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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the OmniPro™ System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the OmniPro™ System does not explicitly state quantitative acceptance criteria in terms of specific performance metrics with target thresholds. Instead, it describes a set of tests to ensure the device meets safety, electromagnetic compatibility, and software design requirements. The "reported device performance" is essentially that the device successfully passed these tests, indicating compliance.

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance
Safety	IEC 60601-1, IEC 60601-2-16	Successfully conducted to ensure no detrimental effects on patients, other persons, or surroundings.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 (Emissions)	Successfully conducted to ensure no intolerable magnetic disturbances are introduced.
Electromagnetic Immunity	IEC 60601-1-2 (Immunity)	Successfully conducted to ensure satisfactory operation in its electromagnetic environment.
Software Functionality	Compliance testing to Software Test Specification	Successfully conducted to ensure the system conforms to all system design requirements.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify a sample size or data provenance (e.g., country of origin, retrospective/prospective) for any clinical or performance test set. The tests mentioned are primarily engineering and compliance tests, not clinical performance studies involving patient data in the way one might typically describe for an AI/CADe device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the 510(k) summary. Given the nature of the tests described (safety, EMC, software compliance), it's unlikely that "experts to establish ground truth" (in the medical diagnostic sense) were required for these specific tests.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the 510(k) summary. The tests described are compliance-based, not involving expert adjudication of diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted or described in this 510(k) summary. The OmniPro™ System is an electroencephalograph, not an AI/CADe device that assists human readers in interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This information is not applicable in the context of an electroencephalograph (EEG) system. The OmniPro™ system is a data acquisition and display system for physiological signals, not an algorithm that provides standalone diagnostic interpretations. Its "performance" is related to its technical specifications (e.g., noise, sample rate, filter capabilities) and its ability to accurately acquire and present data, which is demonstrated through engineering tests, not a standalone diagnostic study.

7. The Type of Ground Truth Used

Given the types of tests described (safety, EMC, software functionality), the ground truth for these tests would be defined by:

Safety standards: The requirements outlined in IEC 60601-1 and IEC 60601-2-16.
Electromagnetic compatibility standards: The limits and procedures defined in IEC 60601-1-2.
Software design requirements: The predefined specifications in the Software Test Specification.

There is no mention of medical ground truth (e.g., pathology, clinical outcomes, expert consensus on disease presence) because the device's conformity was assessed against engineering and regulatory standards, not diagnostic accuracy.

8. The Sample Size for the Training Set

This information is not applicable/provided in the 510(k) summary. The OmniPro™ System is a hardware and software system for data acquisition and display of EEG/PSG signals. It does not employ machine learning or AI models that require a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided as the device does not utilize a training set for machine learning.

Summary

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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 CircleFranklin, TN 37067
Telephone:	(615) 794-6247 Voice(615) 794-9792 Fax
Contact:	Burke MaysPresident
E-mail:	bmays4@bellsouth.net

2. Submission correspondent:

Company Name:	Delphi Consulting Group
Address:	11874 South Evelyn CircleHouston, Texas 77071-3404
Telephone:	832-285-9423 Voice832-615-3550 Fax
Contact:	J. Harvey KnaussConsultant
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

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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:

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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	CompumedicsE-Series EEG/PSGK000068	Cadwell Easy IIK946094
Configuration	Mobile Cart or Desktop	Mobile Cart or Desktop	Mobile Cart or Desktop
Headbox/preampconfiguration	25 Ch IsolatedAmplifier with AnalogOutput	32 Ch IsolatedAmplifier with DigitalOutput	32 Ch Isolated Amplifierand 7 active referencepairs
Number ofChannels	32Recordable/displayed	32Recordable/displayed/isolated	32
Montage Selection	Up to 1000Programmable	256 Programmable	Virtually unlimited
Sensitivity Controls	Yes	Yes	Yes
Fixed LowFrequency AnalogFilters	Yes	Yes	Yes
Fixed HighFrequency AnalogFilters	Yes	Yes	Yes
Selectable DigitalHigh and LowFrequency Filters	Yes	Yes	Yes
Master Notch Filter	Yes, Master Off,Enabled per Channel	Yes	Yes
Sample Rate	Up to 1080 Hz perchannel	Up to 512 Hz perchannel	2400 Hz/channel
Noise	2 uVpp	2 uVpp	3 uVpp
ElectrodeImpedance Check	LED indicators onAmplifier Module	LED indicators onAmplifier Module	LED indicators onAmplifier Module
Calibration Check	100 uVpp square waveinjected at amplifiermodule	100 uVpp square waveinjected at headbox	Square wave, 50 mV,0.5 Hz
System Types	Laboratory Based orPortable	Laboratory Based orPortable	LED indicators onAmplifier Module
Time Base Controls	Yes	Yes	Yes
Selectable MontageSequences	Yes	Yes	Yes
Automatic EventLogging	Yes	Yes	Yes
Annotations OnStudy	Yes	Yes	Yes
Timers on StudyEvents	Yes	Yes	Yes
Storage	Hard Disk, WritableCD, USB Flash	Hard disk, Writable CD,optical disk	Hard disk, Writable CD,optical disk
Study Modes	Routine EEGRecording, RoutinePSG Recording,Retrieval and Replay	Routine EEGRecording, Long TermMonitoring, Retrievaland Replay	Routine EEG Recording,Long Term Monitoring,Retrieval and Replay
EEG/PSG	Yes	Yes	Yes

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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.

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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.

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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,

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

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Indications for Use Statement

510(k) Number K 050143

OmniPro™ System Device Name:

Indications for Use:

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

K050143

510(k)

Regulation Number and Section

§ 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).