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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.

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.

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The LIV is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MRI systems up to 3.0T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall! be rah Uized or otherwise secured to prevent falling and rolling.

The Linde Integrated Valve™ ("LIV") is a portable oxyqen delivery system, consisting of a fully integrated cylinder, valve, requlator, flow meter, and shock-absorbing quard. A range of user-selectable flow settings is available, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 50psig oxygen delivery, while an optional bed hanger allows the LIV to be readily attached to a bed. The LIV is suitable for use in all healthcare settings, including, but not limited to, hospital, outpatient, imaging center, ambulatory, and home healthcare.

The Linde Integrated Valve (LIV) is a portable oxygen delivery system. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way one might for a novel AI/software device.

Here's the breakdown based on the provided information, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the LIV primarily relies on demonstrating substantial equivalence to a predicate device (MEDICYL-E-Lite K033897) rather than setting specific quantitative acceptance criteria for novel performance, as one would for an AI/software device. The "acceptance criteria" here are implicitly met by showing the device's technical characteristics are substantially similar and that it conforms to relevant standards.

• Flowrate Selector and Flow Outlet (yes)
• Cylinder On/Off (yes)
• Filling Port (active; w/ non-return valve)
• Excess Flow Device (yes)
• Residual Pressure Valve (yes)
• Burst Disk (yes)
• Single stage piston style (yes)
• Guard (2 grip, Access Ports, green color)
• Cylinder Sizes (D, E)
• Materials/construction (Aluminum)
• MRI Compatibility (yes; tested up to 3.0T) |
  | Compliance with 21CFR49 § 178.46 | Aluminum cylinders conform to the requirements of 21CFR49 § 178.46, Specification SAL seamless aluminum cylinders. |
  | MRI Compatibility (ASTM standard 2503-05 and CDRH document) | Evaluated in accordance with the draft CDRH Magnetic Resonance Working Group document, "A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems," dated February 7, 1997.
  MR-conditional (per ASTM standard 2503-05). Intended for use during MR imaging for MRI systems up to 3.0T. |
  | Safety and Effectiveness (Implicit) | The manufacturer believes that the LIV is substantially equivalent to the predicate device and "does not raise any new questions of safety or effectiveness" based on safety and performance testing and compliance with voluntary standards. |
  | Intended Use Alignment with Predicate | Both devices are portable oxygen delivery systems. The LIV's indications for use: "integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MRI systems up to 3.0T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only." |
  | Additional Features (no new safety/effectiveness concerns) | The LIV includes features not in the predicate: Pressure Outlet (yes) and Contents Gauge (active), which are implicitly deemed not to raise new safety or effectiveness concerns. |

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable in the context of this 510(k) summary. This document does not describe a "test set" or data provenance in the way one would for a clinical study comparing AI performance against ground truth. The evaluation is primarily based on engineering design, materials, and compliance with standards, along with a comparison of technological characteristics to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a medical device (hardware) submission, not an AI/software device submission requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable for the same reasons as above.

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 LIV is a hardware device for oxygen delivery, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The "ground truth" for this type of device submission revolves around engineering specifications, material properties, and functionality meeting established standards and being comparable to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. No AI/machine learning training set is involved.

9. How the ground truth for the training set was established

Not applicable. No AI/machine learning training set is involved.

In summary:

The provided document is a 510(k) summary for a physical medical device (an oxygen delivery system). It demonstrates the device's safety and effectiveness by establishing substantial equivalence to an already legally marketed predicate device, rather than through a standalone performance study with clinical endpoints or AI-specific validation metrics. The "study" implicitly referenced is the "safety and performance testing and compliance with voluntary standards" conducted by the manufacturer, which is deemed sufficient to demonstrate this equivalence. The "acceptance criteria" are met by matching or exceeding the predicate's characteristics and complying with relevant engineering and safety standards.

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