RITA MODEL 70 ELECTROSURGICAL PROBE

K983871 · Rita Medical Systems · GEI · Dec 1, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K983871
• Device Name: RITA MODEL 70 ELECTROSURGICAL PROBE
• Applicant: Rita Medical Systems
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 1, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Model 70 Electrosurgical Probe is designed to supply energy (generated by the RITA Medical Systems' Model 500 electrosurgical generator) for use in electrosurgery and is designed for the following: Incorporation of multiple needles on each probe minimizing the number of invasive accesses necessary to achieve desired lesions. Provide a minimally invasive laparoscopic, percutaneous, or intraoperative access to the targeted tissue. Deliver radiofrequency energy in a controlled fashion to create coagulative necrotic lesions. Incorporate thermocouples for temperature feedback. Provide for local delivery of fluid.

Device Story

Model 70 Electrosurgical Probe is a radiofrequency (RF) ablation device used to create coagulative necrotic lesions in targeted tissue. It connects to the RITA Model 500 Electrosurgical Generator to deliver RF energy. The probe features multiple extendible stainless-steel needles that deploy from a trocar to form a 3 cm spherical lesion. It includes integrated thermocouples for temperature feedback and a Luer port for local fluid delivery. Used in laparoscopic, percutaneous, or intraoperative procedures by physicians. The device allows for minimally invasive access, reducing the number of needle insertions required to treat lesions. The healthcare provider monitors temperature feedback during energy delivery to control lesion formation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: stainless-steel hypodermic tubing, PVC, ABS, polyester shrink tubing. Energy: Radiofrequency (RF) via external generator. Form factor: 15 cm and 25 cm lengths, multi-needle array. Features: 4 integrated thermocouples, Luer port for fluid infusion, 6-pin Lemo connector. Biocompatible materials used.

Indications for Use

Indicated for patients requiring electrosurgical creation of coagulative necrotic lesions via laparoscopic, percutaneous, or intraoperative access.

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 30 Electrosurgical Probe

Submission Summary (Full Text)

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Model 70 Electrosurgical Probe

Attachments

| DEC 1 1998 | K983871 |
|--------------------------------------------------|---------|
| Attachment 4 Summary of Safety and Effectiveness | |

Summary of Safety and Effectiveness

| General Provisions | Trade Name: Model 70 Electrosurgical Probe |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Common/Classification Name: Electrosurgical Cutting and Coagulation Accessory |
| Name of Predicate Devices | RITA Medical Systems Inc. - Model 30 Electrosurgical Probe |
| Classification | Class II. |
| Performance Standards | Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act. |
| Intended Use and Device Description | The Model 70 Electrosurgical Probe is designed to supply energy (generated by the RITA Medical Systems' Model 500 Electrosurgical Generator) for use in elec for the following: |

- Incorporation of multiple needles on number of invasive accesses necessa lesions.
- Provide a minimally invasive laparo intraoperative access to the targeted tissue.
- Deliver radiofrequency energy in a controlled fashion to create coagulative necrotic lesions.
- Incorporate thermocouples for temperature feedback.
- Provide for local delivery of fluid.

SCAN1

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The device description of the Model 70 Electrosurgical Probe is as follows: This RITA device is available in 15 cm and 25 cm lengths for a variety of medical applications. The secondary electrodes deploy forming a spherical lesion 3 centimeters in diameter. The RITA device consists of the following components: primary electrode: stainless-steel hypodermic tubing with a . portion exposed as an electrode secondary electrodes: stainless-steel extendible flexible . hypodermic tubing at the distal end of probe . trocar insulation: fixed clear polyester shrink tubing handle: PVC and ABS with markings to indicate the amount of . electrode array deployment from the trocar . RF pathway: connection through 6 pin Lemo connector built into the handle fluid infusion: delivery through Luer port at side of the handle . temperature sensors: 4 temperature sensors at the periphery of . the array depth indicators: Incremental 1 cm marks denote needle . penetration depth Biocompatability All materials used in the Model 70 Electrosurgical Probe are Biocompatible. Summary of The Model 70 Electrosurgical Probe is substantially equivalent to Substantial the previously cleared Model 30 Electrosurgical Probes. Equivalence

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Image /page/2/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 image of an eagle with three lines representing its head and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1998

Mr. David A. Tucker Vice President of Quality Assurance and Regulatory Affairs RITA Medical Systems, Inc. 967 North Shoreline Boulevard Mountain View, California 94043

K983871 Re: RITA Model 70 Electrosurqical Probe Trade Name: Requlatory Class: II Product Code: GEI Dated: October 30, 1998 Received: November 2, 1998

Dear Mr. Tucker:

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 - Mr. David A. Tucker

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally rinang or edicate device results in a classification for your markets produces 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 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/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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| | Indications for Use Statement |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number (if known) | K983871 |
| Device Name | Model 70 Electrosurgical Probe |
| Indication for Use | The Model 70 Electrosurgical Probe is designed to supply energy (generated by the RITA Medical Systems' Model 500 electrosurgical generator) for use in electrosurgery and is designed for the following: |
| | <ul><li>Incorporation of multiple needles on each probe minimizing the number of invasive accesses necessary to achieve desired lesions.</li><li>Provide a minimally invasive laparoscopic, percutaneous, or intraoperative access to the targeted tissue.</li><li>Deliver radiofrequency energy in a controlled fashion to create coagulative necrotic lesions.</li><li>Incorporate thermocouples for temperature feedback.</li><li>Provide for local delivery of fluid.</li></ul> |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General Restorative Devices 838 ರ್ಥಿ 510(k) Number

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