(29 days)
Not Found
NotFound
No
The summary describes a standard electrosurgical probe with temperature feedback and fluid delivery, but there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is designed to deliver radiofrequency energy to create coagulative necrotic lesions in targeted tissue, which is a therapeutic action.
No
The Model 90 Electrosurgical Probe is designed to deliver radiofrequency energy to create coagulative necrotic lesions, making it a therapeutic device rather than a diagnostic one. Its functions are centered on treatment, not detection or diagnosis of conditions.
No
The device description clearly outlines multiple hardware components including stainless-steel tubing, polymer materials, a Lemo connector, a Luer port, and temperature sensors. The performance studies also focus on electrical, mechanical, and biocompatibility testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Model 90 Electrosurgical Probe is designed to supply energy to create coagulative necrotic lesions in targeted tissue within the body. It is used for electrosurgery, which is a surgical procedure.
- Lack of Sample Analysis: There is no mention of this device analyzing any samples taken from the body. Its function is to directly interact with tissue in vivo.
Therefore, the Model 90 Electrosurgical Probe is a surgical device used for therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Model 90 Electrosurgical Probe is designed to supply energy (generated by the RITA Medical Systems' 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 (comma separated list FDA assigned to the subject device)
GEI
Device Description
This RITA® Model 90 device is available in 15 cm and 25 cm lengths for a variety of medical applications. The secondary electrodes deploy out from the trocar tip. The RITA Model 90 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 polymer shrink tubing handle: polymer materials with markings to indicate the amount of electrode array deployment from the trocar RF pathway: connection through a Lemo connector built into the handle fluid infusion: delivery through Luer port at side of the handle temperature sensors: Five temperature sensors at the periphery of the array depth indicators: Incremental 1-cm marks denote needle penetration depth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
targeted tissue
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Model 90 devices were subjected to a battery of electrical, mechanical, and biocompatibility testing to verify that the devices met the specifications. The devices met the specifications and the materials did not elicit toxicological responses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 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
SEP 1 0 1999
K992693 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 8.0
| General
Provisions | Trade Name: Model 90 Electrosurgical Probe
Common/Classification Name: Electrosurgical cutting and coagulation accessory |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate | RITA Medical Systems Inc. - Model 70 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 | The Model 90 Electrosurgical Probe is designed to supply energy (generated by the
RITA Medical Systems' 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. |
| Device
Description | This RITA® Model 90 device is available in 15 cm and 25 cm lengths for a variety
of medical applications. The secondary electrodes deploy out from the trocar
tip. The RITA Model 90 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 polymer shrink tubing handle: polymer materials with markings to indicate the amount of electrode array deployment from the trocar RF pathway: connection through a Lemo connector built into the handle fluid infusion: delivery through Luer port at side of the handle temperature sensors: Five temperature sensors at the periphery of the array
depth indicators: Incremental 1-cm marks denote needle penetration depth. |
| Performance
Data | The Model 90 devices were subjected to a battery of electrical, mechanical, and
biocompatibility testing to verify that the devices met the specifications. The
devices met the specifications and the materials did not elicit toxicological
responses. |
1
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 stripes representing the department's mission. 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
SEP 1 0 1999
Ms. Erin Dignan Director, Regulatory Affairs RITA Medical Systems, Inc. 967 North Shoreline Boulevard Mountain View, California 94043
Re: K992693 Trade Name: RITA Model 90 Electrosurgical Accessory Regulatory Class: II Product Code: GEI Dated: August 10, 1999 Received: August 12, 1999
Dear Ms. Dignan:
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. Erin Dignan
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 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 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) | K 992693 |
| Device Name | Model 90 Electrosurgical Probe |
| The Model 90 Electrosurgical Probe is designed to supply energy (generated | |
| by the RITA Medical Systems' 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 Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number: K992693 | |
| (per 21 CFR 801.109) | Prescription Use V OR Over the Counter Use ______ |
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