OMNI 3 OXYGEN SYSTEM

K120785 · Caire, Inc. · CAW · Oct 25, 2012 · Anesthesiology

Device Facts

• Record ID: K120785
• Device Name: OMNI 3 OXYGEN SYSTEM
• Applicant: Caire, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Oct 25, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The eQuinox Oxygen System is intended for the administration of supplemental oxygen. The eQuinox Oxygen System is prescription legend required.

Device Story

Portable oxygen concentrator; utilizes pressure swing adsorption (PSA) with synthetic zeolite molecular sieve beds to generate oxygen from ambient air. Operates in continuous flow or pulse mode; pulse mode delivers oxygen bolus upon detection of inhalation via pulse flow valve. Powered by AC, DC, or rechargeable lithium-ion batteries. Includes air compressor, inlet/outlet filtration, and electronic flow control. Features ultrasonic oxygen monitor and audible/visual alarms for power loss, low oxygen concentration, flow issues, and system malfunction. Used in clinical or home settings; operated by patients or caregivers. Provides supplemental oxygen to improve patient respiratory status. Healthcare providers use LCD display to monitor settings and flow rates.

Clinical Evidence

Bench testing only. Compliance with ISO 8359 (Oxygen Concentrators), IEC 60601-1 (Electrical Safety), and IEC 60601-1-2 (Electromagnetic Compatibility) was demonstrated. No clinical data provided.

Technological Characteristics

Pressure swing adsorption (PSA) technology; synthetic zeolite molecular sieve beds; rotary valves. Brushless DC piston-type compressor. Inlet/HEPA filtration. Power: AC/DC/Lithium-ion battery. Dimensions: 15.5" x 10.8" x 7.3". Weight: 12 lbs. Ultrasonic oxygen concentration monitoring. Alarms: loss of power, low O2 concentration, flow high/low, no inspiratory detect, low battery, unit malfunction. Visual indicators: Red/Yellow/Green LEDs.

Indications for Use

Indicated for the administration of supplemental oxygen to patients requiring such therapy. Prescription use only.

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

• OMNI Oxygen System (K013931)
• OMNI 2 Oxygen System (K083163)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "SEQUAL" in a stylized font. To the left of the word is an image of a stack of wavy lines. The word "SEQUAL" is written in all capital letters, with the letters slightly overlapping each other. The font is a serif font, with the serifs being slightly curved.

# 510(k) Summary

#### Submitter Information:

| Submitter: | Chart SeQual Technologies Inc.<br>12230 World Trade Drive, Suite 100<br>San Diego, CA 92128 |
|----------------------------|---------------------------------------------------------------------------------------------|
| Contact:<br>Phone:<br>FAX: | Brian Jarrell, Manager of Quality and Regulatory<br>[phone]<br>[phone] |
| Date of Summary: | September 10, 2012 |
| Device Name: | |

| Proprietary Name: | eQuinox Oxygen System |
|---------------------------|----------------------------------------------------|
| Common Name: | Oxygen Concentrator |
| Classification of Device: | Generator, Oxygen, Portable as per 21 CFR 868.5440 |

#### Predicate Device Equivalence:

Chart SeQual Technologies is claiming substantial equivalence to the following legally marketed predicate devices:

K013931 – OMNI Oxygen System K083163 – OMNI 2 Oxygen System

#### Description of Device:

The eQuinox Oxygen System is an oxygen concentrator that provides continuous flow or in pulse mode, an oxygen bolus. The eQuinox Oxygen System is based on pressure swing adsorption (PSA) principles. The eQuinox Oxygen System operates from AC power, or rechargeable batteries. This device delivers supplemental oxygen for patients through the molecular sieve beds and is designed to conserve the use of oxygen while operating in pulse flow mode. During pulse flow mode, oxygen is delivered to the patient through a pulse flow valve when the start of inhalation is detected.

The eQuinox Oxygen System consists of pneumatic and electrical components, AC power supply, DC cable and lithium ion batteries. The system has inlet filtration, air compressor, and

OCT 2 5 2012

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Synthetic Zeolite molecular sieve beds with a rotary valves, outlet filtration, electronic flow control and audible / visual alarms.

#### Intended Use:

The eQuinox Oxygen System is intended for the administration of supplemental oxygen.

The eQuinox Oxygen System is prescription legend required.

## Technological Characteristics:

The eQuinox Oxygen System technology employed to generate oxygen is based on pressure swing adsorption (PSA) principles. This is identical to the technology employed within the predicate devices.

| | Chart Sequal<br>Technologies Inc.<br>eQuinox Oxygen System<br>510(k) K120785 | Sequal Technologies<br>Inc.<br>OMNI 2 Oxygen System<br>510(k) K083163 | Sequal Technologies<br>Inc.<br>OMNI Oxygen System<br>510(k) K013931 |
|-----------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------|
| Concentration (in %)<br>at: | | | |
| 1.0 LPM Continuous | 90 ± 3 | 93 ± 3 | 90 ± 3 |
| 2.0 LPM Continuous | 90 ± 3 | 93 ± 3 | 90 ± 3 |
| 3.0 LPM Continuous | 90 ± 3 | 93 ± 3 | 90 ± 3 |
| 16mL Pulse Mode | 90 ± 3 | 93 ± 3 | 90 ± 3 |
| 32mL Pulse Mode | 90 ± 3 | 93 ± 3 | 90 ± 3 |
| 48mL Pulse Mode | 90 ± 3 | 93 ± 3 | 90 ± 3 |
| 64mL Pulse Mode | 90 ± 3 | 93 ± 3 | 90 ± 3 |
| 80mL Pulse Mode | 90 ± 3 | 93 ± 3 | 90 ± 3 |
| 96mL Pulse Mode | 90 ± 3 | 93 ± 3 | 90 ± 3 |
| 128 mL Pulse Mode | 90 ± 3 | - | - |
| 160 mL Pulse Mode | 90 ± 3 | - | - |
| 192 mL Pulse Mode | 90 ± 3 | - | - |
| Weight | 12 lbs | 10 lbs | 17.9 lbs |
| Width | 10.8" | - | 12.3 inches |
| Depth | 7.3" | - | 7.1 inches |
| Diameter | - | 4.4 inches | - |

## Device Comparison Table

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| Height | 15.5" | 26 inches | 19.3 inches |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Consumption | Continuous Mode 42 Watts @ 1LPM 110 Watts @ 3LPM Pulse Mode 36 Watts @ 16mL 60 Watts @ 96mL 110 Watts @ 3 LPM | Continuous Mode 52 Watts @ 1LPM 128 Watts @ 3LPM Pulse Mode 39 Watts @ Setting 1 (16mL) 76 Watts @ Setting 6 (96mL) | Continuous Mode 52 Watts @ 1LPM 145 Watts @ 3LPM Pulse Mode 44 Watts @ Setting 1 (16mL) 85 Watts @ Setting 6 (96mL) |
| Output pressure | 5.0 psig nominal | 5.0 psig nominal | 5.0 psig nominal |
| Flow Adjustment, Type<br>and Range of Readout | Continuous Flow: 0.5 - 3 LPM Pulse Mode: 16mL – 192 mL Readouts by LCD Display | Continuous Flow: 1 - 3 LPM Pulse Mode: 16mL – 96 mL Readouts by LCD Display | Continuous Flow: 0.5 - 3 LPM Pulse Mode: 1 - 6 (Equivalent to 16mL - 96ml) Readouts by LED Display |
| Electrical<br>Requirements | AC (100 VAC, 50/60 Hz) DC, 12 V Nominal Power Cartridge 88 W-Hrs | AC (100 VAC, 50/60 Hz) DC, 12 – 24 V Nominal Power Cartridge 88 W-Hrs | AC (100 VAC, 50/60 Hz) DC, 12V Nominal Power Cartridge 195 W-Hrs |
| Alarms | Loss of Power Low Oxygen Concentration O2 Flow High or Low No Inspiratory Detect in Pulse Mode Low Power Cartridge Unit Malfunction | Loss of Power Low Oxygen Concentration O2 Flow High or Low No Inspiratory Detect in Pulse Mode Low Power Cartridge Unit Malfunction | Loss of Power Low Oxygen Concentration O2 Flow High or Low No Inspiratory Detect in Pulse Mode Low Power Cartridge Unit Malfunction |
| High Compressor<br>Pressure Relief | Integrated with ATF Module to relieve system pressure > 15 psig | Integrated with ATF Module to relieve system pressure > 15 psig | Integrated with ATF Module to relieve system pressure > 15 psig |
| Oxygen Concentration<br>Warning | 70 – 85 % | 70 – 85 % | 70 – 85 % |
| Oxygen Concentration<br>Low | < 70% | < 70% | < 70% |
| Visual Indicators | Red LED for high priority alarms Yellow LED for low / medium priority alarms Green to indicate system is function properly | Red LED for high priority alarms Yellow LED for low / medium priority alarms Green to indicate system is function properly | Red LED for high priority alarms Yellow LED for low / medium priority alarms Green to indicate system is function properly |
| Oxygen System<br>Monitor | Ultrasonic | Ultrasonic | Ultrasonic |
| PSA Valve Type | Rotary | Rotary | Rotary |
| Compressor | Brushless DC - Piston<br>Type | Brushless DC - Scroll<br>Type | Brushless DC - Piston<br>Type |
| Filtration | Dust<br>Compressor Inlet<br>HEPA | Dust<br>Compressor Inlet<br>HEPA | Dust<br>Compressor Inlet<br>HEPA |
| Intended Use | The eQuinox Oxygen<br>System is intended for the<br>administration of<br>supplemental oxygen.<br>The eQuinox Oxygen<br>System is prescription<br>legend required. | The OMNI 2 Oxygen<br>System is intended for the<br>administration of<br>supplemental oxygen.<br>The device is not intended<br>for life support nor does it<br>provide any patient<br>monitoring capabilities.<br>The OMNI 2 Oxygen<br>System is prescription<br>legend required. | The Model 1000 OMNI<br>Oxygen System is<br>intended for the<br>administration of<br>supplemental oxygen.<br>The device is not intended<br>for life support nor does it<br>provide any patient<br>monitoring capabilities.<br>The OMNI Oxygen System<br>is prescription legend<br>required. |

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## Performance Data:

Performance testing demonstrates that the eQuinox Oxygen System is compliant with ISO 8359 standard for Oxygen Concentrators. Testing also demonstrates that the product electrical safety and electromagnetic compatibility are substantially equivalent to predicate device and are in compliance with IEC 60601-1 and IEC 60601-1-2 standards.

## Conclusion:

Based on the design, testing, and intended use, the eQuinox Oxygen System is substantially equivalent to the currently marketed devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Caire, Incorporated C/O Chart SeQual Technologies, Incorporated Mr. Brian Jarrell Manager, Quality Assurance & Regulatory Affairs 12230 World Trade Drive, Suite 100 San Diego, California 92128

OCT 25 2012

Re: K120785

Trade/Device Name: eQuinox Oxygen System Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: September 10, 2012 Received: September 25, 2012

Dear Mr. Jarrell:

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. Jarrell

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/ucm115809.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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Zh 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

Enclosure

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# Chart SeQual Technologies Inc. 12230 World Trade Drive, Suite 100, San Diego CA 92128 USA

# Indications for Use Statement

Applicant: Chart SeQual Technologies Inc.

510(k) Number (if known):

Device Name: eQuinox Oxygen System

Indications For Use:

The eQuinox Oxygen System is intended for the administration of supplemental oxygen.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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

nesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k120785