(224 days)
The eQuinox Oxygen System is intended for the administration of supplemental oxygen. The eQuinox Oxygen System is prescription legend required.
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 Synthetic Zeolite molecular sieve beds with a rotary valves, outlet filtration, electronic flow control and audible / visual alarms.
This document is a 510(k) summary for the eQuinox Oxygen System, which is an oxygen concentrator. The device is being submitted for substantial equivalence to previously marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Predicate Device K013931 / K083163) | Reported Device Performance (eQuinox Oxygen System) |
|---|---|
| Purity (Oxygen Concentration) | 90 ± 3% at all flow rates |
| 1.0 LPM Continuous: 90 ± 3% (K013931), 93 ± 3% (K083163) | 90 ± 3% (Continuous Flow: 1.0, 2.0, 3.0 LPM) |
| 2.0 LPM Continuous: 90 ± 3% (K013931), 93 ± 3% (K083163) | 90 ± 3% (Pulse Mode: 16mL, 32mL, 48mL, 64mL, 80mL, 96mL, 128mL, 160mL, 192mL) |
| 3.0 LPM Continuous: 90 ± 3% (K013931), 93 ± 3% (K083163) | |
| Pulse Mode (various mL): 90 ± 3% (K013931), 93 ± 3% (K083163) | |
| Physical Characteristics (Comparison to predicate devices, not explicit acceptance criteria) | |
| Weight: 17.9 lbs (K013931), 10 lbs (K083163) | 12 lbs |
| Width: 12.3" (K013931), - (K083163) | 10.8" |
| Depth: 7.1" (K013931), - (K083163) | 7.3" |
| Height: 19.3" (K013931), 26" (K083163) | 15.5" |
| Other Performance Characteristics (All predicate devices: K013931, K083163) | |
| Output Pressure: 5.0 psig nominal | 5.0 psig nominal |
| High Compressor Pressure Relief: > 15 psig | > 15 psig |
| Oxygen Concentration Warning: 70 – 85 % | 70 – 85 % |
| Oxygen Concentration Low: < 70% | < 70% |
| Alarms: Loss of Power, Low Oxygen Concentration, O2 Flow High or Low, No Inspiratory Detect in Pulse Mode, Low Power Cartridge, Unit Malfunction | Same features |
| Visual Indicators: Red LED for high priority, Yellow LED for low/medium priority, Green for system function | Same features |
Note: The document explicitly states that "Performance testing demonstrates that the eQuinox Oxygen System is compliant with ISO 8359 standard for Oxygen Concentrators." This standard would contain the detailed acceptance criteria which are summarized in the table above based on the comparative data provided. The specific numerical values for oxygen concentration (90 ± 3%) are presented as the device's technical specifications and implicitly serve as the acceptance criteria for the purpose of demonstrating substantial equivalence to the predicate devices.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a distinct sample size for a "test set" in the context of typical clinical evaluations. The performance data discussed relates to the device's inherent functional characteristics (e.g., oxygen concentration, electrical safety). It's implied that various units of the eQuinox Oxygen System were tested to confirm these specifications.
- Data Provenance: The data is primarily from in-house performance testing conducted by the manufacturer, Chart SeQual Technologies Inc. The document does not mention data from external clinical studies or specific countries of origin for the data. The testing is retrospective in the sense that it was performed on pre-manufactured devices to verify their compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The performance data relates to objective physical and electrical measurements of the device's function, not interpretations by medical experts.
4. Adjudication method for the test set:
- This information is not provided as the performance testing involves objective measurements against established engineering and medical device standards (ISO 8359, IEC 60601-1, IEC 60601-1-2), rather than subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is an oxygen concentrator, not an AI-powered diagnostic tool requiring human interpretation enhancements.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is hardware-based for oxygen delivery and does not involve an algorithm for diagnostic or interpretative purposes.
7. The type of ground truth used:
- The "ground truth" for the performance data is based on objective measurements against established international standards for oxygen concentrators (ISO 8359), electrical safety (IEC 60601-1), and electromagnetic compatibility (IEC 60601-1-2). For example, a gas analyzer would be used to objectively measure oxygen concentration, and electrical testing equipment would measure power consumption and safety parameters.
8. The sample size for the training set:
- This information is not applicable. The eQuinox Oxygen System is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable as there is no training set for this type of device.
{0}------------------------------------------------
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.12230 World Trade Drive, Suite 100San Diego, CA 92128 |
|---|---|
| Contact:Phone:FAX: | Brian Jarrell, Manager of Quality and Regulatory(858) 202-3157(858) 558-1915 |
| 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
{1}------------------------------------------------
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 SequalTechnologies Inc.eQuinox Oxygen System510(k) K120785 | Sequal TechnologiesInc.OMNI 2 Oxygen System510(k) K083163 | Sequal TechnologiesInc.OMNI Oxygen System510(k) K013931 | |
|---|---|---|---|
| Concentration (in %)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
{2}------------------------------------------------
| 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, Typeand 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 |
| ElectricalRequirements | 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 CompressorPressure 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 ConcentrationWarning | 70 – 85 % | 70 – 85 % | 70 – 85 % |
| Oxygen ConcentrationLow | < 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 SystemMonitor | Ultrasonic | Ultrasonic | Ultrasonic |
| PSA Valve Type | Rotary | Rotary | Rotary |
| Compressor | Brushless DC - PistonType | Brushless DC - ScrollType | Brushless DC - PistonType |
| Filtration | DustCompressor InletHEPA | DustCompressor InletHEPA | DustCompressor InletHEPA |
| Intended Use | The eQuinox OxygenSystem is intended for theadministration ofsupplemental oxygen.The eQuinox OxygenSystem is prescriptionlegend required. | The OMNI 2 OxygenSystem is intended for theadministration ofsupplemental oxygen.The device is not intendedfor life support nor does itprovide any patientmonitoring capabilities.The OMNI 2 OxygenSystem is prescriptionlegend required. | The Model 1000 OMNIOxygen System isintended for theadministration ofsupplemental oxygen.The device is not intendedfor life support nor does itprovide any patientmonitoring capabilities.The OMNI Oxygen Systemis prescription legendrequired. |
{3}------------------------------------------------
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.
{4}------------------------------------------------
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.
{5}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the word "SEQUAL" in a stylized font. To the left of the word is an image of what appears to be waves. The word is in all caps and the font is bold. The image is black and white.
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
§ 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).