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510(k) Data Aggregation
(177 days)
The Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to adult patients requiring respiratory therapy on a prescriptive basis. It may be used at home, in institution, vehicle, train, airplane, boats and other transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.
Users should follow their doctor's advice on setting the oxygen flow rate and should not adjust the flow rate without consulting a healthcare professional.
Note: Patients should regularly consult with their physician to evaluate the need for adjustments in their oxygen therapy settings.
The Portable Oxygen Concentrator is a Class II, low-risk medical device designed to provide a high-concentration oxygen supply (87%-95.5%) to adult patients requiring supplemental oxygen therapy as prescribed by a healthcare professional. It is intended for use at home, in institution, vehicle, train, airplane, boats and other transport modalities and complies with FAA regulations for in-flight use. The device is not intended for life-support or life-sustaining purposes.
The Portable Oxygen Concentrator utilizes Pressure Swing Adsorption (PSA) technology, which extracts oxygen from ambient air by selectively adsorbing nitrogen through molecular sieve beds. Oxygen is delivered through a pulse dose mechanism, synchronizing oxygen release with the patient's inhalation cycle to optimize efficiency and minimize waste.
The series consists of four models, each offering different pulse dose settings:
- W-R1 (MAX): 1, 2, 3, 4, 5, 6, S
- W-R1: 1, 2, 3, 4, 5, 6
- W-R2: 1, 2, 3, 4, 5
- W-R2 (Lite): 1, 2, 3, 4
The device operates in pulse flow mode and supports multiple power sources, including 100–240V AC (50–60Hz) and a rechargeable lithium-ion battery (14.4V / 6500mAh). While the hardware supports 13.0–16.8V DC input, DC operation is not currently supported, as no DC accessories are provided or authorized. A single battery charge provides up to 4.5 hours of continuous use, ensuring flexibility across various environments.
Designed for portability and efficiency, the W-R Series features a lightweight build (1.8 kg), low noise operation, and an intuitive LCD display. Its ergonomic and user-friendly design has been internationally recognized with six global design awards, including iF, Red Dot, and IDEA, for its usability, portability, and patient-centered innovation.
The device is suitable for operation within a temperature range of -5°C to 40°C (23°F to 104°F), humidity levels of 5% to 90% (non-condensing), and atmospheric pressure from 54kPa to 106kPa. It can function at altitudes up to 5,000 meters (16,400 feet).
The Portable Oxygen Concentrator consists of a casing, compressor, molecular sieve system, solenoid valve, battery, cooling fan, control board, and display screen.
Note: The device does not include a nasal cannula; patients should purchase one separately. The oxygen outlet follows international standards, and recommended cannula specifications can be found in Section 2.12: Cannula Use of the user manual.
The provided FDA 510(k) clearance letter is for a Portable Oxygen Concentrator. This device is not an AI/ML-enabled device. The information requested in the prompt (acceptance criteria, study details, sample size, ground truth, expert adjudication, MRMC studies, etc.) is typically associated with the rigorous evaluation of AI/ML software as a medical device (SaMD) or AI-enabled medical devices, especially those using diagnostic imaging.
Medical devices like portable oxygen concentrators are evaluated primarily on their physical performance characteristics, safety standards, and conformity to established regulations for mechanical and electrical safety. The clearance letter outlines the non-clinical tests performed (safety and performance testing, biocompatibility testing, electrical safety and EMC testing, battery safety testing, and software verification/validation), but these are not the types of studies that involve expert readers, ground truth consensus, or MRMC comparative effectiveness specific to AI diagnostics.
Therefore, I cannot extract the requested information (acceptance criteria in the context of an AI study, sample sizes for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML) directly from this document, as it pertains to a different type of medical device evaluation.
To directly answer your request based on the provided document, which is for a Portable Oxygen Concentrator (not an AI/ML diagnostic device):
The FDA 510(k) Clearance Letter for the Portable Oxygen Concentrator focuses on demonstrating substantial equivalence to a predicate device through:
- Same Intended Use: Providing supplemental oxygen to adult patients on a prescriptive basis for respiratory therapy.
- Similar Technological Characteristics: Utilizing breath detection, molecular sieve/pressure swing adsorption, and a pulse dose mechanism.
- Performance Data: Presenting specifications like oxygen concentration, pulse volumes, sound levels, and mechanical/electrical safety.
- Compliance with Recognized Standards: Adhering to various international IEC and ISO standards for medical electrical equipment, biocompatibility, and oxygen concentrators.
The "acceptance criteria" for a device of this type are generally meeting the performance specifications and safety standards outlined in the non-clinical testing section, and demonstrating that any differences from the predicate device do not raise new questions of safety or effectiveness.
Here's a breakdown of the closest equivalents to your requested categories, given the nature of the device and the document:
1. A table of acceptance criteria and the reported device performance
For a portable oxygen concentrator, acceptance criteria are generally related to its physical and performance specifications like oxygen purity, flow rates, noise levels, and battery life, rather than diagnostic accuracy metrics.
| Feature | Acceptance Criteria (Subject Device Specification) | Reported Device Performance (from "Specifications" and "Performance" sections) |
|---|---|---|
| Oxygen Concentration | 90% - 3% /+ 5.5% at all settings | 90% - 3% /+ 5.5% at all settings |
| Inspiratory Trigger Sensitivity |
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(175 days)
GCE Zen-O Portable Oxygen Concentrator Model RS-00500.,K162433
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.
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(147 days)
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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