The MaxO2 CU is a continuous use monitor of oxygen concentration in a patient breathing environment. It may be provided with an oxygen concentration dilution method which could be of a flowmeter, manifold or venturi design, which can deliver a set or adjustable FiO2 oxygen concentrations and flow rates to the patient. It is not intended for use with life supporting systems.

Device Description

The MaxO2 CU is a combination of a continuous use oxygen monitor and a venturi oxygen dilution system in one device. An analogous device could be assembled by attaching a wall mount oxygen flow meter to a commercially available venturi and attaching the venturity a standard in-line oxygen analyzer. The MaxO2 CU offers this set-up to the clinician in one package. There are two models, one with adjustable flow and adjustable FiO2. The other has fixed flow and adjustable FiO. The flow adjustment is accomplished by adjusting the flow of oxygen through the venturi orifice. The adjustable oxygen % is accomplished by adjusting the flow of oxygen into the region surrounding the venturi orifice. This oxygen is drawn into the venturi stream in place of room air, increasing oxygen content in the mixture. The oxygen analyzer electronics, sensor, and programming are identical to the MaxQ+ predicate K040484.

AI/ML Overview

Here's an analysis of the provided text regarding the MaxO2 CU device's acceptance criteria and documented performance.

1. Table of Acceptance Criteria and Reported Device Performance

Attribute	Acceptance Criteria (Stated)	Reported Device Performance
Display range	0-100% oxygen	0-100% oxygen
Display Resolution	0.1% oxygen	0.1% oxygen
Response Time	Not explicitly stated as "acceptance criteria" but

                             implied performance goal for the device. The
                             predicate device may have set a benchmark.
                            | 90% of final value in ~ 15 seconds @ 23C |

Note: The document lists "Device Attributes" with specific values. While not explicitly termed "acceptance criteria," for a 510(k) submission, these values represent the performance the manufacturer claims to meet and which the FDA reviews for substantial equivalence to predicate devices. The absence of specific "acceptance criteria" numbers often means the device is being compared to the predicate's established performance without a formal, new testing standard being defined for this submission beyond maintaining functional equivalence.

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

The provided document does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission refers to performance specifications (e.g., accuracy, response time) but does not detail the studies conducted to verify these specifications for this specific device. This is common in 510(k) submissions where substantial equivalence is demonstrated primarily through comparison to predicate devices, and underlying performance data might be referenced from internal testing or previous submissions for the predicate.

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

The document does not mention any experts or ground truth establishment relevant to a clinical or performance test set. The device is an oxygen analyzer, and its performance characteristics (accuracy, linearity) would typically be verified against calibrated reference gases or standards, not through expert consensus on medical imagery or patient outcomes.

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

As there is no mention of a clinical or performance test set involving human interpretation, there is no adjudication method described. This device measures gas concentration, a quantitative physical parameter.

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 MRMC comparative effectiveness study was done or is mentioned. This device is an oxygen analyzer, not an AI diagnostic tool that assists human readers.

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

The document does not describe a standalone algorithm performance study. The device itself is a standalone physical instrument for measuring oxygen concentration. The performance metrics listed (accuracy, drift, response time) are inherent to the device's function, not an algorithm in the AI sense.

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

The "ground truth" for verifying the performance attributes of an oxygen analyzer (like Display Range, Accuracy, Linearity error, Drift) would typically be based on calibrated reference gases with known oxygen concentrations, or highly accurate laboratory instruments. The document does not explicitly state the methodology for establishing this ground truth, but it would be a metrological standard, not clinical expert consensus or pathology.

8. The sample size for the training set

The document does not refer to a training set. This device is an electro-mechanical oxygen analyzer; it does not utilize machine learning or AI models that require a training set.

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

As there is no training set, there is no discussion of how its ground truth was established.

Summary

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510(k) Summary

Non-Confidential Summary of Safety and Effectiveness Page 1 of 2

12-Feb-07

FEB 2 2 2007

Maxtec, Inc.6526 South Cottonwood 300 WestSalt Lake City, UT 84107	Tel -- 801-266-5300Fax - 801-270-5590
Official Contact:	Tod Cook- QA
Proprietary or Trade Name:	MaxO2 CU
Common/Usual Name:	Oxygen analyzer with flowmeter and gas source
Classification Name:	Analyzer, Oxygen, Gaseous-phase
Device:	MaxO2 CU
Predicate Devices:	Maxtec - MAXO2 + - K040484Ceramatec - Handi - K973282Sensidyne - K010328

Indications for Use:
Indicated Use --	The MaxO2 CU is a continuous use monitor of oxygenconcentration in a patient breathing environment. It may beprovided with an oxygen concentration dilution method whichcould be of a flowmeter, manifold or venturi design, which candeliver a set or adjustable FiO2 oxygen concentrations and flowrates to the patient. It is not intended for use with life supportingsystems.
Environment of Use --	Hospital, Sub-acute institutions, Homecare, intra-hospitaltransport

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K063488 – MaxO2 CU 510(k) Response to E-mail of 12-Feb-07

Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 12-Feb-07

Device Attributes:
Attribute	MaxO2 CU
Features
Display range	0-100% oxygen
Display Resolution	0.1% oxygen
Response Time	90% of final value in ~ 15 seconds @ 23C
Accuracy	+ 3% full scale
Linearity error	< 3% of reading
Drift	< 1% oxygen over 8 hours
Humidity influence	+3% full scale
Humidity conditions	0-95% RH non-condensing
Pressure influence	Proportional to changes in atmospheric pressure
Operating temperature	15 - 40°C
Storage temperature	-15 to 55°C
Recommended storage temperature	-20 to 55°C
Battery power indicator	Indicator on LCD
Analyzer life	Battery life - 5000 hours (user replaceable)Sensor life >900,000 % oxygen hours
Sensor type	Galvanic fuel cell
Power requirement	2 replaceable AA battery
Weight	N/A
Display	3 digit LCD
On / Auto-off button	Standard ON/OFF (No auto OFF)
Connection or use with othercomponents allowing for adjustmentof flow and FiO2	YesBuilt in oxygen diluter (venturi or flowmetermanifold).
Calibrations	Calibrate to room air or 100% oxygen
Alarms	NoneExcept Low battery
Materials	Same as K040484
Performance	None under 514

Differences between Other Legally Marketed Predicate Devices

The MaxO2 CU is viewed as substantially equivalent to the following predicate device – Maxtec Max O2 + - K040484, Ceramatec - Handi - K973282, and Sensidyne - K010328.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of the department's name, which is arranged in a circular fashion around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EB 2 2 2007

Maxtec, Incorporated C/O Mr. Paul Dryden ProMedic, Incorporated 3460 Pointe Creek Court, #102 Bonita Springs, Florida 34134

Re: K063488

Trade/Device Name: Max02 CU Regulation Number: 21 CFR 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: II Product Code: CCL Dated: January 23, 2007 Received: January 24, 2007

Dear Mr. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Dryden

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K063488 - MaxO2 CU 510(k) Response to E-mail of 12-Feb-07

4 Indications for Use Statement

Page 1 of 1

510(k) Number:

K063488 (To be assigned)

Device Name: MaxO2 CU

Indications for Use:

The MaxO2 CU is a continuous use monitor of oxygen concentration in a patient breathing environment. It may be provided with an oxygen concentration dilution method which could be of a flowmeter, manifold or venturi design, which can deliver set or adjustable FiO2 oxygen concentrations and flow rates to the patient. It is not intended for use with life supporting systems.

Prescription Use XX (Part 21 CFR 801 Subpart D)

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)

W. Mala for M. Husband

.... CONSERVED SEQUENCE

K0 63488

Page T2.12

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).