(55 days)
Not Found
No
The device description and intended use focus on the physical characteristics and function of RF injection needles for nerve blocks and lesioning, utilizing electrical stimulation or contrast medium with radiography. There is no mention of AI or ML in the text.
Yes
The device is explicitly described as being used for "radio frequency lesioning" and "percutaneous nerve blocks with local anesthetic solution" for "the relief of pain," which are therapeutic interventions.
Yes
The device aids in localizing a nerve through electrical stimulation or by injecting contrast medium with radiography, which are diagnostic steps for identifying the target nerve prior to a therapeutic intervention.
No
The device description clearly details physical components (needles, tubing, electrical leads, Luer hubs) and their materials and functions, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is an injection needle used for procedures performed directly on the patient's body (percutaneous nerve blocks and radio frequency lesioning). It is used to deliver substances (local anesthetic, contrast medium) or apply energy (radio frequency) to the nerve.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. While contrast medium is injected and visualized with radiography, the device itself is not performing an analysis of the contrast medium or any other bodily fluid or tissue in vitro.
The device is a therapeutic and procedural device used for pain management and nerve interventions, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
A RF Injection Needle is an injection needle, which may be used either for percutaneous nerve blocks with local anesthetic solution or for radio frequency lesioning. The nerve is localized either by using electrical stimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic or a radio frequency lesion may be made.
Product codes (comma separated list FDA assigned to the subject device)
GXI, GXD
Device Description
There are four types of needles: SMK, CXE, CX and RCN
SMK is used in radiofrequency (RF) lesion procedures for the relief of pain. The device allows an injection of local anesthetic to relieve the pain of RF. A SMK-TC electrode is then place into the cannulae to create the lesion. The length of the cannula is insulated except for a section of the tip. The RF energy is then transferred from the electrode through this uninsulated portion which heats the surrounding tissue to create a lesion.
CXE is used for percutaneous facet denervations. The device consists of a shaft of hypodermic tubing, which is insulated except for 5mm at the tip. Plastic tubing and an electrical lead are unitized in a single flexible leader portion, which connects to the shaft. The lead is insulated and feed through the plastic tube. A Luer hub on the tubing allows injection of local anesthetic. The needle can be connected to a Radionics generator for stimulation and lesioning. The RF pole does not allow for temperature monitoring.
CX is used for percutaneous stimulation and injection. The design of the pole is similar to the RF pole except for the exposed tip. Only the beveled surface, 1mm, is uninsulated. The pole is intended to be connected to a stimulus generator.
RCN is used for prognostic block injections of local anesthetics or injection of contrast media. The device consists of hvoodermic tubing attached PVC tubing. The needle has no electrical connection. The tubing has a Luer hub to allow the injection with a syringe at a more remote position from the needle field.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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.
K021942, K980430, K963577, K870028
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
§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).
0
OCT 2 6 2004
Attachment D:
్ని
510(k) Summary
| Manufacturer: | Technomed Europe
Amerikalaan 71
6199 AE Maastricht Airport
The Netherlands | | |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitted by: | Technomed Europe
Amerikalaan 71
6199 AE Maastricht Airport
The Netherlands | | |
| Contact person: | René Roncken
Manager Quality Assurance
Tel.: (+31) 43-408 6868
Fax: (+31) 43-408 6888
E-mail: rroncken@technomed.nl | | |
| Date: | August 18, 2004 | | |
| Proprietary Name: | RF Injections Needles | | |
| Common/usual Name: | Disposable cannula for radio frequency electrode | | |
| Classification Name: | Radiofrequency lesion probe (21 CFR section 882.4725) | | |
| Substantial Equivalence: | K021942:
K980430:
K963577:
K870028: | Radionics Pole Needles
Radionics disposable RF Cannulae (SC-C, RFK-
DB, RFK-DS)
RSM-C, Sluijter-Mehta Cannula
SMK Sluijter-Mehta Cannulae, RF Pole, Pole and
Flexible Needles | |
| Device description: | There are four types of needles: SMK, CXE, CX and RCN
SMK is used in radiofrequency (RF) lesion procedures for the
relief of pain. The device allows an injection of local anesthetic
to relieve the pain of RF. A SMK-TC electrode is then place
into the cannulae to create the lesion. The length of the cannula
is insulated except for a section of the tip. The RF energy is
then transferred from the electrode through this uninsulated
portion which heats the surrounding tissue to create a lesion.
CXE is used for percutaneous facet denervations. The device
consists of a shaft of hypodermic tubing, which is insulated
except for 5mm at the tip. Plastic tubing and an electrical lead
are unitized in a single flexible leader portion, which connects
to the shaft. The lead is insulated and feed through the plastic
tube. A Luer hub on the tubing allows injection of local
anesthetic. The needle can be connected to a Radionics
generator for stimulation and lesioning. The RF pole does not
allow for temperature monitoring. | | |
1
Page 2 of 2
CX is used for percutaneous stimulation and injection. The design of the pole is similar to the RF pole except for the exposed tip. Only the beveled surface, 1mm, is uninsulated. The pole is intended to be connected to a stimulus generator.
RCN is used for prognostic block injections of local anesthetics or injection of contrast media. The device consists of hvoodermic tubing attached PVC tubing. The needle has no electrical connection. The tubing has a Luer hub to allow the injection with a syringe at a more remote position from the needle field.
A RF Injection Needle is an injection needle, which may be Intended Use: used either for percutaneous nerve blocks with local anesthetic solution or for radio frequency lesioning. The nerve is localized either by using electrical stimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic or a radio frequency lesion may be made.
Technological characteristics:
The design, materials, chemical composition, packaging and other technological characteristics of the subject devices are considered to be the equivalent of the predicated devices.
2
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2004
Mr. René Roncken Manager Quality Assurance Technomed Europe Amerikalaan 71 6199 AE Maastricht Airport The Netherlands
Re: K042375
Trade/Device Name: RF Injection Needle Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI, GXD Dated: October 7, 2004 Received: October 12, 2004
Dear Mr. Roncken:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encrosuly to trgans actment date of the Medical Device Amendments, or to commerce proc to may 20, 1978, are excordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Costiere rece (1 tor) that be device, subject to the general controls provisions of the Act. The r ou may, morelore, maneve of the Act include requirements for annual registration, listing of general controls provisions of use tice, 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 If your device is elaboried (tional controls. Existing major regulations affecting your device can may be subject to such address a legulations, 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 I loast of advised that I Drivieran that your device complies with other requirements of the Act that I DA has made a coulations administered by other Federal agencies. You must of any it catal statuted and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. René Roncken
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 (240) 276-0115. 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 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
4
- Statement Indications for Use 2.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: RF Injection Needle
August 17, 2004
Indications for Use:
A RF Injection Needle is an injection needle, which may be used either for A KF Injection Needle is an injection froction froction or for radiofrequency
percutaneous nerve blocks with local anesthetic solution at stigulation through perculaneous netve blocks with lood antines electrical stimulation through the lessoning. The nerve is localized entiler of assist the needle and using radiography
needle or by injection contrast medium through the needle and using their or a needle of by injection contrast medialin the ough by injecting local anesthetic or a radiofrequency lesion may be made.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE OMN ANOTHER PAGE IF NEEDED)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K142375