(55 days)
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.
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.
The provided 510(k) summary for the "RF Injection Needles" does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically expected for performance claims (e.g., accuracy, sensitivity, specificity, or specific functional benchmarks).
This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use: The device shares the same intended use as predicate devices: percutaneous nerve blocks with local anesthetic solution or radiofrequency lesioning, with nerve localization via electrical stimulation or contrast medium injection and radiography.
- Technological Characteristics: The manufacturer states that "The design, materials, chemical composition, packaging and other technological characteristics of the subject devices are considered to be the equivalent of the predicated devices."
Therefore, the requested information elements related to performance criteria, study design, expert involvement, and ground truth are not applicable to this specific 510(k) submission as no performance study was conducted or reported.
Here's a breakdown of why each point is not addressed by the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable: The document does not define specific performance acceptance criteria for the RF Injection Needles nor does it report any associated performance metrics like accuracy, sensitivity, or specificity. The submission aims to show substantial equivalence through intended use and technological characteristics rather than quantitative performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: No test set or performance evaluation study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: No ground truth establishment is mentioned as there was no performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No test set adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: This is not an AI-enabled device; no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical medical device (needles), not an algorithm or software. Standalone performance is not relevant in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: No ground truth was established for performance evaluation within this 510(k) submission.
8. The sample size for the training set
- Not Applicable: This device is not an algorithm, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable: As above, this is not an algorithm, so no training set or ground truth for it.
In summary: The provided 510(k) is a submission for a physical medical device demonstrating substantial equivalence to previously cleared predicate devices based on shared intended use and technological characteristics. It does not contain a performance study with acceptance criteria, test sets, or ground truth as these are typically required for novel performance claims or AI/software devices.
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OCT 2 6 2004
Attachment D:
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510(k) Summary
| Manufacturer: | Technomed EuropeAmerikalaan 716199 AE Maastricht AirportThe Netherlands | ||
|---|---|---|---|
| Submitted by: | Technomed EuropeAmerikalaan 716199 AE Maastricht AirportThe Netherlands | ||
| Contact person: | René RonckenManager Quality AssuranceTel.: (+31) 43-408 6868Fax: (+31) 43-408 6888E-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 NeedlesRadionics disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)RSM-C, Sluijter-Mehta CannulaSMK Sluijter-Mehta Cannulae, RF Pole, Pole andFlexible Needles | |
| Device description: | There are four types of needles: SMK, CXE, CX and RCNSMK is used in radiofrequency (RF) lesion procedures for therelief of pain. The device allows an injection of local anestheticto relieve the pain of RF. A SMK-TC electrode is then placeinto the cannulae to create the lesion. The length of the cannulais insulated except for a section of the tip. The RF energy isthen transferred from the electrode through this uninsulatedportion which heats the surrounding tissue to create a lesion.CXE is used for percutaneous facet denervations. The deviceconsists of a shaft of hypodermic tubing, which is insulatedexcept for 5mm at the tip. Plastic tubing and an electrical leadare unitized in a single flexible leader portion, which connectsto the shaft. The lead is insulated and feed through the plastictube. A Luer hub on the tubing allows injection of localanesthetic. The needle can be connected to a Radionicsgenerator for stimulation and lesioning. The RF pole does notallow for temperature monitoring. |
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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.
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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.
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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
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- 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
§ 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).