(24 days)
Not Found
No
The description focuses on standard electrosurgical generator functionality, monitoring parameters like temperature, impedance, and power, and automatic shut-off based on pre-set limits. There is no mention of AI or ML algorithms for decision-making, analysis, or adaptation.
Yes
The device is used for the "coagulation and ablation of soft tissue" and "palliation of pain associated with metastatic lesions involving bone," which are therapeutic interventions.
No
Explanation: The device is described as an RF generator for electrosurgery, used for tissue coagulation and ablation. Its function is to deliver energy to treat existing conditions, not to diagnose them. While it monitors parameters during the ablation process, this monitoring is for controlling the treatment delivery, not for diagnosing a condition.
No
The device description clearly outlines hardware components including an RF Generator, electrosurgical devices, cables, and a Thermo Pad. The software mentioned is part of the control system for this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapeutic procedure (ablation of soft tissue and palliation of pain) performed directly on the patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a system that delivers energy into the patient's body for treatment. This is characteristic of a therapeutic device, not a diagnostic one.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens or providing diagnostic information based on such analysis.
The RITA® System is a therapeutic device used for electrosurgery and ablation.
N/A
Intended Use / Indications for Use
The Model 1500X Electrosurgical RF Generator and accessories are indicated for use in percutaneous, laparoscopic, and 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 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.
Product codes
GEI
Device Description
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 Thermo Pad is placed on the appropriate location of the body and is connected to its ports on the RF Generator via a cable adapter. 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, liver, bone
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 1500X RF Generator and accessories were 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 1500X Electrosurgical RF Generator and accessories (e.g., RITA Dispersive Electrode)
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 8.0 KO31926
| General
Provisions | Trade Name: RITA® Model 1500X Electrosurgical RF Generator and accessories
(e.g., RITA Thermo Pad and cable adapter) |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Classification Name: Electrosurgical cutting and coagulation device | |
| Name of
Predicate | RITA Medical Systems Inc. - Model 1500X Electrosurgical RF Generator and
accessories (e.g., RITA Dispersive Electrode) |
| 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 1500X Electrosurgical RF Generator and accessories are indicated for
use in percutaneous, laparoscopic, and 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. |
| Device
Description | 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 Thermo Pad is placed on the appropriate location of the body and is
connected to its ports on the RF Generator via a cable adapter. 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 1500X RF Generator and accessories were 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 U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
JUL 17 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Erin Mazzone Director, Quality/Regulatory Affairs Rita Medical Systems, Inc. 967 N. Shoreline Boulevard Mountain View, California 94043
Re: K031926
Trade/Device Name: Model 1500X Electrosurgical RF Generator and accessories (e.g., RITA Thermo Pad and cable adapter) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 20, 2003 Received: June 25, 2003
Dear Mr. Mazzone:
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.
2
Page 2 - Ms. Erin Mazzone
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. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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
3
INTENDED USE 3.0
Indications for Use Statement
| 510(K) Number
| (if known) | K031926 |
|---|---|
| Device Name | Model 1500X Electrosurgical RF Generator and accessories (e.g., RITA |
| Thermo Pad and cable adapter) |
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 Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K031926 |
|---|---|
| Prescription Use | ✓ |
| OR Over the Counter Use | __________ |
(per 21 CFR 801 109)(per 21 CFR 801.109)