(57 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 250 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 placed 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 the RITA® Model 1500X Electrosurgical RF Generator and its 510(k) submission. However, it does not contain detailed information regarding acceptance criteria and a study proving the device meets those criteria in the way typically expected for performance claims of AI-driven diagnostic devices (e.g., sensitivity, specificity, AUC).
Instead, the "Performance Data" section of the 510(k) summary simply states: "The Model 1500X RF Generator is subjected to software validation testing." This implies that the device's performance was evaluated against functional and safety requirements, which are inherent to software validation for medical devices, rather than a clinical effectiveness study with specific diagnostic metrics.
Given this, I will interpret "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of general device validation for an electrosurgical generator, focusing on safety and functional performance rather than diagnostic accuracy.
Here's an attempt to answer your questions based only on the provided text, highlighting the limitations:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific quantitative acceptance criteria for clinical performance (like sensitivity, specificity, etc.) are not mentioned. The performance data section vaguely states "software validation testing," which implies functional and safety criteria were met.
Since no specific performance metrics are given, I can only infer the general intent which is functioning as described and safely.
| Acceptance Criteria (Inferred from Device Description & General Medical Device Requirements) | Reported Device Performance (Inferred from "Software Validation Testing" and 510(k) Clearance) |
|---|---|
| Functional Performance: | |
| Delivers monopolar radiofrequency (RF) energy. | Yes, the device is designed to provide monopolar RF energy. |
| Delivers up to 250 W of RF power. | Yes, it is a 250 W electrosurgical generator. |
| Can read multiple temperature sensors. | Yes, it can read multiple temperature sensors. |
| Includes impedance monitoring. | Yes, it includes impedance monitoring. |
| Includes power monitoring. | Yes, it includes power monitoring. |
| Assists physician in monitoring and controlling ablation. | Yes, through temperature, impedance, and power monitoring. |
| Allows user to set parameters (mode, time, target temperature, power level). | Yes, the user can set these parameters. |
| Continuously monitors and displays system parameters. | Yes, system parameters are continuously monitored and displayed. |
| Automatically stops RF energy delivery if measured parameters are outside acceptable limits. | Yes, RF energy delivery automatically stops if parameters are outside limits. |
| Displays a message on LCD if parameters are outside limits. | Yes, a message appears on the LCD. |
| Automatically ceases RF energy delivery once ablation is completed based on user-defined parameters. | Yes, automatically ceases when ablation is completed. |
| Allows RF energy to be stopped at any time by pressing ON/OFF switch. | Yes, RF energy can be stopped using the ON/OFF switch. |
| Device is safe for intended use. | Implied by 510(k) clearance following software validation and general safety testing. |
| Device is substantially equivalent to predicate device. | Yes, determined by FDA. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "software validation testing" but provides no details on what was tested (e.g., number of test cases, specific scenarios, or any clinical data). Therefore, the sample size, data provenance, and whether it was retrospective or prospective are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As "software validation testing" is mentioned, it likely refers to engineering and quality assurance personnel performing functional tests against specifications, rather than clinical experts establishing ground truth for diagnostic or therapeutic outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Given the nature of "software validation testing" for an electrosurgical generator, clinical adjudication methods would typically not be applicable.
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
An MRMC comparative effectiveness study was not mentioned and is not applicable to this device. The RITA Model 1500X is an electrosurgical RF generator, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to an electrosurgical RF generator. The device delivers energy under physician control. The "software validation testing" would be for the internal algorithms controlling power delivery, monitoring, and safety features, which are inherently "standalone" in their function but always within a human-in-the-loop context for actual patient use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For "software validation testing" of an electrosurgical generator, the "ground truth" would typically be the pre-defined functional specifications and safety requirements of the software and hardware. This is not clinical ground truth (like pathology results for a lesion). The text does not provide specifics.
8. The sample size for the training set
This information is not provided. Electrosurgical generators typically operate based on established physical principles and control algorithms, not machine learning models that require "training sets" in the conventional sense. The "software validation testing" is more about verifying correct implementation of these algorithms.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as there is no mention of machine learning or a "training set" in the context of this device. The "ground truth" for verifying its function would be based on engineering specifications and regulatory standards.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 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 1500X & 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 RITA System (RF Generator and electrosurgical devices) supplies energy foruse in electrosurgery and is indicated for use in percutaneous, laparoscopic, orintraoperative coagulation and ablation of soft tissue, including the partial orcomplete ablation of non-resectable liver lesions, and the palliation of painassociated with metastatic lesions involving bone in patients who have failed or arenot candidates for standard pain therapy. |
| DeviceDescription | The Model 1500X Electrosurgical RF Generator is designed to provide monopolarradiofrequency (RF) energy. The RF Generator is a 250 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 Power Cord.The electrosurgical device is connected to the RF Generator via the MainCable. The Dispersive Electrode is placed 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 is subjected to software validation testing. |
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SEP - 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rita Medical Systems. Inc. c/o Mr. Morten Christensen Office Coordinator, 510(k) Review Program Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050-4169
Re: K032149
Trade/Device Name: RITA® Model 1500X Electrosurgical RF Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 26, 2003 Received: August 27, 2003
Dear Mr. Christensen:
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.
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Page 2 - Mr. Morten Christensen
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/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
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INTENDED USE 3.0
Indications for Use Statement
| 510(K) Number(if known) | KO32149 | |
|---|---|---|
| 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) Mirronm
(Division Sign-Division of General, Restorative and Neurological Devices
510(k) Number K032149
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.