(175 days)
The Inogen Rove 6 Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in the home, institution, and transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.
The Inogen Rove 6 Portable Oxygen Concentrator (Inogen Rove 6) is a Class 2, low risk, portable oxygen generator that provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution, vehicle, and other transport modalities. It is used with a nasal cannula to channel oxygen from the device to the patient. The concentrator and the nasal cannula are non-sterile. The Inogen Rove 6 Portable Oxygen Concentrator is capable of continuous use in a home, institution, vehicle, and various mobile environments. Power options include 100 - 240 V-AC (50-60Hz) power supply, rechargeable battery packs, or a 13.5 -15.0 V-DC power cable. The Inogen Rove 6 Portable Oxygen Concentrator uses molecular sieve/pressure swing adsorption technology. Ambient air is drawn through particle filters by a compressor and forced through molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed, and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, manifolds and precision valves, sensors and embedded software are used to control the cycle to make the system function. Oxygen is delivered to the patient on a pulse dose basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. The Inogen Rove 6 Portable Oxygen Concentrator senses the beginning of the inhalation cvcle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, through a final filter, into the connected nasal cannula and on to the patient. The Inogen Rove 6 Portable Oxygen Concentrator utilizes Bluetooth technology that pairs the portable oxygen concentrator to a mobile device or tablet using the Inogen Connect App.
This is information extracted from a medical device 510(k) submission.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Inogen Rove 6 Portable Oxygen Concentrator are based on comparison to its predicate device (Inogen Rove 4) and a reference device (GCE Zen-O), as well as compliance with relevant international standards.
| Acceptance Criteria Category | Specific Criteria (Predicate/Reference) | Reported Device Performance (Inogen Rove 6) |
|---|---|---|
| Indications for Use | The Inogen Rove 4 Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution, and transport modalities. (K222086) | Provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution, vehicle, and other transport modalities. Substantially equivalent to predicate. |
| Fundamental Scientific Technology | Breath detection technology, Molecular Sieve/pressure swing adsorption technology (Predicate and Reference) | Breath detection technology, Molecular Sieve/pressure swing adsorption technology. Substantially equivalent. |
| Patient Use | Patients requiring supplemental oxygen (Predicate). Adult patients with chronic pulmonary diseases such as chronic bronchitis, emphysema, asthma, or lung cancer, those in the terminal stage of cancer, or any patient requiring supplemental oxygen (Reference). | Patients requiring respiratory therapy on a prescriptive basis. Substantially equivalent to predicate. |
| Oxygen Concentration | 90% -3%/+6% at all settings (Predicate and Reference) | 90% -3%/+6% at all settings. Substantially equivalent. |
| Output Flow | Predicate (Inogen Rove 4): |
- Setting 1 (10-40 BPM): 7.0-21.0 ml/breath
- Setting 4 (10-40 BPM): 21.0-84.0 ml/breath
- Max total volume per minute: 840 ml/min.
Reference (GCE Zen-O): - Pulse mode settings 1-6 (15-40 BPM): ml/breath varies from 5.25 ml/breath at setting 1, 40 BPM to 66ml/breath at setting 6, 15-35 BPM. Max total volume per minute: e.g., setting 6 at 35 breath/min = 2310 ml/min. | Inogen Rove 6:
- Setting 1 (10-40 BPM): 5.25-21.0 ml/breath
- Setting 6 (10-40 BPM): 31.5-126.0 ml/breath
- Max total volume per minute: 1260 ml/min. Similar, with 2 additional flow settings delivering a higher maximum output. The maximum output is similar to Zen-O setting 6 at 20 breaths/min (1320 ml/min). |
| Maximum Outlet Pressure | 30 days) per ISO 18562-2: 2017 (Particulate matter) and ISO 18562-3:2017 (Volatile organic compounds) (Predicate).
Externally Communicating, Tissue, Limited duration (30 days) per ISO 18562-2: 2017 (Particulate matter) and ISO 18562-3:2017 (Volatile organic compounds). Similar to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test sets in non-clinical testing. It only mentions "Inogen performed testing to demonstrate and support safety and effectiveness when compared to the predicate and the applicable standards."
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It refers to "Bench Testing" and "testing at a nationally registered test laboratory," implying laboratory-based testing rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given document. The testing described is non-clinical bench testing and compliance with performance standards, which does not typically involve expert ground truth establishment in the same way clinical studies or image-based AI studies do.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The document describes non-clinical bench testing against technical specifications and performance standards, not a study requiring adjudication of human-read results.
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
This information is not applicable/provided. The Inogen Rove 6 Portable Oxygen Concentrator is a hardware medical device (portable oxygen generator), not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not have been performed for this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/provided. As explained above, this device is not an AI algorithm. Its performance is evaluated through bench testing of its mechanical and electrical functions and oxygen delivery specifications. The device does contain "embedded software" (page 4), and "Software verification and validation" (page 19) was performed, indicating standalone testing of the software components. However, this is not an "algorithm only" study in the context of AI performance, but rather software testing for the device's operational control.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" is defined by:
- Established Technical Specifications: Such as oxygen concentration levels (90% -3%/+6%), pulse volumes (± 15% of rated volume), pressure values, sound levels, etc.
- International Standards: Specifically, ISO 80601-2-69, ISO 80601-2-67, various parts of IEC 60601, and IEC 62366-1.
- Comparison to Predicate and Reference Devices: Demonstrating "substantial equivalence" to the performance and characteristics of previously cleared devices, particularly for aspects like oxygen delivery mode, purity, and flow.
This is primarily performance data and compliance with objective technical and regulatory standards, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This information is not applicable/provided. No AI model requiring a "training set" in the context of machine learning is described for this device. The software validation mentioned refers to verification of the device's embedded control software.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided, as no AI model with a training set is described.
§ 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).