(339 days)
The O2asis Personal Oxygen Humidifier is indicated to add moisture and may warm breathing gases for administration to infant, pediatric and adult patients in the home, hospital, and clinical settings. It is used with an external gas source of up to 6 Lpm via nasal cannula.
The O₂asis Personal Oxygen Humidifier is a self-contained, palm-sized, mobile device, making it possible for an individual to move the system to a new location without assistance. The O₂asis Personal OxygenHumidifier provides heat and humidified gas when used with a home oxygen concentrator or cylinder supply with flow rates up to 6 lpm. The subject device humidifies and heats the gas (oxygen) and delivers the warmed gas via a nasal cannula. When unplugged, the subject device provides passive humidification but no heat.
The Perma Pure LLC O2asis Personal Oxygen Humidifier, intended to add moisture and potentially warm breathing gases for patients, underwent various non-clinical testing to demonstrate its performance and substantial equivalence to predicate devices. The information provided heavily focuses on the comparison with predicate and reference devices and a summary of the types of tests conducted rather than a detailed study report with specific acceptance criteria and performance results in a table format.
Based on the provided information, the following can be extracted, acknowledging that detailed performance metrics and acceptance criteria values are largely absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Test | Acceptance Criteria (if specified) | Reported Device Performance (if specified) |
|---|---|---|---|
| Performance | Humidification Output | 40-50 mg H2O/L (predicate) | Up to 49 mg H2O/L (similar to predicate) |
| Heated Patient Delivery Tube O2 Temperature | Up to 41°C at exit of nasal cannula | Up to 41°C at exit of nasal cannula | |
| Adjustable heat and Humidity Levels | Adjustable temperature and flow settings (predicate) | 3 pre-set temperature levels (Low - 34°C, Medium - 36°C, High - 39°C) | |
| Flow rate range | 1 to 40 Lpm (predicate) | 0.5 to 6 Lpm (low flow subset of predicate) | |
| Safety & Essential Performance | ISO 80601-2-74:2017 (Respiratory Humidifying Equipment) | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" |
| AAMI ANSI ES 60601-1: 2005 +A1: 2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" | |
| Electromagnetic Compatibility | IEC 60601-1-2: 2014 (Collateral standard: Electromagnetic disturbances Requirements O and Tests) | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" |
| IEC 60601-1-11: 2015 (Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare Environment) | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" | |
| AIM Standard 7351731 Rev. 2.00 2017-02-23 (Medical Electrical Equipment and System O Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers) | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" | |
| Device Functionality | Humidifier Active and Passive Performance | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" |
| Cleaning & Durability | Cleaning compatibility | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" |
| Cross-contamination transfer | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" | |
| Effects of Age and Durability | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" | |
| Software | Software Verification and Validation | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" |
| Biocompatibility | ISO 10993-5:2009 (Cytotoxicity) | Not explicitly detailed but implied compliance | "The materials were found to meet the applicable endpoints of the specific tests." |
| ISO 10993-10:2010 (Sensitization and Irritation) | Not explicitly detailed but implied compliance | "The materials were found to meet the applicable endpoints of the specific tests." | |
| ISO 10993-11:2017 (Acute Systemic Toxicity) | Not explicitly detailed but implied compliance | "The materials were found to meet the applicable endpoints of the specific tests." | |
| ISO 10993-18:2020 (Chemical Characterization) | Not explicitly detailed but implied compliance | "The materials were found to meet the applicable endpoints of the specific tests." | |
| ISO 18562-2:2017 (Particulate Matter) | Not explicitly detailed but implied compliance | "The materials were found to meet the applicable endpoints of the specific tests." | |
| ISO 18562-3:2017 (VOC Compounds) | Not explicitly detailed but implied compliance | "The materials were found to meet the applicable endpoints of the specific tests." | |
| ISO 18562-4:2017 (Leachables in Condensate) | Not explicitly detailed but implied compliance | "The materials were found to meet the applicable endpoints of the specific tests." | |
| Human Factors/Usability | FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices:2016 | Implied compliance with guidance | "A Human Factors / usability study was performed with the user population" |
Note on "Acceptance Criteria" and "Reported Device Performance": The document primarily lists the types of tests performed and broad statements of compliance ("The device meet the applicable performance for the applicable standards" or "The materials were found to meet the applicable endpoints"). Specific quantitative acceptance criteria and detailed performance results are generally not provided in this summary. The table uses predicate device performance as a proxy for implied acceptance criteria where available (e.g., humidification output).
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document describes non-clinical bench testing, biocompatibility testing, and a human factors study, but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature for any data collection). The tests appear to be conducted on the device itself (bench testing) or its components (biocompatibility).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The testing described is primarily non-clinical (bench, biocompatibility, software V&V, human factors). There is no mention of an expert panel establishing ground truth for a test set in the context of clinical imagery review or similar applications. The "Human Factors / Usability" study mentions a "user population," implying participation from intended users, but details on their qualifications or how "ground truth" was established are absent for this type of test.
4. Adjudication Method for the Test Set
This information is not provided. As the tests are non-clinical and do not involve diagnostic interpretation or multi-reader review, an adjudication method as typically understood in those contexts is not applicable or detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The device is a physical humidifier; its evaluation does not involve diagnostic image interpretation or AI assistance to human readers in a way that an MRMC study would be relevant.
6. If a Standalone (Algorithm Only) Performance Study Was Done
This is not applicable as the O2asis Personal Oxygen Humidifier is a physical medical device, not an algorithm or AI software. Therefore, no standalone algorithm-only performance study was conducted.
7. The Type of Ground Truth Used
For the non-clinical tests described, the "ground truth" is based on adherence to:
- Engineering and Performance Standards: The device's physical performance (e.g., humidification output, temperature, flow rates) is measured against the specifications of relevant ISO and IEC standards.
- Biocompatibility Standards: The materials are tested against endpoints defined in ISO 10993 and ISO 18562 series.
- FDA Guidance Documents: For human factors/usability, the study adheres to FDA guidance, implying that successful completion against the guidance's recommendations constitutes the ground truth for usability.
- Design Specifications: Implicitly, the device's design and functionality are tested against its own pre-defined specifications.
There is no mention of "expert consensus," "pathology," or "outcomes data" as ground truth in the context of this device's evaluation, as these are typically relevant for diagnostic or treatment efficacy studies.
8. The Sample Size for the Training Set
This is not applicable. The O2asis Personal Oxygen Humidifier is a hardware device; it does not involve machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this device.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).