HABIB 4X LAPAROSCOPIC

K062935 · Rita Medical Systems · GEI · Oct 13, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062935
• Device Name: HABIB 4X LAPAROSCOPIC
• Applicant: Rita Medical Systems
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

The Habib 4X Laparoscopic is intended to be used to assist in coagulation of tissue during intraoperative and laparoscopic surgical procedures

Device Story

Habib 4X Laparoscopic is a bipolar radiofrequency (RF) electrosurgical device. Input: RF energy delivered via four-needle array at distal end. Operation: Device connects to RITA Medical 1500X RF generator; electrodes inserted into tissue to induce coagulation via RF power. Context: Used in laparoscopic surgery; shaft fits 10mm port; handle features integrated RF on/off switch for ambidextrous use. Output: Thermal coagulation of tissue. User: Physician/surgeon. Benefit: Facilitates tissue coagulation during surgical procedures. Single-use device.

Clinical Evidence

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

Technological Characteristics

Bipolar RF electrosurgical device. Features handle, instrument shaft, and four-needle electrode array. Compatible with RITA Medical 1500X RF generator. Dimensions: 10mm shaft diameter for laparoscopic port access. Single-use. No software or complex algorithms described.

Indications for Use

Indicated for coagulation of tissue during intraoperative and laparoscopic surgical procedures. No specific patient population, 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

• Habib 4X (K051420)
• Cool-Tip RF System (K984552)

Submission Summary (Full Text)

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SECTION 3 Summary of Safety and Effectiveness Sponsor: RITA Medical Systems, Inc Contact Person: Darrin Uecker CT 1 3 2006 Chief Technology Officer 46421 Landing Parkway Fremont Ca 94538 [phone] Summary Prepared: September 5, 2006 Trade Name: Habib 4X Laparoscopic Common Name: Electrosurgical cutting and coagulation device and accessories Classification: Class II per 21 CFR 878.4400 Product Code: GEI Predicate Devices: Habib 4X (K051420) Cool-Tip RF System (K984552)

Intended Use:

The Habib 4X Laparoscopic is intended to be used to assist in coagulation of tissue during intraoperative and laparoscopic surgical procedures

Description:

The Habib 4X Laparoscopic is a bipolar radiofrequency (RF) device that consists of a handle, an instrument shaft, and an array of four needles at the distal end of the instrument. The instrument has an attached cable which connects the device directly to the RITA Medical 1500X RF generator. The device electrodes are inserted into tissue is coagulated using the RF power. The Habib 4X Laparoscopic is designed for use in laparoscopic surgery and the instrument shaft fits through a standard 10mm laparoscopic port. The handle includes an RF on/off switch which can be operated with either the left or right hand. The Habib 4X Laparoscopic is a single use device.

Technological Differences:

The RITA Medical Systems, Inc. Habib 4X Laparoscopic has the same technological characteristics as the Habib 4X (K051420). The configuration of the electrodes and the method

| No of the county process and A - A | Comments of the contract of the controlled in American in American and Children and Children and Children |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Habib 4X Laparoscopic 510(k) | |
| | RITA Medical Systems |
| | |
| Eection 3. Summary of Safety and Effectiveness-------------------------------------------------------------------------------------------------------------------------------- | |

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## SECTION 3 Summary of Safety and Effectiveness

the device uses to coagulate tissues is identical. The differences are primarily to facilitate the use of the device through a laparoscopic port. The Habib 4X Laparoscopic has similar technological characteristics as the Cool-Tip RF System (K984552) in that they both use electrodes and RF energy to coagulate tissue and have the same intended use.

Performance Data:

Performance testing was done to ensure that the Habib 4 X Laparoscopic 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 3 2006

Rita Medical Systems, Inc. % Underwriters Laboratories, Inc. Mr. Morten Simon Christensen 455 East Trimble Road San Jose, California 95131-1230

Re: K062935

Trade/Device Name: Habib 4X Laparoscopic Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 27, 2006 Received: September 28, 2006

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 3 legal) marketed predicate device results in a classification for your device and thus, permitts 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 ventitled, "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 vours.

Mark A. Milkersen

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) __

Habib 4X Laparoscopic Device Name

The Habib 4X Laparoscopic is intended to be used to assist in coagulation of tissue during intraoperative and laparoscopic surgical procedures

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Milburn
Division Sign-Off

Division of General, Restorative, and Neurological Devices

510(k) Number K062935

V Prescription Use OR Over the Counter Use ______________________________________________________________________________________________________________________________________________________ (per 21 CFR 801.109)