RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR

K032149 · Rita Medical Systems, Inc. · GEI · Sep 9, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032149
• Device Name: RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
• Applicant: Rita Medical Systems, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The RITA System (RF generator and electrosurgical devices) supplies energy for use in electrosurgery and is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including the partial or complete ablation of non-resectable liver lesions, and the palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard pain therapy.

Device Story

Model 1500X Electrosurgical RF Generator provides 250W monopolar radiofrequency energy for soft tissue ablation. System inputs include temperature sensor data, impedance, and power levels. Physician sets ablation mode, time, target temperature, and power. Generator monitors parameters continuously; automatically stops energy delivery if limits exceeded or ablation complete. Used in OR or clinic settings by physicians. Output displayed on LCD; assists physician in controlling ablation process. Benefits include controlled tissue destruction for non-resectable lesions and pain palliation.

Clinical Evidence

No clinical data provided. Bench testing only, specifically software validation testing.

Technological Characteristics

250W monopolar RF generator. Features temperature, impedance, and power monitoring. Includes LCD for parameter display and user interface for setting ablation parameters. Software-controlled energy delivery with automatic safety shut-off. Connectivity via main cable to electrosurgical device and dispersive electrode.

Indications for Use

Indicated for percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, specifically non-resectable liver lesions and palliation of bone metastatic pain in patients failing or ineligible for standard therapy.

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 1500X & Model 2500 Electrosurgical RF Generator

Submission Summary (Full Text)

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

| General<br>Provisions | Trade Name: RITA® Model 1500X Electrosurgical RF Generator<br>Common/Classification Name: Electrosurgical cutting and coagulation device |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate | RITA Medical Systems Inc. - Model 1500X & Model 2500 Electrosurgical RF<br>Generator |
| 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 RITA System (RF Generator and electrosurgical devices) supplies energy for<br>use in electrosurgery and is indicated for use in percutaneous, laparoscopic, or<br>intraoperative coagulation and ablation of soft tissue, including the partial or<br>complete ablation of non-resectable liver lesions, and the palliation of pain<br>associated with metastatic lesions involving bone in patients who have failed or are<br>not candidates for standard pain therapy. |
| Device<br>Description | The Model 1500X Electrosurgical RF Generator is designed to provide monopolar<br>radiofrequency (RF) energy. The RF Generator is a 250 W electrosurgical<br>generator specifically designed for use with RITA electrosurgical devices. It can<br>read multiple temperature sensors and includes impedance and power monitoring to<br>assist the physician in monitoring and controlling the ablation. |
| | To use the system, the RF Generator is plugged into the wall outlet via the Power Cord.<br>The electrosurgical device is connected to the RF Generator via the Main<br>Cable. The Dispersive Electrode is placed on the appropriate location of the body<br>and is connected to its port on the RF Generator. Once the system is successfully<br>powered up, the user can set the parameters of the ablation such as the mode of<br>operation, the ablation time, the target temperature, and the power delivery level.<br>With the electrosurgical device placed in the tissue to be ablated and its electrodes<br>deployed, RF power can be turned on. The system parameters are continuously<br>monitored and displayed on the RF Generator. If the measured parameters are<br>outside the acceptable limits, the RF energy delivery automatically stops and a<br>message appears on the liquid crystal display (LCD). The RF energy delivery also<br>automatically ceases once the ablation is completed based on the initial user-<br>defined parameters. RF energy can be stopped at any time by pressing the RF<br>ON/OFF switch. |
| Performance<br>Data | The Model 1500X RF Generator is subjected to software validation testing. |

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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 stylized eagle with three swooping lines representing its wings. The eagle's head is facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

SEP - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Rita Medical Systems. Inc. c/o Mr. Morten Christensen Office Coordinator, 510(k) Review Program Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050-4169

Re: K032149

Trade/Device Name: RITA® Model 1500X Electrosurgical RF Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 26, 2003 Received: August 27, 2003

Dear Mr. Christensen:

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 - Mr. Morten Christensen

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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.

Miriam C. Provost

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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## INTENDED USE 3.0

## Indications for Use Statement

| 510(K) Number<br>(if known) | KO32149 | |
|-----------------------------|------------------------------------------|--|
| Device Name | Model 1500X Electrosurgical RF Generator | |

The RITA® System (RF generator and electrosurgical devices) supplies energy for use in electrosurgery and is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including:

- the partial or complete ablation of non-resectable liver lesions and
- . the palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard pain therapy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Mirronm

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

510(k) Number K032149

Prescription Use ___ OR Over the Counter Use _______

(per 21 CFR 801.109)