The OxiCheck is intended as a tool for use by qualified personnel to check or measure oxygen concentration of a delivered air / oxygen mixture. The OxiCheck is not intended for use in breathing systems and is not intended for patient monitoring. It is not intended to be used to continuously monitor or confirm oxygen delivery to a patient. The OxiCheck is intended to be used in hospitals, Sub-acute Institutions, Transport, and Home care. The OxiCheck is not intended for use in a MRI environment.

Device Description

The OxiCheck is a disposable oxygen analyzer that checks the oxygen concentration (also called fractional inspired oxygen, FiO2) of a delivered air/oxygen mixture.

AI/ML Overview

Here's an analysis of the provided text regarding the OxiCheck device, focusing on acceptance criteria and study information:

The document (K023565) describes the Caradyne OxiCheck, an oxygen analyzer. It is a 510(k) submission, meaning it aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the document primarily focuses on technical specifications and similarities to predicate devices, rather than detailed clinical study data typically associated with new medical device approvals.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a separate section. However, the "Design and Specifications" and "Performance Standards" tables effectively serve as the acceptance criteria that the device claims to meet.

Attribute/Acceptance Criteria (Implicit)	Reported Device Performance (OxiCheck)
Measurement range	0 to 100% O₂
Display resolution	1% O₂
Response time	< 10 seconds to 90% of final value
Linearity error	< 3% of reading
Drift	< 1% O₂ over 8 hours
Humidity influence	< 1% O₂ between 0 and 95% RH at 25°C
Pressure influence	Proportional to changes in atmospheric pressure
Operating temperature	0 to 50°C
Temperature compensation	Integral NTC compensation
Operating humidity	0 to 95% RH
Storage temperature	-20 to 60°C in supplied shipping container. Recommended: 5 to 15°C
Battery power indicator	Device powers off when battery is depleted
Analyzer life	500,000 oxygen hours (15 months continuous use at 45% O₂ or 5000 hours at 100% O₂)
Materials (In-line tee)	PVC (Same material as Criterion 60 – K000959)
Compliance to ASTM F1462-93 (Oxygen Analyzers)	Complies to applicable sections
Compliance to ISO 7767:1997 (Oxygen Monitors)	Complies to applicable sections
Compliance to ISO 5356 (Conical fittings)	Complies

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 explicitly describe a separate "test set" and its sample size in the context of clinical or performance data for the OxiCheck itself. The information provided heavily relies on a comparison to predicate devices and compliance with international standards.

For the predicate devices (Ceramatec - Handi - K973282 and Caradyne - Criterion 60 - K000959), it's implied that their prior FDA clearance served as validation. The document states, "The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices." This suggests that the "test" primarily involved demonstrating that the OxiCheck's specifications and functionality are comparable to these already cleared devices, rather than conducting new, large-scale studies.

Data Provenance: Not specified for any performance testing of the OxiCheck itself. The manufacturer is Caradyne, Ltd. in Galway, Ireland, suggesting the device development and internal testing likely occurred there.
Retrospective/Prospective: Not applicable or specified for a distinct clinical test set.

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)

This is not applicable to the information provided. The OxiCheck is an oxygen analyzer, and its "ground truth" would be established by reference gas mixtures or calibrated laboratory equipment, not by human expert opinion or interpretation of medical images.

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

Not applicable. This device's performance is measured against objective physical standards (e.g., accuracy against a known oxygen concentration), not subjective human interpretation requiring adjudication.

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-assisted diagnostic device, nor is it a device that relies on human "readers" in the context of an MRMC study. It is a standalone measurement tool.

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

Yes, in essence. The provided performance specifications for the OxiCheck (measurement range, accuracy, response time, drift, etc.) describe its intrinsic, standalone performance without a human in the loop for its measurement function. The device's function is to measure and display oxygen concentration, which is an automated process. The human interacts with the device by reading its display and applying it in a clinical context.

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

For the performance specifications listed, the ground truth would be based on highly accurate and calibrated reference gas mixtures (e.g., nitrogen/oxygen blends of known concentrations) used in a laboratory setting to test the device's accuracy, linearity, and response time. Environmental chambers would be used to test humidity, temperature, and pressure influences.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. Its functionality is based on electrochemical principles for oxygen sensing and electronic design, not learned patterns from data.

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

Not applicable, as no training set is relevant for this device.

Summary

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KO23565

MAR 2 8 2003

510(k) Summary of Safety and Effectiveness

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

January 22, 2003

Caradyne, Ltd.	Tel 011 (353) 91-709010
Parkmore Business Park	Fax 011 (353) 91-758929
Parkmore West
Galway, Ireland
Official Contact:	John, O'Dea, PhD - General Manager
Proprietary or Trade Name:	OxiCheck

Proprietary or Trade Name: Common/Usual Name: Classification Name: Predicate Devices:

OxiCheck Oxygen analyzer Analyzer, Gas, Oxygen, gaseous phase Ceramatec - Handi - K973282 Caradyne - Criterion 60 - K000959

Device Description:

The OxiCheck is a disposable oxygen analyzer that checks the oxygen concentration (also called fractional inspired oxygen, FiO2) of a delivered air/oxygen mixture.

Intended Use:

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

The OxiCheck is not intended for use in breathing systems and is not intended for patient monitoring. It is not intended to be used to continuously monitor or confirm oxygen delivery to a patient.

Environment of Use:

Intended for use in Hospitals, Sub-acute Institutions, Transport, and Home care settings. The OxiCheck is not intended for use in a MRI environment.

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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 January 22, 2003

General Technical Characteristics
Attribute	Caradyne - OxiCheck - Proposed device
Indications for use	The OxiCheck is intended as a tool for use by qualified personnel tocheck or measure oxygen concentration of a delivered air / oxygenmixture. The OxiCheck is not intended for use in breathing systemsand is not intended for patient monitoring. It is not intended to beused to continuously monitor or confirm oxygen delivery to apatient.
Disposable	Yes
Prescription	Yes
Intended Environment of Use	Hospitals, Sub-acute Institutions, Transport, Home care.The OxiCheck is not intended for use in a MRI environment.
Design and Specifications
Measurement range	0 to 100% O₂.
Display resolution	1% O₂.
Response time	< 10 seconds to 90% of final value.
Linearity error	< 3% of reading.
Drift	< 1% O₂ over 8 hours.
Humidity influence	< 1% O₂ between 0 and 95% RH at 25°C.
Pressure influence	Proportional to changes in atmospheric pressure.
Operating temperature	0 to 50°C.
Temperature compensation	Integral NTC compensation.
Operating humidity	0 to 95% RH.
Storage temperature	-20 to 60°C in supplied shipping container.
Recommended storage temperature	5 to 15°C.
Battery power indicator	Device powers off when battery is depleted.
Analyzer life	500,000 oxygen hours (15 months continuous use at 45% O₂ or 5000hour at 100% O₂).
Weight	~ 90 gram
Materials
In-line tee - PVC	Yes - Same material as Criterion 60 – K000959
Performance Standards
None under Section 514	Yes
ASTM F1462-93 - Specification forOxygen Analyzers	Complies to applicable sections
ISO 7767:1997 - Oxygen Monitors forMonitoring Patient Breathing Mixtures –Safety Requirements	Complies to applicable sections
ISO 5356 – 15 / 22 mm Conical fittings	Complies

Differences between Other Legally Marketed Predicate Devices

The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of three wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2003

Caradyne Limited C/O Mr. Paul Dryden ProMedic, Incorporated 6329 West Waterview Court McCordsville, Indiana 46055-9501

Re: K023565

Trade/Device Name: OxiCheck Regulation Number: 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: II Product Code: CCL Dated: January 22, 2003 Received: January 23, 2003

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 (OS) 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 (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 Division 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 vours.

Susan Renner

Susan Runner, DDS, MA Interim 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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Indications for Use

	Page 1 of 1
510(k) Number:	K023565 (To be assigned)
Device Name:	OxiCheck
Intended Use:	The OxiCheck is intended as a tool for use by qualified personnel to check or measure oxygen concentration of a delivered air / oxygen mixture.The OxiCheck is not intended for use in breathing systems and is not intended for patient monitoring. It is not intended to be used to continuously monitor or confirm oxygen delivery to a patient.The OxiCheck is intended to be used in hospitals, Sub-acute Institutions, Transport, and Home care.The OxiCheck is not intended for use in a MRI environment.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per CFR 801.109) or Over-the-counter use __

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K023565

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).