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

Device Description

The CLEO monitor is a comprehensive monitoring system with two or three traces compiling, and processing, analyzing and displaying data from up to three 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 CLEO Patient monitor can be powered by an internal battery pack that provides 3 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

The associated accessories include:

Sp02 Finger Sensors
NIBP Monitor
Blood Pressure Cuff
ETCO2 Module

AI/ML Overview

The provided document is limited to the FDA 510(k) summary for the CLEO Patient Monitor. This document outlines the device's regulatory status, intended use, and a summary of performance testing to support substantial equivalence to a predicate device.

It does not contain the detailed information needed to fully answer all aspects of your request, particularly regarding specific acceptance criteria values and a comprehensive study report with ground truth establishment and expert involvement, as would be expected for a comparative effectiveness study or a rigorous standalone algorithm performance study.

The information provided largely focuses on demonstrating compliance with recognized standards for medical devices rather than detailed clinical performance studies for a diagnostic algorithm.

Here's a breakdown of what can be extracted and what is missing:

Description of Acceptance Criteria and Device Performance

The document describes various performance tests conducted to support the substantial equivalence of the CLEO Patient Monitor. However, it does not explicitly state numerical "acceptance criteria" for each parameter in the way one might expect for a diagnostic algorithm. Instead, it lists the standards of compliance that the device met. The "reported device performance" is implicitly that the device complied with these standards.

Table of Acceptance Criteria (as inferred from Standards of Compliance) and Reported Device Performance:

Feature/Parameter Tested	Standard of Compliance (Implied Acceptance Criteria)	Reported Device Performance
NIBP	ANSI/AAMI SP10:1992 and 2002, ANSI/AAMI/IEC 80601-2-30:2009	Complied with NIBP standards. (NIBP subsystem identical to K040799)
SpO2	EN ISO 9919:2009	Complied with SpO2 performance test standards.
ETCO2	80601-2-55:2011 (for CO2 Measurement Accuracy, Drift, Gas Sampling, etc.)	Complied with ETCO2 performance test standards for accuracy, etc.
Electrical Safety	IEC 60601-1:2005/ EN 60601-1:2006	Complied with electrical safety standards.
EMC	IEC 60601-1-2:2007	Complied with electromagnetic compatibility standards.
Biocompatibility	(Not explicitly stated, but mentioned for FDA cleared components)	Components are "Generally Regarded as Safe (GRAS)" and FDA cleared.
Software Verification	FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."	Software verification and validation conducted; classified as "Moderate" level of concern.
Mechanical Testing	(Various standards implied for CO2, Respiration Rate, etc.)	CO2 Measurement Accuracy & Drift, Gas Sampling Rate Accuracy, etc. were tested.

Missing Information:

The document does not provide the following information that would be necessary to answer the remaining parts of your request:

Sample size used for the test set and the data provenance: The document mentions "performance tests" for NIBP, SpO2, and ETCO2 but does not specify the number of subjects, the type of data (e.g., patient data, simulated data), or its origin (e.g., country, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present. The testing described seems to rely on standardized methods and calibrated equipment rather than expert human assessment for ground truth.
Adjudication method: Not applicable/not mentioned, as there isn't a human-expert-based ground truth outlined.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: No MRMC study is mentioned. This device is a physiological monitor, not a diagnostic imaging AI algorithm typically requiring MRMC studies.
If a standalone performance study was done: The document describes various performance tests ("Mechanical Testing," "SPO2 Performance Test," "NIBP Performance Test," "CO2 Measurement Accuracy and Drift") which could be considered standalone performance assessments against established standards. However, it's not a standalone algorithm performance in the sense of a machine learning model's output being compared to ground truth.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the physiological measurements would be derived from highly accurate reference instruments or test setups that simulate physiological conditions according to the respective standards (e.g., a calibrated pressure transducer for NIBP, a pulse oximeter simulator for SpO2, a gas analyzer for ETCO2). Expert consensus, pathology, or outcomes data are not relevant for establishing ground truth for these types of physiological measurements.
The sample size for the training set: This device is a traditional physiological monitor, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" would be the engineering design, calibration, and validation against known physical and physiological principles.
How the ground truth for the training set was established: Not applicable, as it's not an AI/ML device with a training set.

In summary: The provided document is a 510(k) summary for a traditional patient monitor. It focuses on demonstrating compliance with established medical device safety and performance standards for its physiological measurement capabilities (NIBP, SpO2, ETCO2). It does not describe an AI/machine learning algorithm or the types of studies (MRMC, expert consensus for ground truth, training/test sets for AI) that your request specifically asks about. The "acceptance criteria" are implied by compliance with the listed international and national standards.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of three human profiles facing right, with flowing lines beneath them.

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

February 6, 2015

Infinium Medical % John O'Brien Regulatory and Quality Systems Lead AJW Technology Consultants, Inc 445 Apollo Beach Blvd. Apollo Beach, Florida 33572

Re: K142244

Trade/Device Name: Cleo Patient Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI, DXN, DQA, CCK Dated: January 6, 2015 Received: January 8, 2015

Dear John 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 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.

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

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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 contact the Division of Industry and Consumer Education 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 Industry and Consumer Education 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.

Sincerely yours.

Melissa A. Torres -S

For 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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Indications for Use

510(k) Number (if known): K142244

Device Name: CLEO Patient Monitor

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

NIBP (systolic and diastolic)
SpO2
ETCO2

The target population is for adults only.

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)

Page 1 of 1

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510(k) SUMMARY (as required by 807.92)

I. SUBMITTER

Infinium Medical 12151 62nd Street North #5 Largo, FL 33773

Phone: 727-531-8434 Fax: 727-531-8436

Contact Person: Oz Ozkaya Date Prepared: August 1, 2014

REGULATORY CORRESPONDENT

AJW Technology Consultants, Inc 445 Apollo Beach, Blvd Apollo Beach, FL 33572

Phone: 813-645-2855 x101 Fax: 813-645-2856

Contact Person: John O'Brien Email: jobrien@ajwtech.com

II. DEVICE

Name of Device: CLEO Patient Monitor Common or Usual Name: Patient Physiological Monitor (without Arrhythmia Detection or Alarm) Classification Name: Monitor, physiological, patient (without Arrhythmia detection or alarms) Device Panel: Cardiovascular Regulatory Class: II Product Code: MWI

Subsequent Product Codes:

RegulationNumber	Description	Product Code
870.1130	Noninvasive Blood PressureMeasurement	DXN
870.2700	Oximeter	DQA
868.1400	Carbon dioxide gas analyzer	CCK

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III. PREDICATE DEVICE

The CLEO patent monitor is substantially equivalent in intended use and similar technological characteristics of NIBP, ETC02, and Sp02 as the OMNI Express Patient Monitor which is one of the monitors cleared as part of K132229. The internal Infinium CAPNOTRAK CO2 sensor is substantially equivalent in intended use and technological characteristics to the Respironics LoFlo CO2 Sensor which was cleared under K053174.

This predicate has not been subject to a design-related recall. No reference devices were used in this submission

DEVICE DESCRIPTION IV.

The associated accessories include:

Sp02 Finger Sensors ●
NIBP Monitor ●
Blood Pressure Cuff ●
ETCO2 Module ●

V. INDICATIONS FOR USE

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

NIBP (systolic and diastolic)
SpO2 ●
ETCO2 ●

The target population is for adults only.

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VI. COMPARISON OF TECHNOLIGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The monitoring of basic physiological parameters is the technological principle for both the subject and predicate devices. It is based on the use of modules and accessories that are either connected internally or externally to the monitors in order to monitor the specific physiological parameter. At a high level, the subject and predicate devices are based on the following same technological characteristics:

Energy Source ●
The monitoring of Non-invasive blood pressure
The monitoring of pulse oximetry
The monitoring of End Tidal CO2 ●
Touch Screen Technology ●
. Software

Because CLEO Patient Monitor's NIBP subsystem is identical to Suntech Medical's NIBP subsystem cleared under K040799 substantial equivalence was not based on performance testing.

The following technological differences exist between the subject and predicate devices:

. ECG waveform
Heart Rate Monitoring ●
Respiration ●
Temperature
Anesthetic agents
Physical Dimensions

VII. PERFORMANCE DATA

The following performance date were provided in support of the substantial equivalence determination

Biocompatibility Testing

The product contact materials utilized in the CLEO Patient Monitor have been well characterized chemically and physically and have a long history of safe use in predicate devices and are categorized as Generally Regarded as Safe (GRAS). In addition, all patient contact components have been FDA cleared through the 510(k) Premarket Notification process and have been tested for biocompatibility.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Infinium device, consisting of the CLEO Monitor, NIBP Monitor and Cuff, SPO2 finger Sensors

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and the ETCO> Module. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw could directly result in minor injury to the patient or operator.

Mechanical Testing

CO2 Measurement Accuracy and Drift of Measurement Accuracy
Gas Sampling Rate Accuracy ●
System Response/Rise Time ●
Respiratory Rate Accuracy ●
Gas Mixture Accuracy ●
Interfering Agents
SPO2 Performance Test ●
NIBP Performance Test ●

Summary of Non-Clinical Data:

The Cleo Patient Monitor underwent testing according to several different performance standards. Below is a chart of the different testing that was completed.

Devices	Performance Test	Standard of Compliance
CLEO Monitor	NIBP	ANSI/AAMI SP10:1992 and2002, ANSI/AAMI/IEC 80601-2-30:2009
	SPO2	EN ISO 9919:2009
	Electrical Safety	IEC 60601-1:2005/ EN 60601-1:2006
	EMC	IEC 60601-1-2:2007
	ETCO2	80601-2-55:2011

VIII. CONCLUSIONS

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The testing completed demonstrates that the CLEO Patient Monitor exhibits comparable mechanical and functional characteristics to the predicate device in addition to being biocompatible acceptable. Based on those characteristics, the CLEO Patient Monitor is substantially equivalent to the predicate device in safety and effectiveness in addition to being intended for the same uses.

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).