AURA-PSG

K050425 · Astro-Med, Inc. · OLV · Oct 20, 2005 · Neurology

Device Facts

• Record ID: K050425
• Device Name: AURA-PSG
• Applicant: Astro-Med, Inc.
• Product Code: OLV · Neurology
• Decision Date: Oct 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The AURA-PSG amplifier system is intended for recording routine Electroencephalography (EEG) and Polysomnography (PSG). This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in EEG and/or PSG.

Device Story

AURA-PSG is a multi-channel amplifier and data acquisition system for EEG and PSG recording. System comprises an Amplifier Unit (worn by patient in vest/pocket) and a Base Station. Inputs: physiological signals from electrodes/sensors. Amplifier performs signal conditioning, isolation, and digitization; transmits data to Base Station via tether or wireless link. Base Station converts data to network protocols for host computer processing. Supports off-line ambulatory recording using internal battery and non-volatile memory. Used in clinical settings by trained professionals. Output: digitized waveforms displayed and analyzed via Twin software on host computer. Healthcare providers use output for clinical assessment of EEG/PSG data. Benefits: enables routine monitoring and ambulatory recording for diagnostic purposes.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and technological comparison to predicate devices.

Technological Characteristics

Compact multi-channel amplifier; referential amplifier design; signal conditioning for EEG/PSG sensors. Connectivity: tethered or wireless transmission to Base Station; internal memory for ambulatory storage. Power: battery (ambulatory) or medical-grade regulated power supply (+12V DC). Safety: transformer coupling and optical isolation. Dimensions: Amplifier 5.5"x3.5"x1.0"; Base Station 7"x6"x2". Software: Twin software for filtering, visualization, and analysis.

Indications for Use

Indicated for recording routine EEG and PSG in patients requiring neurological or sleep monitoring. Intended for use by trained physicians, technicians, or medical professionals.

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

• Grass-Telefactor TS3201/6401 (K994142)
• Grass-Telefactor AS-40 Amplifier (K021807)
• Grass-Telefactor AURA Amplifier (K033978)

Reference Devices

• Twin software (K012976)

Submission Summary (Full Text)

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001 2005

### K050425 510 (K) Summary 2

This summary is submitted in accordance with the requirements of 807.92. This summary was prepared on Feb 11, 2005

| Submitted By: | Grass-Telefactor Product Group<br>Astro-Med, Inc. |
|---------------|---------------------------------------------------|
| | 600 East Greenwich Ave |
| | West Warwick, RI 02893 |
| | Tel: [phone] |
| | Fax: [phone] |

- Michael J. Sullivan Contact Person: VP Engineering Tel: [phone] x212 Email: [e-mail]
Proprietary Name : AURA-PSG

EEG Amplifier System Common Name:

Product Category: Electroencephalograph Requlation number: 882.1400 Medical Speciality: NE Product Code: GWQ Class II Device Product Class:

This device claims substantial equivalence to the following:

| Grass-Telefactor TS3201/6401: | 510(k) number K994142 |
|-----------------------------------|-----------------------|
| Grass-Telefactor AS-40 Amplifier: | 510(k) number K021807 |
| Grass-Telefactor AURA Amplifier: | 510(k) number K033978 |

Intended Use:

The AURA-PSG amplifier system is intended for recording routine Electroencephalography (EEG) and Polysomnography (PSG). This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in EEG and/or PSG.

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## Device Description 2.1

AURA-PSG is a compact multi-channel amplifier and data acquisition device Aort F OO is a compoephalography (EEG) and polysomnography (PSG) recording applications. It provides for patient safety isolation, signal conditioning, and data sampling.

The AURA-PSG amplifier system consists of two major components: the Amplifier Unit and the Base Station. The Amplifier Unit provides connections for electrodes and sensors and is normally worn by the subject in a vest or pocket. The Amplifier and sonoord and to hernRay istation using either a signal cable (tether) or a wireless connection. Both transmit digitized waveform to the Base Station where it is converted to standard network protocols and made available to supporting computers.

AURA-PSG can be used for off-line, ambulatory recording. When used in this fashion, power is supplied by a battery and data is stored in internal memory. When the study is complete, data can be sent to a computer for review.

The Base Station provides Menu selections for configuring the unit, communicating with the host computer, and implementing an electrode impedance test. It contains an LCD that can display status and other information. Power is supplied to the AURA-PSG Base Station through a rear connector that attaches to a medical-grade requlated power supply (+12 volts DC).

The AURA-PSG Amplifier Unit is 5.5 inches x 3.5 inches by 1.0 inches and the AURA-PSG Base Station is approximately 7" x 6" x 2" inches. The Base Station can be attached to a cart arm, mounted on a wall or flat on a tabletop.

## 2.2 Technological Characteristics

The AURA-PSG and all devices listed as substantially equivalent use the same connections for referential electrodes and employ essentially the same referential amplifier design. All are designed to provide the signal conditioning required for EEG/PSG sensors. When connected to a computer with the appropriate software these systems are designed to monitor EEG/PSG waveforms and store the signals to the computer's hard drive. These products have very similar intended use and safety characteristics.

AURA-PSG and all devices listed as substantially equivalent depend on computer software to provide the majority of waveform filtering and waveform visualization. All are compatible with the Twin software package marketed by Grass-Telefactor. Twin software is compatible with a variety of EEG devices and provides functions for review, filtering and analysis of EEG waveform data. Twin is described in 510K Notification #K012976 (permission to market granted on 2/12/2002).

The essential safety characteristics of these devices are very similar. Each is powered from a low-voltage, medical-grade power supply that acts as safety isolation from mains. Each relies additionally on a second level of safety isolation using transformer coupling and optical techniques to isolate the patient leads from ground.

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Both AURA-PSG and AURA are able to record waveforms to internal memory while the device is disconnected from the host computer. In both devices, this memory is removable, non-volatile and approximately the same capacity. Both AURA-PSG and AURA can operate from battery power to record waveforms for several hours without connection to the host computer.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) in the United States. The seal features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a simple, official representation of the department.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2005

Michael J. Sullivan VP Engineering Astro-Med, Inc. 600 East Greenwich Avenue West Warwick, Rhode Island 02893

Re: K050425 Trade/Device Name: AURA-PSG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: October 12, 2005 Received: October 13, 2005

Dear Mr. Sullivan:

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 Mcdical Device Amendments, or 10 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, 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 (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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in yours of substantial equivalence of your device to a legally premanted 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general s. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincercly yours,

partiere Buehrens
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): KOSOY25

Device Name: AURA-PSG

Indications for Use:

The AURA-PSG amplifier system is intended for recording routine Flectroencephalography (EEG) and Polysomnography (PSG).

This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in EEG and/or PSG.

Image /page/5/Picture/6 description: The image shows the words "Prescription Use" followed by the text "(Part 21 CFR 801 Subpart D)". There is a check mark above the text. The text is black and the background is white.

AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ubare monum

Division of General, Restorative, and Neurological Devices

**510(k) Number** K050425

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