The MAXO2+ is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/ oxygen mixture. The MAXO2+ is not intended for use in continuous monitoring of oxygen delivery to a patient.

Device Description

The MAXO2+ A(E) oxygen analyzer is a member of Maxtec's MAXO2 analyzer line of oxygen analyzers and monitors. It utilizes the MAX-250 oxygen sensor and is engineered for long life, maximum reliability and stable performance.

AI/ML Overview

The provided documents (K040484) describe a 510(k) premarket notification for the MAXO2+ oxygen analyzer by Maxtec, Inc. The submission outlines the device's intended use and general characteristics but does not include details about specific acceptance criteria or a study proving that the device meets such criteria.

Therefore, based on the information provided, it is not possible to complete the requested table and answer the questions related to the device's acceptance criteria and performance study. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Caradyne - OxiCheck - K023565) rather than presenting a detailed performance study with acceptance criteria.

Missing Information:

The provided text does not contain any information regarding:

A table of acceptance criteria and reported device performance.
Sample sizes used for a test set.
Data provenance (country of origin, retrospective/prospective).
Number of experts or their qualifications for ground truth establishment.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone (algorithm-only) performance studies.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
Sample size for the training set.
How ground truth for the training set was established.

Conclusion:

The provided 510(k) documents for the Maxtec MAXO2+ are primarily a regulatory submission demonstrating substantial equivalence. They do not contain the detailed technical validation study information that would be necessary to answer your specific questions regarding acceptance criteria, study design, and performance metrics.

Summary

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Maxtec, Inc

K040484
MAXO₂

510(k) NOTIFICATION - 9 2004

Section 1 - 510(k) Summary of Safety and Effectiveness

Non-Confidential Summary of Safety and Effectiveness February 19, 2004 Page 1 of 3

Maxtec, Inc 6526 S. Cottonwood Street Salt Lake City, UT 84107 U.S.A. Phone: (801) 266-5300 (801) 270-5590 Fax:

Official Contact:	Gordon R. Roth - Quality System Manager
Proprietary or Trade Name:	MAXO2+
Common/Usual Name:	Oxygen Analyzer
Classification Name:	Analyzer, Gas, Oxygen, Gaseous Phase
Predicate Device:	Caradyne - OxiCheck - K023565

Device Description:

Intended Use:

The MAXO2+ is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/ oxygen mixture.

The MAXO2+ is not intended for use in continuous monitoring of oxygen delivery to a patient.

Environment of Use:

The MAXO2+ is intended for use in Hospitals, Home Care, Transport, and Sub-acute Institutions. The MAXO2+ is not intended for use in a MRI environment.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2004

Mr. Gordon R. Roth Quality System Manager Maxtec. Incorporated 6526 South Cottonwood Street Salt Lake City, Utah 84107

Re: K040484

Trade/Device Name: MAX02+ Model "A" and "AE" Regulation Number: 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: II Product Code: CCL Dated: May 25, 2004 Received: May 26, 2004

Dear Mr. Roth:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined 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 mendments, or to devices that have been reclassified in accordance with the provisions of /incentinents, or to are rood Cosmetic Act (Act) that do not require approval of a premarket the redelar 1 000; Drag). You may, therefore, market the device, subject to the general approvial applicans of the Act. The general controls provisions of the Act include controls providens of an 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 (1 Mrx), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Roth

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 Incan that I DA mas made a statutes and regulations administered by other Federal agencies. of the Act of ally I outeral timated including, but not limited to: registration r ou intist comply wan and 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 CF Real 80%), systems (QS) regulation (21 CFR Part 820); and if requirenches as bet form inroduct 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) This letter wifi and in J . The FDA finding of substantial equivalence of your device to a premaired 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), If you desire specific at Compliance at (301) 594-4646. 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Carls

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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Maxtec, Inc

Statement of Indications for Use

MAXO2+

510(k) Number (if known): _ Ko4 o 40 40 4

Device Name: -----------------------------------------------------------------------------------------------------------------------------------------------------------------

Indications for Use: -------------------------------------- The MAXO2+ is intended as a tool for use by

qualified personnel to spot-check or measure oxygen concentration of a delivered air/ oxygen mixture

The MAXO2+ is not intended for use in continuous monitoring of oxygen delivery to a patient.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Quytlepour

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:________________________________________________________________________________________________________________________________________________________________

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).