(140 days)
Not Found
No
The description focuses on the physical characteristics and intended use of injection needles for nerve blocks and radiofrequency lesioning, with no mention of AI or ML for localization, treatment planning, or any other function.
No
The device is an injection needle used for nerve blocks or radiofrequency lesioning, which are procedures, not therapeutic devices themselves.
No
The device is an injection needle used for therapeutic procedures (nerve blocks or radiofrequency lesioning), not for diagnosing a condition or disease. The localization methods mentioned (electrostimulation, contrast medium with radiography) are to guide the therapeutic procedure, not to diagnose a disease.
No
The device description clearly states it is an injection needle, which is a physical hardware component, not software.
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 the Top Neuropole Needles are used for procedures performed directly on the patient's body (percutaneous nerve blocks and radiofrequency lesioning). They are used to deliver substances or energy to a nerve, not to analyze a sample taken from the body.
- The procedures described are interventional. The needles are used for therapeutic (nerve blocks, radiofrequency lesioning) and diagnostic (nerve localization) procedures performed in vivo.
Therefore, the Top Neuropole Needles fall under the category of medical devices used for in-vivo procedures, not in-vitro diagnostics.
N/A
Intended Use / Indications for Use
The Top Neuropole Needles are used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning.
The Top Neuropole Needles are injection needles used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation 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 solution or a radiofrequency lesion may be made.
Product codes
GXI
Device Description
Top Neuropole Needles are teflon insulated injection needles for safe thermolesion procedures and regional anesthesia. There are 5 models offered, the ST, X, RC, XE and TL. The Top Neuropole Needle models TL, XE and RC are for pain management, while models ST and X are for local anesthesia. The needles are available in multiple sizes. The needle gauge ranges from 20 to 24 and the length from 30 to 200 mm. They are for single use only and supplied sterile.
They may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The nerve is localized either through the needle or by injecting contrast medium 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiography
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)
Top Neuropole Needles have been tested to ensure the devices comply with applicable industry standards and US regulations
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Radionics (K870028)
Reference Device(s)
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
L062946
510(k) SUMMARY
-EB 1 5 2007
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c)
| Submitter's Name And Address: | Top Corporation
19-10 Senjunakai-cho
Adachi-ku
Tokyo, Japan 120-0035 |
|-------------------------------|-------------------------------------------------------------------------------|
| Contact Name: | Toshimitsu Suzuki |
| Tel. | +81 3-3882-3101 |
| Submission Date: | April 24, 2006 |
Device
| Trade or (Proprietary) Name: | Top Neuropole Needles |
|---|---|
| Common or usual name: | Pole Needles |
| Classification Name: | Probe, radiofrequency lesion |
| Class II devices. (21 C.F.R. § 882.4725) | |
| Product Code: | GXI |
| Legally Marketed Device To Which Claim Substantial Equivalence: | Radionics (K870028) |
DEVICE DESCRIPTION
Top Neuropole Needles are teflon insulated injection needles for safe thermolesion procedures and regional anesthesia. There are 5 models offered, the ST, X, RC, XE and TL. The Top Neuropole Needle models TL, XE and RC are for pain management, while models ST and X are for local anesthesia. The needles are available in multiple sizes. The needle gauge ranges from 20 to 24 and the length from 30 to 200 mm. They are for single use only and supplied sterile.
They may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The nerve is localized either through the needle or by injecting contrast medium 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.
INTENDED USE
The Top Neuropole Needles are used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning.
1
TECHNOLOGICAL CHARACTERISTICS
Top Neuropole Needles have the same device characteristics, materials, dimensions and intended use as the predicate device.
Top Neuropole Needles have been tested to ensure the devices comply with applicable industry standards and US regulations
CONCLUSIONS
The intended use and performance characteristics of the Top Neuropole Needles are the same as the predicate and raise no new questions of safety and effectiveness. The Top Neuropole Needles are substantially equivalent to the predicate device.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Top Corporation % Cambria Regulatory Consulting, Inc. Ms. Cathryn N. Cambria 5536 Trowbridge Drive Dunwoody, Georgia 30338
FEB 1 5 2007
Re: K062946
Trade/Device Name: Top Neuropole Needles Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI Dated: February 2, 2007 Received: February 5, 2007
Dear Ms. Cambria:
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 - Ms. Cathryn N. Cambria
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K062946
Device Name: Top Neuropole Needles
Indications for Use:
The Top Neuropole Needles are injection needles used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation 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 solution or a radiofrequency lesion may be made.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter |
|---|---|---|---|
| Use | |||
| (Per 21 CFR 801.109) |
(Division Sign-O)
Division of Gene al, Restorative,
and Neurological Devices
| 510(k) Number | 1062946 |
|---|---|
| --------------- | --------- |