GUIDELINE SYSTEM

K970943 · Axon Instruments, Inc. · GZL · Aug 18, 1997 · Neurology

Device Facts

• Record ID: K970943
• Device Name: GUIDELINE SYSTEM
• Applicant: Axon Instruments, Inc.
• Product Code: GZL · Neurology
• Decision Date: Aug 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2

Intended Use

To record from and stimulate brain motor and sensory neurons to aid in the placement of depth electrodes.

Device Story

The Guideline System 3000 (GS3000) is a neurophysiological recording and stimulation system. It functions by recording electrical signals from brain motor and sensory neurons and providing electrical stimulation to these neurons. The device is used by clinicians to assist in the accurate placement of depth electrodes during neurosurgical procedures. By monitoring neuronal activity and response to stimulation, the system provides real-time feedback to the surgeon, facilitating precise electrode positioning. This aids in clinical decision-making during surgical interventions, potentially improving the accuracy of electrode placement and patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a neurophysiological recording and stimulation system designed for clinical use. It operates by interfacing with depth electrodes to capture and deliver electrical signals. Technical specifications and materials are not detailed in the provided documentation.

Indications for Use

Indicated for recording from and stimulating brain motor and sensory neurons to aid in the placement of depth electrodes.

Regulatory Classification

Identification

A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Andrew L. Blatz, Ph.D.
Regulatory Affairs Manager
Axon Instruments, Inc.
1101 Chess Drive
Foster City, California 94404

AUG 1.8 1997

Re: K970943
Trade Name: Guideline System 3000
Regulatory Class: II
Product Code: 84GZL
Dated: June 4, 1997
Received: June 5, 1997

Dear Dr. Blatz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Andrew L. Blatz, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K970943

Device Name: GS3000

Indications For Use:

To record from and stimulate brain motor and sensory neurons to aid in the placement of depth electrodes.

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

Concurrence of CDRH, Office of Device Evaluation (ODI:)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970943

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)