The purpose and function of the OMNI Patient monitor is to monitor ECG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature, for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities.

Device Description

The OMNI patient monitor is a comprehensive monitoring system with three or six traces compiling, processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.

The OMNI patient monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

AI/ML Overview

This 510(k) submission describes the Infinium Omni Patient Monitor, a device that measures various physiological parameters. The submission focuses on demonstrating substantial equivalence to a predicate device (Infinium OMNI II Patient Monitor, K103737) rather than providing a detailed clinical study demonstrating specific performance against acceptance criteria with associated numerical results.

Therefore, the requested information elements related to specific performance metrics, sample sizes, expert involvement, and ground truth for a clinical study are not explicitly present in the provided text. The submission relies on non-clinical data (electrical safety tests and software validation) and a comparison of technological characteristics to the predicate.

Here's an analysis of the provided information based on your request, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the submission does not contain specific acceptance criteria with corresponding numerical performance results for physiological measurements in the way a clinical study would typically present them. Instead, it relies on demonstrating compliance with recognized standards.

Acceptance Criteria Category	Reported Device Performance / Assessment Method
Electrical Safety	"The Omni Patient monitor underwent several electrical safety tests to verify safety and effectiveness." Compliance with: - ANSI/AAMI EC13:2002 Cardiac Monitors, Heart rate meters and alarms - IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and tests - ISO 9919:2005 Medical electrical equipment - particular requirements for the basic safety and essential performance of pulse oximeters. - IEC 60601-2-27: (2005-08), Medical electrical equipment -- Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment. - AAMI/ANSI SP10:2002 Manual, electronic or automated sphygmomanometers. (Cardiovascular)
Software Validation	"Software Validation" was performed.
Functional Equivalence	The device has the "same intended use and similar technological characteristics" as the predicate (Infinium OMNI II Patient Monitor K103737). Differences noted are physical (size, weight) and display characteristics (3-6 traces vs. 4, 6 or 8 traces).

2. Sample size used for the test set and the data provenance

Not explicitly stated. The submission focuses on non-clinical testing and comparison to a predicate, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no mention of a clinical test set requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no clinical test set mentioned that would require adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a patient physiological monitor, not an AI-assisted diagnostic device for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

While the device functions as a "standalone" monitor in the sense it provides measurements, the submission does not detail standalone algorithmic performance against a defined ground truth or reference standard in the context of, for example, diagnostic algorithms. The performance is assessed by compliance with electrical safety and performance standards for each measured parameter.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the electrical safety and performance tests, the "ground truth" is often established by adherence to defined test protocols and reference measurements established by the specified standards (e.g., a known voltage/current for electrical safety, a calibrated pressure source for NIBP, a known oxygen saturation for SpO2, and a known heart rate for ECG testing). This is not "expert consensus" or "pathology" in the typical sense for clinical performance.

8. The sample size for the training set

Not applicable. This submission does not describe a machine learning or AI algorithm that would require a training set.

9. How the ground truth for the training set was established

Not applicable. No training set is mentioned.

Summary

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SEP - 8 2011

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Section 5 - 510k Summary

Special 510(k) SUMMARY (as required by 807.92(c))

Regulatory Correspondent:	AJW Technology Consultants, Inc962 Allegro LaneApollo Beach, FL 33572John O'Brienjobrien@ajwtech.com(813)645-2855(813)677-4787
Submitter of 510(k):	Infinium Medical12151 62nd Street North #5Largo, FL 33773Suleyman Bilgutaysales@infiniummedical.com
Date of Summary:	July 27, 2011
Trade/Proprietary Name:	Omni Patient Monitor
Classification Name:	Monitor, physiological, patient (without arrhythmia detection or alarms.
Product Code:	MWI

Reason for Submission:

The reason for this submission is to provide information that will verify the safety and effectiveness of the Omni patient monitor in order to be cleared for sale in the United States. The main differences between the Omni and the Omni II are:

The Omni is smaller which enables it to have a display that is 10.1 inches compared to ● the predicates 12.1 inch display.
The Omni is lighter in weight 4.7kgs than the Omni II which is 5.0kgs. .
. The Omni waveforms have 3 to 6 traces instead of the 4, 6 or 8 traces that the Omni II has.

Intended Use:

The purpose and function of the Omni patient monitor basic physiological parameters including, ECG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature for adult, neonate and pediatric patients. It may be used as a

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bedside or portable monitor and be used in all hospital-type facilities such as clinics and emergency room facilities.

Device Description:

K103737 - OMNI II Patient Monitor

compared to the predicate device.

Predicate Device:

Substantial Equivalence:

Summary of Non-Clinical Data:

The Omni Patient monitor underwent several electrical safety tests to verify safety and effectiveness as well as Software Validation.

The proposed device is substantially equivalent to the Infinium OMNI II Patient monitor which has been cleared

under K103737. The proposed device has the same intended use and similar technological characteristics as

ANSI/AAMI EC13:2002 Cardiac Monitors, Heart . rate meters and alarms
IEC 60601-1-2:2007 Medical electrical equipment . - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and tests
ISO 9919:2005 Medical electrical equipment -. particular requirements for the basic safety and essential performance of pulse oximeters.
IEC 60601-2-27: (2005-08), Medical electrical . equipment -- Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment.
. AAMI/ANSI SP10:2002 Manual, electronic or automated sphygmomanometers. (Cardiovascular) Based on the conclusions of each of these tests it is determined that the Omni patient monitor is safe and effective.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring. MD 20993-0002

Infinium Medical c/o Mr. John O'Brien AJW Technology Consultants, Inc 962 Allegro Lane Apollo Beach, FL 33572

SEP - 8 201

Re: K112329

Trade/Device Name: OMNI Regulation Number: 21 CFR 870.2300 Regulation Name: Patient Physiological Monitor (without arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Codes: MWI, DPS, DXN, DQA, BZQ, FLL Dated: July 27, 2011 Received: August 12, 2011

Dear Mr. O'Brien:

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 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 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.

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Page 2 – Infinium Medical c/o Mr. John O'Brien

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/ReportalProblem/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,

fs, Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4- Indications for Use

510(k) Number (if known):

Device Name: OMNI Patient Monitor

Prescription Use(Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use(21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	K112329
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Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).