The MaxO2ME oxygen monitor is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. It can be used in the pre-hospital, hospital and sub-acute settings. The MaxO2ME is not intended as a life supporting device.

Device Description

The MaxO-ME is a handheld oxygen analyzer/monitor capable of measuring the oxygen concentration from 0% to 100% in a sample gas. A MAX-550E oxygen sensor outputs a voltage which is used by the Max O2ME to determine the concentration of oxygen based on a calibration at room air or 100% oxygen. The MaxO2ME contains alarms that can be controlled by the user to set a maximum or minimum allowable oxygen concentration.

AI/ML Overview

Below is an analysis of the provided text regarding the MaxO2ME oxygen monitor's acceptance criteria and studies.

1. Table of Acceptance Criteria and Reported Device Performance

The document outlines acceptance criteria implied by the "Performance Specifications" and the reported performance of the MaxO2ME device compared to a predicate device (Precision Medical PM5900 - K063096) and a reference device (MiniOX - K961644). The "Discussion" section for "Non-clinical Testing" states, "In all cases the proposed device passed or meets the acceptance criteria," but does not explicitly list the criteria themselves or the specific values for each test type in the Performance Testing section beyond the initial performance specifications table.

Based on the "Performance Specifications - The following is a list of the differences between the proposed device and the predicate" and the subsequent "Discussion" for performance, some criteria and performance points can be inferred:

Performance Attribute	Predicate Device (PM5900) Acceptance Criteria (or comparable performance)	MaxO2ME Reported Device Performance	Reference Device (MiniOX) Performance (for context)
Measurement Range	0.0 to 100%	0.0 to 100%	(Not explicitly stated for MiniOX)
Resolution	0.1%	0.1%	(Not explicitly stated for MiniOX)
Accuracy and Linearity	±1% of full scale (constant T, RH, P; calibrated at full scale)	±1% of full scale (constant T, RH, P; calibrated at full scale)	(Not explicitly stated for MiniOX)
Total Accuracy	±3% Actual oxygen level over full operating temperature range	±3% Actual oxygen level over full operating temperature range	(Not explicitly stated for MiniOX)
Response Time	90% of final value in 12 seconds at 25°C	90% of final value in approx. 15 seconds at 23°C	90% in 20 to 30 seconds
Warm-up Time	None required (predicate is 3 seconds less than 15s warm-up time of proposed device)	None required	(Not explicitly stated for MiniOX)
Operating Temperature	10°C – 45°C (50°F – 113°F)	15°C – 40°C (59°F – 104°F)	(Not explicitly stated for MiniOX)
Storage Temperature	-15°C – 50°C (5°F – 122°F)	-15°C – 50°C (5°F – 122°F)	(Not explicitly stated for MiniOX)
Atmospheric Pressure	Up to 8,000 ft.	800 – 1012 mBars	(Not explicitly stated for MiniOX)
Humidity	0-95% (non-condensing)	0-95% (non-condensing)	(Not explicitly stated for MiniOX)
Battery Life	Approx. 1,500 – 2,000 hours, typical use	Approx. 5000 hours, typical use	(Not explicitly stated for MiniOX)
Expected Sensor Life	> 1,000,000% O2 Hours	> 1,500,000 % O2 Hours, over 2 years typical application	(Not explicitly stated for MiniOX)
Low Oxygen Alarm Range	15% - 99% (>1% lower than high alarm)	15% - 99% (>1% lower than high alarm)	15 – 99%
High Oxygen Alarm Range	18% - 99% (>1% higher than low alarm)	16% - 100% (>1% higher than low alarm)	16 - 100%
Alarm Systems (Audible)	Not explicitly detailed for audible	Nominal 975 Hz audio buzzer (IEC 60601-1-8)	Not explicitly detailed for audible

Study Proving Acceptance Criteria:
The document states: "We performed a number of tests to demonstrate that the proposed device performed as intended."
The following non-clinical performance tests were conducted:

ISO 80601-2-55 Performance of respiratory gas monitors
ISTA2A Shipping Validation Test Report
Sensor performance Test Report
Gas leakage Test Report
Interfering gas effects Test Report
Temperature compensation Test Report
Drift of measurement accuracy Test Report
MaxO2ME Operating and Storage Environment Report
Device Cleaning Report and Disinfection Test
Measurement accuracy Test Report
IEC 60601-1 Electrical safety
IEC 60601-1-2 - EMC
IEC 60601-1-8 - Alarms
Shelf-life / Real-time

The document concludes: "In all cases the proposed device passed or meets the acceptance criteria."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for any test set or the data provenance. The tests listed are general performance and safety tests for a medical device, which typically involve device units rather than patient data.

3. 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. The tests performed are objective, non-clinical engineering and performance tests on the device itself, not requiring expert ground truth for interpretation.

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

Not applicable. As noted above, the tests are objective, non-clinical performance and safety tests, not requiring adjudication of results from multiple reviewers.

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

Not applicable. This is not an AI/imaging device. No MRMC study was conducted. The device is an oxygen monitor, and its performance tests are related to its physical and functional specifications.

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

Yes, the studies conducted were standalone tests of the device itself ("algorithm only" in the sense of the device's functionality) without human-in-the-loop performance being evaluated. The device is an oxygen monitor and its performance is measured against technical specifications.

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

The ground truth for the performance and safety tests would have been established by calibrated reference equipment and standardized testing protocols (e.g., ISO and IEC standards). For example, a gas analyzer would be calibrated against known gas concentrations to determine its accuracy.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set."

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

Not applicable. As there is no training set for an AI/machine learning model, this question is not relevant.

Summary

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

June 10, 2016

Maxtec, LLC C/O Paul Dryden Consultant 2305 South 1070 West Salt Lake City, Utah 84119

Re: K153659

Trade/Device Name: MaxO2ME Regulation Number: 21 CFR 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: Class II Product Code: CCL Dated: May 12, 2016 Received: May 13, 2016

Dear Paul Dryden:

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 devicerelated 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.

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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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K153659

Device Name

MaxO2ME

Indications for Use (Describe)

The MaxO2ME oxygen monitor is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. It can be used in the pre-hospital, and subacute settings. The MaxO2ME is not intended as a life supporting device.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary June 10, 2016 Page 1 of 5

Official Contact:	Bruce BrierleyPresidentMaxtec LLC2305 South 1070 WestSalt Lake City, Utah 84119Tel – 385-549-8070
Proprietary or Trade Name:	MaxO2ME
Common/Usual Name:	Oxygen analyzer
Classification Name:	21CFR 868.1720Class IICCL
Predicate Device:	Precision PM5900 - K063096
Reference Device:	MiniOX - K961644

Device Description:

Device Features:

Oxygen sensor of approximately 1,500,000 O2 percent hours and / or 2 years.
External probe with 10 ft., extendable cable and diverter fitting for standard 15 mm "T" adapter. ●
Operation using 4 AA alkaline batteries (4 x 1.5 volts) for approximately 5,000 hours of ● performance with typical use.
Oxygen-specific, galvanic sensor that achieves 90% of final value in approximately 15 seconds at ● room temperature.
Self-diagnostic check of analog and microprocessor circuitry. ●
Low battery indication.
Calibration reminder timer that alerts the operator, using a calibration icon on the LCD display, to ● perform a unit calibration.
. Adjustable high-level and low-level alarming capability with flashing LED and audible indication of alarm conditions.
Smart high-low alarm setting to help adjust alarm settings quickly.
. Back-light display with auto ambient light level detection.
Sleep Mode operation to extend battery life. ●

Indications for Use:

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Patient Population

The MaxO2ME may be used on equipment where one desires to measure and monitor the delivered oxygen concentration. This is independent of a patient population.

Contraindications

There are no contraindications.

Environments of Use

Pre-hospital, hospital and sub-acute settings

Substantial Equivalence

This discusses how one can find the MaxO2ME substantially equivalent to the predicate Precision Medical PM5900 (K063096).

Indications for Use

Table 1 outlines the indications for use for both devices and one can see that they are similar, namely oxygen monitor is intended for continuous monitoring of the concentration of oxygen being delivered to patients, not intended as a life supporting device.

Discussion: One can find the proposed device substantially equivalent to the predicate Precision Medical PM5900 (K063096). There are no differences which raise any new substantial equivalence concerns.

Environment of Use -Oxygen monitors have commonly been used in pre-hospital and healthcare settings. The reference to the types of equipment that the predicate discloses supports pre-hospital and healthcare setting.

Population - The predicate submission does not disclose details on patient population but does include incubators which would suggest newborns.

Discussion: Based upon the available information one can find the proposed device substantially equivalent to the predicate Precision Medical PM5900 (K063096). There are no differences which raise any new substantial equivalence concerns.

Performance Specifications - The following is a list of the differences between the proposed device and the predicate.

. Response time is 15 seconds vs. 12 seconds for the predicate
- o The reference device MiniOX (K961644) has a response time of 20-30 seconds
. Warm-up time is 3 seconds less for the predicate (12 vs. 15 seconds)
Operating temperature range is wide by 10 degrees for the predicate vs. the proposed. ●
Battery life is about 50% less than the proposed device (2000 hours vs. 5000 hours) ●
The Sensor Life is less for the predicate vs. the proposed ●
High Oxygen Alarm range is smaller by 3 % points (19-99% vs. 16-100%)
- o The reference device MiniOX (K961644) has the identical high alarm range
. Size and weight are slightly different

Discussion:

While the subject device has some differences when compared to the Response Time and High Alarm range, the reference device, MiniOX (K961644), which has similar intended use, population and environment has similar Response time and High alarm, which supports that the differences do not raise any new substantial equivalence concerns. The other differences, battery life, warm-up time, sensor

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510(k) Summary June 10, 2016

Page 3 of 5

life and physical size are similar and the defenses are improvements vs. the predicate. As such they would not raise any new substantial equivalence concerns. One can find the proposed device substantially equivalent to the predicate Precision Medical PM5900 (K063096) and reference device MiniOX (K961644).

Non-clinical Testing

Performance Testing

We performed a number of tests to demonstrate that the proposed device performed as intended.

. ISO 80601-2-55 Performance of respiratory gas monitors
ISTA2A Shipping Validation Test Report ●
Sensor performance Test Report ●
Gas leakage Test Report ●
. Interfering gas effects Test Report
. Temperature compensation Test Report
Drift of measurement accuracy Test Report
MaxO2ME Operating and Storage Environment Report
Device Cleaning Report and Disinfection Test
. Measurement accuracy Test Report
IEC 60601-1 Electrical safety ●
IEC 60601-1-2 - EMC
IEC 60601-1-8 - Alarms
Shelf-life / Real-time ●

Discussion: In all cases the proposed device passed or meets the acceptance criteria. One can find the proposed device substantially equivalent to the predicate Precision Medical PM5900 (K063096).

Biocompatibility - The materials that are in the gas pathway for the oxygen sensor. "Tee" adapter and diverter, are identical to other Maxtec supplied or cleared products which has similar intended use, population, environment of use and type of patient contact. As such no biocompatibility testing was performed.

Per G95-1 and ISO 10993-1:2009, these materials would be considered as:

Externally communicating, Tissue contact, and Duration of Use prolonged (> 24 hours, < 30 ● days)
Animal - No animal testing was performed.

Clinical - No human clinical testing was performed.

Substantial Equivalence Conclusion-

It is sponsor's opinion that the MaxO2ME oxygen analyzer based upon the comparative testing is substantially equivalent to the predicate device.

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510(k) Summary

Attributes	ProposedMaxO2ME	PredicatePrecision Medical – PM5900 (K063096)
Indications for Use	The MaxO2ME oxygen monitor is intended for continuousmonitoring of the concentration of oxygen being delivered topatients ranging from newborns to adults. It can be used in thepre-hospital, hospital and sub-acute settings. The MaxO2ME isnot intended as a life supporting device.	Intended to measure the concentration of oxygen beingdelivered to the patient. The oxygen monitor is not intended asa life supporting device
Environments of Use	Pre-hospital, hospital and sub-acute settings	Variety of medical applications such as anesthesiology (e.g.,anesthesia machines), Respiratory devices (e.g., respirators,ventilators, pediatric incubators), and oxygen therapy (e.g.,oxygen tents). Can be considered Pre-hospital, hospital andsub-acute settings
Patient Population	The MaxO2ME may be used on equipment where one desires tomeasure and monitor the delivered oxygen concentration. Thisis independent of a patient population.	Not specific but includes reference to pediatrics and incubatorswhich would imply newborns and older
Measurement Range	0.0 to 100%	0.0 to 100%
Resolution	0.1%	0.1%
Accuracy and Linearity	±1% of full scale at constant temperature, RH and pressurewhen calibrated at fill scale	±1% of full scale at constant temperature, RH and pressurewhen calibrated at fill scale
Total Accuracy	±3% Actual oxygen level over full operating temperature range	±3% Actual oxygen level over full operating temperature range
Response Time	90% of final value in approx. 15 seconds at 23°C	90% of final value in 12 seconds at 25°CReference device - MiniOX – K96164490% in 20 to 30 seconds
Warm-up Time	None required	None required
Operating Temperature	15°C – 40°C (59°F – 104°F)	10°C – 45°C (50°F – 113°F)
Storage Temperature	-15°C – 50°C (5°F – 122°F)	-15°C – 50°C (5°F – 122°F)
Atmospheric Pressure	800 – 1012 mBars	Up to 8,000 ft.
Humidity	0-95% (non-condensing)	0-95% (non-condensing)
Power requirements	4 – AA Alkaline batteries	4 – AA Alkaline batteries
Battery Life	Approx. 5000 hours, typical use	Approx. 1,500 – 2,000 hours, typical use
Low Battery Indications	“LOWBAT” icon on LCD display	Icon on LCD display
Sensor Type	Maxtec MAX-550F galvanic fuel cell	Galvanic fuel cell
Attributes	ProposedMaxO2ME	PredicatePrecision Medical – PM5900 (K063096)
Expected Sensor Life	> 1,500,000 % O2 Hours, over 2 years typical application	> 1,000,000% O2 Hours
Alarm Systems	High/Low alarms, flashing yellow LEDsNominal 975 Hz audio buzzer (IEC 60601-1-8)	High/Low alarms, flashing yellow LEDs
Low Oxygen Alarm Range	15% - 99% (>1% lower than high alarm)	15% - 99% (>1% lower than high alarm)Reference device - MiniOX – K96164415 – 99%
High Oxygen Alarm Range	16% - 100% (>1% higher than low alarm)	18% - 99% (>1% higher than low alarm) inconsistentSummary shows 19-99%, literature shows 18-100%Reference device - MiniOX – K96164416 - 100%
Accuracy	Exact to display alarm value	Exact to display alarm value
Materials	The materials in the gas pathway are considered as Externallycommunicating, Tissue contact, and Duration of Use –prolonged (> 24 hours, < 30 days)The components of the sensor and diffuser are identical to theMaxtec components cleared under K131252 and Tee adapter isidentical to Envitec K122290.These components have similar intended use, population,environment of use and type of patient contact
Dimensions	3.6"(W) x 5.8"(H)x1.2"(D)	3.6"(W) x 5.4"(H)x1.7"(D)
Weight	Approx. 0.89 lbs.	Approx. 1.11 lbs.
Cable length	9 ft.	10 ft.
Accessories	DiverterTee adapter (15 mmm x 22 mm fittings)Mounting bracketsDC power adapter	DiverterTee adapter (15 mmm x 22 mm fittings)Mounting bracketsDC power adapter

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510(k) Summary June 10, 2016

Page 5 of 5

Regulation Number and Section

§ 868.1720 Oxygen gas analyzer.

(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).