(17 days)
Not Found
No
The summary describes a radiofrequency 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 "supply energy ... for use in electrosurgery" and "deliver radiofrequency energy ... to create coagulative necrotic lesions," indicating a direct therapeutic action on tissue.
No
The device is used to deliver radiofrequency energy to create lesions, which is a therapeutic action, not a diagnostic one.
No
The device description clearly outlines physical components such as electrodes, tubing, a handle, and connectors, indicating it is a hardware device.
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 device designed to deliver radiofrequency energy directly to targeted tissue within the body to create coagulative necrotic lesions. This is an in vivo procedure (performed within a living organism).
- Device Description: The description details components like electrodes, a trocar tip, and a handle for manipulating the device inside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly treat or interact with tissue inside the body. This device is an electrosurgical probe used for therapeutic purposes in vivo.
N/A
Intended Use / Indications for Use
The MR Compatible 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® MR Compatible 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 MR Compatible Model 90 device consists of the following components: primary electrode: hypodermic tubing with a portion exposed as an electrosecondary electrodes: extendible flexible hypodermic tubing at the distal end of probetrocar insulation: shrink tubinghandle: polymer materials with markings to indicate the amount of electrode array deployment from the trocarRF pathway: connection through a Lemo connector built into the handlefluid infusion: delivery through Luer port at side of the handletemperature sensors: five temperature sensors at the periphery of the arraydepth 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 MR Compatible Model 90 devices were subjected to a battery of electrical, mechanical, biocompatibility, and magnetic resonance 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.
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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 9.0 KO23846
| General
Provisions | Trade Name: MR Compatible Model 90 Electrosurgical Probe
Common/Classification Name: Electrosurgical cutting and coagulation accessory |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate | RITA Medical Systems Inc. - Model 90 Electrosurgical Probe |
| | Radiotherapeutics Corp. - MR Compatible LeVeen Needle 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 MR Compatible 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® MR Compatible 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 MR Compatible Model 90 device consists of
the following components:
primary electrode: hypodermic tubing with a portion exposed as an
electrodesecondary electrodes: extendible flexible hypodermic tubing at the distal
end of probetrocar insulation: shrink tubinghandle: polymer materials with markings to indicate the amount of
electrode array deployment from the trocarRF pathway: connection through a Lemo connector built into the handlefluid infusion: delivery through Luer port at side of the handletemperature sensors: five temperature sensors at the periphery of the arraydepth indicators: Incremental 1-cm marks denote needle penetration depth. |
| Performance
Data | The MR Compatible Model 90 devices were subjected to a battery of electrical,
mechanical, biocompatibility, and magnetic resonance testing to verify that the
devices met the specifications. The devices met the specifications and the materials
did not elicit toxicological responses. |
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, which also forms the shape of a bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2002
Rita Medical Systems Karen Frischmeyer Director. Clinical Programs 967 North Shoreline Boulevard Mountain View, California 94043
Re: K023846
Trade/Device Name: MR Compatible Model 90 Electrosurgical Probe Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation accessory Regulatory Class: Class II Product Code: GEI Dated: November 18, 2002 Received: November 19, 2002
Dear Ms. Frischmeyer:
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
2
Page 2 – Ms. Karen Frischmeyer
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.
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). 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
RITA Medical Systems, Inc.
INTENDED USE · 3.0
| Indications for Use Statement | |
|---|---|
| 510(K) Number (if known) | K023846 |
| Device Name | MR Compatible Model 90 Electrosurgical Probe |
The MR Compatible 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)
Prescription Use / OR Over the Counter Use _
(per 21 CFR 801.109)
Meriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510/k) Namber
November 18, 2002