(141 days)
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.
Rx use: A portable oxygen generator intended to produce oxygen to provide supplemental oxygen as prescribed by a physician. Environment of use – Home, institutional, travel / mobile environments.
A portable oxygen generator that utilizes a chemical reaction to generate oxygen. It is available in two versions: Emergency Use - OTC and Rx use. The Emergency Use version provides a minimum flow rate of 6 LPM for at least 15 minutes with a total oxygen capacity of 90 liters. The Rx use version provides variable flow rates (0.5 LPM for 60 minutes/30 liters capacity and 3 LPM for 30 minutes/90 liters capacity) as prescribed by a physician. Both versions are single use and disposable and use a standard oxygen mask or nasal cannula for patient interface.
The provided text describes two devices, O2-in-a-box™ for Emergency Use (OTC) and O2-in-a-box™ for Rx Use, which are portable oxygen generators. The document focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria. However, based on the comparative tables and performance testing sections, we can infer acceptance criteria and reported performance.
1. Table of Acceptance Criteria and Reported Device Performance
Here's a table summarizing the acceptance criteria (primarily based on predicate device specifications and stated minimums) and the reported performance of the O2-in-a-box™ devices.
| Feature / Metric | Acceptance Criteria (Emergency Use - OTC) | Reported Device Performance (Emergency Use - OTC) | Acceptance Criteria (Rx Use) | Reported Device Performance (Rx Use) |
|---|---|---|---|---|
| % Oxygen | > 99% | > 99% | 89% +/- 3% (from predicate, but proposed device states > 99%) | > 99% |
| Flow rate minimum | 6 LPM | > 6 LPM | Variable flow rates (0.5 LPM, 3.0 LPM) | 0.5 LPM and 3.0 LPM |
| Duration of flow | At least 15 minutes | At least 15 minutes | 0.5 LPM for 60 minutes; 3.0 LPM for 30 minutes | 0.5 LPM for 60 minutes; 3.0 LPM for 30 minutes |
| Total Oxygen Capacity | 90 liters | 90 liters | 0.5 LPM: 30 liters; 3.0 LPM: 90 liters | 0.5 LPM: 30 liters; 3.0 LPM: 90 liters |
| VOC / PM2.5 | Within acceptable limits (based on EPA TO-15 VOC and NIOSH 0500 PM2.5) | Met and passed testing; demonstrated within acceptable limits | Within acceptable limits (based on EPA TO-15 VOC and NIOSH 0500 PM2.5) | Met and passed testing; demonstrated within acceptable limits |
| Bacteria / Mold Testing | Passed testing (implied by "met and passed all performance testing") | Met and passed testing | Passed testing (implied by "demonstrate safety we have performed the following bench tests") | Met and passed testing |
| Environmental Testing (Temp) | Passed high and low temperature conditions (implied) | Met and passed testing | Passed high and low temperature conditions (implied) | Met and passed testing |
| Mechanical Testing (Vibration) | Passed vibration testing (implied) | Met and passed testing | Passed vibration testing (implied) | Met and passed testing |
| External Container Temp | Not explicitly stated as criterion, but tested ("including external container temperature") | Not explicitly stated, but results passed "all performance testing" | < 45°C (from predicate) | < 45°C |
| Temperature of Gas at Outlet | Not explicitly stated as criterion, but tested ("including temperature of gas at outlet") | Not explicitly stated, but results passed "all performance testing" | Ambient at patient interface (from predicate); < 45°C at outlet (proposed device) | < 45°C at outlet; Ambient at patient interface |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for performance testing. It mentions "Performance testing was performed" and lists various tests, concluding that "The proposed devices met and passed all the performance testing as outlined above." This implies that a sufficient number of units were tested to demonstrate compliance, but specific numbers are not provided.
The data provenance is from bench testing conducted by Get-O2, Inc. The document does not specify the country of origin of the data beyond "Get-O2, Inc." being located in Westport, CT, USA. It is prospective testing performed on the O2-in-a-box™ devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in this context. The "ground truth" for these tests relates to physical measurements and chemical analyses (e.g., oxygen concentration, flow rate, temperature, chemical composition). These are objective measurements determined by laboratory equipment and standard test methods (e.g., EPA TO-15 VOC, NIOSH 0500 PM2.5), not through expert consensus or interpretation.
4. Adjudication Method for the Test Set
This is not applicable. As mentioned above, the performance tests involve objective measurements, not subjective evaluations requiring adjudication. The results are either within the specified limits or not.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is evaluated. The O2-in-a-box™ devices are portable oxygen generators, which are therapeutic medical devices whose performance is assessed through bench testing against physical and chemical specifications, not by human reader interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, standalone performance testing was done. The entire performance testing described (VOC/PM2.5, Bacteria/Mold, Environmental, Mechanical, Flow Rate, Duration, % Oxygen) assesses the device's inherent performance characteristics independent of human interaction during operation other than activating the device. The reported performance refers exclusively to the device's capabilities.
7. The Type of Ground Truth Used
The ground truth used for performance testing is based on objective physical and chemical measurements obtained through standard laboratory test methods. Examples include:
- Direct measurement of oxygen concentration using appropriate sensors.
- Measurement of flow rate and duration using flow meters and timers.
- Chemical analysis for VOCs, PM2.5, and residual hydrogen peroxide according to established methods (e.g., EPA TO-15 VOC, NIOSH 0500 PM2.5).
- Microbiological testing for bacteria and mold.
- Temperature measurements for housing and gas outlet.
- Mechanical stress tests for vibration.
8. The Sample Size for the Training Set
This is not applicable. The O2-in-a-box™ is a physical, chemical-reaction-based device, not an AI or algorithm-driven system that requires a "training set" in the machine learning sense. Its performance is inherent in its design and manufacturing.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8. There is no AI training set for this device.
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FEB 1 1 2011
510(k) Summary Page 1 of 5 10-Feb-11
| Get-O2, Inc.27 Bayberry LaneWestport, CT 06880 | Tel - 603-570-2579 |
|---|---|
| Official Contact: | Richard P. Imbruce, Ph.D, President |
| Proprietary or Trade Name: | O2-in-a-boxTM - Emergency Use - OTCO2-in-a-boxTM - Rx use |
| Common/Usual Name: | Portable oxygen generator |
| Classification Name: | Portable Oxygen GeneratorCAW - 868.5440 |
| Predicate Devices: | OxySure - Model 615 - K052396 - Emergency UseOxytec - 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 .
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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 | PredicateOxySure K052396 | Proposed DeviceO₂-in-a-box™OTC - Emergency Use |
|---|---|---|
| Indications for use | To produce oxygen for emergencyuse | To produce oxygen foremergency 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 nasalcannula | Standard oxygen mask or nasalcannula |
| Specifications | % Oxygen - 99%Flow rate minimum - 6 LPMDuration at least 15 minutes90 liter oxygen capacity | % Oxygen - 99%Flow rate minimum - 6 LPMDuration at least 15 minutes90 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 | MaskOxygen cannula | MaskOxygen 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.
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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:
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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 | < 45°C | < 45°C |
| Temperature of gas at outlet | Ambient at patient interface | < 45°C at outlet |
| Ambient at patient interface | ||
| Accessories / Patient interface | Mask | Mask |
| Oxygen cannula | Oxygen cannula |
Indications -
The O2-in-a-box™ for Rx Use is intended to provide supplemental oxygen to individuals as prescribed by a clinician. These indications are identical to predicate - Oxytec (K043615).
Technology -
The O2-in-a-box™ for Rx Use utilizes chemical reaction technology which is equivalent to the predicate OxySure (K052396) for flow rates < 6 LPM.
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510(k) Summarv Page 5 of 5 10-Feb-11
Environment of Use -
The O2-in-a-box™ for Rx Use is intended to be used in environments which are equivalent to the predicate Oxytec (K043615). These can include home, institutional, travel / mobile environments.
Patient Population -
The O4-in-a-box™ for Rx Use has the identical patient population, those requiring supplemental oxygen, as the predicate Oxytec (K043615). In addition, as defined in the FDA guidelines for devices delivery < 6 LPM or 90 liters oxygen capacity they are to be considered prescriptive.
Performance Specifications -
The O2-in-a-box™ for Rx Use has similar performance specifications, variable flow rates, as the predicate Oxytec (K043615).
Since this is a prescriptive device, the prescriber is to instruct the patient as to the prescribed flow rates of oxygen needed and the proposed device will be matched to those prescribed requirements. This is similar to the predicate Oxytec (K043615) device.
Performance Testing -
To demonstrate safety we have performed the following bench tests:
- VOC / PM > < 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 .
Materials and Biocompatibility -
To demonstrate biocompatibility, all the materials in the gas pathway have been tested via VOC and PM2 < and found to be within the acceptable limits as outlined in Volatile Organic Compounds (VOC) test method - EPA TO-15 VOC and Particulate Material (PM) test method -NIOSH 0500 PM2 5.
Conclusion -
The O2-in-a-box™ for Rx Use is equivalent to the predicates for indications for use, environments of use, patient population, technology, and performance specifications.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 1 2011
Geto2. Incorporated C/O Mr. Paul Dryden Promedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134
Re: K102750
Trade/Device Name: O²-in-a-box™ portable oxygen generator –Emergency – OTC
O²-in-a box" - Rxx use Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: February 3, 2011 Received: February 4, 2011
Dear Mr. 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. 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.
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Page 2- Mr. Dryden
Enclosure
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices.and Radiological Health
{7}------------------------------------------------
Indications for Use Statement
Page 1 of 2
510(k) Number: K102750
O2-in-a-box™ portable oxygen generator -Device Name: Emergency - OTC
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.
Environment of use - locations where emergency oxygen maybe needed
Prescription Use (Part 21 CFR 801 Subpart D) or
Over-the-counter use XX (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)
(Division Sign-Off) (Division Sign-off)
Division of Anesthesiology, General Hospital
Division of Anest Partist Davises Division of Anoot, Dental Devices
K102750 510(k) Number: _
{8}------------------------------------------------
Indications for Use Statement
Page 2 of 2
| 510(k) Number: | K102750 |
|---|---|
| Device Name: | O 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
§ 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).