MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM

K970942 · Physiometrix, Inc. · GWQ · Jun 2, 1997 · Neurology

Device Facts

• Record ID: K970942
• Device Name: MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM
• Applicant: Physiometrix, Inc.
• Product Code: GWQ · Neurology
• Decision Date: Jun 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

System for recording electroencephalogram of brain electrical activity to Host Digital EEG Machine.

Device Story

NeuroLink II (Model 1320) is a physiological signal amplifier system for EEG acquisition. It captures brain electrical activity via biosensor electrodes or an e-Net headpiece connected to a Patient Module. The Patient Module, which now includes an electrode headbox and optional AC power supply, transmits signals via a 5-meter fiber optic cable to a DSP Interface Card installed in a host digital EEG computer. The fiber optic link provides patient isolation. The system supports remote or local activation of self-tests, calibration, and impedance testing. Status and impedance data are displayed on an LCD controlled by the host computer. The device is used in clinical settings to facilitate EEG recording and analysis by healthcare professionals.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Physiological signal amplifier. Components: Biosensor electrodes, e-Net headpiece, Patient Module, fiber optic cable, DSP Interface Card. Power: Battery or AC. Connectivity: Fiber optic cable for signal transmission and patient isolation. Signal processing: Impedance testing, self-test, and calibration routines.

Indications for Use

Indicated for recording electroencephalogram (EEG) of brain electrical activity for transmission to a Host Digital EEG Machine. Intended for prescription use.

Regulatory Classification

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.

Predicate Devices

• NeuroLink NeuroMonitoring System, Model 1310 (K962157)

Submission Summary (Full Text)

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Physiometrix, Inc.
510(k), Premarket Notification
Model 1320, NeuroLink II
K970942
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

Contact: Dawn E. Frazer
Director, Regulatory Affairs & Quality Assurance
[phone]
[phone]

Subject Device: NeuroLink II, Model 1320

Predicate Device: K962157, NeuroLink NeuroMonitoring System, Model 1310

Classification: Class II, 21 CFR Part 882.1835, Physiological Signal Amplifier

Description: 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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
Trade Name: Model 1320: NeuroLink II NeuroMonitoring System
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) 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 - Ms. Dawn E. Frazer

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): Unknown

Device Name: NeuroLink II NeuroMonitoring System

Indications for Use: System for recording electroencephalogram of brain electrical activity to Host Digital EEG Machine.

(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 Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970942

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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