RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER)

Q: Who is the manufacturer of RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER)?

Rita Medical Systems, Inc. filed the 510(k) submission for RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER) (K031926).

Q: What is the FDA product code for RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER)?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER)?

510(k) clearance (submission type: Special).

Q: Who can help prepare an FDA 510(k) submission like RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K031926 · Rita Medical Systems, Inc. · GEI · Jul 17, 2003 · General, Plastic Surgery

Device Facts

Record ID	K031926
Device Name	RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER)
Applicant	Rita Medical Systems, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Jul 17, 2003
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The RITA® System (RF generator and electrosurgical devices) supplies energy 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 of 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 pain therapy.

Device Story

The Model 1500X Electrosurgical RF Generator provides monopolar radiofrequency (RF) energy for soft tissue ablation. The system includes the generator, RITA electrosurgical devices, and a dispersive Thermo Pad. The physician operates the system in percutaneous, laparoscopic, or intraoperative settings. The user connects the generator to power, the electrosurgical device, and the Thermo Pad; sets ablation parameters (mode, time, target temperature, power level); and deploys electrodes into the target tissue. The generator continuously monitors temperature, impedance, and power. If parameters exceed limits, RF energy delivery automatically stops and an alert displays on the LCD. Energy delivery also ceases automatically upon completion of the user-defined ablation cycle. The physician can manually terminate energy via an RF ON/OFF switch. The system assists in monitoring and controlling ablation, potentially benefiting patients by providing a minimally invasive option for treating non-resectable liver lesions and palliating metastatic bone pain.

Clinical Evidence

No clinical data provided. The device underwent a battery of electrical, mechanical, and software validation testing to demonstrate safety and performance.

Technological Characteristics

150/200 W monopolar RF generator. Features include temperature sensor inputs, impedance monitoring, and power monitoring. Includes LCD for parameter display and status alerts. System components include the generator, electrosurgical devices, Thermo Pad, and cable adapters. Software-controlled energy delivery with automated safety cut-offs based on monitored parameters.

Indications for Use

Indicated for percutaneous, laparoscopic, or intraoperative soft tissue coagulation and ablation, including non-resectable liver lesions and palliative treatment of metastatic bone lesions in patients failing or ineligible for standard pain 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 1500X Electrosurgical RF Generator and accessories (e.g., RITA Dispersive Electrode)

Related Devices

K031257 — RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR · Rita Medical Systems, Inc. · May 2, 2003
K032149 — RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR · Rita Medical Systems, Inc. · Sep 9, 2003
K993944 — RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE · Rita Medical Systems · Dec 2, 1999
K080451 — UNIBLATE ELECTROSURGICAL DEVICE · AngioDynamics, Inc. · Jul 3, 2008
K040989 — RITA SYSTEMS · Rita Medical Systems · Apr 28, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ ## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 8.0 KO31926 | General Provisions | Trade Name: RITA® Model 1500X Electrosurgical RF Generator and accessories (e.g., RITA Thermo Pad and cable adapter) | |----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common/Classification Name: Electrosurgical cutting and coagulation device | | | Name of Predicate | RITA Medical Systems Inc. - Model 1500X Electrosurgical RF Generator and accessories (e.g., RITA Dispersive Electrode) | | 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 | The Model 1500X Electrosurgical RF Generator and accessories are indicated for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue, including the partial or complete ablation of 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 pain therapy. | | Device Description | The Model 1500X Electrosurgical RF Generator is designed to provide monopolar radiofrequency (RF) energy. The RF Generator is a 150/200 W electrosurgical generator specifically designed for use with RITA electrosurgical devices. It can read multiple temperature sensors and includes impedance and power monitoring to assist the physician in monitoring and controlling the ablation. | | | To use the system, the RF Generator is plugged into the wall outlet via the Power Cord. The electrosurgical device is connected to the RF Generator via the Main Cable. The Thermo Pad is placed on the appropriate location of the body and is connected to its ports on the RF Generator via a cable adapter. Once the system is successfully powered up, the user can set the parameters of the ablation such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the electrosurgical device placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the RF Generator. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the liquid crystal display (LCD). The RF energy delivery also automatically ceases once the ablation is completed based on the initial user-defined parameters. RF energy can be stopped at any time by pressing the RF ON/OFF switch. | | Performance Data | The Model 1500X RF Generator and accessories were subjected to a battery of electrical, mechanical, and software validation testing. | {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle. Public Health Service JUL 17 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: K031926 Trade/Device Name: Model 1500X Electrosurgical RF Generator and accessories (e.g., RITA Thermo Pad and cable adapter) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 20, 2003 Received: June 25, 2003 Dear Mr. 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. {2}------------------------------------------------ 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Miriam C. Provost ( Celia 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 {3}------------------------------------------------ ## INTENDED USE 3.0 Indications for Use Statement | 510(K) Number (if known) | K031926 | |-----------------------------|-------------------------------------------------------------------------------------------------------| | Device Name | Model 1500X Electrosurgical RF Generator and accessories (e.g., RITA Thermo Pad and cable adapter) | The RITA® System (RF generator and electrosurgical devices) supplies energy 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 of 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 pain therapy. ## PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED | Concurrence of CDRH, Office of Device Evaluation (ODE) | |--------------------------------------------------------| |--------------------------------------------------------| Miriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices | 510(k) Number | K031926 | |-------------------------|---------------------| | Prescription Use | <div> ✓ </div> | | OR Over the Counter Use | __________ | (per 21 CFR 801 109)(per 21 CFR 801.109)