(141 days)
Not Found
No
The device description and performance studies focus on chemical reaction and mechanical properties, with no mention of AI or ML.
Yes.
The device is intended to produce oxygen for emergency use and to provide supplemental oxygen as prescribed by a physician, which are therapeutic applications.
No
The device is an oxygen generator intended to produce oxygen for emergency use or as supplemental oxygen as prescribed by a physician. It does not perform any diagnostic function.
No
The device description clearly states it is a "portable oxygen generator that utilizes a chemical reaction to generate oxygen," indicating it is a physical device with hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that this device generates oxygen for inhalation, either for emergency use or as prescribed supplemental oxygen. It does not involve the analysis of any biological samples.
- The device's function is to provide a therapeutic gas (oxygen) directly to the patient. This falls under the category of medical devices used for treatment or support, not for diagnostic testing.
- The performance studies and key metrics focus on the device's ability to generate and deliver oxygen at specific flow rates and durations. They do not involve any measurements or analysis of patient samples or biological markers.
Therefore, this device is a medical device, specifically an oxygen generator, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Emergency Use - OTC: Intended to produce oxygen for emergency use. There is a minimum 6 LPM flow rate for at least 15 minutes established a minimum total oxygen capacity of 90 liters. Environment of use - locations where emergency oxygen maybe needed.
- Prescriptive Use: A portable oxygen generator intended to produce oxygen to provide supplemental oxygen as prescribed by a physician.
| Flow rate | Delivery Time | Total Oxygen Capacity |
|---|---|---|
| 0.5 LPM | 60 minutes | 30 liters |
| 3 LPM | 30 minutes | 90 liters |
Environment of use – Home, institutional, travel / mobile environments
Product codes
CAW
Device Description
The O2-in-a-boxTM is a portable oxygen generator available in two versions: Emergency Use - OTC and Rx use. The device utilizes a chemical reaction to generate oxygen. For Emergency Use - OTC, it provides a minimum 6 LPM flow rate for at least 15 minutes, with a total oxygen capacity of 90 liters. For Rx use, it offers variable flow rates and durations: 0.5 LPM for 60 minutes (30 liters total oxygen) and 3 LPM for 30 minutes (90 liters total oxygen). Both versions are single-use and disposable, and deliver > 99% oxygen. Patient interface is via a standard oxygen mask or nasal cannula.
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
Patient Population: No limitations (for OTC), Require supplemental oxygen (for Rx use).
Intended User / Care Setting
- Emergency Use - OTC: emergency locations
- Rx use: Home, institutional, travel / mobile environments. Caregivers, self directed (administers oxygen).
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)
Performance testing was performed:
- VOC / PM 2.5 and Residual Hydrogen Peroxide.
- Bacteria / Mold Testing.
- Environmental testing high and low temperature conditions.
- Mechanical testing vibration.
- Flow rate and flow duration for Emergency OTC and Rx Use including external container temperature and temperature of gas at outlet.
- % oxygen generated.
The proposed devices met and passed all the performance testing as outlined above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- % Oxygen - 99% (for OTC) / > 99% (for Rx)
- Flow rate minimum - 6 LPM (for OTC) / > 1-5 lpm (Predicate for Rx), 0.5 LPM and 3.0 LPM (Proposed device for Rx)
- Duration at least 15 minutes (for OTC) / Limited by battery life (Predicate for Rx), 0.5 LPM - 60 min - 30 l O2 and 3.0 LPM - 30 LPM - 90 l O2 (Proposed device for Rx)
- 90 liter oxygen capacity (for OTC)
- Housing temperature:
§ 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
FEB 1 1 2011
510(k) Summary Page 1 of 5 10-Feb-11
| Get-O2, Inc.
27 Bayberry Lane
| Westport, CT 06880 | Tel - 603-570-2579 |
|---|---|
| Official Contact: | Richard P. Imbruce, Ph.D, President |
| Proprietary or Trade Name: | O2-in-a-boxTM - Emergency Use - OTC |
| O2-in-a-boxTM - Rx use | |
| Common/Usual Name: | Portable oxygen generator |
| Classification Name: | Portable Oxygen Generator |
| CAW - 868.5440 | |
| Predicate Devices: | OxySure - Model 615 - K052396 - Emergency Use |
| Oxytec - Model 900 - K043615 - Rx use |
Device Description
Indications for Use
Emergency Use - OTC
Intended to produce oxygen for emergency use.
There is a minimum 6 LPM flow rate for at least 15 minutes established a minimum total oxygen capacity of 90 liters.
Prescriptive Use -
A portable oxygen generator intended to produce oxygen to provide supplemental oxygen as prescribed by a physician.
| Flow rate | Delivery Time | Total Oxygen Capacity |
|---|---|---|
| 0.5 LPM | 60 minutes | 30 liters |
| 3 LPM | 30 minutes | 90 liters |
Environment of Use
Emergency - OTC - locations where emergency oxygen maybe needed Rx use - Home, institutional, travel / mobile environments
Performance Testing
Performance testing was performed:
- VOC / PM 2.5 and Residual Hydrogen Peroxide .
- Bacteria / Mold Testing .
- Environmental testing high and low temperature conditions .
1
510(k) Summary Page 2 of 5 10-Feb-11
- Mechanical testing vibration ●
- . Flow rate and flow duration for Emergency OTC and Rx Use including external container temperature and temperature of gas at outlet
- . % oxygen generated
The proposed devices met and passed all the performance testing as outlined above.
Comparative Table - OTC - Emergency Use
| Features | Predicate
OxySure K052396 | Proposed Device
O₂-in-a-box™
OTC - Emergency Use |
|------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Indications for use | To produce oxygen for emergency
use | To produce oxygen for
emergency use |
| Environment of Use | Home, emergency locations | emergency locations |
| Patient Population | Not discussed | No limitations |
| Contraindications | None | None |
| Method for oxygen generation | Chemical reaction | Chemical reaction |
| Patient interface | Standard oxygen mask or nasal
cannula | Standard oxygen mask or nasal
cannula |
| Specifications | % Oxygen - 99%
Flow rate minimum - 6 LPM
Duration at least 15 minutes
90 liter oxygen capacity | % Oxygen - 99%
Flow rate minimum - 6 LPM
Duration at least 15 minutes
90 liter oxygen capacity |
| Single use, disposable | Yes | Yes |
| OTC designation | Yes | Yes |
| Performance testing | | |
| Flow rate | > 6 LPM | > 6 LPM |
| Duration of flow | At least 15 minutes | At least 15 minutes |
| % oxygen | >99% | > 99% |
| VOC / PM₂.₅ | Yes | Yes |
| Housing temperature | Yes | Yes |
| Temperature of gas at outlet | Yes | Yes |
| Accessories | Mask
Oxygen cannula | Mask
Oxygen cannula |
OTC - Emergency Use Substantial Equivalence
The O2-in-a-box™ for Emergency Use - OTC is viewed as substantially equivalent to the predicate device because:
Indications for Use -
Intended to produce oxygen for emergency use. There is a minimum 6 LPM flow rate for at least 15 minutes established a minimum total oxygen capacity of 90 liters.
2
510(k) Summary Page 3 of 5 10-Feb-11
Environment of use -
Locations where emergency oxygen may be needed.
Technology -
The O2-in-a-box™ for Emergency Use - OTC utilizes chemicals to be mixed when the device is ready for use. There chemical reaction generates oxygen. The used a chemical reaction to generate oxygen is identical technology to predicate OxySure (K052396).
Materials -
The materials in the gas pathway have been tested via VOC and PM2,5 as is expected for such devices. The test results demonstrate that the O2-in-a-box™ for Emergency Use - OTC does not generate unwanted particulate matter or undesirable gases. This is similar to the predicate OxySure (K052396).
Environment of Use -
The O2-in-a-box™ for Emergency Use - OTC has the identical environments of use, i.e. emergency settings, as does the predicate OxySure (K052396).
Patient Population -
The patient population is not specified by the predicate in the 510(k) Summary but the intended use is for individuals require oxygen in an emergency setting. This would be identical to the predicate OxySure (K052396).
Performance Specifications and Testing -
The O--in-a-box™ for Emergency Use - OTC has the minimum performance specifications required to meet emergency use, which are - at least a flow rate of 6 LPM for at least 15 minutes. This is identical to the predicate OxySure (K052396).
The O2-in-a-box™ for Emergency Use - OTC is equivalent to the predicate, OxySure (K052396), for performance specifications and testing.
The rationale for choosing the predicate is summarized as follows:
RX Use Substantial Equivalence
The O2-in-a-box™ for Rx Use is viewed as substantially equivalent to the predicate devices because:
3
510(k) Summary Page 4 of 5 10-Feb-11
Comparative Table - Rx Use
| Features | Predicate | Proposed Device |
|---|---|---|
| Oxytec Model 900 | O2-in-a-boxTM | |
| K043615 | OTC - Emergency Use | |
| Indications for use | For prescription use by patients | For prescription use by |
| requiring high concentration of | patients requiring oxygen on a | |
| oxygen on a supplemental basis | supplemental basis | |
| Environment of Use | Home, institutional, travel / | Home, institutional, travel / |
| mobile environments | mobile environments | |
| Patient Population | Require supplemental oxygen | Require supplemental oxygen |
| Contraindications | None | None |
| Method for oxygen generation | Molecular sieve | Chemical reaction |
| Patient interface | Standard oxygen mask or nasal | Standard oxygen mask or nasal |
| cannula | cannula | |
| Single use, disposable | No | Yes |
| Rx designation | Yes | Yes |
| Who designates use and sets | Clinician prescribes and designate | Clinician prescribes and |
| flow rate | flow rate | designate flow rate |
| Who administers oxygen | Caregivers, self directed | Caregivers, self directed |
| Performance testing | ||
| Flow rate range | > 1-5 1pm | 0.5 LPM and 3.0 LPM |
| Duration of flow / O2 capacity | Limited by battery life | 0.5 LPM - 60 min - 30 l O2 |
| 3.0 LPM - 30 LPM - 90 l O2 | ||
| % oxygen | 89% +/- 3% | > 99% |
| VOC / PM25 | Yes | Yes |
| Housing temperature | 2 -in-a-box™ portable oxygen generator -- Rx Use |
Indications for Use:
A portable oxygen generator intended to produce oxygen to provide supplemental oxygen as prescribed by a physician.
| Flow rate | Delivery Time | Total Oxygen Capacity | |
|---|---|---|---|
| 0.5 LPM. | 60 minutes | 30 liters | |
| 3 LPM | 30 minutes | 90 liters |
Environment of use – Home, institutional, travel / mobile environments
1 100
.....
.
| Prescription Use XX_ | or | Over-the-counter use _ |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
11/02750 510(k) Number: __
. .
. . .
100 100 100