RITA SYSTEM

K021329 · Rita Medical Systems · GEI · Oct 9, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021329
• Device Name: RITA SYSTEM
• Applicant: Rita Medical Systems
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

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

RITA System consists of RF generator and disposable electrosurgical probes with deployable needle arrays. Used in percutaneous, laparoscopic, or intraoperative settings by physicians to create coagulative necrotic lesions in soft tissue. Generator monitors temperature, impedance, and power to control energy delivery; allows localized fluid delivery to lesion. Output provides predictable volumes of ablated tissue. Used for palliative treatment of metastatic bone lesions and ablation of liver lesions. Benefits include pain reduction and tissue destruction in patients failing conventional therapies.

Clinical Evidence

Clinical study conducted on patients with skeletal metastases who failed conventional therapies (analgesics, radiation). Primary endpoint: pain reduction measured by validated cancer pain instrument. Results: 75% of patients achieved at least a two-point reduction in worst pain, and 80% achieved at least a two-point reduction in average pain from baseline to week four. Low morbidity reported; three adverse events potentially related to RF ablation.

Technological Characteristics

System comprises RF generator and monopolar electrosurgical probes with deployable needle arrays. Features integrated temperature, impedance, and power monitoring. Energy source: radiofrequency. Form factor: generator unit with disposable probes. Sterilization: not specified. Software: rule-based monitoring of impedance and temperature.

Indications for Use

Indicated for patients with non-resectable liver lesions or metastatic bone lesions who have failed or are not candidates for standard pain 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. - RITA® System (K983214, K992693, K993944, K003676)
• Radionics - Radiofrequency system (K963577, K965182, K980430, K982489)

Submission Summary (Full Text)

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. HES TO THE LEW LEASE STATE AND ATTACTAL PRODUCT PRODUCT AND ASSOCIATION PRODUCTION

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| 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS | | |
|--------------------------------------------|--|--|
| | | |

| General | Trade Name: RITA® System | | | | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Provisions | Common/Classification Name: Electrosurgical Radiofrequency Generator and<br>Electrosurgical Devices | | | | |
| Name of<br>Marketed Device | RITA Medical Systems Inc. - RITA® System (K983214, K992693, K993944,<br>K003676) | | | | |
| | Radionics - Radiofrequency system (K963577, K965182, K980430, K982489) | | | | |
| Classification | Class II | | | | |
| Performance<br>Standards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not<br>established performance standards. | | | | |
| 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 complete ablation of non-resectable liver lesions and<br>� | | | | |
| | the palliation of pain associated with metastatic lesions involving bone in<br>patients who have failed or are not candidates for standard pain therapy. | | | | |
| Device<br>Description | The RITA System (RF Generator and electrosurgical devices) is designed to create<br>coagulative necrotic lesions in soft tissue, and allow localized delivery of fluid to<br>The RF Generator is specifically designed for use with RITA<br>the lesion.<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 electrosurgical devices<br>consist of monopolar electrosurgical devices that include disposable electrosurgical<br>probes with deployable needle arrays that deliver RF power with temperature and<br>impedance monitoring to ablate predictable volumes of tissue. | | | | |
| Performance<br>Data | Bench studies were conducted to determine the effect the bone environment has on<br>ablation characteristics and to determine ablation parameters. Clinical studies were<br>conducted to determine the safety and effectiveness of the RITA System for the<br>ablation of painful bone lesions in order to alleviate pain. All of the studies were<br>conducted on patients with lesions that had metastasized to one or more locations<br>in the skeleton. The RITA System was used in patients who had failed<br>conventional therapies (e.g., analgesics, radiation therapy). Effectiveness was<br>measured using an instrument validated for evaluating cancer pain. From baseline<br>to week four, 75% and 80% patients experienced at least a two-point reduction is<br>worst pain and average pain respectively. The ablation procedure had low<br>attendant morbidity (no reports of death related to use of the devices) and three<br>adverse events potentially related to RF ablation. | | | | |

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 0 9 2002

Ms. Erin Mazzone RITA Medical Systems, Inc. Director, Regulatory Affairs 967 N. Shoreline Boulevard Mountain View, California 94043

Re: K021329

> Trade/Device Name: RITA® System Regulatory Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device And Accessories

Regulatory Class: II Product Code: GEI Dated: July 30, 2002 Received: July 31, 2002

Dear Ms. Mazzone:

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. Erin Mazzone

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.

sincerely yours,

Stypt Rwords

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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## Indications for Use Statement

| 510(K) Number (if known) | K021329 |
|--------------------------|--------------|
| Device Name | RITA® System |

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

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

pain therapy.

bone in patients who have failed or are not candidates for standard

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(per 21 CFR 801.109)

Stupt Dwork

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________