RITA STARBURST SDE ELECTROSURGICAL DEVICE

K030967 · Rita Medical Systems · GEI · Apr 21, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030967
• Device Name: RITA STARBURST SDE ELECTROSURGICAL DEVICE
• Applicant: Rita Medical Systems
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RITA® StarBurst SDE Electrosurgical Device is designed to supply energy (generated by the RITA Medical Systems' electrosurgical generator) 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 on 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 therapy.

Device Story

RITA StarBurst SDE is an electrosurgical device for soft tissue ablation. It connects to an external RITA electrosurgical generator to deliver RF energy. The device features a primary trocar electrode and deployable secondary electrodes that extend from the trocar side. It includes integrated temperature sensors in the distal secondary electrodes, a Luer port for fluid infusion, and a handle with depth markings. Used in percutaneous, laparoscopic, or intraoperative settings by physicians. The device is inserted into target tissue; secondary electrodes are deployed to the desired extent; RF energy is applied to induce coagulation/ablation. Temperature sensors provide feedback to the generator to monitor the procedure. The device is intended to treat non-resectable liver lesions and provide pain palliation for metastatic bone lesions.

Clinical Evidence

Bench testing only. The device underwent a battery of electrical, mechanical, and functional tests to verify performance against specifications. No clinical data was provided.

Technological Characteristics

12-cm electrosurgical probe; primary trocar electrode with deployable secondary electrodes; RF energy source (external generator); integrated temperature sensors; Luer port for fluid infusion; nine-pin Lemo connector; depth indicators (1 cm increments).

Indications for Use

Indicated for percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, specifically non-resectable liver lesions and palliation of pain from metastatic bone lesions in patients who failed or are not candidates 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 90/StarBurst Electrosurgical Device

Submission Summary (Full Text)

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K030967

## APR 2 1 2003

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

| General<br>Provisions | Trade Name: StarBurst SDE Electrosurgical Device<br>Common/Classification Name: Electrosurgical cutting and coagulation accessory |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate | RITA Medical Systems Inc. - Model 90/StarBurst Electrosurgical Device |
| 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® StarBurst SDE Electrosurgical Device is designed to supply energy<br>(generated by the RITA Medical Systems' electrosurgical generator) for use in<br>electrosurgery and is indicated for use in percutaneous, laparoscopic, or<br>intraoperative coagulation and ablation of soft tissue including:<br>The partial or complete ablation on non-resectable liver lesions and The palliation of pain associated with metastatic lesions involving bone in<br>patients who have failed or are not candidates for standard therapy. |
| Device<br>Description | The RITA StarBurst SDE device is 12-cm in length and can be used for a variety of<br>medical applications. Each secondary electrode deploys out from the side of the<br>trocar through a hole in the wall of the trocar (primary electrode). The RITA device<br>consists of the following components: primary electrode: tubing with a portion exposed as an electrode secondary electrodes: tubing at the distal end of probe trocar insulation: shrink tubing handle: with markings to indicate the amount of secondary electrode deployment from the trocar RF pathway: connection through nine-pin Lemo connector built into the handle fluid infusion: delivery through Luer port at side of the handle temperature sensors: three temperature sensors in the distal section of the<br>secondary electrodes depth indicators: incremental 1 cm marks denote needle penetration depth |
| Performance<br>Data | The StarBurst SDE devices were subjected to a battery of electrical, mechanical,<br>and functional testing to verify that the devices met the specifications. The devices<br>met the specifications. |

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

APR 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030967

Trade/Device Name: RITA® StarBurst SDE Electrosurgical Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 24, 2003 Received: March 26, 2003

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), 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) you may obtain. 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,

Miriam C. Provost

forCelia 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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## 3.0 INTENDED USE

## Indications for Use Statement

| 510(K) Number<br>(if known) | K030967 |
|-----------------------------|--------------------------------------------|
| Device Name | RITA® StarBurst SDE Electrosurgical Device |

The RITA® StarBurst SDE Electrosurgical Device is designed to supply energy (generated by the RITA Medical Systems' electrosurgical generator) 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 on 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 therapy.

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)

uriam C. Provost

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

April 15, 2003

KO30967 510(k) Number -