(86 days)
Not Found
No
The description focuses on the hardware (amplifier, headbox, system unit) and software for data acquisition and control. There is no mention of AI, ML, or related concepts in the intended use, device description, or the specific sections indicating their presence.
No.
The device is intended for "measuring recording of the electrical activity of a patient's brain" and "monitoring and diagnosis," which are diagnostic functions, not therapeutic.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is intended "to aid in monitoring and diagnosis" and that "The data acquired must be interpreted by qualified physicians," which indicates a diagnostic purpose.
No
The device description explicitly details hardware components including an amplifier, data acquisition electronics housed in a Headbox, and a System Unit that interfaces with a host computer. While software controls the system, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "measuring recording of the electrical activity of a patient's brain" and "for the EEG and long/middle/short-latency EP registration." This involves measuring physiological signals directly from the patient's body.
- Device Description: The device description details an amplifier and data acquisition system that connects to electrodes placed on the patient. This is consistent with a device that measures electrical activity from the body.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze such specimens.
Therefore, the Neuroscan SynAmps2 system, as described, is a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Neuroscan SynAmps2 system is intended for measuring recording of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short-latency EP registration in the research environment. The system is intended to be used by qualified/trained EEG technologists and/or physicians. The data acquired must be interpreted by qualified physicians.
Product codes
GWQ, GWP, GWF, GWE, GWJ
Device Description
The SynAmps2® Amplifier System is an EEG/ERP/EP amplifier and data acquisition system. The amplifier and data acquisition electronics are housed in a small enclosure (Headbox) placed near the patient, and into which individual electrodes, collections of electrodes, may be connected. Additionally a high density electrode cap connector is provided on the Headbox. The Headbox also contains a connector for the interconnect cable to the System Unit.
The System Unit is slightly larger than the Headbox and serves as an interface between up to four Headboxes and the host computer.
The system operates under the software control of a host computer over a USB 2.0 interface. Data flows from the SynAmps2 amplifier over this interface. Multiple System Units may be connected to the host, to obtain systems of up to 512 channels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified/trained EEG technologists and/or physicians / clinical settings, research environment
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
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
V. 510(k) Summary
Safety and effectiveness information concerning this device is summarized below. Because this is not a Class III device, the special certification defined in this section is not required.
| Submitted by: | Neuroscan
7850 Paseo Del Norte, Suite 101
El Paso, TX 79912
Phone: 915-845-5600 ext 217
Fax: 915-845-2965 | FEB 06 2003 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Elvira Garcia | |
| Date Prepared: | October 30, 2002 | |
| Proprietary Name: | SynAmps2 | |
| Common Name: | Electroencephalograph (EEG) | |
| Classification Name: | GWQ, GWP, GWF, GWE, GWJ | |
| Device Classification
Class II: | 21 CFR § 882.1400 Electroencephalograph | |
| Predicate Device: | SynAmps
510(k) # K001324 | |
Description of the Device:
The SynAmps2® Amplifier System is an EEG/ERP/EP amplifier and data acquisition system. The amplifier and data acquisition electronics are housed in a small enclosure (Headbox) placed near the patient, and into which individual electrodes, collections of electrodes, may be connected. Additionally a high density electrode cap connector is provided on the Headbox. The Headbox also contains a connector for the interconnect cable to the System Unit.
The System Unit is slightly larger than the Headbox and serves as an interface between up to four Headboxes and the host computer.
The system operates under the software control of a host computer over a USB 2.0 interface. Data flows from the SynAmps2 amplifier over this interface. Multiple System Units may be connected to the host, to obtain systems of up to 512 channels.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/12 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three heads, symbolizing service to the nation. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 6 2003
Neuroscan Elvira Garcia Quality Assurance Manager 7850 Paseo Del Norte, Suite 101 El Paso, Texas 79912
Re: K023771
Trade/Device Name: SynAmps2 Regulation Number: 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ Dated: November 6, 2002 Received: November 12, 2002
Dear Ms. Garcia:
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. Iisting 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. Elvira Garcia
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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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IV. Statement of Indications for Use
| Applicant: | Neuroscan
7850 Paseo Del Norte, Suite 101
El Paso, TX 79912
Phone: 915-845-5600 ext. 217
Fax: 915-845-2965 |
| ------------ | ------------------------------------------------------------------------------------------------------------------------ |
|---|
KOLS 771 51(k) Number:
Device Name:
Neuroscan SynAmps2
Indications For Use: The Neuroscan SynAmps2 system is intended for measuring recording of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short-latency EP registration in the research environment. The system is intended to be used by qualified/trained EEG technologists and/or physicians. The data acquired must be interpreted by qualified physicians.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of device Evaluation (ODE)
Musiam C. Provost
eral, Restorative Division Neurological Devices
510(k) Number K023771
(Per 21 CFR 801.109)
SynAmps2 510(k) Application