(13 days)
Not Found
No
The description focuses on standard electrosurgical generator functionality, including monitoring and automatic shut-off based on pre-defined parameters and limits, not AI/ML algorithms. There is no mention of learning, adaptation, or complex pattern recognition.
Yes
The 'Intended Use / Indications for Use' section states that the device is indicated for "coagulation and ablation of soft tissue," which are therapeutic procedures.
No.
The device is an electrosurgical RF generator used for coagulation and ablation of soft tissue, which are therapeutic procedures. While it monitors parameters like temperature, impedance, and power, this monitoring is for controlling the ablation process, not primarily for diagnosing a medical condition.
No
The device description clearly describes a hardware component, the "Model 1500 Electrosurgical RF Generator," which is a physical device that generates and delivers RF energy. While it includes software for monitoring and control, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue." This describes a therapeutic procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a generator that delivers radiofrequency energy to tissue for ablation. It monitors parameters like temperature, impedance, and power during the procedure on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly treat tissue within the body.
N/A
Intended Use / Indications for Use
The Model 1500 Electrosurgical RF Generator and accessories are indicated for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue.
Product codes
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Model 1500 RF Generator was subjected to a battery of electrical, mechanical, and software validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RITA Medical Systems Inc. - Model 500 Electrosurgical RF Generator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 9.0
| General
Provisions | Trade Name: RITA® Model 1500 Electrosurgical RF Generator
Common/Classification Name: Electrosurgical cutting and coagulation device |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate | RITA Medical Systems Inc. - Model 500 Electrosurgical RF Generator |
| 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 1500 Electrosurgical RF Generator and accessories are indicated for use
in percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft
tissue. |
| Device
Description | 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. |
| Performance
Data | The Model 1500 RF Generator was 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 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.
2
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
3
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 ______ |
|---|---|
| ---------------------- | ---------------------------------------------------------------------------------------------------- |