(11 days)
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.
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 Dispersive Electrode is place on the appropriate location of the body and is connected to its port on the RF Generator. 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.
The provided text describes a 510(k) summary for the RITA® Model 1500X Electrosurgical RF Generator. This document is a regulatory submission for a medical device and, as such, does not contain the detailed information typically found in a clinical study report regarding acceptance criteria and performance data as requested in your prompt.
Specifically, the text states:
- Performance Data: "The Model 1500X RF Generator was subjected to a battery of electrical, mechanical, and software validation testing."
- Performance Standards: "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act."
This indicates that the submission relies on engineering and software validation rather than a clinical study evaluating the device's performance against specific clinical acceptance criteria in a human population. The focus is on demonstrating safety and efficacy through equivalence to a predicate device based on its intended use and technology, rather than a quantifiable clinical performance study with predefined acceptance metrics.
Therefore, I cannot provide the requested information from the given text because:
- A table of acceptance criteria and the reported device performance: The document does not define specific clinical acceptance criteria or report clinical performance metrics. It refers to "electrical, mechanical, and software validation testing" but does not provide details of these tests or their results.
- Sample size used for the test set and the data provenance: Not applicable as no clinical test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrosurgical generator, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of device submission.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document focuses on the intended use, device description, and regulatory classification, concluding that the device is "substantially equivalent" to a predicate device based on its design and safety testing, not on a clinical performance study with the metrics you've asked for.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
CO 31 2 S 7 9.0
| GeneralProvisions | Trade Name: RITA® Model 1500X Electrosurgical RF GeneratorCommon/Classification Name: Electrosurgical cutting and coagulation device |
|---|---|
| Name ofPredicate | RITA Medical Systems Inc. - Model 1500 & Model 2500 Electrosurgical RFGenerator |
| Classification | Class II |
| PerformanceStandards | Performance standards have not been established by the FDA under section 514 ofthe Food, Drug and Cosmetic Act. |
| Intended Use | The Model 1500X Electrosurgical RF Generator and accessories are indicated foruse in percutaneous, laparoscopic, and intraoperative coagulation and ablation ofsoft tissue, including the partial or complete ablation of non-resectable liver lesionsand the palliation of pain associated with metastatic lesions involving bone inpatients who have failed or are not candidates for standard pain therapy. |
| DeviceDescription | The Model 1500X Electrosurgical RF Generator is designed to provide monopolarradiofrequency (RF) energy. The RF Generator is a 150/200 W electrosurgicalgenerator specifically designed for use with RITA electrosurgical devices. It canread multiple temperature sensors and includes impedance and power monitoring toassist the physician in monitoring and controlling the ablation.To use the system, the RF Generator is plugged into the wall outlet via the PowerCord. The electrosurgical device is connected to the RF Generator via the MainCable. The Dispersive Electrode is place on the appropriate location of the bodyand is connected to its port on the RF Generator. Once the system is successfullypowered up, the user can set the parameters of the ablation such as the mode ofoperation, the ablation time, the target temperature, and the power delivery level.With the electrosurgical device placed in the tissue to be ablated and its electrodesdeployed, RF power can be turned on. The system parameters are continuouslymonitored and displayed on the RF Generator. If the measured parameters areoutside the acceptable limits, the RF energy delivery automatically stops and amessage appears on the liquid crystal display (LCD). The RF energy delivery alsoautomatically ceases once the ablation is completed based on the initial user-defined parameters. RF energy can be stopped at any time by pressing the RFON/OFF switch. |
| PerformanceData | The Model 1500X RF Generator was subjected to a battery of electrical,mechanical, and software validation testing. |
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other.
MAY = 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
RITA Medical Systems Incorporated c/o Ms. Denise Leung Klinker Underwriters Laboratories Incorporated 1655 Scott Boulevard Santa Clara, CA 95050-4169
Re: K031257
Trade/Device Name: RITA® Model 1500X Electrosurgical RF Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessosries Regulatory Class: II Product Code: GEI Dated: April 10, 2003 Received: April 21, 2003
Dear Ms. Klinker:
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
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Page 2 - Ms. Denise Leung Klinker
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/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
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3.0 INTENDED USE
Indications for Use Statement
| 510(K) Number (if known) | K 031257 |
|---|---|
| Device Name | Model 1500X Electrosurgical RF Generator |
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 Star 22
Division of General, Restorative and Neurologi al Device
510(k) Number K031257
Prescription Use OR Over the Counter Use
(per 21 CFR 801.109)
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.