(116 days)
The Precision Flow® - Heliox is intended to warm and add moisture to breathing gases from an external source for administration to neonate/infant, pediatric and adult patients in the hospital and sub-acute institutions. It adds heat and moisture to a blended medical heliox (79% helium. 21% oxygen)/oxygen mixture and assures the integrity of the precise heliox (79% helium, 21% oxygen)/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
The Precision Flow® - Heliox consists of two parts: The main unit which contains all the electrical and electronic components including the electronic blender and flow controllers. All the sensors are located in the main unit. The main unit has no water pathways and the gas pathway contains only dry gas at room temperature, and consequently does not need internal cleaning or disinfection. The disposable components comprising the disposable water module, vapor transfer cartridge and heated delivery tube. Conditions in the circulating water and gas streams are sensed remotely via the interface between the main unit and the disposable module.
The Vapotherm Precision Flow® - Heliox is a medical device intended to warm and humidify breathing gases, specifically a heliox/oxygen mixture, for neonate/infant, pediatric, and adult patients in hospital and sub-acute settings.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document lists various standards that the Precision Flow® - Heliox met, with some exceptions. It also includes functional and design verification tests. The "Reported Device Performance" for these tests is generally stated as: "In all instances, the Precision Flow® - Heliox functioned as intended and the results observed were as expected." Specific quantitative performance data is limited within this summary but is generally implied by compliance with the referenced standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| I. Compliance with Standards: | "In all instances, the Precision Flow® - Heliox functioned as intended and the results observed were as expected." (Implied compliance with the intent of the standard, with specific exceptions noted) |
| ISO 62304: Medical Device Software - Software Life Cycle Process | Met |
| ISO 8185:2007: Respiratory tract humidifiers for medical use | Met |
| ISO 10993-5:2009: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Met |
| ISO 10993-10:2010: Tests for Irritation and Sensitization | Met |
| ISO 11195:1995: Gas mixers for medical use - Stand-alone gas mixers | Met |
| ISO 14971:2007: Medical devices - Application of risk management to medical devices | Met |
| ANSI/AAMI/ISO 15223-1:2007/A1:2008: Medical Devices - Symbols to be used with Medical Device Labels, Labeling and information to be supplied - Part 1: General Requirements | Met |
| ANSI/AAMI ES60601-1:2005: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance | Met |
| ANSI/AAMI/IEC 60601-1-2:2007 3rd edition: Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Compatibility - Requirements and tests | Met (with exceptions: Section 5: Device cannot produce hazardous radiation; Section 6: Anesthetic mixtures not applicable) |
| EN60601-1-4:1999: Medical Electrical Equipment: Part 1: General Requirements for Safety 4. Collateral Standard: Programmable Electrical Medical Systems | Met |
| IEC 60601-1-8 2006-10: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | Met |
| IEC 60529 IPX1: Drip Proof | Met |
| AAMI TIR 32:2004: Software Risk Management | Met |
| AAMI TIR 36:2007: Validation of Software | Met |
| ISTA -1A:2001: Procedure 1A: Packaged-Products weighing 150 LB (68 KG) or Less | Met |
| EPA/625/R-96/010b (VOC) Method TO-15 (1999): Compendium Method TO-15 Determination of Volatile Organic Compounds (VOCs) in Air collected in specially-Prepared canisters and analyzed by chromatography/mass spectrometry (GC/MS) | Met |
| NIOSH Method 0500 (1994): NIOSH manual of Analytical methods (NMNM) fourth edition August 1994 (Particulate Matter Testing) | Met |
| II. Design Verification Plan (Required Tests): | "In all instances, the Precision Flow® - Heliox functioned as intended and the results observed were as expected." |
| Functional Performance Test | Met |
| Alarms & Fault Conditions Test | Met |
| Patient Connector Attachment Test | Met |
| Water Connector Attachment Test | Met |
| Extended Life Test | Met |
| Membrane Switch and Adjustment Dial Test | Met |
| Software Verification Test | Met |
| Fluid & Gas Pathways Leak Test | Met |
| Cartridge Insertion Test | Met |
| Door Test | Met |
| IPX Test | Met |
| Environmental Temperature/Humidity Extremes Test | Met |
| III. Performance Characteristics (Implied by Comparison for Substantial Equivalence): | |
| Oxygen % Range | 21 to 100% (Equivalent to predicates) |
| FiO2 Accuracy | 2 to 40 lpm: +/-2%; 1 to 2 lpm: +/-5% (Equivalent to predicates) |
| Max Flow Range | 40 lpm (Equivalent to predicates) |
| Alarm Sound Level (Medium Priority) | 47 dB @ 1m (Equivalent to predicate) |
| Alarm Sound Level (Low Priority) | 45 dB @ 1m (Equivalent to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide specific sample sizes for particular performance tests or explicitly mention a "test set" in the context of clinical or image-based studies. The performance data section broadly states: "In all instances, the Precision Flow® - Heliox functioned as intended and the results observed were as expected." This implies that the design verification tests listed were conducted on the device.
- Sample Size for Test Set: Not explicitly stated for each test, but implied to be sufficient for demonstrating compliance with cited standards and internal design verification plans.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. The tests are likely laboratory or bench testing, not clinical studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable to this type of device and study. The testing for the Precision Flow® - Heliox involves engineering and performance validation against objective technical standards (e.g., flow rates, temperature, alarm function, electrical safety), not subjective interpretation requiring expert consensus.
4. Adjudication Method for the Test Set
- This information is not applicable as the evaluation relies on objective measurements against engineering specifications and regulatory standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This device is a medical gas humidifier/blender, not an AI-powered diagnostic or decision-support tool. It does not involve human readers interpreting cases with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, this is not applicable. The device is hardware with integrated software for control, not a standalone algorithm. Its performance is inherent to its physical operation and control systems.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by objective engineering specifications, technical standards (e.g., ISO, ANSI/AAMI, IEC), and manufacturer-defined design requirements. This includes accuracy of gas blending, flow rates, temperature control, alarm thresholds, electrical safety, and biocompatibility.
8. The Sample Size for the Training Set
- This is not applicable in the context of a traditional "training set" for machine learning or AI models. The device's software is likely developed using standard software engineering practices and verified accordingly, rather than trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable for the reasons stated above. The "ground truth" for the device's operational parameters is derived from engineering design, relevant medical standards, and intended physiological effects of humidified gas delivery.
§ 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).