(80 days)
System for recording electroencephalogram of brain electrical activity to Host Digital EEG Machine.
The NeuroLink NeuroMonitoring System (predicate device) consists of a set of components that work together to acquire and present EEG signal to any existing EEG recording and analysis equipment. The components include Biosensor electrodes, e-Net headpiece, Patient Module, battery module, fiber optic cable, and DSP Interface Card. Changes in the Patient Module and power supply are described in this submission. An electrode headbox has been added to the Patient Module and an AC power supply is available as an alternate to the battery module. The Patient Module is a small battery powered or AC powered amplifier. The EEG signals are transmitted from the head via conventional electrodes that are input into the attached headbox or e-Net that has a mating connector on the patient module. Power is enabled when the Patient Module is plugged into the DSP Card via the fiber optic cable, the host digital EEG computer is in the powered state and the Patient Module is enabled by pressing the control button located on the Patient Module. A five meter fiber optic cable is standard. The fiber optic cable provides patient isolation and flexible patient EEG Record Station placement options. Self test, calibration and impedance tests are remotely activated from the Host Digital EEG Machine through the DSP Interface Card or locally by depressing the appropriate test button on the Patient Module. A visual indication of control button function, system status and out of range impedance can be provided on the LCD display as controlled from the Host Digital EEG Machine.
The provided text describes a 510(k) premarket notification for the Physiometrix. Inc. Model 1320 NeuroLink II NeuroMonitoring System. This device is a physiological signal amplifier designed to acquire and present EEG signals to existing EEG recording and analysis equipment. The submission highlights changes to a previously cleared predicate device (K962157, NeuroLink Model 1310).
Based on the provided text, there is no acceptance criteria or detailed study information presented that would allow for the completion of the requested table and answers. The document is a regulatory approval letter and a summary of the device's description and indications for use, not a study report or a performance validation document.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document mainly focuses on:
- Device Description: What the NeuroLink II does and how it's constructed, noting changes from its predicate.
- Regulatory Approval: The FDA's determination of substantial equivalence to a legally marketed predicate device.
- Indications for Use: Recording electroencephalogram of brain electrical activity to a Host Digital EEG Machine.
To provide the requested information, a different type of document, such as a test report, clinical study protocol, or performance validation report, would be necessary.
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Physiometrix. Inc. 510(k). Premarket Notification Model 1320. NeuroLink II
SUMMARY OF SAFETY AND EFFECTIVENESS
JUN - 2 1997
Date: March 3, 1997 Company: Physiometrix, Inc. Five Billerica Park 101 Billerica Avenue N. Billerica, MA 01862 Dawn E. Frazer Contact: Director, Regulatory Affairs & Quality Assurance (508) 670-2422 (800) 474-9746 NeuroLink II, Model 1320 Subject Device: Predicate Device: K962157. NeuroLink NeuroMonitorina System. Model 1310 Classification: Class II, 21 CFR Part 882.1835, Physiological Signal Amplifier The NeuroLink NeuroMonitoring System (predicate device) consists of a set of Description: components that work together to acquire and present EEG signal to any existing EEG recording and analysis equipment. The components include Biosensor electrodes, e-Net headpiece, Patient Module, battery module, fiber optic cable, and DSP Interface Card. Changes in the Patient Module and power supply are described in this submission. An electrode headbox has been added to the Patient Module and an AC power supply is available as an alternate to the battery module. The Patient Module is a small battery powered or AC powered amplifier. The EEG signals are transmitted from the head via conventional electrodes that are input into the attached headbox or e-Net that has a mating connector on the patient module. Power is enabled when the Patient Module is plugged into the DSP Card via the fiber optic cable, the host digital EEG computer is in the powered state and the Patient Module is enabled by pressing the control button located on the Patient Module. A five meter fiber optic cable is standard. The fiber optic cable provides patient isolation and flexible patient EEG Record Station placement options. Self test, calibration and impedance tests are remotely activated from the Host Digital EEG Machine through the DSP Interface Card or locally by depressing the appropriate test button on the Patient Module. A visual indication of control button function, system status and out of range impedance can be provided on the LCD display as controlled from the Host Digital EEG Machine.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dawn E. Frazer Director, Regulatory Affairs & Quality Assurance Physiometrix, Inc. Five Billerica Park 101 Billerica Avenue North Billerica, Massachusetts 01862
Re: K970942 Model 1320: NeuroLink II NeuroMonitoring System Trade Name: Regulatory Class: II Product Code: 84GWQ JUN - 2 1997 Dated: March 3, 1997 Received: March 14, 1997
Dear Ms. Frazer:
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 Failure to comply with the GMP regulation may result in assumptions. 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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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 Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(K) Number (if known): | Unknown |
|---|---|
| Device Name: | NeuroLink II NeuroMonitoring System |
| Indications for Use: | System for recording electroencephalogram of brain electrical activity to HostDigital EEG Machine. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahan
(Division Sign-Off) Division of Cartionascular, Respiratory, and Neurological Devices 51(Kk) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _
§ 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).