(29 days)
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No
The description focuses on the physical components and function of an electrosurgical probe, with no mention of AI or ML capabilities.
Yes
The device is designed to create coagulative necrotic lesions in targeted tissue to treat medical conditions, which aligns with the definition of a therapeutic device.
No
The device is designed to supply energy to create coagulative necrotic lesions when used in electrosurgery, indicating its therapeutic rather than diagnostic function. It also incorporates thermocouples for "temperature feedback" but this is for control during energy delivery, not for diagnosing a condition.
No
The device description clearly outlines multiple hardware components including electrodes, tubing, insulation, a handle, connectors, and sensors. It is a physical electrosurgical probe, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
- The description of the Model 70 Electrosurgical Probe clearly indicates it is used within the body to deliver energy to targeted tissue for creating lesions. It is a surgical device used for treatment, not for diagnostic testing of samples.
The intended use and device description focus on surgical intervention and energy delivery within the patient, which is the opposite of the function of an IVD.
N/A
Intended Use / Indications for Use
The Model 70 Electrosurgical Probe is designed to supply energy (generated by the RITA Medical Systems' Model 500 electrosurgical generator) for use in electrosurgery and is designed for the following:
- Incorporation of multiple needles on each probe minimizing the number of invasive accesses necessary to achieve desired lesions.
- Provide a minimally invasive laparoscopic, percutaneous, or intraoperative access to the targeted tissue.
- Deliver radiofrequency energy in a controlled fashion to create coagulative necrotic lesions.
- Incorporate thermocouples for temperature feedback.
- Provide for local delivery of fluid.
Product codes
GEI
Device Description
The Model 70 Electrosurgical Probe is available in 15 cm and 25 cm lengths for a variety of medical applications. The secondary electrodes deploy forming a spherical lesion 3 centimeters in diameter. The device consists of the following components: primary electrode: stainless-steel hypodermic tubing with a . portion exposed as an electrode secondary electrodes: stainless-steel extendible flexible . hypodermic tubing at the distal end of probe . trocar insulation: fixed clear polyester shrink tubing handle: PVC and ABS with markings to indicate the amount of . electrode array deployment from the trocar . RF pathway: connection through 6 pin Lemo connector built into the handle fluid infusion: delivery through Luer port at side of the handle . temperature sensors: 4 temperature sensors at the periphery of . the array depth indicators: Incremental 1 cm marks denote needle . penetration depth. All materials used in the Model 70 Electrosurgical Probe are Biocompatible.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
targeted tissue
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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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.
Model 30 Electrosurgical Probe
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.
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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).
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§ 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
Model 70 Electrosurgical Probe
Attachments
| DEC 1 1998 | K983871 |
|---|---|
| Attachment 4 Summary of Safety and Effectiveness |
Summary of Safety and Effectiveness
| General Provisions | Trade Name: Model 70 Electrosurgical Probe |
|---|---|
| Common/Classification Name: Electrosurgical Cutting and Coagulation Accessory | |
| Name of Predicate Devices | RITA Medical Systems Inc. - Model 30 Electrosurgical Probe |
| 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 and Device Description | The Model 70 Electrosurgical Probe is designed to supply energy (generated by the RITA Medical Systems' Model 500 Electrosurgical Generator) for use in elec for the following: |
- Incorporation of multiple needles on number of invasive accesses necessa lesions.
- Provide a minimally invasive laparo intraoperative access to the targeted tissue.
- Deliver radiofrequency energy in a controlled fashion to create coagulative necrotic lesions.
- Incorporate thermocouples for temperature feedback.
- Provide for local delivery of fluid.
SCAN1
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1
The device description of the Model 70 Electrosurgical Probe is as follows: This RITA device is available in 15 cm and 25 cm lengths for a variety of medical applications. The secondary electrodes deploy forming a spherical lesion 3 centimeters in diameter. The RITA device consists of the following components: primary electrode: stainless-steel hypodermic tubing with a . portion exposed as an electrode secondary electrodes: stainless-steel extendible flexible . hypodermic tubing at the distal end of probe . trocar insulation: fixed clear polyester shrink tubing handle: PVC and ABS with markings to indicate the amount of . electrode array deployment from the trocar . RF pathway: connection through 6 pin Lemo connector built into the handle fluid infusion: delivery through Luer port at side of the handle . temperature sensors: 4 temperature sensors at the periphery of . the array depth indicators: Incremental 1 cm marks denote needle . penetration depth Biocompatability All materials used in the Model 70 Electrosurgical Probe are Biocompatible. Summary of The Model 70 Electrosurgical Probe is substantially equivalent to Substantial the previously cleared Model 30 Electrosurgical Probes. Equivalence
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its head and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1998
Mr. David A. Tucker Vice President of Quality Assurance and Regulatory Affairs RITA Medical Systems, Inc. 967 North Shoreline Boulevard Mountain View, California 94043
K983871 Re: RITA Model 70 Electrosurqical Probe Trade Name: Requlatory Class: II Product Code: GEI Dated: October 30, 1998 Received: November 2, 1998
Dear Mr. Tucker:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ 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 requlation 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.
3
Page 2 - Mr. David A. Tucker
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 rinang or edicate device results in a classification for your markets produces permits your 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,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
.
| Indications for Use Statement | |
|---|---|
| 510(K) Number (if known) | K983871 |
| Device Name | Model 70 Electrosurgical Probe |
| Indication for Use | The Model 70 Electrosurgical Probe is designed to supply energy (generated by the RITA Medical Systems' Model 500 electrosurgical generator) for use in electrosurgery and is designed for the following: |
| Incorporation of multiple needles on each probe minimizing the number of invasive accesses necessary to achieve desired lesions.Provide a minimally invasive laparoscopic, percutaneous, or intraoperative access to the targeted tissue.Deliver radiofrequency energy in a controlled fashion to create coagulative necrotic lesions.Incorporate thermocouples for temperature feedback.Provide for local delivery of fluid. |
PLEASE DO NO WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General Restorative Devices 838 ರ್ಥಿ 510(k) Number
Image /page/4/Picture/4 description: The image shows the words "Prescription Use" and the phrase "(per 21 CFR 801. 09)" written below it. There is a large "X" drawn over the text. The text is written in a simple, sans-serif font. The image appears to be a scan or photocopy of a document.
OR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________