addition, each device is supplied with an insulated introducer sheath/stylet assembly to allow the physician to locate the target tissue prior to placing and deploying the electrode. The device is connected to a RadioTherapeutics RF generator so that RF energy passes from the array to a patient ground pad and heats the tissue surrounding the array. |
| Intended Use | The LeVeen™ Electrode is intended to be used in conjunction with a RadioTherapeutics Corporation radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions. |

;

July 20, 2001

RadioTherapeutics Corporation

1308 Borregas Avenue, Sunnyvale, CA 94089 [phone] • Fax [phone]

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Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing the wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 1 2001

Ms. Kirsten Valley Vice President, Regulatory RadioTherapeutics Incorporated 1308 Borregas Avenue Sunnyvale, California 94089

Re: K012315

Trade/Device Name: LeVeen™ Electrode Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, JOS Dated: July 20, 2001 Received: July 23, 2001

Dear Ms. Valley :

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Ms. Kirsten Valley

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walk, my

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Unifer (in humber

012315

Device Name: The LeVeen™ Electrode

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

SN

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number Kot 2315

Prescription Use

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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