O2-IN-A-BOX, O2-IN-A-BOX

K102750 · Geto2, Inc. · CAW · Feb 11, 2011 · Anesthesiology

Device Facts

• Record ID: K102750
• Device Name: O2-IN-A-BOX, O2-IN-A-BOX
• Applicant: Geto2, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Feb 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Portable oxygen generator; utilizes chemical reaction to produce oxygen; single-use, disposable device. Emergency version provides minimum 6 LPM for 15 minutes (90L capacity). Rx version provides variable flow (0.5 LPM for 60 min or 3.0 LPM for 30 min). Used in emergency settings (OTC) or home/institutional/travel environments (Rx). Operated by patients or caregivers. Output is supplemental oxygen delivered via standard mask or nasal cannula. Benefits include immediate access to oxygen in emergency or prescribed supplemental settings.

Clinical Evidence

Bench testing only. Testing included VOC/PM2.5, residual hydrogen peroxide, bacteria/mold, environmental (temperature), mechanical (vibration), flow rate, flow duration, and oxygen concentration percentage. All tests passed.

Technological Characteristics

Portable oxygen generator; chemical reaction-based oxygen generation. Gas pathway materials tested for biocompatibility per EPA TO-15 and NIOSH 0500. Single-use, disposable form factor. No electronic components or software.

Indications for Use

Indicated for individuals requiring emergency oxygen (OTC) or supplemental oxygen as prescribed by a physician (Rx). No specific age or gender limitations. No contraindications.

Regulatory Classification

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).

Predicate Devices

• OxySure - Model 615 - K052396
• Oxytec - Model 900 - K043615

Submission Summary (Full Text)

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# FEB 1 1 2011

## 510(k) Summary Page 1 of 5 10-Feb-11

| Get-O2, Inc.<br>27 Bayberry Lane<br>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<br>O2-in-a-boxTM - Rx use |
| Common/Usual Name: | Portable oxygen generator |
| Classification Name: | Portable Oxygen Generator<br>CAW - 868.5440 |
| Predicate Devices: | OxySure - Model 615 - K052396 - Emergency Use<br>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 .

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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 | Predicate<br>OxySure K052396 | Proposed Device<br>O₂-in-a-box™<br>OTC - Emergency Use |
|------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Indications for use | To produce oxygen for emergency<br>use | To produce oxygen for<br>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<br>cannula | Standard oxygen mask or nasal<br>cannula |
| Specifications | % Oxygen - 99%<br>Flow rate minimum - 6 LPM<br>Duration at least 15 minutes<br>90 liter oxygen capacity | % Oxygen - 99%<br>Flow rate minimum - 6 LPM<br>Duration at least 15 minutes<br>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<br>Oxygen cannula | Mask<br>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.

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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 [phone] or [phone] 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

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## 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: _

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## 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