(13 days)
The Model 1500 Electrosurgical RF Generator and accessories are indicated for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue.
The Model 1500 Electrosurgical RF Generator is designed to provide monopolar radiofrequency (RF) energy. The RF Generator is a 150 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 does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics. The document is a 510(k) summary for the RITA Model 1500 Electrosurgical RF Generator, which focuses on regulatory approval rather than detailed performance study results against predefined acceptance criteria.
The "Performance Data" section vaguely states: "The Model 1500 RF Generator was subjected to a battery of electrical, mechanical, and software validation testing." However, it does not provide any specifics about:
- Acceptance Criteria: No defined metrics or thresholds for performance are listed.
- Reported Device Performance: No actual results from the validation testing are provided.
- Study Design Details: Information regarding sample size, data provenance, ground truth establishment, expert involvement, adjudication methods, or comparative effectiveness studies is absent.
- Standalone Performance: While electrical, mechanical, and software validation testing might imply standalone performance, no specific results or metrics are given.
Therefore,Based on the provided text, I cannot complete the table or answer the questions regarding acceptance criteria and performance studies.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 9.0
| GeneralProvisions | Trade Name: RITA® Model 1500 Electrosurgical RF GeneratorCommon/Classification Name: Electrosurgical cutting and coagulation device |
|---|---|
| Name ofPredicate | RITA Medical Systems Inc. - Model 500 Electrosurgical RF Generator |
| 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 1500 Electrosurgical RF Generator and accessories are indicated for usein percutaneous, laparoscopic, and intraoperative coagulation and ablation of softtissue. |
| DeviceDescription | The Model 1500 Electrosurgical RF Generator is designed to provide monopolarradiofrequency (RF) energy. The RF Generator is a 150 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 1500 RF Generator was subjected to a battery of electrical, mechanical,and software validation testing. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a person with outstretched arms.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 1999
Rita Medical Systems c/o Ms. Chantel Carson Project Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062-2096
Re: K993944
Trade Name: Model 1500 Electrosurgical RF Generator Regulatory Class: II Product Code: GEI Dated: November 9, 1999 Received: November 19, 1999
Dear Ms. Carson:
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. Chantel Carson
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 vour 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 (301) 594-4595. 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/dsmamain.html".
Sincerely yours.
to Colle, Jt
James E. Dillard III Acting 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 (if known) | |
|---|---|
| -------------------------- | -- |
大993944
Device Name
Model 1500 Electrosurgical RF Generator
The Model 1500 RF Electrosurgical Generator and accessories are indicated for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue.
PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) Division of General Restorative Devices | |
|---|---|
| 510(k) Number | K993944 |
| (per 21 CFR 801.109) | Prescription Use X OR Over the Counter Use ______ |
|---|---|
| ---------------------- | ---------------------------------------------------------------------------------------------------- |
§ 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.