(217 days)
No
The description mentions "digital signal processing techniques" and a "proprietary computed EEG variable (PSI™)", but there is no mention of AI, ML, or related concepts like training/test sets for model development. The predicate device is the same model, suggesting no significant technological change related to AI/ML.
No
The device is described as an "EEG monitor" intended to "monitor the state of the brain" and display real-time EEG waveforms and processed data. Its purpose is diagnostic/monitoring, not therapeutic intervention.
No
The device is described as a monitor intended to acquire and display real-time EEG waveforms and process this data, primarily to monitor the state of the brain in relation to anesthetic agents. It does not state that it provides a diagnosis of any condition or disease.
No
The device description explicitly states that the PSA4000 consists of three main components: the monitor, the amplifier, and the archive media (optional), indicating it includes hardware components beyond just software.
Based on the provided information, the PSA4000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This testing is done in vitro (in glass, or outside the body).
- PSA4000 Function: The PSA4000 monitors the state of the brain by acquiring and processing real-time EEG signals directly from the patient's forehead. This is a form of in vivo (in the living body) monitoring.
- Intended Use: The intended use clearly states it monitors the brain by processing EEG signals, not by analyzing samples taken from the body.
- Device Description: The description focuses on acquiring and processing EEG waveforms, not on analyzing biological specimens.
Therefore, the PSA4000 falls under the category of a medical device used for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The PSA4000 is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI™), a proprietary computed EEG variable that is related to the effect of anesthetic agents.
Product codes
OLW, OMC, ORT
Device Description
The PSA4000 is an EEG monitor designed for use in the OR, ICU, EEG laboratory and for clinical research. It provides the ability to acquire and display real-time EEG waveforms, process the real time EEG data using digital signal processing techniques, display the processed EEG data in several different formats, and archive the real-time or processed EEG data for future review.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain, forehead, scalp, ears
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room (OR), intensive care unit (ICU), and clinical research laboratory.
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
The following tests have been conducted in order to verify and validate the device: software, mechanical and electrical validation testing and EMC testing. The test results are all positive and indicate that the device meets product requirements and satisfies customer needs and expectations.
Key Metrics
Not Found
Predicate Device(s)
PSA4000 EEG Monitor with PSI (K001069)
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).
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KO20671
February 28, 2002
page vii
510(K) SUMMARY
OCT 0 4 2002
| Company: | Physiometrix, Inc.
Five Billerica Park
101 Billerica Avenue
N. Billerica, MA 01862 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dawn E. Frazer
Vice President
Regulatory Affairs & Quality Assurance
(978) 670-2422 x243
dfrazer@physiometrix.com |
| Subject Device: | PSA4000 EEG Monitor with Frontal PSI |
| Classification: | Class II, 21 CFR Part 882.1400, Electroencephalograph |
| Intended Use: | The PSA4000 is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the
brain by real-time data acquisition and processing of EEG signals. The system
includes the Patient State Index (PSI™), a proprietary computed EEG variable
that is related to the effect of anesthetic agents. |
Photograph:
Date:
Image /page/0/Picture/7 description: The image shows a medical device used for brain monitoring. The device includes a head mannequin with sensors attached to the forehead, a monitor displaying brain activity, and a processing unit labeled "PSA-4000". The monitor shows a waveform and the number 79, likely indicating a measurement value. The device appears to be used for diagnostic or research purposes related to brain function.
Description:
The PSA4000 is an EEG monitor designed for use in the OR, ICU, EEG laboratory and for clinical research. It provides the ability to acquire and display real-time EEG waveforms, process the real time EEG data using digital signal
1
processing techniques, display the processed EEG data in several different formats, and archive the real-time or processed EEG data for future review.
The PSA4000 consists of three main components, the monitor, the amplifier and the archive media (oplional). The device performs automatic self tests upon power up to ensure that the monitor and its components are functioning properly.
Monitor
The monitor provides signal processing and display capabilities for the 4 channels of real-time EEG data acquired from the preamplifier.
The monitor dimensions are 8.5" wide x 6.75" high x 20.75" deep. The color display area is 3.75" high x 5.2" wide. In addition to the display area, the front panel is configured with a number of soft and hard keys to allow for configuration of the display and data acquisition settings.
The processor is a PC-based CPU that processes the EEG data, calculates the processed parameters and displays the real-time EEG data and processed data. Processed parameters include Electromyograph (EMG), Artifact (ART), Suppression Ratio (SR), and the Patient State Index (PSI).
Patient Module
The patient module is an electrically isolated, low noise, high gain, analog to digital signal converter that can process up to 4 channels of real-time data. The preamplifier dimensions are 4.25" wide x 1.75" thick x 5.5" high. The patient module includes a clamp that can be used to secure the unit. The clamp can accommodate a pole of up to 1° in diameter. The preamplifier is connected to the patient and monitor through flexible, shielded cabling.
Archive Media (optional)
The PSA4000 has an optional PCMCIA slot. When a PCMCIA card is detected on start up of the monitor, data will be automatically stored on the PCMCIA Hard Disk Drive.
Predicate Device: PSA4000 EEG Monitor with PSI (K001069)
Similarities: The subject device is similar to the predicate device in the following ways:
- Both systems are EEG monitors. a.
- b. Both systems provide a variety of processed parameters,
- Both systems include a proprietary computed EEG variable that is related to C. the affects of anesthetics.
- Both conduct self tests at start up to assure that the device is operating. ರ.
- Both systems have two main components, a monitor and a preamplifier. e.
Differences:
- The subject device is different from the predicate device in the following way:
- The subject device is intended for use with the PSArray, which consists of 6 a. electrodes located on the forehead while the predicate device is intended for
2
K020671 page J+[}
Physiometrix PSA4000 EEG Monitor with Frontal PSI 510(k) Notification
use with the PSArray, which consists of 7 electrodes located on the forehead, scalp and ears.
Test Results: The following tests have been conducted in order to verify and validate the device: software, mechanical and electrical validation testing and EMC testing.
The PSA4000 has been testing in accordance with the following standards.
- UL 2601 .
- CSA 22.2 No. 601-1 .
- IEC 601-1 ●
- IEC 601-2-26 .
- FDA Reviewer Guidance for Premarket Notification Submissions, Section 7, . Electromagnetic Compatibility dated November 1993.
The test results are all positive and indicate that the device meets product requirements and satisfies customer needs and expectations.
3
Image /page/3/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 or bird symbol, with three curved lines forming the body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 9 2012
Ms. Dawn E. Frazer Vice President, Regulatory Affairs and Quality Assurance Physiometrix Five Billerica Park 101 Billerica Avenue North Billerica, MA 01862
Re: K020671
Trade/Device Name: PSA4000 EEG Monitor with Frontal PSI Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, ORT Dated (Date on orig SE ltr): October 1, 2002 Received (Date on orig SE ltr): October 2, 2002
Dear Ms. Frazer:
This letter corrects our substantially equivalent letter of October 4, 2002.
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 (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 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.
4
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
!
Enclosure
5
INDICATIONS FOR USE STATEMENT
| Applicant: | Physiometrix, Inc. | |
|---|---|---|
| 510(k) Number (if known) | Not assigned | |
| Device Name | PSA4000 EEG Monitor with Frontal PSI | |
| Indications For Use | The PSA4000 EEG Monitor with Frontal PSI is indicated for use in | |
| the operating room (OR), intensive care unit (ICU), and clinical | ||
| research laboratory. It is intended to monitor the state of the brain | ||
| by real-time data acquisition and processing of EEG signals. The | ||
| system includes the Patient State Index (PSITM), a proprietary | ||
| computed EEG variable that is related to the effect of anesthetic | ||
| agents. |
(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 General, Restorative and Neurological Devices | |
| 510(k) Number | K020671 |
| Prescription Use | |
| (Per 21 CFR 801.109) | OR Over-The-Counter Use |
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