(560 days)
The RITA® System (Model 500 RF Generator and Accessories) supplies energy for use in electrosurgery, and are 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.
The RITA Model 500 Electrosurgical Generator and Accessories are designed to create coagulative necrotic lesions in soft tissue, and allow localized delivery of fluid to the lesion. The RF Generator is specifically designed for use with RITA Electrosurgical Devices (Accessories). The RF Generator provides multiple temperature sensors, impedance, and power monitoring to assist the user in delivering the desired energy to the target tissue. The Accessories consist of monopolar electrosurgical devices that include disposable electrosurgical probes with deployable needle arrays that deliver RF power with temperature and impedance monitoring to ablate predictable volumes of tissue.
The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics in a structured format often associated with AI/ML device evaluations. Instead, it describes a traditional medical device (an electrosurgical RF generator) and its clinical studies, which are assessed differently from typical AI/ML devices.
However, based on the information provided, here's an attempt to answer the questions, focusing on the available details for a non-AI device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Low attendant morbidity | Low attendant morbidity (no reports of death related to use of the devices) and a low adverse event rate. |
| Low adverse event rate | Low adverse event rate. |
| Consistent ablation diameter (for a single ablation) | The diameter of a single ablation consistently averaged 3-4 cm (as determined by post-procedure CT scans). |
2. Sample Size Used for the Test Set and Data Provenance
The text mentions "Clinical studies were conducted" and "In one study, lesions were ablated in patients who were scheduled for surgical resection. In other studies, the RITA System was used for the ablation of cancerous liver lesions (primary and metastatic) in patients whose liver cancer was considered to be non-resectable."
- Sample Size: Not explicitly stated. The text refers to "patients," indicating human subjects, but no specific number is provided for any of the studies mentioned.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective clinical studies, as they involved patients undergoing ablation procedures specifically for the purpose of evaluating the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this device and the provided text. The evaluation method described is clinical outcome and physical measurements (CT scans), not expert consensus on interpretations.
4. Adjudication Method for the Test Set
Not applicable. The clinical studies assessed outcomes directly (e.g., morbidity, adverse events, ablation size from CT scans), not expert interpretations requiring adjudication.
5. 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 RF generator, not an AI/ML imaging or diagnostic aid. Therefore, no MRMC study or AI-assisted improvement analysis would be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device that requires direct human operation and intervention for its function. It is not an algorithm that can operate standalone.
7. The Type of Ground Truth Used
The ground truth or evaluation metrics were based on:
- Clinical Outcomes/Events: Morbidity, adverse event rates, and mortality ("no reports of death related to use of the devices")
- Imaging Data: Post-procedure CT scans to determine ablation diameter (consistently averaged 3-4 cm).
8. The Sample Size for the Training Set
Not applicable. This pertains to AI/ML models. The device's performance was evaluated through clinical studies, not by training an algorithm on a dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML model for this device.
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510(k) Summary of Safety and Effectiveness
| GeneralProvisions | Trade Name: RITA® Model 500 Electrosurgical RF Generator and AccessoriesCommon/Classification Name: Electrosurgical cutting and coagulation devices |
|---|---|
| Name ofPredicate | RITA Medical Systems Inc. - Model 10 Electrosurgical AccessoryRITA Medical Systems Inc. - Model 500 Electrosurgical RF GeneratorRITA Medical Systems Inc. – Models 20 and 30 Electrosurgical AccessoriesRITA Medical Systems Inc. - Model 30F Electrosurgical ProbeRITA Medical Systems Inc. - Model 200C Electrosurgical ProbeRITA Medical Systems Inc. - Model 30-6 Electrode Array Electrosurgical ProbeRITA Medical Systems Inc. - Model 10P Passive Temperature Probe Accessory |
| 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 RITA® System (Model 500 RF Generator and Accessories) supplies energyfor use in electrosurgery, and are indicated for use in percutaneous, laparoscopic,or intraoperative coagulation and ablation of soft tissue, including the partial orcomplete ablation of non-resectable liver lesions. |
| DeviceDescription | The RITA Model 500 Electrosurgical Generator and Accessories are designed tocreate coagulative necrotic lesions in soft tissue, and allow localized delivery offluid to the lesion. The RF Generator is specifically designed for use with RITAElectrosurgical Devices (Accessories). The RF Generator provides multipletemperature sensors, impedance, and power monitoring to assist the user indelivering the desired energy to the target tissue. The Accessories consist ofmonopolar electrosurgical devices that include disposable electrosurgical probeswith deployable needle arrays that deliver RF power with temperature andimpedance monitoring to ablate predictable volumes of tissue. |
| PerformanceData | Clinical studies were conducted to determine the safety and effectiveness of theRITA System for the ablation of cancerous liver lesions. In one study, lesions wereablated in patients who were scheduled for surgical resection. In other studies, theRITA System was used for the ablation of cancerous liver lesions (primary andmetastatic) in patients whose liver cancer was considered to be non-resectable. Thenon-resectable lesion studies demonstrated that the ablation procedure had lowattendant morbidity (no reports of death related to use of the devices) and a lowadverse event rate. All of the studies demonstrated that, in general, the diameterof a single ablation consistently averaged 3-4 cm (as determined by post procedureCT scans). |
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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 features a stylized eagle with three lines representing its wings and body. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
MAR 2 7 2000
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K983214
Trade Name: RITA RF generator and Accessories, Model 500 series Dated: January 14, 2000 Received: January 18, 2000
Dear Ms. Dignan-Mazzone:
Ms. Erin Dignan-Mazzone
Director, Regulatory Affairs RITA Medical Systems, Inc. 967 North Shoreline Boulevard Mountain View, California 94043
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
Although this device is substantially equivalent to other devices used for ablation of soft tissue, we are concerned that users may overestimate the capability of the device. It is on this basis that we are requesting that you include the following statement in the precautions section of the labeling:
The effectiveness of this device for use in the treatment of liver cancer or liver disease (i.e., improved clinical outcomes) has not been established.
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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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-Mazzone
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510/k) premarket notification if the limitation statement above is added to your labeling, as described.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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"(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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Philip J. Phillips
Philip llips Deputy Director Science and Regulatory Policy Office of Device Evaluation Center for Devices and Radiological Health
1
Enclosure
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510(k) Number: K983214
Device Name: RITA RF generator and Accessories, Model 500 series
FDA's Statement of the Indications For Use for device:
The RITA System (Model 500 RF Generator and Accessories) supplies energy for use in electrosurgery, and are indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including the partial or complete ablation of nonresectable liver lesions.
Philipe
Prescription Use XXXX OR Over-T
Use XXXXX (Per 21 CFR 801.109)
Over-The-Counter Use
β
§ 882.4400 Radiofrequency lesion generator.
(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).