(560 days)
Not Found
Not Found
No
The summary describes a standard electrosurgical generator and accessories that use temperature, impedance, and power monitoring for tissue ablation, without mentioning any AI or ML capabilities.
Yes
The device is indicated for the coagulation and ablation of soft tissue, including non-resectable liver lesions, to create coagulative necrotic lesions in soft tissue using RF energy. This describes a therapeutic action to treat a medical condition.
No
The device is indicated for coagulation and ablation of soft tissue, specifically non-resectable liver lesions, which are therapeutic rather than diagnostic actions.
No
The device description clearly outlines hardware components including an RF Generator and Accessories (electrosurgical probes with needle arrays). The summary of performance studies also describes clinical studies involving the physical ablation of tissue, which requires hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This testing is performed outside of the living body (in vitro).
- RITA System Function: The RITA System is an electrosurgical device that directly applies energy to soft tissue within the body (in vivo) for coagulation and ablation. It is a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly states "for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue." This describes a surgical procedure performed on the patient, not a laboratory test on a specimen.
- Device Description: The description focuses on the delivery of energy to create lesions in tissue, temperature and impedance monitoring during the procedure, and the physical components used for this direct application of energy. There is no mention of analyzing biological samples.
The RITA System is a therapeutic medical device used for surgical intervention, not an IVD used for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
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.
Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, liver lesions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical studies were conducted to determine the safety and effectiveness of the RITA System for the ablation of cancerous liver lesions. 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. The non-resectable lesion studies demonstrated that the ablation procedure had low attendant morbidity (no reports of death related to use of the devices) and a low adverse event rate. All of the studies demonstrated that, in general, the diameter of a single ablation consistently averaged 3-4 cm (as determined by post procedure CT scans).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510(k) Summary of Safety and Effectiveness
| General
Provisions | Trade Name: RITA® Model 500 Electrosurgical RF Generator and Accessories
Common/Classification Name: Electrosurgical cutting and coagulation devices |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate | RITA Medical Systems Inc. - Model 10 Electrosurgical Accessory
RITA Medical Systems Inc. - Model 500 Electrosurgical RF Generator
RITA Medical Systems Inc. – Models 20 and 30 Electrosurgical Accessories
RITA Medical Systems Inc. - Model 30F Electrosurgical Probe
RITA Medical Systems Inc. - Model 200C Electrosurgical Probe
RITA Medical Systems Inc. - Model 30-6 Electrode Array Electrosurgical Probe
RITA Medical Systems Inc. - Model 10P Passive Temperature Probe Accessory |
| 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 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. |
| Device
Description | 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. |
| Performance
Data | Clinical studies were conducted to determine the safety and effectiveness of the
RITA System for the ablation of cancerous liver lesions. 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. The
non-resectable lesion studies demonstrated that the ablation procedure had low
attendant morbidity (no reports of death related to use of the devices) and a low
adverse event rate. All of the studies demonstrated that, in general, the diameter
of a single ablation consistently averaged 3-4 cm (as determined by post procedure
CT scans). |
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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 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.
2
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
3
Page 1 of 1
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
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