K Number
K080771
Device Name
TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC
Manufacturer
Date Cleared
2008-11-10

(236 days)

Product Code
Regulation Number
882.4725
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Top Neuropole Needles are injection needles which may be 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.
Device Description
Top Neuropole Needles are injection needles which are used for temperature controlled radiofrequency lesioning. A nerve is localized either by using electrical stimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. After injection of anesthetics the nerve may then be blocked by radiofrequency lesion. Top Neuropole Needles are supplied sterile and are labeled for Single Use Only.
More Information

Not Found

No
The summary describes a physical needle used for nerve blocks and radiofrequency lesioning, with localization methods based on electrical stimulation or radiography. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.

Yes
The device is used to perform nerve blocks with local anesthetic solution or radiofrequency lesions, both of which are therapeutic interventions.

No
The device is described as an injection needle used for nerve blocks or radiofrequency lesioning. While it aids in nerve localization (which can be seen as gathering information), its primary function is therapeutic (injection, lesioning), not purely diagnostic. The localization methods (electrostimulation, injecting contrast with radiography) are steps to enable a therapeutic procedure.

No

The device description explicitly states it is an "injection needle" and is supplied "sterile," indicating it is a physical hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Function: The Top Neuropole Needles are used for direct intervention on a nerve within the body (percutaneous nerve blocks and radiofrequency lesioning). They are used to deliver substances (local anesthetic, contrast medium) or energy (radiofrequency) directly to the nerve.
  • Lack of Sample Analysis: The device does not analyze samples taken from the body. While it uses techniques like electrostimulation and radiography to locate the nerve, the primary function is the direct treatment or blocking of the nerve in situ.

Therefore, the function and intended use of the Top Neuropole Needles fall outside the scope of in vitro diagnostics.

N/A

Intended Use / Indications for Use

The Top Neuropole Needles are injection needles which may be 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 (comma separated list FDA assigned to the subject device)

GXI

Device Description

Top Neuropole Needles are injection needles which are used for temperature controlled radiofrequency lesioning. A nerve is localized either by using electrical stimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. After injection of anesthetics the nerve may then be blocked by radiofrequency lesion. Top Neuropole Needles are supplied sterile and are labeled for Single Use Only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

radiography

Anatomical Site

nerve

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): 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.

K870028, K980430, K010202, K062946, K060799

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

K08077/

Page 1 of 2

g

510(k) SUMMARY

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 Senju Nakai-cho Adachi-ku Tokyo, Japan 120-0035

NOV 10 2008

Contact Name: Tel. Submission Date: Toshimitsu Suzuki +81 3-3882-3101 December 12, 2007

Device

Trade or (Proprietary) Name:

Top Neuropole Needles

Probe, radiofrequency lesion

Pole Needles

Common or usual name:

Classification Name:

Product Code:

GXI

Legally Marketed Device To Which Claim Substantial Equivalence:

Radionics: K870028. K980430. K010202 Top: K062946 Cosman: K060799

Class II devices. (21 C.F.R. § 882.4725)

DEVICE DESCRIPTION

Top Neuropole Needles are injection needles which are used for temperature controlled radiofrequency lesioning. A nerve is localized either by using electrical stimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. After injection of anesthetics the nerve may then be blocked by radiofrequency lesion. Top Neuropole Needles are supplied sterile and are labeled for Single Use Only.

INTENDED USE

The Top Neuropole Needles are injection needles which may be 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.

1

Kv8077/

Page 2 of 2

1 (

TECHNOLOGICAL CHARACTERISTICS

Top Neuropole Needles have the same device characteristics, materials, dimensions and intended use as the predicate device(s).

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(s) 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, clutching a caduceus in its talons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

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

NOV 1 0 2008

Re: K080771

Trade/Device Name: Top Neuropole Needles, Model SH, BL, SC & TC Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI Dated: October 16, 2008 Received: October 20, 2008

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 M. Millman

  • Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
    Enclosure

4

Ko.8077/

Indications for Use:

510(k) Number (if known): K080771

Device Name: Top Neuropole Needles, Model SH, BL, SC & TC

Indications for Use:

The Top Neuropole Needles are injection needles which may be 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.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden for mxm

Page 1 of 1

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K080771