(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: |
§ 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).