Percent Oxygen Sensors are intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.

Device Description

The subject device is a family of Medical Oxygen Sensors which may be used as industry replacement types with various medical inspired-oxygen measuring devices. The oxygen sensors are all electrochemical galvanic type devices. The difference between models is merely the physical shape of the external housing (the basic oxygen sensor is often time encapsulated in a secondary housing), signal connection, signal output and the response time. The family of oxygen sensors concept extends to OEM manufacturers of anesthesia and respiratory therapy equipment. Again, the difference between models is merely the physical shape of the external housing (the basic oxygen sensor is often time encapsulated in a secondary housing), signal connection, signal output and the response time in order for the OEM to exercise a degree of control over the recurring replacement of oxygen sensors.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Percent Oxygen Sensors" by CareOx, LLC, referencing the predicate device K952736 by Analytic Industries Percent Oxygen Sensors. The submission argues for substantial equivalence based on identical technology, principle of operation, indications for use, and similar operating specifications, environment of use, and patient population.

However, the document does not contain the detailed acceptance criteria for standalone device performance, nor the specific results of a study proving the device meets those criteria. It states that "The subject devices are manufactured by Analytical Industries Inc. and were cleared under K952736. CareOx, the sponsor of this submission is purchasing final, finished oxygen sensors from Analytical Industries Inc. with the private label of CareOx." This implies that the device itself is identical to the predicate.

The document mentions "Non-clinical Testing" including "Accuracy, Precision, Specificity, Sensitivity, Linearity, Range, Response time" and states that "We have performed the applicable test from ISO 80601-2-55." However, it does not provide the acceptance criteria for these tests or the reported performance results against those criteria.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can be extracted, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Attribute	Acceptance Criteria (Not explicitly stated for the subject device results)	Reported Device Performance (Not explicitly stated for the subject device results)
Accuracy	Not explicitly stated	Not explicitly stated (only that "applicable tests" were performed)
Precision	Not explicitly stated	Not explicitly stated (only that "applicable tests" were performed)
Specificity	Not explicitly stated	Not explicitly stated (only that "applicable tests" were performed)
Sensitivity	Not explicitly stated	Not explicitly stated (only that "applicable tests" were performed)
Linearity	Not explicitly stated	Not explicitly stated (only that "applicable tests" were performed)
Range	Not explicitly stated	Not explicitly stated (only that "applicable tests" were performed)
Response time	Not explicitly stated	Not explicitly stated (only that "applicable tests" were performed)
Substantial Equivalence	Equivalence to predicate device K952736	Demonstrated through performance testing, design, and non-clinical testing; no differences reported from predicate.

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

Sample size: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing mentioned is "Non-clinical Testing" performed to ISO 80601-2-55.

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

This information is not applicable and not provided. The testing described is non-clinical (device performance against standards), not clinical evaluation requiring expert ground truth for interpretation like imaging studies.

4. Adjudication method for the test set

Not applicable and not provided. See point 3.

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, an MRMC study was not done. This device is an oxygen sensor, not an AI-assisted diagnostic tool.

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

Yes, the non-clinical testing described (Accuracy, Precision, Specificity, Sensitivity, Linearity, Range, Response time) is considered standalone performance testing of the device itself. Specific results are not provided in this document, but the claim is that "applicable test[s] from ISO 80601-2-55" were performed.

7. The type of ground truth used

For the non-clinical tests, the ground truth would typically be established by calibrated reference standards (e.g., known concentrations of oxygen for accuracy and linearity testing). The document does not explicitly state the specific reference standards used.

8. The sample size for the training set

Not applicable. This device is a sensor, not a machine learning algorithm that requires a training set.

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

Not applicable. See point 8.

Summary

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August 19, 2022

CareOx, LLC % Paul Dryden Consultant ProMedic Consulting, LLC 131 Bav Point Dr NE Saint Petersburg, Florida 33704

Re: K213933

Trade/Device Name: Percent Oxygen Sensors Regulation Number: 21 CFR 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: Class II Product Code: CCL Dated: July 20, 2022 Received: July 21, 2022

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality 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) K213933

Device Name Percent Oxygen Sensors

Indications for Use (Describe)

Percent Oxygen Sensors are intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Date:	August 16, 2022
Sponsor:	CAREOX®, LLC103 Carnegie Center Ste. 300Princeton, NJ 08540
	Tel - 609.524.2540
Sponsor Contact:	Young Kim – CEO
Submission Correspondent:	Paul DrydenProMedic, LLC
Proprietary or Trade Name:	Percent Oxygen Sensors
Common/Usual Name:	Oxygen Sensors
Regulation Number:	21CFR 868.1720
Regulation Code:	Analyzer, Gas, Oxygen, Gaseous-Phase
Product Code:	CCL
Regulatory Class:	II
Predicate Device:	K952736 Analytic Industries Percent Oxygen Sensors

Device Description:

The subject device is a family of Medical Oxygen Sensors which may be used as industry replacement types with various medical inspired-oxygen measuring devices.

The oxygen sensors are all electrochemical galvanic type devices. The difference between models is merely the physical shape of the external housing (the basic oxygen sensor is often time encapsulated in a secondary housing), signal connection, signal output and the response time.

The family of oxygen sensors concept extends to OEM manufacturers of anesthesia and respiratory therapy equipment. Again, the difference between models is merely the physical shape of the external housing (the basic oxygen sensor is often time encapsulated in a secondary housing), signal connection, signal output and the response time in order for the OEM to exercise a degree of control over the recurring replacement of oxygen sensors.

Indications for Use:

Percent Oxygen Sensors are intended to replace the original oxygen-sensing components of an oxygen analyzer that measures oxygen concentration in breathing gases.

Patient Population:	The sensor follows the population of the equipment for which it is attached.
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Environment of Use: Hospital/institutional, pre-hospital, industrial and home settings.

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Substantial Equivalence Discussion:

The subject devices are manufactured by Analytical Industries Inc. and were cleared under K952736. CareOx, the sponsor of this submission is purchasing final, finished oxygen sensors from Analytical Industries Inc. with the private label of CareOx.

Indications - Equivalent to the predicate

Technology - The technology is identical

Principal of Operation - The principal of operation is identical

Operating specifications – Equivalent

Environment of Use - Similar

Patient Population – Similar

Non-clinical Testing

We have performed the applicable test from ISO 80601-2-55.

These tests includes: Accuracy Precision Specificity Sensitivity Linearity Range Response time

Differences:

There are no differences between the proposed device and the predicate device.

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Table of Comparison to Predicate

Attribute	PredicateAnalytic IndustriesPercent Oxygen Sensors	Subject DeviceCareOx	Equivalency to at least one orboth devices
K#	K952736	TBD	Similar
Product CodeClassification Name	Analyzer, Gas, Oxygen, Gaseous-PhaseCCL	Analyzer, Gas, Oxygen, Gaseous-PhaseCCL	Similar
Indications for Use	Percent Oxygen Sensors are intended to replace theoriginal oxygen-sensing components of an oxygenanalyzer that measures oxygen concentration inbreathing gases.	Percent Oxygen Sensors are intended to replace theoriginal oxygen-sensing components of an oxygenanalyzer that measures oxygen concentration inbreathing gases.	Similar
Environments ofuse	Replacement sensor for equipment that providesinspired oxygen concentrations	Replacement sensor for equipment that providesinspired oxygen concentrations	Similar
Principle ofoperation	Electrochemical galvanic	Electrochemical galvanic	Similar
Prescriptive	Yes	Yes	Similar
Service Life	The life of sensor is based on the Faraday's law ofelectrolysis, i.e., the current generated by the sensorper unit volume of oxygen and the amount of thelead anode in the sensor determines the life of thesensor. Only 70% of theoretically calculated sensorlife is used to claim the useful life of the sensor. Forexample, if theoretical life is calculated as 90months, the claimed life of the sensor would be 63months.	The life of sensor is based on the Faraday's law ofelectrolysis, i.e., the current generated by the sensorper unit volume of oxygen and the amount of thelead anode in the sensor determines the life of thesensor. Only 70% of theoretically calculated sensorlife is used to claim the useful life of the sensor. Forexample, if theoretical life is calculated as 90months, the claimed life of the sensor would be 63months.	Similar

Substantial Equivalence Conclusion:

The sponsor has demonstrated through performance testing, design and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.

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).