It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

The purpose and function of the OMNI II patient monitor is to monitor basic physiological parameters including

ECG waveform derived from 3, 5 or 12 lead measurements .
Heart Rate .
NIBP(systolic, diastolic, and mean arterial pressure) .
SpO2 .
Respiration .
Temperature up to 2 channels (Dual Temperature) .
. CO2
. Cardiac Output
IBP .
. Anesthetic agents

The target population is for adult, neonate and pediatric patients with the exception of:

· Cardiac Output for which the target population is adult only.
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

The purpose and function of the OMNI III patient monitor is to monitor basic physiological parameters including

ECG waveform derived from 3, 5 or 12 lead measurements .
Heart Rate .
NIBP(systolic, diastolic, and mean arterial pressure) .
SpO2 .
Respiration .
Temperature up to 2 channels (Dual Temperature) .
CO2 .
Cardiac Output ●
. IBP
Anesthetic agents .

The target population is for adult, neonate and pediatric patients with the exception of:

· Cardiac Output for which the target population is adult only.
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

The purpose and function of the OMNI Express patient monitor is to monitor basic physiological parameters including

ECG waveform derived from 3 to 5 lead measurements .
Heart Rate .
NIBP(systolic, diastolic, and mean arterial pressure) ●
. SpO2
. Respiration
. Temperature - up to 2 channels (Dual Temperature)
CO2
. Anesthetic agents

The target population is for adult, neonate and pediatric patients.

Device Description

The OMNI monitor is a comprehensive monitoring system with four, six or eight traces compiling, and 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 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.

The OMNI II monitor is a comprehensive monitoring system with four, six or eight traces compiling, and 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 II 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.

The OMNI III monitor is a comprehensive monitoring system with eight traces compiling, and processing, analyzing and displaying data from up to six 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 III 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.

The OMNI EXPRESS monitor is a comprehensive monitoring system with two or three traces compiling, and 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 EXPRESS monitor can be powered by an internal battery pack that provides 2 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

AI/ML Overview

This document describes several patient monitors (OMNI, OMNI II, OMNI III, and OMNI Express) and their performance with respect to various physiological parameters. However, the provided text does not contain specific acceptance criteria, reported device performance values against these criteria, or a detailed study description with sample sizes, data provenance, ground truth establishment, or expert qualifications.

The document discusses substantial equivalence to predicate devices and lists performance tests conducted according to certain standards, but it does not explicitly state the quantitative acceptance criteria or the specific results obtained in numerical terms.

Therefore, I cannot fully complete the requested table and answer many of the questions directly. However, I can extract the available information.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria and corresponding reported device performance values are NOT explicitly stated. The document refers to compliance with performance standards rather than specific numerical targets.

The table below indicates the standards of compliance mentioned for certain parameters, which would imply that the device met the requirements of these standards.

Patient Monitor	Parameter	Standard of Compliance	Reported Device Performance
OMNI	IBP	BS EN 60601-2-34:2000	"Based on the conclusions of each of these tests it is determined that the OMNI Patient Monitors are safe and effective." (Implies compliance with the standard)
OMNI	ECG	ANSI/AAMI EC13:2002/(R)2007	"Based on the conclusions of each of these tests it is determined that the OMNI Patient Monitors are safe and effective." (Implies compliance with the standard)
OMNI II, OMNI III	IBP	BS EN 60601-2-34:2000	"Based on the conclusions of each of these tests it is determined that the OMNI Patient Monitors are safe and effective." (Implies compliance with the standard)
OMNI II, OMNI III	ECG	ANSI/AAMI EC13:2002/(R)2007	"Based on the conclusions of each of these tests it is determined that the OMNI Patient Monitors are safe and effective." (Implies compliance with the standard)
OMNI II, OMNI III	Cardiac Output	No Standard (mentioned as "No Standard")	"Based on the conclusions of each of these tests it is determined that the OMNI Patient Monitors are safe and effective." (Implies internal validation for safety and effectiveness without a specific external standard listed here)

Note: The document only states that testing was completed according to these standards and that "Based on the conclusions of each of these tests it is determined that the OMNI Patient Monitors are safe and effective." It does not provide the specific numerical results or tolerance limits (acceptance criteria) from these tests.

Study Details:

As the document primarily focuses on demonstrating substantial equivalence through compliance with recognized standards and non-clinical bench testing, it does not describe a clinical study in the conventional sense (e.g., with human subjects, test sets, ground truth panels, etc., for evaluating classification performance or diagnostic accuracy). The non-clinical data section references "bench testing" only.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated. The document refers to "bench testing" and compliance with performance standards. These are typically laboratory tests using simulated signals or controlled environments, not human subject data sets as "test sets" in the context of AI/diagnostic algorithm evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable / Not stated. Since this is bench testing against performance standards, "ground truth" would be established by the characteristics of the test equipment or reference signals used to simulate physiological parameters, not by human expert consensus on clinical data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not stated. Adjudication methods are relevant for clinical studies where multiple experts interpret data. This document describes bench testing.
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. The document does not describe any MRMC study. These are patient physiological monitors, not AI-assisted diagnostic tools for image interpretation or similar.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially applicable, but for hardware/software performance, not an AI algorithm. The "bench testing" described evaluates the device (hardware and embedded software) in a standalone capacity against technical standards for performance (e.g., accuracy of ECG measurement, IBP measurement, etc.). It is not a standalone evaluation of an AI algorithm in the context of diagnostic decision-making.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated in clinical terms. For bench testing against standards, the "ground truth" would be the known, controlled inputs provided by test equipment or calibrated sources, as defined by the respective performance standards (e.g., a signal generator producing a known ECG waveform or a pressure calibrator for IBP).
The sample size for the training set:
- Not applicable / Not stated. The document describes a patient monitor that monitors basic physiological parameters. There's no indication of machine learning or an "AI algorithm" requiring a training set in the context of the information provided for this 510(k) summary. The device's functionality appears to be based on established signal processing and measurement techniques, not learned models.
How the ground truth for the training set was established:
- Not applicable / Not stated. As above, no training set for an AI algorithm is mentioned.

Summary

{0}------------------------------------------------

FEB 2 1 2014

ﮨﮯ ﻧ

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

Regulatory Correspondent:	AJW Technology Consultants Inc445 Apollo Beach BlvdApollo Beach, FL 33572John O'Brienjobrien@ajwtech.com813-645-2855 x101813-645-2856
Submitter of 510(k):	Infinium Medical12151 62nd Street North #5Largo, FL 33773Suleyman Bilgutaysales@infiniummedical.com
Date of Summary:	June 8, 2013
Trade/Proprietary Name:	Omni Series Patient Monitors
Common Name:	Patient Physiological Monitor (without ArrhythmiaDetection or Alarms)
Classification Name:	Monitor, physiological, patient (without Arrhythmiadetection or alarms)
Device Class:	II
Device Panel:	Cardiovascular
Product Code:	MWI

Subsequent Product Codes:

Regulation Number	Description	Product Code	Applicable Monitor
870.2340	Electrocardiograph	DPS	All
870.1130	Noninvasive BloodPressureMeasurement	DXN	All
870.2700	Oximeter	DQA	All
868.2375	Breathing frequency	BZQ	All

{1}------------------------------------------------

K132229

page 2 of 7

	monitor
880.2910	Clinical ElectronicThermometer	FLL	All
870.1110	Blood PressureComputer	DSK	OMNI, OMNI II,OMNI III
870.1425	Programmablediagnostic computer	DQK	All
870.1435	Single-function,preprogrammeddiagnostic computer	DXG	OMNI II, OMNI III
868.1400	Carbon dioxide gasanalyzer	CCK	All

Intended Use:

OMNI

The purpose and function of the OMNI patient monitor is to monitor basic physiological parameters including

ECG waveform derived from 3, 5 or 12 lead measurements .
Heart Rate .
NIBP(systolic, diastolic, and mean arterial pressure) .
. SpO2
Respiration .
Temperature up to 2 channels (Dual Temperature) .
. CO2
IBP .
Anesthetic agents .

The target population is for adult, neonate and pediatric patients.

{2}------------------------------------------------

OMNI II

The purpose and function of the OMNI II patient monitor is to monitor basic physiological parameters including

ECG waveform derived from 3, 5 or 12 lead measurements .
Heart Rate .
NIBP(systolic, diastolic, and mean arterial pressure) .
SpO2 .
Respiration .
Temperature up to 2 channels (Dual Temperature) .
. CO2
. Cardiac Output
IBP .
. Anesthetic agents

The target population is for adult, neonate and pediatric patients with the exception of:

· Cardiac Output for which the target population is adult only.
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

{3}------------------------------------------------

page 4 of 7

OMNI III

The purpose and function of the OMNI III patient monitor is to monitor basic physiological parameters including

ECG waveform derived from 3, 5 or 12 lead measurements .
Heart Rate .
NIBP(systolic, diastolic, and mean arterial pressure) .
SpO2 .
Respiration .
Temperature up to 2 channels (Dual Temperature) .
CO2 .
Cardiac Output ●
. IBP
Anesthetic agents .

The target population is for adult, neonate and pediatric patients with the exception of:

· Cardiac Output for which the target population is adult only.
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

{4}------------------------------------------------

OMNI Express

The purpose and function of the OMNI Express patient monitor is to monitor basic physiological parameters including

ECG waveform derived from 3 to 5 lead measurements .
Heart Rate .
NIBP(systolic, diastolic, and mean arterial pressure) ●
. SpO2
. Respiration
. Temperature - up to 2 channels (Dual Temperature)
CO2
. Anesthetic agents

The target population is for adult, neonate and pediatric patients.

Device Description:

OMNI

OMNI II

{5}------------------------------------------------

OMNI III

OMNI Express

Substantial Equivalence:

The OMNI patent monitor is substantial equivalent in intended use and similar technological characteristics of IBP, CO2. Anesthetic Agents, and 12 Lead ECG to the Datascope Corp. Spectrum™ Monitor under K062098.

The OMNI II and OMNI III are substantially equivalent to the Datascope Corp. Spectrum™ Monitor under K062098 in intended use and similar technological characteristics of IBP, CO2, Anesthetic Agents, 12 Lead ECG and Cardiac output .

The OMNI Express is substantially equivalent to the Datascope Corp. Spectrum™ Monitor under K062098 as it pertains to CO2 and Anesthetic Agents.

The OMNI Patient Monitors are substantially equivalent to the previously cleared OMNI Patient Monitors as it pertains to previously cleared technological characteristics and performance. A comparison of these technological characteristics is included in the submission.

Device	Clearance Number	Substantial Equivalence to
Datascope Corp - SpectrumTM Monitor	K062098	Intended use and functions of IBP,CO2, Cardiac Output, AnestheticAgents
OMNI Patient Monitor	K112329	Intended usePreviously Cleared TechnologicalCharacteristics and Performance
OMNI II Patient Monitor	K103737	Intended use

{6}------------------------------------------------

		Previously Cleared TechnologicalCharacteristics and Performance
OMNI III Patient Monitor	K101052	Intended usePreviously Cleared TechnologicalCharacteristics and Performance
OMNI Express PatientMonitor	K1037268	Intended usePreviously Cleared TechnologicalCharacteristics and Performance

Rational for Substantial Equivalence:

The testing completed in the previously cleared submissions along with the additional testing completed demonstrates that the OMNI Series Patient Monitors exhibit comparable mechanical and functional characteristics to the predicate devices in addition to being biocompatible acceptable. Based on those characteristics, the Infinium OMNI Patient Monitors are substantially equivalent to the predicate devices in safety and effectiveness in addition to being intended for the same uses.

Summary of Non-Clinical Data:

The OMNI series patient monitors underwent bench testing according to several different performance standards. Below is a chart of the different testing that was completed.

Patient Monitor	Performance Test	Standard of Compliance
OMNI	IBP	BS EN 60601-2-34:2000
OMNI	ECG	ANSI/AAMIEC13:2002/(R)2007
OMNI II, OMNI III	IBP	BS EN 60601-2-34:2000
OMNI II, OMNI III	ECG	ANSI/AAMIEC13:2002/(R)2007
OMNI II, OMNI III	Cardiac Output	No Standard

Based on the conclusions of each of these tests it is determined that the OMNI Patient Monitors are safe and effective.

{7}------------------------------------------------

Public Health Scrvice

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

Image /page/7/Picture/3 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side and a stylized symbol on the right. The symbol is a graphic representation of an abstract human figure embracing or protecting something, possibly representing health and well-being.

Re:

February 21, 2014

Infinium Medical c/o Mr. John O'Brien 445 Apollo Beach Blvd Apollo Beach, FL 33572 US

K13229 Trade/Device Name: Omni Patient Monitors (Models: Omni, Omni II, Omni III and Omni Express) Regulation Number: 21 CFR 870.2340 Regulation Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Regulatory Class: Class II Product Code: MWI Dated: January 13, 2014 Received: January 16, 2014

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it r your device 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.

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 statues 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 of medical device-related adverse labornig (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.

{8}------------------------------------------------

Page 2 - Mr. John O'Brien

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Owen P. Faris -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{9}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: OMNI Patient Monitor

The purpose and function of the OMNI patient monitor is to monitor basic physiological parameters including

ECG waveform derived from 3, 5 or 12 lead measurements .
Heart Rate .
NIBP(systolic, diastolic, and mean arterial pressure) t
. SpO2
Respiration .
Temperature up to 2 channels (Dual Temperature) .
. CO2
. IBP
Anesthetic agents .

The target population is for adult, neonate and pediatric patients:

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

the control control control control controllers.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by
Owen P. Faris -S
Date: 2014.02.21
14:03:26-05'00'

Page I of I

{10}------------------------------------------------

K132229 page 2 of 4

Indications for Use

510(k) Number (if known):

Device Name: OMNI II Patient Monitor

The purpose and function of the OMNI II patient monitor is to monitor basic physiological parameters including

ECG waveform derived from 3, 5 or 12 lead measurements .
Heart Rate ●
NIBP(systolic, diastolic, and mean arterial pressure) .
SpOz ●
Respiration .
. Temperature - up to 2 channels (Dual Temperature)
. CO2
Cardiac Output ●
. IBP
Anesthetic agents ●

The target population is for adult, neonate and pediatric patients with the exception of:

Cardiac Output for which the target population is adult only. .
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by
Owen P. Faris -S
Date: 2014.02.21
14:03:43 -05'00'

Page i of I

{11}------------------------------------------------

K132229 page 3 of 4

Indications for Use

510(k) Number (if known):

Device Name: OMNI III Patient Monitor

The purpose and function of the OMNI III patient monitor is to monitor basic physiological parameters including

ECG waveform derived from 3, 5 or 12 lead measurements ●
Heart Rate �
NIBP(systolic, diastolic, and mean arterial pressure) .
. SpOz
Respiration .
Temperature up to 2 channels (Dual Temperature) ●
� CO2
Cardiac Output .
IBP
Anesthetic agents .

The target population is for adult, neonate and pediatric patients with the exception of:

· Cardiac Output for which the target population is adult only.
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by
Owen P. Faris -5
Date: 2014.02.21
14:04:01 -05'00'

Page 1 of 1

{12}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: OMNI Express Patient Monitor

The purpose and function of the OMNI Express patient monitor is to monitor basic physiological parameters including

ECG waveform derived from 3 to 5 lead measurements .
Heart Rate .
NIBP(systolic, diastolic, and mean arterial pressure) .
SpO2 .
Respiration .
Temperature up to 2 channels (Dual Temperature) .
. CO2
� Anesthetic agents

The target population is for adult, neonate and pediatric patients:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by
Owen P. Faris -S
Date: 2014.02.21
14:04:19 -05'00'

Page 1 of 1

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).