(215 days)
Not Found
No
The description focuses on a chemical reaction for oxygen generation and does not mention any computational or algorithmic components indicative of AI/ML.
No
The device is intended for emergency first aid administration of oxygen, which is a supportive rather than therapeutic function in the context of the device itself. The oxygen generator is considered a portable oxygen generator according to the provided text.
No
The device is intended to generate and administer oxygen for emergency first aid, not to diagnose a medical condition.
No
The device description clearly outlines a physical, portable device that produces oxygen through a chemical reaction, involving components like a container, tubing, and a face mask. This is a hardware device, not software.
Based on the provided information, the emOx™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "generate 99% pure oxygen for emergency first aid administration." This is a therapeutic use, providing a substance to the patient for treatment.
- Device Description: The device produces oxygen for direct administration to the patient via a mask. It does not analyze samples taken from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic purposes, or any of the typical functions of an IVD device.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The emOx™ device's function is to provide oxygen directly to the patient, which is a therapeutic intervention, not a diagnostic one.
N/A
Intended Use / Indications for Use
The emOx™ device by MedTrak is intended to generate 99% pure oxygen for emergency first aid administration.
Product codes
Not Found
Device Description
The emOx™ device is a lightweight, portable device that produces oxygen of greater than 99% purity by a chemical reaction. The evolved oxygen bubbles pass through a water-filled chamber to humidify the gas on its way to the patient via flexible, ribbed tubing and an open adult or pediatric face mask.
The device, other than the face mask, does not come into contact with the patient. The mask is a currently legally marketed adult or pediatric mask. The oxygen container is constructed of polypropylene. Therefore, the biocompatibility of the materials used is without significance.
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
Not Found
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
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Summary of Performance Studies
Non-clinical Tests:
Testing was performed by independent test laboratories for the following:
- Purity of oxygen produced - >99% pure
- Contaminants - Non-toxic
- Stability
- Decomposition products - No detectable CO or CO2 No fire or explosion hazard
- Mean Flow rate - 4.6 L/min
Clinical Tests:
No clinical tests were performed.
Test Conclusions:
MedTrak's emOx™ device meets product specifications and requirements of the Food and Drug Administration for classification as a Portable Oxygen Generator.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).
0
510(k) Premarket Notification for MedTrak International Inc: emOxTM
Appendix VI, Page 1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
- General Information 】.
| A. Submitted By: | MedTrak International, Inc.
9841 Broken Land Parkway, Suite 107
Columbia, MD 21406
Tel: (410) 381-6488
Fax: (410) 381-6496 |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Belinda E. Berning at address above |
| B. Device Trade Name:
Common Name
Classification Name: | emOx™™™
Emergency Oxygen Generator
Portable Oxygen Generator |
| C. Predicate Device: | Model 415 Oxygen Canister
(Jet Research, Inc. - K780020) |
D. Device Description:
The emOx™ device is a lightweight, portable device that produces oxygen of greater than 99% purity by a chemical reaction. The evolved oxygen bubbles pass through a water-filled chamber to humidify the gas on its way to the patient via flexible, ribbed tubing and an open adult or pediatric face mask.
The device, other than the face mask, does not come into contact with the patient. The mask is a currently legally marketed adult or pediatric mask. The oxygen container is constructed of polypropylene. Therefore, the biocompatibility of the materials used is without significance.
-
E. Intended Use:
The emOx™ device by MedTrak is intended to generate 99% pure oxygen for emergency first aid administration. -
F. Device Comparison:
The MedTrak emOx™ Emergency Oxygen Generator is substantially equivalent to various other currently legally marketed devices, including the Model 415 Oxygen Canister by Jet Research Center, Inc. Each of these devices generates a minimum of 60 liters of oxygen of greater than 99% purity by chemical
1
PREUNDIN
reaction, which can be delivered to the patient at 4.0 L/min. or greater mean flow rates.
- II. Testing
- A. Non-clinical Tests:
Testing was performed by independent test laboratories for the following:
99% pure
Non-toxic 4.6 L/min
No detectable CO or CO2 No fire or explosion hazard
-
- Purity of oxygen produced
-
- Contaminants
-
- Stability
-
- Decomposition products
-
- Mean Flow rate
B. Clinical Tests:
No clinical tests were performed.
- C. Test Conclusions:
MedTrak's emOx™ device meets product specifications and requirements of the Food and Drug Administration for classification as a Portable Oxygen Generator.