(366 days)
The Helontix Vent is designed to deliver helium/oxygen mixtures to spontaneously breathing patients via a facemask with or without pressure support. The system is designed for facility use and should only be used under the orders of a clinician.
The Helontix Vent delivery system is not intended as a life support device and is not intended for intubated patients.
The Helontix vent is a stand alone assembly to deliver heliox or oxygen. To accomplish this, the Helontix vent consists of a device with a built in battery and a trollev with mounted oxygen and Heliox gas cylinders. When connected to O2 and Heliox (79%He, 21%O2) the Helontix vent delivers a mixture of oxygen and helium in the required fraction to the patient who can breathe over a mask that is connected to the device via a hose system. The Helontix vent interacts with the user via a user interface, i.e. a display, diodes, speaker, several keys and a control wheel. The device informs the user on the screen about set values, monitored values, alarms, ventilation modes and the navigation through the menus while the user can choose the ventilation mode, set values, silence alarms and navigate through menus by using keys and control wheel. The Helontix vent is device designed for Non-invasive Positive Pressure Ventilations (NPPV) for spontaneous breathing patients. The inspiration flow can be either triggered by the patient with a surplus support of pressure (pressure support mode, PSM, 3-30mbar@peak flow 160SLPM) or alternatively a constant flow from 5-60 SLPM without a pressure support (constant flow mode, CFM) can be selected. The breathing circuit, mask and filter used are purchased previously cleared devices.
The provided text describes a 510(k) premarket notification for the Linde Gas Therapeutics Helontix Vent, a device designed to deliver helium/oxygen mixtures to spontaneously breathing patients. The document focuses on establishing substantial equivalence to predicate devices and adherence to regulatory standards, rather than presenting a detailed clinical study with specific acceptance criteria and outcome data in the format requested.
Therefore, the following information can be extracted about the device's validation, but will not fully align with the requested structure of a study proving a device meets acceptance criteria derived from a clinical trial, as that type of study is not described:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the listed voluntary standards and the assertion of "positive results from extensive testing" demonstrating substantial equivalence. The document does not provide a table with specific, measurable performance metrics and corresponding acceptance thresholds for clinical efficacy, nor does it present quantitative results from a specific clinical study for the Helontix Vent. Instead, it refers to regulatory and engineering standards.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance (General Statement) |
|---|---|
| Compliance with UL 60601-1 (Medical electrical equipment - General safety) | "Positive results from extensive testing demonstrate that the Linde Helontix Vent is substantially equivalent to the predicate devices." (Implies compliance) |
| Compliance with EN/IEC 60601-1 (Medical electrical equipment - General safety) | "Positive results from extensive testing demonstrate that the Linde Helontix Vent is substantially equivalent to the predicate devices." (Implies compliance) |
| Compliance with EN/IEC 60601-1-2 (Electromagnetic compatibility) | "EMC...testing is also provided in support of the submission." (Implies compliance) |
| Compliance with EN/IEC 60601-1-4 (Safety requirements for programmable systems) | "The submissions contains full software information regarding the Level of Concern Analysis, Risk Analysis, Software Development, Software Requirements and Design, Verification and Validation testing, and Traceability." (Implies compliance) |
| Compliance with EN 60601-2-12/ASTM F1100 (Lung ventilators - Critical care) | "Positive results from extensive testing..." (Implies compliance, though the device is not for critical care according to the 'intended use' statement). This is a potential discrepancy in the document's presentation or the standard's applicability. The intended use states it is not a life support device. |
| Compliance with EN 60601-1-8 (Electrical Alarm signals) | "Positive results from extensive testing..." (Implies compliance) |
| Compliance with EN 980 (Graphical symbols) | "Positive results from extensive testing..." (Implies compliance) |
| Compliance with EN ISO 21647 (Respiratory gas monitors) | "Positive results from extensive testing..." (Implies compliance) |
| Compliance with EN 739/ISO 5359 (Low-pressure hose assemblies) | "Positive results from extensive testing..." (Implies compliance) |
| Compliance with EN 14971 (Risk management) | "The submissions contains full software information regarding the Level of Concern Analysis, Risk Analysis..." (Implies compliance) |
| Compliance with EN 60601-1-6 (Usability) | "Positive results from extensive testing..." (Implies compliance) |
| Compliance with ISO 5356-1 (Conical connectors) | "Positive results from extensive testing..." (Implies compliance) |
| Compliance with Draft Reviewer Guidance for Ventilators | "Positive results from extensive testing..." (Implies compliance) |
| Software Validation (major concern device) | "The submissions contains full software information regarding the Level of Concern Analysis, Risk Analysis, Software Development, Software Requirements and Design, Verification and Validation testing, and Traceability." (Implies successful validation) |
| Electrical and Environmental Performance | "EMC, Electrical, Environmental and full performance testing is also provided in support of the submission." (Implies successful performance) |
| Substantial Equivalence to predicate devices | "The Linde Helontix Vent and the currently marketed device are substantially equivalent in design concepts, technologies and materials." |
2. Sample size used for the test set and the data provenance:
The document does not describe a clinical study or a test set of patient data. The "extensive testing" mentioned refers to engineering and software validation, not a clinical trial with human subjects. Thus, information on sample size and data provenance (country, retrospective/prospective) for a clinical test set is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical test set with expert-established ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable as no clinical test set requiring adjudication is described.
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:
Not applicable. The device is a ventilator for heliox delivery, not an AI-powered diagnostic or reader-assistance tool. No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device for gas delivery, not an algorithm. Performance assessment would involve engineering and physical testing, not algorithm-only performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context refers to compliance with established engineering standards, software requirements, and safety regulations. These are verified through various physical and software tests, rather than human expert consensus on clinical data or pathology.
8. The sample size for the training set:
Not applicable as no machine learning algorithm with a training set is described.
9. How the ground truth for the training set was established:
Not applicable as no machine learning algorithm with a training set is described.
Summary of Study (Based on Provided Text):
The "study" described in the 510(k) summary is primarily a premarket notification to demonstrate substantial equivalence to legally marketed predicate devices and compliance with relevant voluntary standards and regulatory requirements. It is a technical and regulatory validation process, not a clinical study designed to prove device efficacy through patient outcomes or expert reads.
The document states:
- "Positive results from extensive testing demonstrate that the Linde Helontix Vent is substantially equivalent to the predicate devices."
- "EMC, Electrical, Environmental and full performance testing is also provided in support of the submission."
- "The submissions contains full software information regarding the Level of Concern Analysis, Risk Analysis, Software Development, Software Requirements and Design, Verification and Validation testing, and Traceability."
These statements indicate that the device underwent various forms of engineering, software, and performance testing to ensure it met safety requirements and functioned as intended within the parameters of the industry standards listed. The "ground truth" for these tests would be the specifications and requirements defined by those standards and the device's design documentation. No clinical trial with patient-specific outcome data, expert reviews, or AI performance metrics is mentioned or detailed.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).