(224 days)
Not Found
No
The summary describes a standard oxygen concentrator based on pressure swing adsorption (PSA) principles. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for the administration of supplemental oxygen, which is a therapeutic intervention for patients who require it.
No
The device description states it "provides continuous flow or in pulse mode, an oxygen bolus" and "delivers supplemental oxygen for patients." Its intended use is "for the administration of supplemental oxygen," which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states that the eQuinox Oxygen System consists of pneumatic and electrical components, an air compressor, molecular sieve beds, valves, and batteries, indicating it is a hardware device with integrated software for control.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the administration of supplemental oxygen." This is a therapeutic use, delivering a substance to the patient's body.
- Device Description: The description details an oxygen concentrator that provides oxygen directly to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used in vitro (outside the body) to examine specimens from the body. This device operates in vivo (within the body) by delivering oxygen.
N/A
Intended Use / Indications for Use
The eQuinox Oxygen System is intended for the administration of supplemental oxygen.
Product codes
CAW
Device Description
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.
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
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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 100
San 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 Sequal
Technologies Inc.
eQuinox Oxygen System
510(k) K120785 | Sequal Technologies
Inc.
OMNI 2 Oxygen System
510(k) K083163 | Sequal Technologies
Inc.
OMNI Oxygen System
510(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, Type | |||
| 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 | |||
| 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 | |||
| 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 | |||
| Warning | 70 – 85 % | 70 – 85 % | 70 – 85 % |
| Oxygen Concentration | |||
| Low |