RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE

K993944 · Rita Medical Systems · GEI · Dec 2, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K993944
• Device Name: RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE
• Applicant: Rita Medical Systems
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Model 1500 Electrosurgical RF Generator and accessories are indicated for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue.

Device Story

Model 1500 Electrosurgical RF Generator provides 150W monopolar radiofrequency (RF) energy for soft tissue ablation. System inputs include temperature sensor data, impedance, and power levels. Physician sets ablation parameters (mode, time, target temperature, power) via interface. Generator monitors parameters continuously; automatically ceases energy delivery if limits exceeded or ablation complete. Used in percutaneous, laparoscopic, or intraoperative settings. Output displayed on LCD; provides real-time feedback to physician for procedure control. Benefits include automated monitoring and controlled tissue ablation.

Clinical Evidence

Bench testing only. The device underwent a battery of electrical, mechanical, and software validation testing to demonstrate safety and performance.

Technological Characteristics

150W monopolar RF electrosurgical generator. Features include temperature sensor inputs, impedance monitoring, and power control circuitry. Includes LCD for parameter display and user interface for setting ablation parameters. System is designed for use with RITA electrosurgical devices. Software-controlled energy delivery with automated safety cut-offs.

Indications for Use

Indicated for percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue in patients requiring such 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 500 Electrosurgical RF Generator

Submission Summary (Full Text)

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k993944

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

| General<br>Provisions | Trade Name: RITA® Model 1500 Electrosurgical RF Generator<br>Common/Classification Name: Electrosurgical cutting and coagulation device |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate | RITA Medical Systems Inc. - Model 500 Electrosurgical RF 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 Model 1500 Electrosurgical RF Generator and accessories are indicated for use<br>in percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft<br>tissue. |
| Device<br>Description | The Model 1500 Electrosurgical RF Generator is designed to provide monopolar<br>radiofrequency (RF) energy. The RF Generator is a 150 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<br>Cord. The electrosurgical device is connected to the RF Generator via the Main<br>Cable. The Dispersive Electrode is place 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 1500 RF Generator was subjected to a battery of electrical, mechanical,<br>and software validation testing. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a person with outstretched arms.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1999

Rita Medical Systems c/o Ms. Chantel Carson Project Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062-2096

Re: K993944

> Trade Name: Model 1500 Electrosurgical RF Generator Regulatory Class: II Product Code: GEI Dated: November 9, 1999 Received: November 19, 1999

Dear Ms. Carson:

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 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 (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 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 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 - Ms. Chantel Carson

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 vour 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 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" (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.

to Colle, Jt

James E. Dillard III Acting Director Division of General and Restorative 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 (if known) | |
|--------------------------|--|
|--------------------------|--|

大993944

Device Name

Model 1500 Electrosurgical RF Generator

The Model 1500 RF Electrosurgical Generator and accessories are indicated for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | (Division Sign-Off) <div>Division of General Restorative Devices</div> |
|---------------|------------------------------------------------------------------------|
| 510(k) Number | K993944 |

| (per 21 CFR 801.109) | Prescription Use <span style="text-decoration: underline;">X</span> OR Over the Counter Use ______ |
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