RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES

K983214 · Rita Medical Systems · GXD · Mar 27, 2000 · Neurology

Device Facts

• Record ID: K983214
• Device Name: RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES
• Applicant: Rita Medical Systems
• Product Code: GXD · Neurology
• Decision Date: Mar 27, 2000
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 882.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RITA® System (Model 500 RF Generator and Accessories) supplies energy for use in electrosurgery, and are 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.

Device Story

RITA Model 500 Electrosurgical RF Generator and Accessories create coagulative necrotic lesions in soft tissue. System delivers RF energy via monopolar electrosurgical probes featuring deployable needle arrays. Generator monitors temperature, impedance, and power to assist user in delivering energy to target tissue; allows localized fluid delivery to lesion. Used in percutaneous, laparoscopic, or intraoperative settings by physicians. Output provides predictable volumes of tissue ablation (typically 3-4 cm diameter). Clinical benefit includes treatment of non-resectable liver lesions; however, effectiveness for improved clinical outcomes in liver cancer/disease is not established.

Clinical Evidence

Clinical studies evaluated safety and effectiveness for cancerous liver lesion ablation. Studies included patients scheduled for surgical resection and patients with non-resectable primary/metastatic liver cancer. Results showed low morbidity, no device-related deaths, and low adverse event rates. Post-procedure CT scans demonstrated consistent ablation diameters of 3-4 cm.

Technological Characteristics

Electrosurgical RF generator and monopolar probes with deployable needle arrays. Features temperature, impedance, and power monitoring sensors. Designed for soft tissue coagulation and ablation. Includes localized fluid delivery capability.

Indications for Use

Indicated for percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including partial or complete ablation of non-resectable liver lesions in patients requiring electrosurgical intervention.

Regulatory Classification

Identification

A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.

Predicate Devices

• RITA Medical Systems Inc. - Model 10 Electrosurgical Accessory
• RITA Medical Systems Inc. - Model 500 Electrosurgical RF Generator
• RITA Medical Systems Inc. – Models 20 and 30 Electrosurgical Accessories
• RITA Medical Systems Inc. - Model 30F Electrosurgical Probe
• RITA Medical Systems Inc. - Model 200C Electrosurgical Probe
• RITA Medical Systems Inc. - Model 30-6 Electrode Array Electrosurgical Probe
• RITA Medical Systems Inc. - Model 10P Passive Temperature Probe Accessory

Submission Summary (Full Text)

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K983214

## 510(k) Summary of Safety and Effectiveness

| General<br>Provisions | Trade Name: RITA® Model 500 Electrosurgical RF Generator and Accessories<br>Common/Classification Name: Electrosurgical cutting and coagulation devices |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate | RITA Medical Systems Inc. - Model 10 Electrosurgical Accessory<br>RITA Medical Systems Inc. - Model 500 Electrosurgical RF Generator<br>RITA Medical Systems Inc. – Models 20 and 30 Electrosurgical Accessories<br>RITA Medical Systems Inc. - Model 30F Electrosurgical Probe<br>RITA Medical Systems Inc. - Model 200C Electrosurgical Probe<br>RITA Medical Systems Inc. - Model 30-6 Electrode Array Electrosurgical Probe<br>RITA Medical Systems Inc. - Model 10P Passive Temperature Probe Accessory |
| 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 (Model 500 RF Generator and Accessories) supplies energy<br>for use in electrosurgery, and are indicated for use in percutaneous, laparoscopic,<br>or intraoperative coagulation and ablation of soft tissue, including the partial or<br>complete ablation of non-resectable liver lesions. |
| Device<br>Description | The RITA Model 500 Electrosurgical Generator and Accessories are designed to<br>create coagulative necrotic lesions in soft tissue, and allow localized delivery of<br>fluid to the lesion. The RF Generator is specifically designed for use with RITA<br>Electrosurgical Devices (Accessories). The RF Generator provides multiple<br>temperature sensors, impedance, and power monitoring to assist the user in<br>delivering the desired energy to the target tissue. The Accessories consist of<br>monopolar electrosurgical devices that include disposable electrosurgical probes<br>with deployable needle arrays that deliver RF power with temperature and<br>impedance monitoring to ablate predictable volumes of tissue. |
| Performance<br>Data | Clinical studies were conducted to determine the safety and effectiveness of the<br>RITA System for the ablation of cancerous liver lesions. In one study, lesions were<br>ablated in patients who were scheduled for surgical resection. In other studies, the<br>RITA System was used for the ablation of cancerous liver lesions (primary and<br>metastatic) in patients whose liver cancer was considered to be non-resectable. The<br>non-resectable lesion studies demonstrated that the ablation procedure had low<br>attendant morbidity (no reports of death related to use of the devices) and a low<br>adverse event rate. All of the studies demonstrated that, in general, the diameter<br>of a single ablation consistently averaged 3-4 cm (as determined by post procedure<br>CT scans). |

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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 features a stylized eagle with three lines representing its wings and body. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

MAR 2 7 2000

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K983214

Trade Name: RITA RF generator and Accessories, Model 500 series Dated: January 14, 2000 Received: January 18, 2000

Dear Ms. Dignan-Mazzone:

Ms. Erin Dignan-Mazzone

Director, Regulatory Affairs RITA Medical Systems, Inc. 967 North Shoreline Boulevard Mountain View, California 94043

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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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. Erin Dignan-Mazzone

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510/k) premarket 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 device (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/dsmaldsmamain.html".

Sincerely yours,

Philip J. Phillips

Philip llips Deputy Director Science and Regulatory Policy Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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510(k) Number: K983214

Device Name: RITA RF generator and Accessories, Model 500 series

FDA's Statement of the Indications For Use for device:

The RITA System (Model 500 RF Generator and Accessories) supplies energy for use in electrosurgery, and are indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including the partial or complete ablation of nonresectable liver lesions.

Philipe

Prescription Use XXXX OR Over-T

Use XXXXX (Per 21 CFR 801.109)

Over-The-Counter Use

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