UNIBLATE ELECTROSURGICAL DEVICE

K070101 · Rita Medical Systems, Inc. · GEI · Feb 14, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070101
• Device Name: UNIBLATE ELECTROSURGICAL DEVICE
• Applicant: Rita Medical Systems, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The RITA Medical Systems UniBlate Electrosurgical Device is intended to coagulate tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.

Device Story

Monopolar radiofrequency (RF) electrosurgical device; consists of variably insulated electrode, electrical cable, and infusion tubing. Connects to RITA Medical 1500X RF generator and IntelliFlow peristaltic pump. Device delivers RF energy to tissue for coagulation; saline infusion via pump facilitates procedure. Electrode active length adjustable (1 cm to 3 cm) by retracting insulating sheath. Used in percutaneous, laparoscopic, or intraoperative settings by physicians. Provides scalable coagulation zone; temperature feedback provided to generator. Single-use device.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing confirmed device functions as intended and meets design specifications.

Technological Characteristics

Monopolar RF electrosurgical device. Features adjustable active electrode (1-3 cm) via retractable insulating sheath. Includes electrical cable for RF energy/temperature feedback and infusion tubing for saline delivery. Single-use. Compatible with RITA 1500X RF generator and IntelliFlow peristaltic pump.

Indications for Use

Indicated for coagulation of soft tissue during percutaneous, laparoscopic, and intraoperative surgical procedures. No specific age or gender restrictions provided.

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

• StarBurst XLi (K010060)
• Cool-Tip RF System (K984552)

Submission Summary (Full Text)

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| | SECTION 3<br>510(k) Summary | K070101 |
|--------------------|----------------------------------------------------------------------------------------------------------------|-------------|
| Sponsor: | RITA Medical Systems, Inc | |
| Contact Person: | Kam Leung<br>Manager of Regulatory Affairs, RFA<br>46421 Landing Parkway<br>Fremont CA 94538<br>[phone] | FEB 14 2007 |
| Summary Prepared: | December 20, 2006 | |
| Trade Name: | UniBlate Electrosurgical Device | |
| Common Name: | Electrosurgical cutting and coagulation device and accessories | |
| Classification: | Class II per 21 CFR 878.4400 | |
| Product Code: | GEI | |
| Predicate Devices: | StarBurst XLi (K010060)<br>Cool-Tip RF System (K984552) | |

Intended Use:

The RITA Medical Systems UniBlate Electrosurgical Device is intended to coagulate tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.

Description:

The UniBlate Electrosurgical Device is a monopolar radiofrequency (RF) device that consists of a variably insulated electrode. The instrument has an attached electrical cable and infusion tubing set which connects the device directly to the RITA Medical 1500X RF generator and the IntelliFlow peristaltic pump respectively. The electrical cable provides RF energy and temperature feedback to the generator and the pump infuses normal saline through the infusion tubing set. The UniBlate Electrosurgical Device is a single use device.

# Technological Differences:

The RITA UniBlate, RITA StarBurst XLi (K010060) and Radionics Cool-Tip (K984552) are monopolar electrodes used to deliver RF energy during open, laparoscopic or percutaneous procedures to ablate and coagulate soft tissue. The UniBlate and StarBurst XLi devices are designed to provide a scaleable coagulation zone. The UniBlate electrode has a single active electrode that can be exposed

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#### SECTION 3

# 510(k) Summary

from 1 cm to 3 cm by retracting an insulating sheath. The StarBurst XLi consists of multiple electrodes which are deployed into the tissue from an insulated trocar. The Cool-Tip has a fixed length active electrode, but is available in different sizes. Both the UniBlate and StarBurst XLi allow for local fluid delivery as well as temperature monitoring. The UniBlate Electrosurgical Device is similar to the predicate RITA StarBurst XLi and Radionics Cool-Tip in principles of operation and construction and has the same intended use as the Cool-Tip.

Performance Data:

....

Performance testing was done to ensure that the UniBlate Device functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services in the USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Underwriters Laboratories, Inc. % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator 455 East Trimble Road San Jose, California 95131-1230

FEB 1 4 2007

Re: K070101

Trade/Device Name: Uniblate Electrosurgical Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: January 29, 2007 Received: January 30, 2007

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 Simon 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/industry/support/index.html.

Sincerely yours,

Mark A. Milken

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# SECTION 2 Indications for Use Statement

Indications for Use Statement

510(K) Number (if known)

Device Name

UniBlate Electrosurgical Device

Indications for Use:

The RITA Medical Systems UniBlate Electrosurgical Device is intended to coagulate tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.

Monk A. Mulkerson

sion Sign : Restorative ion of Ge irologi Numb

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (per 21 CFR 801.109)

OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________