(129 days)
Not Found
No
The document describes a standard RF generator for neurological procedures with temperature and impedance monitoring, and stimulation capabilities. There is no mention of AI, ML, image processing, or any data-driven decision-making processes.
Yes
The device is described as a radiofrequency generator intended for procedures like "lesioning nerve tissue for functional neurosurgical procedures" and "radiofrequency heat lesion procedures for the relief of pain," which are therapeutic interventions.
No
The device is a radiofrequency generator used for lesioning or stimulating nerve tissue, which are therapeutic procedures, not diagnostic ones. While it mentions monitoring impedance and functions for various types of stimulation (provoking, localized, blocking, intraoperative test stimulation), these functions support the therapeutic application rather than being standalone diagnostic functions to identify a disease or condition.
No
The device description explicitly states the system consists of a "radio frequency generator and accessories," indicating it includes hardware components beyond just software.
Based on the provided information, the Stockert NEURO N50 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 examine these samples outside of the body.
- Stockert NEURO N50 Function: The description clearly states that the Stockert NEURO N50 is a radio frequency generator used to deliver energy directly to neurological tissue within the body for lesioning or stimulation. This is an in vivo procedure, not an in vitro test.
The device's purpose is to physically alter tissue within the patient, not to analyze samples taken from the patient.
N/A
Intended Use / Indications for Use
Stockert NEURO N50 is a RF generator for general high frequency applications:
-
- Lesioning nerve tissue for functional neurosurgical procedures; or
-
- Radiofrequency heat lesion procedures for the relief of pain; or
-
- Stimulation procedures like provoking stimulation, localized stimulation, blocking stimulation or intraoperative test stimulation
Product codes
GXD
Device Description
The system consists of a radio frequency generator and accessories intended for neurological applications. Its purpose is to generate RF energy for delivery to a site in neurological tissue via a neurological instrument for a specified time period. The thermal energy emitted at the site of application produces a lesio that interrupts an electrical active area of neurological tissues. The STOCKERT NEURO N50 can be used either in bipolar or unipolar mode and includes functions for controlling temperature at the tip of the instrument and for monitoring impedance. It also has a unit for stimulation for provoking, localized, blocking and intraoperative test stimulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurological tissue
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4400 Radiofrequency lesion generator.
(a)
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.(b)
Classification. Class II (performance standards).
0
FDA CDRH DMC
RECEIVED
510(k) Summary
2007-01-31
Stockert GmbH
lesion
Bötzinger Straße 72 79111 Freiburg phone: ++49-761-20716-0 ++49-761-20716-20 Fax: eMail: info@stockert.de 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 |
| 21 CFR 882.4400, Product Code GXD, Class II | |
| Predicate Device: | NEURO N 50 LESION GENERATOR |
| 510(k) No. K896450 | |
| Description: | The system consists of a radio frequency generator and |
| accessories intended for neurological applications. Its purpose is | |
| to generate RF energy for delivery to a site in neurological tissue | |
| via a neurological instrument for a specified time period. The | |
| thermal energy emitted at the site of application produces a lesio | |
| that interrupts an electrical active area of neurological tissues. | |
| The STOCKERT NEURO N50 can be used either in bipolar or | |
| unipolar mode and includes functions for controlling temperature | |
| at the tip of the instrument and for monitoring impedance. It also | |
| has a unit for stimulation for provoking, localized, blocking and | |
| intraoperative test stimulation. |
signed: D.Schule
Dominika Schuler, Business Manager
Stockert GmbH
2007-01 - 31 date:
1
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.
2
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 (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
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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:
-
- Lesioning nerve tissue for functional neurosurgical procedures; or
-
- Radiofrequency heat lesion procedures for the relief of pain; or
-
- 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) | |
|---|---|
| Division of General, Restorative, and Neurological Devices | |
| Page 1 of 1 | |
| 510(k) Number | L07033 |