RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90

K992693 · Rita Medical Systems · GEI · Sep 10, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992693
• Device Name: RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90
• Applicant: Rita Medical Systems
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 10, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Model 90 Electrosurgical Probe is designed to supply energy (generated by the RITA Medical Systems' 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 90 Electrosurgical Probe; accessory to RITA electrosurgical generator. Device features multiple needles for tissue access; delivers radiofrequency (RF) energy to create coagulative necrotic lesions. Includes thermocouples for temperature feedback and Luer port for local fluid delivery. Used in laparoscopic, percutaneous, or intraoperative settings by physicians. Stainless-steel primary and secondary electrodes; secondary electrodes deploy from trocar tip. Depth indicators (1-cm marks) assist needle placement. Output allows controlled tissue coagulation; benefits patient by minimizing invasive access points.

Clinical Evidence

Bench testing only. Device subjected to electrical, mechanical, and biocompatibility testing. Results confirmed device met all specifications and materials elicited no toxicological responses.

Technological Characteristics

Stainless-steel hypodermic tubing electrodes; polymer handle and insulation. RF energy source via external generator. Features: extendible secondary electrodes, 5 integrated thermocouples, Luer port for fluid infusion, 1-cm depth markings. Available in 15 cm and 25 cm lengths. Connectivity via Lemo connector. Sterilization method not specified.

Indications for Use

Indicated for patients requiring electrosurgical creation of coagulative necrotic lesions via minimally invasive 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 70 Electrosurgical Probe

Submission Summary (Full Text)

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SEP 1 0 1999

## K992693 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 8.0

| General<br>Provisions | Trade Name: Model 90 Electrosurgical Probe<br>Common/Classification Name: Electrosurgical cutting and coagulation accessory |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate | RITA Medical Systems Inc. - Model 70 Electrosurgical Probe |
| 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 Model 90 Electrosurgical Probe is designed to supply energy (generated by the<br>RITA Medical Systems' Electrosurgical Generator) for use in electrosurgery and is<br>designed for the following: |
| | Incorporation of multiple needles on each probe minimizing the number of<br>invasive accesses necessary to achieve desired lesions. Provide a minimally invasive laparoscopic, percutaneous, or intraoperative<br>access to the targeted tissue. Deliver radiofrequency energy in a controlled fashion to create coagulative<br>necrotic lesions. Incorporate thermocouples for temperature feedback. Provide for local delivery of fluid. |
| Device<br>Description | This RITA® Model 90 device is available in 15 cm and 25 cm lengths for a variety<br>of medical applications. The secondary electrodes deploy out from the trocar<br>tip. The RITA Model 90 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 polymer shrink tubing handle: polymer materials with markings to indicate the amount of electrode array deployment from the trocar RF pathway: connection through a Lemo connector built into the handle fluid infusion: delivery through Luer port at side of the handle temperature sensors: Five temperature sensors at the periphery of the array<br>depth indicators: Incremental 1-cm marks denote needle penetration depth. |
| Performance<br>Data | The Model 90 devices were subjected to a battery of electrical, mechanical, and<br>biocompatibility testing to verify that the devices met the specifications. The<br>devices met the specifications and the materials did not elicit toxicological<br>responses. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1999

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

Re: K992693 Trade Name: RITA Model 90 Electrosurgical Accessory Regulatory Class: II Product Code: GEI Dated: August 10, 1999 Received: August 12, 1999

Dear Ms. Dignan:

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, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A 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 regulation 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 - Ms. Erin Dignan

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

Enclosure

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## INTENDED USE 3.0

| | Indications for Use Statement |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number<br>(if known) | K 992693 |
| Device Name | Model 90 Electrosurgical Probe |
| | The Model 90 Electrosurgical Probe is designed to supply energy (generated<br>by the RITA Medical Systems' electrosurgical generator) for use in<br>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></ul> |
| | <ul><li>Provide a minimally invasive laparoscopic, percutaneous, or intraoperative access to the targeted tissue.</li></ul> |
| | <ul><li>Deliver radiofrequency energy in a controlled fashion to create coagulative necrotic lesions.</li></ul> |
| | <ul><li>Incorporate thermocouples for temperature feedback.</li></ul> |
| | <ul><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) |
| | <div> <img alt="Signature" src="signature.png" width="200"/> </div> (Division Sign-Off)<br>Division of General Restorative Devices |
| | 510(k) Number: K992693 |
| (per 21 CFR 801.109) | Prescription Use <span style="text-decoration: underline;">V</span> OR Over the Counter Use ______ |

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