MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY

K023846 · Rita Medical Systems · GEI · Dec 6, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K023846
• Device Name: MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY
• Applicant: Rita Medical Systems
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 6, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MR Compatible Model 90 Electrosurgical Probe is designed to supply energy (generated by the RITA Medical Systems' Electrosurgical Generator) for use in electrosurgery and is designed for the following: Incorporation of multiple needles on each probe minimizing the number of invasive accesses necessary to achieve desired lesions. Provide a minimally invasive laparoscopic, percutaneous, or intraoperative access to the targeted tissue. Deliver radiofrequency energy in a controlled fashion to create coagulative necrotic lesions. Incorporate thermocouples for temperature feedback. Provide for local delivery of fluid.

Device Story

MR Compatible Model 90 Electrosurgical Probe is a radiofrequency (RF) electrosurgical accessory; used with RITA Medical Systems' electrosurgical generator. Device features multiple extendible needles deployed from a trocar tip to minimize invasive access. Input: RF energy from generator; Output: controlled delivery of RF energy to tissue to create coagulative necrotic lesions. Includes thermocouples for temperature feedback and a Luer port for local fluid delivery. Used in laparoscopic, percutaneous, or intraoperative settings by clinicians. Provides minimally invasive access to targeted tissue; temperature feedback allows controlled lesion creation; fluid delivery supports procedure. MR compatibility allows use in magnetic resonance environments.

Clinical Evidence

Bench testing only. The device underwent a battery of electrical, mechanical, biocompatibility, and magnetic resonance testing to verify performance specifications. No clinical data was required or provided.

Technological Characteristics

Device consists of a primary electrode (hypodermic tubing), secondary extendible electrodes, polymer handle, Lemo connector for RF, and Luer port for fluid infusion. Features five integrated thermocouples for temperature feedback and 1-cm depth indicators. MR compatible design. Sterilization method not specified. Standalone accessory for use with external RF generator.

Indications for Use

Indicated for patients requiring electrosurgical access to targeted tissue for the creation of coagulative necrotic lesions via laparoscopic, percutaneous, or intraoperative procedures.

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

• RITA Medical Systems Inc. - Model 90 Electrosurgical Probe
• Radiotherapeutics Corp. - MR Compatible LeVeen Needle Electrode

Submission Summary (Full Text)

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## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 9.0 KO23846

| General<br>Provisions | Trade Name: MR Compatible Model 90 Electrosurgical Probe<br>Common/Classification Name: Electrosurgical cutting and coagulation accessory |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate | RITA Medical Systems Inc. - Model 90 Electrosurgical Probe |
| | Radiotherapeutics Corp. - MR Compatible LeVeen Needle Electrode |
| Classification | Class II |
| Performance<br>Standards | Performance standards have not been established by the FDA under section 514 of<br>the Food, Drug and Cosmetic Act. |
| Intended Use | The MR Compatible Model 90 Electrosurgical Probe is designed to supply energy<br>(generated by the RITA Medical Systems' Electrosurgical Generator) for use in<br>electrosurgery and is designed for the following:<br>Incorporation of multiple needles on each probe minimizing the number of<br>invasive accesses necessary to achieve desired lesions.Provide a minimally invasive laparoscopic, percutaneous, or intraoperative<br>access to the targeted tissue.Deliver radiofrequency energy in a controlled fashion to create coagulative<br>necrotic lesions.Incorporate thermocouples for temperature feedback.Provide for local delivery of fluid. |
| Device<br>Description | This RITA® MR Compatible Model 90 device is available in 15 cm and 25 cm<br>lengths for a variety of medical applications. The secondary electrodes deploy<br>out from the trocar tip. The RITA MR Compatible Model 90 device consists of<br>the following components:<br>primary electrode: hypodermic tubing with a portion exposed as an<br>electrodesecondary electrodes: extendible flexible hypodermic tubing at the distal<br>end of probetrocar insulation: shrink tubinghandle: polymer materials with markings to indicate the amount of<br>electrode array deployment from the trocarRF pathway: connection through a Lemo connector built into the handlefluid infusion: delivery through Luer port at side of the handletemperature sensors: five temperature sensors at the periphery of the arraydepth indicators: Incremental 1-cm marks denote needle penetration depth. |
| Performance<br>Data | The MR Compatible Model 90 devices were subjected to a battery of electrical,<br>mechanical, biocompatibility, and magnetic resonance testing to verify that the<br>devices met the specifications. The devices met the specifications and the materials<br>did not elicit toxicological responses. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 three human profiles facing right, which also forms the shape of a bird.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 6 2002

Rita Medical Systems Karen Frischmeyer Director. Clinical Programs 967 North Shoreline Boulevard Mountain View, California 94043

Re: K023846

Trade/Device Name: MR Compatible Model 90 Electrosurgical Probe Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation accessory Regulatory Class: Class II Product Code: GEI Dated: November 18, 2002 Received: November 19, 2002

Dear Ms. Frischmeyer:

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

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Page 2 – Ms. Karen Frischmeyer

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.

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), 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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RITA Medical Systems, Inc.

## INTENDED USE · 3.0

| Indications for Use Statement | |
|-------------------------------|----------------------------------------------|
| 510(K) Number (if known) | K023846 |
| Device Name | MR Compatible Model 90 Electrosurgical Probe |

The MR Compatible Model 90 Electrosurgical Probe is designed to supply energy (generated by the RITA Medical Systems' electrosurgical generator) for use in electrosurgery and is designed for the following:

- Incorporation of multiple needles on each probe minimizing the number of . invasive accesses necessary to achieve desired lesions.
- Provide a minimally invasive laparoscopic, percutaneous, or intraoperative . access to the targeted tissue.
- Deliver radiofrequency energy in a controlled fashion to create coagulative . necrotic lesions.
- Incorporate thermocouples for temperature feedback. .
- Provide for local delivery of fluid. .

PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use \/ OR Over the Counter Use ***_***

(per 21 CFR 801.109)

Meriam C. Provost

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

510/k) Namber

November 18, 2002