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510(k) Data Aggregation
(147 days)
Inogen Rove 4 Portable Oxygen Concentrator
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.
This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.
The Inogen Rove™ 4 Portable Oxygen Concentrator is a 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 and transport modalities. It is used with a nasal cannula to deliver oxygen from the device to the patient. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.
The Inogen Rove 4 Portable Oxygen Concentrator is capable of continuous use in a home, institution, 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 cord.
The Inogen Rove 4 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, valves, sensors, and software are used to control the cycle to make the system function.
Oxygen is delivered to the patient on a pulse dose basis in pre-set 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. Inogen Rove 4 Portable Oxygen Concentrator senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas.
The Inogen Rove 4 Portable Oxygen Concentrator utilizes Bluetooth technology that pairs the portable oxygen concentrator to a mobile device or tablet using the Inogen Connect App.
The Inogen Rove™ 4 Portable Oxygen Concentrator's acceptance criteria and the study that proves its performance are described below.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Specification | Predicate Device: Belluscura X-PLO₂R Performance | Subject Device: Inogen Rove 4 Performance (Reported as 'Similar' or specific values) | Comparison |
|---|---|---|---|
| K Number | K203086 | K222086 | N/A |
| Product Code | CAW | CAW | Substantially equivalent |
| CFR | 21 CFR 868.5440 | 21 CFR 868.5440 | Substantially equivalent |
| Classification | 2 | 2 | Substantially equivalent |
| Indications for Use | Supplemental oxygen for patients requiring high concentrations, portable, continuous use in home, institutional, and travel/mobile environments. Not life-sustaining. | High concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. Used in home, institution, and transport modalities. Not life-sustaining or life-supporting. | Substantially equivalent. |
| Prescriptive | Yes | Yes | Substantially equivalent |
| Fundamental scientific technology | Breath detection, Molecular Sieve/pressure swing adsorption. | Breath detection, Molecular Sieve/pressure swing adsorption. | Substantially equivalent |
| Patient use | Adult patient only | Adult patient only | Substantially equivalent |
| User/Patient Interface - Type | User interface panel | User interface panel | Substantially equivalent |
| User/Patient Interface - Display | LCD Display (numbers, text, symbols) | LCD Display (numbers, symbols) | Substantially equivalent. Setting, battery, and auditory alarm status are displayed. |
| User/Patient Interface - Alarm Indicator | Yellow "Alarm/Warning" triangle symbol on LCD display (ISO 60601-1-8 compliant) | Yellow LED on UIP above "Alarm/Warning" triangle symbol that illuminates (ISO 60601-1-8 compliant) | Substantially equivalent. Both use "Alarm/Warning" triangle symbol. |
| User/Patient Interface - Breath Detect Notification | Breath detect icon pops up on LCD display. | Green LED on UIP illuminates. | Substantially equivalent. Both indicate when a breath is detected and oxygen pulse delivered. |
| User/Patient Interface - Auditory Buzzer | Audible beeps for alarm/status change (ISO 60601-1-8 compliant) | Audible beeps for alarm/status change (ISO 60601-1-8 compliant) | Substantially equivalent. |
| User/Patient Interface - Sieve beds | User replaceable using cartridge pull handle. | User replaceable using M6 hex Allen key. | Substantially Equivalent. Both allow user replacement, but with different tools. |
| User/Patient Interface - Air Intake Filter | Clean once per week. | Clean particle filters once per week. | Substantially equivalent. |
| Optional accessories | Carry Bag, Strap, Backpack, External Battery Charger | Carry Bag, Backpack, External Battery Charger | Substantially equivalent. (Strap is missing from subject device list, but generally comparable). |
| Mobile Application | No | Inogen Connect Mobile Application (iOS/Android) for viewing settings, battery, alerts. | Substantially equivalent. Inogen Rove 4 allows information on mobile device and concentrator display. Predicate only on display. |
| Operating System | Software monitored | Software monitored | Substantially Equivalent |
| Bluetooth Technology | No | Yes (BLE Connection to Android or iPhone with Inogen Connect App) | Substantially Equivalent. (See Mobile Application comparison). |
| AC/DC Power Adapter | 100-240V, 50/60Hz AC. | 100-240V, 50/60Hz AC. | Substantially equivalent. |
| DC Power Cable | 12-volt DC outlet connection. | 12-volt DC outlet connection. | Substantially equivalent. |
| Cannula | Off the shelf 7' nasal cannula. | User supplied off-the-shelf. | Substantially equivalent. |
| Battery | 4 or 8-cell lithium battery, slide-in attachment. | 4 or 8-cell lithium battery, slide-in attachment. | Substantially equivalent. |
| Size (4-cell battery) | 7.0"H, 7.3"W, 2.9"D | 7.5"H, 6.0"W, 2.7"D | Similar: Inogen Rove 4 is smaller. |
| Principle of Operation | Pressure Swing Adsorption (PSA) technology, pulse dose upon inhalation detection. | Molecular sieve / pressure swing adsorption technology, pulse dose upon inhalation detection. | Substantially equivalent. |
| Operating Conditions | Portable. Home, institutional, travel/mobile environments. | Portable. Home, institution and transport modalities. | Substantially equivalent. |
| Oxygen Delivery Mode | Pulse Dose | Pulse Dose | Substantially equivalent. |
| Output Flow (Total Volume/Minute) | 200 ml/min (Setting 1) to 800 ml/min (Setting 4) (at 15-40 BPM) | Higher volumes (e.g., 21.0 ml/min at 10 BPM for Setting 1) | Similar volumes. Inogen Rove 4 has higher volumes per minute for each setting. |
| Oxygen Purity | 82% to 92% at all settings | 87% to 96% at all settings | Similar. Inogen Rove 4 has higher oxygen concentrations per minute for each setting. |
| Maximum Outlet Pressure | 10psig (41.37 kPa) | 30 days). ISO 18562-2:2017 (Particulate matter), ISO 18562-3:2017 (VOCs). | Externally Communicating, Tissue, Permanent Duration (>30 days). ISO 18562-2:2017 (Particulate matter), ISO 18562-3:2017 (VOCs). |
2. Sample size used for the test set and the data provenance
The submission does not explicitly detail a "test set" in the context of clinical data for performance evaluation that would typically measure diagnostic accuracy. Instead, the testing described is primarily non-clinical bench testing to demonstrate safety and effectiveness against standards and comparison to a predicate device's specifications.
Therefore, for aspects like pulse volume, oxygen purity, trigger sensitivity, alarms, software verification/validation, electrical/EMC/RFID, and biocompatibility, there isn't a "test set" sample size in the traditional sense of patient data. The "test set" would consist of the performance parameters measured on the device itself under various conditions.
The provenance of this data is from bench testing conducted by the manufacturer and a nationally registered test laboratory. No specific country of origin for this testing is mentioned, nor is it categorized as retrospective or prospective clinical data, as it is technical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation relies on objective performance measurements against established engineering standards and technical specifications (e.g., oxygen concentration, pressure), rather than expert interpretation of medical images or patient conditions to establish a "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the performance evaluation is based on objective measurements against engineering standards and specifications, not expert consensus on qualitative data.
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 as the device is a portable oxygen concentrator, not an AI-assisted diagnostic or interpretative medical device. The submission describes a comparison between the subject device and a predicate device based on technical specifications and non-clinical testing, not a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable for the core function of the oxygen concentrator. The device does have "Software verification and validation" and a mobile app, but this does not imply a "standalone algorithm-only" performance evaluation in the context of diagnostic accuracy or a similar clinical endpoint. The mobile app's function is for displaying device settings and alerts to the user, not for standalone diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance evaluation is based on:
- Established engineering standards: e.g., IEC 60601 series, ISO 80601 series, IEC 62366-1.
- Objective physical measurements: such as oxygen purity, flow rates, output pressure, trigger sensitivity, battery life, sound levels, dimensions, and weight.
- Predicate device specifications: used as a benchmark for comparison during the "Substantial Equivalence Discussion."
There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for this device.
8. The sample size for the training set
This information is not applicable. The submission describes the premarket notification for a medical device (portable oxygen concentrator) based on physical and technical performance testing, not a machine learning model that would require 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 a machine learning model in this submission.
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