(11 days)
Not Found
No
The description focuses on hardware components, data acquisition, display, and storage of physiological signals (EEG, EMG, etc.). There is no mention of AI or ML algorithms for analysis or interpretation of the data. The analysis mentioned is likely standard signal processing and visual interpretation by a clinician.
No
The device is described as being for "measuring, recording and analysis of the electrical activity of a patient's brain" to "aid in monitoring and diagnosis," which points to a diagnostic rather than therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used "to aid in monitoring and diagnosis."
No
The device description explicitly details hardware components including an amplifier module, interface module, personal computer with a DAQ board, electrodes, and sensors. It also mentions safety and electromagnetic compatibility tests related to hardware standards (IEC 60601 series).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The OmniPro™ System measures and records electrical activity directly from the patient's body through electrodes attached to the skin. This is an in vivo measurement, not an in vitro test on a sample.
- Intended Use: The intended use describes monitoring and diagnosis based on these electrical signals from the patient's brain and other physiological sources (EEG/EMG/EOG/ECG/Air Flow/Oximetry). This is consistent with physiological monitoring and diagnostic tools used directly on the patient.
Therefore, the OmniPro™ System falls under the category of a medical device used for physiological monitoring and diagnosis in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OmniPro™ System is intended for the measuring, recording and analysis of the electrical activity of a patient's brain through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical setting for EEG/EMG/EOG/ECG/Air Flow/Oximetry.
Product codes (comma separated list FDA assigned to the subject device)
GWQ
Device Description
The OmniAmp is a dual-purpose amplifier system for use in polysomnogram (PSG) and electroencephalogram (EEG) studies in a hospital or diagnostic center.
The system hardware consists of an amplifier module with electrode inputs, an interface module and a personal computer (PC) with a data acquisition (DAQ) board. Electrodes and sensors on the patient are connected to the amplifier module, which in turn is connected via a multiconductor cable to an interface box. The interface box is connected via a second multiconductor cable to the DAQ board in the PC, which is used to process display and store the EEG or PSG data. DC power to the amplifier is supplied from the DAQ board through the multiconductor cable. The PC at the patient location is connected to a second PC at a remote monitoring center via modem over the public switched telephone network (PSTN). In EEG studies, the remote PC is used to monitor the waveform data as it is collected by the patient PC to ensure adequate electrode placement and signal quality. At the end of the recorded data is transferred from the patient PC to the remote PC. where it is analyzed and stored.
The amplifier module comes in PSG and EEG versions. These modules utilize the same internal amplifier hardware. They differ in terms of the configuration of the electrode inputs to the amplifier channels. Both versions of the amplifier modules have male safety electrode receptacles for connection of each electrode. They have a graphic panel to indicate the location and name for each electrode connection. The PSG amplifier module has an OEM oximetry module that works with a finger sensor to detect the oxygen saturation (SPO2) and pulse rate. Both versions utilize the same interface cable to connect the amplifier module to an interface module located next to the PC. The interface cable may be up to 50 feet long and is shielded to reduce EM1. Both versions may have a clip to secure the box to the bed covers and may have a means to connect a lanyard for hanging the module from the patient's neck to allow for patient mobility.
The amplifier module has twenty-five electrically isolated differential amplifier channels. Twenty-one of the amplifier channels has the same gain and bandwidth settings and is used for the EEG. EMG, and EOG signals. The amplifier has one channel set for ECG, two channels set for interface with the respiratory effort piezoelectric belt sensors and one channel set to interface with the nasal airflow thermal type sensors. In the PSG mode, the electrode box connects thirteen (twelve in home use configuration) EEG/EMG/EOG amplifier channels, one ECG channel and the three respiratory amplifier channels to patient electrodes. In the EEG mode, the electrode box connects twenty-one amplifiers, set for EEG signals, and one ECG amplifier to the appropriate patient electrodes. The output cable connects all twenty-five-amplifier channels to the DAQ board where the system selects the channels for use in the patient study.
The interface cable carries status information between the interface module and the amplifier module in addition to the measured signals and power In the EEG mode, a iumper in the electrode cap receptacle indicates when it is connected. A digital line from the DAQ card activates the calibration signal to the amplifier channels. These digital inputs and outputs are connected from the amplifier to the DAQ board in the PC via the interface cable. If necessary, the Digital Input/Output (DIO) lines from the DAQ board in the PC will be used to select between PSG and EEG modes and to select the gain of the amplifier channels. The cable from the amplifier module to the PC DAQ board can be up to 50 feet long. It is shielded and has wires grouped to separate sensitive signal wires from the oximeter serial data, any DIO lines and +5V power for the amplifier
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
routinely found in clinical setting
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)
The following is an overview of tests that have been conducted successfully for the OmniPro™ System:
- Safety Tests to conform to IEC 60601-1, IEC60601-2-16 to ensure that there is no A potential for detrimental effects on patients, other persons, or the surroundings.
- Electromagnetic Compatibility tests to IEC 60601-1-2 to ensure no intolerable A magnetic disturbances are introduced into its electromagnetic environment.
- Immunity tests to IEC 60601-1-2 to ensure that the EEG equipment has the ability A to operate satisfactorily in its electromagnetic environment.
- A Compliance testing to Software Test Specification to ensure that the system conforms to all of the system design requirements.
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.
Not Found
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
050143 510(k) Summarv
Date: November 29, 2004
This summary of 510(k)-safety and effectiveness information is for the OmniPro™ System.
1. Company making the submission:
| Company Name: | Mays and Associates, Inc. |
|---|---|
| Address: | 315 Springhouse Circle |
| Franklin, TN 37067 | |
| Telephone: | (615) 794-6247 Voice |
| (615) 794-9792 Fax | |
| Contact: | Burke Mays |
| President | |
| E-mail: | bmays4@bellsouth.net |
2. Submission correspondent:
| Company Name: | Delphi Consulting Group |
|---|---|
| Address: | 11874 South Evelyn Circle |
| Houston, Texas 77071-3404 | |
| Telephone: | 832-285-9423 Voice |
| 832-615-3550 Fax | |
| Contact: | J. Harvey Knauss |
| Consultant | |
| E-mail: | harvey@delphiconsulting.com |
3. Predicate Device:
Compumedics E-Series EEG System, K000068, Compumedics Neuro Science Ply LTD, Minneapolis, MN 55432 and Cadwell Easy II System K946094, Cadwell Laboratories, Inc., Kennewick, WA 99336.
4. Classifications Names & Citations:
Electroencephalograph, Class II, 882.1400, GWQ, Neurology
5. Trade Name:
OmniPro™ System
6. Description:
The OmniAmp is a dual-purpose amplifier system for use in polysomnogram (PSG) and electroencephalogram (EEG) studies in a hospital or diagnostic center.
The system hardware consists of an amplifier module with electrode inputs, an interface module and a personal computer (PC) with a data acquisition (DAQ) board. Electrodes
1
and sensors on the patient are connected to the amplifier module, which in turn is connected via a multiconductor cable to an interface box. The interface box is connected via a second multiconductor cable to the DAQ board in the PC, which is used to process display and store the EEG or PSG data. DC power to the amplifier is supplied from the DAQ board through the multiconductor cable. The PC at the patient location is connected to a second PC at a remote monitoring center via modem over the public switched telephone network (PSTN). In EEG studies, the remote PC is used to monitor the waveform data as it is collected by the patient PC to ensure adequate electrode placement and signal quality. At the end of the recorded data is transferred from the patient PC to the remote PC. where it is analyzed and stored.
The amplifier module comes in PSG and EEG versions. These modules utilize the same internal amplifier hardware. They differ in terms of the configuration of the electrode inputs to the amplifier channels. Both versions of the amplifier modules have male safety electrode receptacles for connection of each electrode. They have a graphic panel to indicate the location and name for each electrode connection. The PSG amplifier module has an OEM oximetry module that works with a finger sensor to detect the oxygen saturation (SPO2) and pulse rate. Both versions utilize the same interface cable to connect the amplifier module to an interface module located next to the PC. The interface cable may be up to 50 feet long and is shielded to reduce EM1. Both versions may have a clip to secure the box to the bed covers and may have a means to connect a lanyard for hanging the module from the patient's neck to allow for patient mobility.
The amplifier module has twenty-five electrically isolated differential amplifier channels. Twenty-one of the amplifier channels has the same gain and bandwidth settings and is used for the EEG. EMG, and EOG signals. The amplifier has one channel set for ECG, two channels set for interface with the respiratory effort piezoelectric belt sensors and one channel set to interface with the nasal airflow thermal type sensors. In the PSG mode, the electrode box connects thirteen (twelve in home use configuration) EEG/EMG/EOG amplifier channels, one ECG channel and the three respiratory amplifier channels to patient electrodes. In the EEG mode, the electrode box connects twenty-one amplifiers, set for EEG signals, and one ECG amplifier to the appropriate patient electrodes. The output cable connects all twenty-five-amplifier channels to the DAQ board where the system selects the channels for use in the patient study.
The interface cable carries status information between the interface module and the amplifier module in addition to the measured signals and power In the EEG mode, a iumper in the electrode cap receptacle indicates when it is connected. A digital line from the DAQ card activates the calibration signal to the amplifier channels. These digital inputs and outputs are connected from the amplifier to the DAQ board in the PC via the interface cable. If necessary, the Digital Input/Output (DIO) lines from the DAQ board in the PC will be used to select between PSG and EEG modes and to select the gain of the amplifier channels. The cable from the amplifier module to the PC DAQ board can be up to 50 feet long. It is shielded and has wires grouped to separate sensitive signal wires from the oximeter serial data, any DIO lines and +5V power for the amplifier
7. Indications for Use:
The OmniPro™ System is intended for the measuring, recording and analysis of the electrical activity of a patient's brain through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical
2
setting for EEG/EMG/EOG/ECG/Air Flow/Oximetry.
8. Contra-indications:
No absolute contra-indications known.
9. Technological characteristics, Comparison to predicate device:
Comparison of OmniAmp and Compumedics EEG/PSG Systems K000068, and Cadwell Easy II System K946094
| Characteristic | Mays and Assoc.
OmniPro™
This Submission | Compumedics
E-Series EEG/PSG
K000068 | Cadwell Easy II
K946094 |
|---------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Configuration | Mobile Cart or Desktop | Mobile Cart or Desktop | Mobile Cart or Desktop |
| Headbox/preamp
configuration | 25 Ch Isolated
Amplifier with Analog
Output | 32 Ch Isolated
Amplifier with Digital
Output | 32 Ch Isolated Amplifier
and 7 active reference
pairs |
| Number of
Channels | 32
Recordable/displayed | 32
Recordable/displayed/isolated | 32 |
| Montage Selection | Up to 1000
Programmable | 256 Programmable | Virtually unlimited |
| Sensitivity Controls | Yes | Yes | Yes |
| Fixed Low
Frequency Analog
Filters | Yes | Yes | Yes |
| Fixed High
Frequency Analog
Filters | Yes | Yes | Yes |
| Selectable Digital
High and Low
Frequency Filters | Yes | Yes | Yes |
| Master Notch Filter | Yes, Master Off,
Enabled per Channel | Yes | Yes |
| Sample Rate | Up to 1080 Hz per
channel | Up to 512 Hz per
channel | 2400 Hz/channel |
| Noise | 2 uVpp | 2 uVpp | 3 uVpp |
| Electrode
Impedance Check | LED indicators on
Amplifier Module | LED indicators on
Amplifier Module | LED indicators on
Amplifier Module |
| Calibration Check | 100 uVpp square wave
injected at amplifier
module | 100 uVpp square wave
injected at headbox | Square wave, 50 mV,
0.5 Hz |
| System Types | Laboratory Based or
Portable | Laboratory Based or
Portable | LED indicators on
Amplifier Module |
| Time Base Controls | Yes | Yes | Yes |
| Selectable Montage
Sequences | Yes | Yes | Yes |
| Automatic Event
Logging | Yes | Yes | Yes |
| Annotations On
Study | Yes | Yes | Yes |
| Timers on Study
Events | Yes | Yes | Yes |
| Storage | Hard Disk, Writable
CD, USB Flash | Hard disk, Writable CD,
optical disk | Hard disk, Writable CD,
optical disk |
| Study Modes | Routine EEG
Recording, Routine
PSG Recording,
Retrieval and Replay | Routine EEG
Recording, Long Term
Monitoring, Retrieval
and Replay | Routine EEG Recording,
Long Term Monitoring,
Retrieval and Replay |
| EEG/PSG | Yes | Yes | Yes |
3
10. Review of Performance Testing:
The following is an overview of tests that have been conducted successfully for the OmniPro™ System:
- Safety Tests to conform to IEC 60601-1, IEC60601-2-16 to ensure that there is no A potential for detrimental effects on patients, other persons, or the surroundings.
- Electromagnetic Compatibility tests to IEC 60601-1-2 to ensure no intolerable A magnetic disturbances are introduced into its electromagnetic environment.
- Immunity tests to IEC 60601-1-2 to ensure that the EEG equipment has the ability A to operate satisfactorily in its electromagnetic environment.
- A Compliance testing to Software Test Specification to ensure that the system conforms to all of the system design requirements.
11. Conclusion:
Based on extensive performance testing and a comparison to the predicate device, it is the conclusion of Mays and Associates, Inc., that the OmniPro™ System is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns regarding safety and effectiveness.
4
Image /page/4/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which represent the department's mission to protect the health of all Americans and provide essential human services.
FEB - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mays and Associates, Inc. c/o Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K050143
Trade/Device Name: OmniPro™ System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: January 21, 2005 Received: January 21, 2005
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Bectorn of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costietle 710 (710) that as neview subject to the general controls provisions of the Act. The r ou may, diererore, mains of the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (see accro).ols. Existing major regulations affecting your device can thay be subject to suer additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Over acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Tease be advised that I Dris issually as your device complies with other requirements of the Act that IDA has made a dolorimination administered by other Federal agencies. You must of any I cactar stututes and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 607), adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 - Mr. Ned E. Devine, Jr.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maing of substantial equivalence of your device to a legally premarket notication: The PDF interessification 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 If you desire specific arrivier J at (240) 276-0115. Also, please note the regulation entitled, Coliner the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorinational 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.
Sincerely yours,
Sincerely yours,
Mark A. Mellemson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number K 050143
OmniPro™ System Device Name:
Indications for Use:
The OmniPro™ System is intended for the measuring, recording and analysis of the electrical activity of a patient's brain through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical setting for EEG/EMG/EOG/ECG/Air Flow/Oximetry.
Image /page/6/Picture/6 description: The image shows the words "Prescription Use" and "(Part 21 CFR 801 Subpart D)" in black font. The word "YES" is written in bold black font and is circled. The image is likely part of a form or document related to prescription medication.
AND/OR
Over-The-Counter Use (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)
Mark N. Milken
Restorative, and Neurologica
510(k)