(156 days)
No
The summary describes a simple disposable oxygen analyzer and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as training and test set descriptions typically associated with AI/ML development.
No
The OxiCheck is an oxygen analyzer, a diagnostic tool for measuring oxygen concentration in air/oxygen mixtures, not for treating patients.
No
The OxiCheck is described as an oxygen analyzer that checks the oxygen concentration of a delivered air/oxygen mixture, not a device used to diagnose a patient's medical condition. It explicitly states it is "not intended for patient monitoring."
No
The device description explicitly states "The OxiCheck is a disposable oxygen analyzer," which implies a physical hardware component for measuring oxygen concentration.
Based on the provided information, the OxiCheck is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- OxiCheck's Function: The OxiCheck measures the oxygen concentration of an air/oxygen mixture delivered to a patient, not a specimen taken from a patient. It's analyzing a gas mixture, not a biological sample.
- Intended Use: The intended use clearly states it's for checking or measuring oxygen concentration of a delivered mixture and is not for patient monitoring or use in breathing systems.
Therefore, the OxiCheck falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
CCL
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.
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
Intended for use in Hospitals, Sub-acute Institutions, Transport, and Home care 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
1
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 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. | |
| 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 |