(246 days)
Not Found
No
The device description and performance studies focus on electrochemical sensing technology and standard performance metrics, with no mention of AI or ML.
No.
The device measures oxygen concentration in breathing gas mixtures and is intended to replace components in oxygen analyzers, which are diagnostic or monitoring tools, not therapeutic devices that directly treat a condition.
No
The device is a sensor used within an oxygen analyzer to measure oxygen concentration. It is a component that measures a physiological parameter (oxygen levels in breathing gas mixtures) rather than directly diagnosing a disease or condition. While the data it provides might be used for diagnostic purposes by a larger system or clinician, the sensor itself is for measurement.
No
The device is described as an "electrochemical galvanic type device" and mentions physical shape, signal connection, and signal output, indicating it is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure oxygen concentration in breathing gas mixtures. This is a measurement of a gas, not a biological sample taken from the human body.
- Device Description: The device is an electrochemical galvanic type sensor that measures oxygen in a gas mixture. It does not interact with or analyze biological specimens.
- Lack of IVD Characteristics: The description does not mention any analysis of blood, urine, tissue, or any other biological sample. The performance studies focus on the accuracy and performance of the sensor in measuring oxygen in a gas, not on diagnostic accuracy related to a disease or condition.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device measures a component of the air being breathed, which is not a biological specimen in the context of IVD regulation.
N/A
Intended Use / Indications for Use
Percent Oxygen Sensors are intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.
Product codes (comma separated list FDA assigned to the subject device)
CCL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Environment of Use: Hospital/institutional, pre-hospital, industrial and home settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy Precision Specificity Sensitivity Linearity Range Response time
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K952736 Analytic Industries Percent Oxygen Sensors
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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®, LLC |
| 103 Carnegie Center Ste. 300 | |
| Princeton, NJ 08540 | |
| Tel - 609.524.2540 | |
| Sponsor Contact: | Young Kim – CEO |
| Submission Correspondent: | Paul Dryden |
| ProMedic, 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. |
|---|---|
| --------------------- | ------------------------------------------------------------------------------ |
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 | Predicate
Analytic Industries
Percent Oxygen Sensors | Subject Device
CareOx | Equivalency to at least one or
both devices |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| K# | K952736 | TBD | Similar |
| Product Code
Classification Name | Analyzer, Gas, Oxygen, Gaseous-Phase
CCL | Analyzer, Gas, Oxygen, Gaseous-Phase
CCL | Similar |
| 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. | Percent Oxygen Sensors are intended to replace the
original oxygen-sensing components of an oxygen
analyzer that measures oxygen concentration in
breathing gases. | Similar |
| Environments of
use | Replacement sensor for equipment that provides
inspired oxygen concentrations | Replacement sensor for equipment that provides
inspired oxygen concentrations | Similar |
| Principle of
operation | Electrochemical galvanic | Electrochemical galvanic | Similar |
| Prescriptive | Yes | Yes | Similar |
| Service Life | The life of sensor is based on the Faraday's law of
electrolysis, i.e., the current generated by the sensor
per unit volume of oxygen and the amount of the
lead anode in the sensor determines the life of the
sensor. Only 70% of theoretically calculated sensor
life is used to claim the useful life of the sensor. For
example, if theoretical life is calculated as 90
months, the claimed life of the sensor would be 63
months. | The life of sensor is based on the Faraday's law of
electrolysis, i.e., the current generated by the sensor
per unit volume of oxygen and the amount of the
lead anode in the sensor determines the life of the
sensor. Only 70% of theoretically calculated sensor
life is used to claim the useful life of the sensor. For
example, if theoretical life is calculated as 90
months, the claimed life of the sensor would be 63
months. | 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.