(157 days)
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No
The provided 510(k) summary contains no mention of AI, ML, deep neural networks (DNN), image processing, or any other terms typically associated with AI/ML technology in medical devices. The description focuses on recording and stimulating brain neurons for electrode placement, which is a common function of neurophysiological monitoring devices that do not necessarily utilize AI/ML.
No
The device is used to aid in the placement of depth electrodes by recording from and stimulating brain neurons, which is a diagnostic or procedural aid function, not a therapeutic one.
No
The device's intended use is to record from and stimulate brain neurons "to aid in the placement of depth electrodes." This describes a therapeutic or interventional function, not a diagnostic one. It assists in a procedure, rather than providing information to identify a disease or condition.
No
The intended use explicitly states the device is used to "record from and stimulate brain motor and sensory neurons," which strongly implies the presence of hardware components for recording and stimulation, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "record from and stimulate brain motor and sensory neurons to aid in the placement of depth electrodes." This describes a device used in vivo (within a living organism) for a surgical or procedural purpose.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The device described here does not involve testing samples outside the body.
The device is clearly intended for direct interaction with the brain during a medical procedure, which falls outside the scope of IVD devices.
N/A
Intended Use / Indications for Use
To record from and stimulate brain motor and sensory neurons to aid in the placement of depih electrodes.
Product codes
84GZL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Brain
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings.
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 Guideline System 3000 Trade Name: Requlatory 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) requlation (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 requlatory 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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
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 depih electrodes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PA 'JE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OD)!)
Thomas J. Callehan
(Division Sign-Off) (Division Sign-Oit)
Division of Cardiovascular, Respiratory, Division of original Devices 510(k) Number
510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
..
(Optical Format 1-2-96)