STOCKERT NEURO N50, MODEL12267

K070336 · Stockert GmbH · GXD · Jun 14, 2007 · Neurology

Device Facts

• Record ID: K070336
• Device Name: STOCKERT NEURO N50, MODEL12267
• Applicant: Stockert GmbH
• Product Code: GXD · Neurology
• Decision Date: Jun 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stockert NEURO N50 is a RF generator for general high frequency applications: 1. Lesioning nerve tissue for functional neurosurgical procedures; or 2. Radiofrequency heat lesion procedures for the relief of pain; or 3. Stimulation procedures like provoking stimulation, localized stimulation, blocking stimulation or intraoperative test stimulation

Device Story

The Stockert NEURO N50 is a radiofrequency (RF) lesion generator used in neurological applications. It delivers RF energy to specific sites in neurological tissue via a connected neurological instrument to create thermal lesions, interrupting electrically active tissue. The device operates in either unipolar or bipolar modes. It includes integrated functions for monitoring impedance and controlling temperature at the instrument tip. Additionally, it features a stimulation unit for intraoperative test stimulation, including provoking, localized, and blocking stimulation. The device is operated by clinicians in a surgical or clinical setting. By providing controlled thermal energy and stimulation, it assists surgeons in functional neurosurgical procedures and pain management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiofrequency lesion generator; unipolar and bipolar modes; includes temperature control and impedance monitoring circuitry; stimulation unit for intraoperative testing. Device is a standalone unit.

Indications for Use

Indicated for patients requiring functional neurosurgical procedures involving nerve tissue lesioning, radiofrequency heat lesion procedures for pain relief, or intraoperative stimulation procedures (provoking, localized, blocking, or test stimulation).

Regulatory Classification

Identification

A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.

Predicate Devices

• NEURO N 50 LESION GENERATOR (K896450)

Submission Summary (Full Text)

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# FDA CDRH DMC

## RECEIVED

### 510(k) Summary

2007-01-31

K070336

# Stockert GmbH

lesion

Bötzinger Straße 72 79111 Freiburg phone: ++49-761-20716-0 ++49-761-20716-20 Fax: eMail: [e-mail] http://www.stockert.de

## TJUN 1 4 2007

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

| Contact: | Dominika Schuler, Business Manager |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | STOCKERT NEURO N50 |
| Common Name: | Radiofrequency Lesion Generator |
| Classification Name: | Generator, Lesion, Radiofrequency<br>21 CFR 882.4400, Product Code GXD, Class II |
| Predicate Device: | NEURO N 50 LESION GENERATOR<br>510(k) No. K896450 |
| Description: | The system consists of a radio frequency generator and<br>accessories intended for neurological applications. Its purpose is<br>to generate RF energy for delivery to a site in neurological tissue<br>via a neurological instrument for a specified time period. The<br>thermal energy emitted at the site of application produces a lesio<br>that interrupts an electrical active area of neurological tissues.<br>The STOCKERT NEURO N50 can be used either in bipolar or<br>unipolar mode and includes functions for controlling temperature<br>at the tip of the instrument and for monitoring impedance. It also<br>has a unit for stimulation for provoking, localized, blocking and<br>intraoperative test stimulation. |

signed: D.Schule
Dominika Schuler, Business Manager
Stockert GmbH

2007-01 - 31 date:

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is depicted in a simple, abstract style, with bold lines forming its body and wings. The text is in a clear, sans-serif font, and the overall design is clean and professional.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stockert GmbH % Ms. Dominika Schuler Business Manager Bötzinger Straße 72 79111 Freiburg Germany

JUN 1 4 2007

Re: K070336

Trade/Device Name: STOCKERT NEURO N50 Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: II Product Code: GXD Dated: May 16, 2007 Received: May 16, 2007

Dear Ms. Schuler:

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.

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Page 2 - Ms. Dominika Schuler

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known):

K070 336

Device Name: STOCKERT NEURO N50

#### Indications for Use:

Stockert NEURO N50 is a RF generator for general high frequency applications:

- 1. Lesioning nerve tissue for functional neurosurgical procedures; or
- 2. Radiofrequency heat lesion procedures for the relief of pain; or
- 3. Stimulation procedures like provoking stimulation, localized stimulation, blocking stimulation or intraoperative test stimulation

Prescription Use × (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 ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
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| Division of General, Restorative, and Neurological Devices | |
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| 510(k) Number | L07033 |