(325 days)
Actives DUO2 Oxygen Concentrator System is used on a prescriptive basis by adult patients who are diagnosed as requiring supplemental oxygen. The oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home or institutional/hospital setting.
The Activox DUO2 Oxygen Concentrator is designed to be primarily a stationary device for home/institutional use. The LifeChoice Activox POC is a portable device that provides additional functionality of the Activox DUO2Oxygen Concentrator System. The Activox DUO2 Oxygen Concentrator base unit must be connected to the LifeChoice Activox POC a minimum of once every 45 days in order for the base unit to function as intent of this feature is to ensure the user at least periodically charges the battery powered LifeChoice Activox POC. While the Activox DUO2 is connected, it will charge the internal battery for the LifeChoice Activox POC. The Activox DUO2 can also charge the external battery (sold separately) for the LifeChoice Activox POC after the internal battery is charged.
This submission for the Activox DUO2 Oxygen Concentrator System focuses on demonstrating substantial equivalence to predicate devices rather than proving a new or novel performance claim. Therefore, the traditional concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as might be seen for an AI/ML diagnostic device with performance metrics like sensitivity, specificity, or AUC, is not directly applicable here.
Instead, the acceptance criteria are implicitly met by demonstrating that the Activox DUO2 System is "as safe and as effective" as the predicate devices based on design verification tests and a comparison of technological characteristics.
Here’s a breakdown of the information as requested, adapted to the context of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of submission, "acceptance criteria" are the characteristics of the predicate devices that the new device must match or be equivalent to. The "reported device performance" is how the Activox DUO2 demonstrates this equivalence.
| Characteristic | Predicate #1 (Respironics L4 / EverFlo) | Predicate #2 (LifeChoice Activox) | Subject Device (Activox DUO2) | Acceptance Criteria Met (Yes/No) |
|---|---|---|---|---|
| Intended Use | Supplemental oxygen therapy, home/hospital (not life-supporting/sustaining) | Supplemental oxygen therapy, portable (not life-supporting/sustaining) | Supplemental oxygen therapy, home/institutional/hospital (not life-supporting/sustaining) | Yes |
| Operation Principle | Pressure Swing Adsorption (PSA) | Pressure Swing Adsorption (PSA) | Pressure Swing Adsorption (PSA) | Yes |
| Flow Rate (LPM) | 0.5 - 5 LPM Continuous | 1 - 3 LPM PULSE-WAVE | 0 - 5 LPM Continuous | Yes (Equivalent) |
| O2 Concentration | 90% - 96% | 87% - 93% | 90% - 96% | Yes (Equivalent) |
| Power Supply | 100-240 VAC, 50-60 Hz | 100-240 VAC, 50-60 Hz | 120 VAC / 60 Hz, 230 VAC / 50 Hz | Yes (Global requirements met) |
| Dimensions (cm) | 35x58x24 | 24x19x7.9 | Base Unit: 36x57x34 | Yes (Equivalent) |
| Weight (kg) | 14 to 15 | 2.3 | Base Unit: 16.5 | Yes (Equivalent) |
| Alarm Conditions | Power Failure, Low Flow, Low O2 | Power Failure, Low Flow, Low O2 | Power Failure, Low Flow, Low O2 | Yes |
| Operational Temp. | 13°C to 32°C | 5°C to 40°C | 10°C to 35°C | Yes (within acceptable range) |
| Operational Humidity | 15% - 95%, Non-cond. | 20% - 95%, Non-cond. | 15% - 95%, Non-cond. | Yes |
| Average Power | Up to 350W (base unit) | Up to 120W (POC) | Up to 372W (base unit) | Yes (within 6.3% of predicate) |
| Safety features | Circuit Breaker, Humidifier Bottle, Cabinet Air Filter, Oxygen Filter, Power LED, Alarm LED, Audible Alarm, Low O2 Purity, Protection for over-heat/over-load, safety valve (or equivalent) | Circuit Breaker (POC), Oxygen Filter, Power LED, Alarm LED, Audible Alarm, Low O2 Purity, Protection for over-heat/over-load, high pressure alarm | Circuit Breaker, Humidifier Bottle, Cabinet Air Filter, Oxygen Filter, Power LED, Alarm LED, Audible Alarm, Low O2 Purity, Protection for over-heat/over-load, high pressure alarm | Yes |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not involve a "test set" in the sense of patient data for evaluating diagnostic performance. Instead, the "testing" refers to design verification tests on the physical device. The sample size for these engineering tests (e.g., number of units tested for vibration, shock, EMC) is not specified in this summary. The data provenance would be internal to Inova Labs, based on their engineering and quality assurance processes, and would be prospective testing of the manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. "Ground truth" in the context of expert review of patient data is not relevant for this engineering device submission. The "truth" is established by adherence to engineering specifications and international standards.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication process for this type of technical device testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic aid (often AI-based) on human reader performance, which doesn't apply to an oxygen concentrator.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, "standalone performance" in the context of an algorithm or AI is not applicable here. This device is a mechanical/electronic medical device.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the safety and effectiveness of the Activox DUO2 System is multi-faceted:
- Engineering Specifications: The device's performance characteristics (e.g., oxygen concentration, flow rate, alarm thresholds) are designed to meet predefined internal specifications.
- International Standards: The device's performance and safety are measured against recognized national and international standards for oxygen concentrators (e.g., IEC 60601-1, IEC 60601-1-2, ISO 8359).
- Predicate Device Performance: The "truth" for substantial equivalence is the established performance and safety profile of the legally marketed predicate devices. The Activox DUO2 must perform equivalently or better.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm that learns from data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
§ 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).