(244 days)
No
The description focuses on the hardware components (amplifier, base station) and their function in acquiring and transmitting physiological signals (EEG/PSG). There is no mention of software analysis, algorithms, or features that would suggest the use of AI or ML for interpretation, analysis, or decision support.
No
This device is for recording EEG and PSG, which are diagnostic procedures, not therapeutic interventions.
Yes
Explanation: The device is intended for "recording routine Electroencephalography (EEG) and Polysomnography (PSG)," which are diagnostic procedures used to evaluate neurological and sleep disorders. The output data (EEG and PSG recordings) is used by medical professionals to make a diagnosis.
No
The device description clearly outlines physical hardware components: an Amplifier Unit and a Base Station, which are integral to the device's function of recording EEG and PSG data.
Based on the provided information, the AURA-PSG amplifier system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for recording routine Electroencephalography (EEG) and Polysomnography (PSG). These are physiological measurements taken directly from the patient's body (in vivo), not tests performed on samples of biological material outside the body (in vitro).
- Device Description: The description details a system for acquiring electrical signals from electrodes and sensors attached to the patient. It focuses on signal conditioning, data sampling, and data storage/transmission. This aligns with a device used for physiological monitoring, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to the analysis of biological specimens like blood, urine, tissue, etc., which are characteristic of IVD devices.
Therefore, the AURA-PSG amplifier system falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GWQ
Device Description
AURA-PSG is a compact multi-channel amplifier and data acquisition device for Electroencephalography (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 sensor record and transmit data to the Base Station 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 regulated 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians, technicians, or other medical professionals that are trained in EEG and/or PSG.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
Astro-Med, Inc. |
|---------------|---------------------------------------------------|
| | 600 East Greenwich Ave |
| | West Warwick, RI 02893 |
| | Tel: (401) 828-4000 |
| | Fax: (401) 822-2480 |
- Michael J. Sullivan Contact Person: VP Engineering Tel: 401-828-4000 x212 Email: msullivan@astromed.com
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.
1
Image /page/1/Picture/1 description: The image contains a handwritten fraction. The numerator is a cursive '2', and the denominator is the number '3'. The fraction is written in black ink on a white background.
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.
2
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.
3
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.
4
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
5
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