(90 days)
Not Found
No
The device description focuses on the physical characteristics and intended use of different types of needles for nerve blocks and radiofrequency lesioning. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The methods for nerve localization (electrical stimulation, contrast medium with radiography) are standard techniques that do not inherently involve AI/ML.
Yes
The device is used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning to relieve pain, which are therapeutic medical procedures.
No
The device is primarily used for therapeutic purposes (nerve blocks, radiofrequency lesioning) and for localizing nerves (using electrical stimulation or contrast medium with radiography). While localization involves gathering information, the overall intended use is not to diagnose a condition, but to treat it or facilitate treatment.
No
The device description clearly details physical needles and associated hardware components for injection, stimulation, and radiofrequency lesioning. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that these needles are used for procedures performed directly on the patient's body (percutaneous nerve blocks, radiofrequency lesioning, stimulation, injection of contrast medium). They are not used to analyze samples like blood, urine, or tissue outside the body.
- The procedures described are interventional. They involve physically interacting with the patient's anatomy (nerves) for therapeutic or diagnostic purposes performed in vivo. IVDs are used for diagnostic purposes performed in vitro.
The device is a surgical/interventional tool used for procedures on the patient, not for analyzing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
A Pole Needle is an injection needle, which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency 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 radiofrequency 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 Sluijter-Mehta Cannulae, RF Pole, Pole and Flexible Needles.
SMK Cannulae is used in radiofrequency (RF) lesion procedures for the relief of pain. The device allows a injection of local anesthetic to relieve the pain of RF. A SMK-TC electrode is then placed 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.
RF Pole 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.
Pole 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.
Flexible Injection Needle is used for prognostic block injections of local anesthetics or injection of contrast media. The device consists of hypodermic tubing attached to 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 needles 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.
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
SEP 1 1 2002
Attachment VIII: Summary of Safety and Effectiveness Information [510(k) Summary]
| SUBMITTER: | Radionics, a division of Tyco Healthcare LP
22 Terry Ave.
Burlington, MA 01803
Tel.: (781) 272-1233
Fax: (978) 663-8405
Contact: Kevin J. O'Connell
Senior Regulatory Associate |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PROPRIETARY NAME: | Radionics Pole Needles |
| COMMON OR USUAL
NAME: | Disposable cannula for radiofrequency electrode |
| CLASSIFICATION CODE: | 21 C.F.R. § 882.4725 |
| PREDICATE DEVICE: | SMK Sluijter-Mehta Cannulae, RF Pole, Pole and Flexible
Needles, K870028;
RSM-C, Sluijter-Mehta Cannula, K963577
Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS),
K980430 |
| INTENDED USE: | A Pole Needle is an injection needle, which may be used either
for percutaneous nerve blocks with local anesthetic solution or
for radiofrequency 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 radiofrequency lesion may be made. |
| DESCRIPTION: | There are four types of needles: SMK Sluijter-Mehta Cannulae,
RF Pole, Pole and Flexible Needles.
SMK Cannulae is used in radiofrequency (RF) lesion procedures
for the relief of pain. The device allows a injection of local
anesthetic to relieve the pain of RF. A SMK-TC electrode is
then placed 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.
RF Pole 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 |
1
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.
- Pole 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.
- Flexible Injection Needle is used for prognostic block injections of local anesthetics or injection of contrast media. The device consists of hypodermic tubing attached to 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 needles field.
2
Image /page/2/Picture/0 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 a stylized symbol featuring a caduceus-like design with three human profiles facing right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Radionics, Inc., A Division of Tyco Healthcare LP Kevin J. O'Connell Senior Regulatory Associate 22 Terry Avenue Burlington, Massachusetts 01803
FP 11 2002
Re: K021942
Trade/Device Name: Radionics Pole Needles Regulation Number: 882.4725; 882.4400 Regulation Name: Probe, radiofrequency lesion; generator, lesion, radiofrequency Regulatory Class: Class II Product Code: GXI; GXD Dated: June 12, 2002 Received: June13, 2002
Dear Mr. O'Connell:
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 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.
3
Page 2 -- Mr. Kevin J. O.'Connell
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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" (21 CFR 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ha tytl Rurds
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
ODE Indications Statement: 2.0
Page 1 of 1
510(k) Number (if known): K021942
Device Name: Radionics Pole Needles
A Pole Needle is an injection needle, which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency 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 radiofrequency lesion may be made.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Styd Purdy
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KO21942 510(k) Number _
PRESCRIPTION USE
OR
Over-The-Counter Use
(Per 21 CFR 801.109
(Optional Format 1-2-96)