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The pNeuton mini is intended to provide ventilatory support for critically ill patients who require the following general types of ventilatory support:

• Positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a mask or nasal prongs)
• CMV and IMV mode of ventilation with or without PEEP / CPAP
• Provide oxygen or a mixture of medical air and oxygen

The pNeuton mini ventilator is a small, lightweight transport ventilator designed for use on patients from neonate to pediatric in size (400 gram to 25 kg). It is a time cycled, flow limited ventilator providing Continuous Mechanical Ventilation (CMV) or Intermittent Mandatory Ventilation (IMV). In these modes of ventilation, an adjustable inspiratory time, expiratory time and pressure is delivered to the patient. The patient is allowed to breath spontaneously between the mandatory breaths with little added work of breathing. A built-in PEEP / CPAP system can be set to provide expiratory positive pressure. The delivered oxygen is adjustable from 21 to 100 percent. The pNeuton mini ventilator is a pure pneumatic ventilator. Electrical power is not used. The ventilator operates from oxygen and medical grade air input pressures from 40 to 70 psi. The various control systems that manage the time controls, PEEP / CPAP, and safety systems / pneumatic alarms is powered with pure oxygen to maintain stability and accuracy. There are no electronic controls or software in this device. The device provides ventilation and CPAP support for the care of individuals who require respiratory assistance. The device is a restricted medical device for use by qualified medical personnel under the direction of a physician. The device may be used in prehospital environments, inter and intra-hospital patient transport, air and ground transport, and all areas of the hospital including the MRI (NOT for use in the presence of flammable anesthetics). The mini ventilator has been specifically designed for ruggedness and ease of use. The pNeuton mini ventilator uses accessories during normal operation. The primary accessory is a patient tubing circuit to attach the device to the patient. The patient circuit is a single-use disposable device. The patient circuit uses the same major component (expiratory valve) included with the predicate pNeuton Ventilator K043085 with smaller diameter hoses.

The pNeuton mini Ventilator is a device designed for providing ventilatory support to critically ill neonate to pediatric patients. Its acceptance criteria and proof of meeting them are detailed in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated through its specifications, which meet or exceed the requirements of relevant voluntary standards. Below is a summary of key performance characteristics and their specifications:

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

The document explicitly states that "Clinical testing was not performed on this device." Therefore, there is no test set in the context of human patient data. The provenance of the data is from non-clinical bench testing and simulated conditions performed by the manufacturer, Airon Corporation, presumably in the USA (where the company is based). The data is retrospective in the sense that it represents controlled lab measurements and simulations based on predefined specifications and standards.

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

As clinical testing was not performed and the data is non-clinical bench testing, the concept of "ground truth" derived from expert clinical opinion is not applicable here. The "truth" or reference for performance was established by engineering specifications and recognized industry standards (e.g., ASTM F1100-90, ISO 10651-3:1997, RTCA DO-160G, MIL-STD-810F). The experts involved would be those who developed these standards and the engineers and technicians at Airon Corporation who conducted the tests and verified compliance. Their qualifications would be in engineering, medical device manufacturing, and testing, rather than medical clinical specialties for patient diagnosis.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was used. The device's performance was judged against pre-defined engineering specifications and compliance with voluntary standards through measurement and direct verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done. The document explicitly states, "Clinical testing was not performed on this device." The submission relies on substantial equivalence to predicate devices and non-clinical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, the non-clinical testing described represents standalone performance of the device. The pNeuton mini Ventilator is a mechanical, pneumatic device with no electronic controls or software, hence no "algorithm" in the modern AI sense. The testing verified the physical and mechanical performance of the device itself against its specifications in a controlled, simulated environment, without direct human interaction or intervention during the operational tests (e.g., the 2,200 hours of continuous operation).

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on:

• Engineering specifications: The target performance parameters (e.g., flow rates, pressure ranges, time accuracies) defined by Airon Corporation for the pNeuton mini Ventilator.
• Voluntary industry standards: Specific requirements and test methodologies outlined in standards such as ASTM F1100-90, ISO 10651-3:1997, RTCA DO-160G, MIL-STD-810F, and CGA V-5:2008. These standards define acceptable ranges and test environments for ventilators.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this device is a mechanical ventilator and does not involve machine learning algorithms that would typically require a training dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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To provide CPAP to spontaneously breathing patients in the hospital, prehospital (EMS) and sub-acute / alternate site facility environments via Face Mask or endo-tracheal tube.

The device provides CPAP support for the care of spontaneously breathing individuals who require oxygen assistance. The device is a restricted medical device for use by qualified medical personnel under the direction of a physician. The device may be used in pre-hospital environments, inter and intra-hospital patient transport, air and ground transport, and all areas of the hospital (NOT for use in the presence of flammable anesthetics or in the MRI). MACS has been specifically designed for ruggedness and ease of use.

The MACS CPAP device uses accessories during normal operation. The primary accessory is a patient tubing circuit and positive airway pressure face mask to attach the device to the patient. The patient circuit and face mask are single-use disposables. The patient circuit is the same circuit included with the previously cleared Pneuton Ventilator K024344 and K043085.

The provided text describes the MACS CPAP System and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the manner described by the request points (e.g., performance metrics, sample sizes, expert adjudication, MRMC studies, or training sets for AI/algorithm performance).

The document details the device's description, intended use, and a comparison with predicate devices in terms of characteristics like environments of use, personnel requirements, operating principle, and safety features. It then summarizes non-clinical testing and validation.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing. The document states: "All functions as listed in the specifications have been validated. The device meets all test requirements as identified in the FDA Draft Emergency Resuscitator Guidance (April, 1993)." However, it does not provide a table outlining specific acceptance criteria values (e.g., pressure accuracy within X mmHg, flow rate within Y L/min) or the exact reported performance values achieved by the MACS CPAP system against these criteria. It only makes a general statement of compliance.

2. Sample size used for the test set and the data provenance

Missing. The document states, "Clinical testing was not performed on this device. Safety and efficacy were established through non-clinical testing." This implies that no human patient data (test set) was used in the evaluation for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Missing. Since clinical testing was not performed and no human data test set was used, there's no mention of experts establishing ground truth for evaluating the device's performance in a clinical context.

4. Adjudication method for the test set

Missing. No clinical test set means no adjudication method was used.

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/Missing. This device is a CPAP system, not an AI or imaging diagnostic device that would involve human "readers" or an MRMC study comparing human performance with and without AI assistance.

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

Not applicable/Missing. This is a hardware medical device, not an algorithm or AI system.

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

Missing/Not applicable in the AI/algorithm context. For regulatory purposes, the "ground truth" for a device like this would typically be established by validated test equipment and simulation environments per engineering and performance standards. The document mentions compliance with ISO standards (ISO 10651-5:2006, ISO 5356-1:2004, CGA V-5:2005) and the FDA Draft Emergency Resuscitator Guidance, implying that performance was measured against these technical benchmarks.

8. The sample size for the training set

Not applicable/Missing. This is not an AI/algorithm device, so there is no "training set."

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

Not applicable/Missing. No training set exists for this type of device.

In summary, the provided document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant non-clinical standards and guidance documents for a mechanical CPAP system. It does not provide the detailed information requested regarding acceptance criteria and performance evaluation methodology that would be typical for an AI/algorithm-based medical device.

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The device is intended for continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified medical personnel under the direction of a physician.

Specifically, the ventilator is applicable for adult and pediatric patients, 23 kg (50 lbs.) and greater who require the following general types of ventilatory support:

• positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a mask)
• CMV and IMV modes of ventilation
• with or without PEEP / CPAP
• with oxygen or a mixture of air and oxygen

The ventilator is suitable for use in:

• Pre-hospital transport applications including accident scene, emergency rescue vehicles
• Hospital ICU and transport applications including emergency, radiology, surgery, recovery and MRI departments
• Air transport via helicopter or fixed wing

Pneuton (pronounced "new-ton") is a small, lightweight transport ventilator designed for use on patients from pediatric to adult in size (23 kg and higher). It is a time cvcled, flow limited ventilator providing Continuous Mechanical Ventilation (CMV) or Intermittent Mandatory Ventilation (IMV). In these modes of ventilation, an adjustable respiratory rate and tidal volume are delivered to the patient. The patient is allowed to breath spontaneously between the mandatory breaths with little added work of breathing. A built-in PEEP / CPAP system can be set to provide expiratory positive pressure. The delivered oxygen is adjustable at 65 or 100 percent.

Pneuton is a pneumatic ventilator. Electrical power is not required for patient ventilation. The pneumatic system operates at input pressures from 41 to over 66 psi. Various control systems manage the tidal volume and rate control, PEEP / CPAP, and safety systems / pneumatic alarms.

This premarket submission makes the following changes to the Pneuton Ventilator:

• adds a patient disconnect alarm system to the ventilator. The alarm includes audible and visual indication of patient disconnect
• changes the minimum respiratory rate from 2 to 3 breaths per minute
• changes to the minimum peak inspiratory pressure from 10 to 15 cm H₂O
• increases the MRI compatibility to 3 tesla

The ventilator will be marketed as a finished component, both with and without the changes identified above. The Pneuton Ventilator model A includes the changes; model S is the original device without the changes.

The Pneuton Ventilator uses accessories for normal operation which are included with this submission. The primary accessory is a patient tubing circuit to attach the ventilator to the patient. The patient circuit is the same circuit included with the previously cleared Pneuton Ventilator K024344. Additional external accessories will be sold with the device including a remote alarm adapter, travel case, pole stand, mounting brackets, oxygen hose and oxygen tanks.

This document describes a 510(k) premarket notification for the Pneuton Ventilator, Model A. The submission focuses on amendments to an existing device rather than a new AI-powered medical device, therefore many of the requested fields are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for specific performance metrics that are then directly compared to reported device performance in a numerical sense. Instead, the "Substantial Equivalence" table implicitly highlights areas where the modified device (Pneuton model A) is considered either "Equivalent" or "Substantially Equivalent" to predicate devices based on functional characteristics and specifications.

The document also states that:

• "All functions as listed in the specifications have been validated."
• "The ventilator meets all test requirements as identified in the FDA Reviewer Guidance for Ventilators."

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

This is a physical medical device (ventilator) submission, not a software or AI device. Therefore, the concepts of "test set" and "data provenance" in the context of an algorithm or AI model are not directly applicable. The testing described is non-clinical and involves testing the physical ventilator's performance against established standards.

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

Not applicable. Ground truth for a physical ventilator's performance is established through engineering and performance testing against industry standards (e.g., ASTM, ISO, MIL STD) and device specifications, not through expert consensus on data interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1, 3+1" are relevant for resolving discrepancies in expert labeling or diagnoses for AI/ML ground truth, which is not the case here.

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. This is not an AI-assisted device.

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

Not applicable. This is a standalone physical ventilator.

7. The Type of Ground Truth Used

For the Pneuton Ventilator, the "ground truth" for its performance is established by:

• Engineering Specification Compliance: The device performing according to its design specifications (e.g., tidal volume delivery, respiratory rate accuracy, alarm functionality).
• Compliance with Recognized Standards: Meeting the requirements of standards such as ASTM F 1100-90, MIL STD 810 E, and ISO 10651-3. These standards define the expected performance and safety characteristics of medical ventilators.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the Pneuton Ventilator Model A meets acceptance criteria is described as "Non-Clinical Testing and Validation."

• Methodology: "The performance of the Pneuton Ventilator has been comprehensively tested. All functions as listed in the specifications have been validated." This would involve bench testing, functional testing, and environmental testing.
• Standards Compliance: The device demonstrated compliance with the following recognized standards:
  • ASTM F 1100-90 Ventilators Intended for Use in Critical Care
  • MIL STD 810 E Test Method Standard for Environmental Engineering Considerations and Laboratory Tests
  • ISO 10651-3 Lung Ventilators for Medical Use. Particular requirements for emergency and transport ventilators
• Conclusion: "Safety and efficacy were established through non-clinical testing. The Pneuton Ventilator model A performs as intended according to it's performance specification and is substantially equivalent to the predicate devices."

The regulatory submission argues that the modifications (patient disconnect alarm, slight changes to min respiratory rate and min peak inspiratory pressure, increased MRI compatibility) do not raise new questions of safety or efficacy and that the device remains "substantially equivalent" to its predicate devices (original Pneuton K024344 and Pneupac Transport Ventilator K030803) based on this non-clinical testing and comparison of characteristics.

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The device is intended for continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified medical personnel under the direction of a physician.

Specifically, the ventilator is applicable for adult and pediatric patients, 23 kg (50 lbs.) and greater who require the following general types of ventilatory support:

• positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a mask)
• CMV and IMV modes of ventilation
• with or without PEEP / CPAP
• with oxygen or a mixture of air and oxygen

The ventilator is suitable for use in:

• Pre-hospital transport applications including accident scene, emergency rescue vehicles
• Hospital ICU and transport applications including emergency, radiology, surgery, recovery and MRI departments
• Air transport via helicopter or fixed wing

Pneuton (pronounced "new-ton") is a small, lightweight transport ventilator designed for use on patients from pediatric to adult in size (10 kg and higher). It is a time cycled, flow limited ventilator providing Continuous Mechanical Ventilation (CMV) or Intermittent Mandatory Ventilation (IMV). In these modes of ventilation, an adjustable respiratory rate and tidal volume are delivered to the patient. The patient is allowed to breath spontaneously between the mandatory breaths with little added work of breathing. A built-in PEEP / CPAP system can be set to provide expiratory positive pressure. The delivered oxygen is adjustable at 65 or 100 percent.

Pneuton is a pneumatic ventilator. Electrical power is not required for patient ventilation. The pneumatic system operates at input pressures from 41 to over 66 psi. Various control systems manage the tidal volume and rate control, PEEP / CPAP, and safety svstems / pneumatic alarms.

The Pneuton Ventilator uses accessories for normal operation which are included with this submission. The primary accessory is a patient tubing circuit to attach the ventilator to the patient. The patient circuit is a class 1 device, currently exempt from premarket notification. The patient circuit is a disposable device, not to be sterilized or disinfected (see section 12 of this submission). Additional accessories will be sold with the device including travel case, pole stand and mounting brackets.

The Pneuton Ventilator did not provide specific acceptance criteria or detailed study results with numbers as typically seen in modern device submissions. Instead, the submission relies on compliance with established standards and a general statement of performance.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document states "The performance of the Pneuton has been comprehensively tested. All functions as listed in the specifications have been validated." This suggests testing of the device itself against its specifications and relevant standards, rather than a clinical dataset.
• Data Provenance: Not applicable in the context of clinical data. The testing was non-clinical, involving the device's functional integrity and adherence to engineering and safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The "ground truth" for this ventilator's performance was established by its compliance with engineering specifications and recognized medical device standards, which are objective measures, not subjective interpretations by experts on a test set of data.

4. Adjudication method for the test set:

• Not applicable. No human adjudication was performed for a clinical test set. The validation was against predefined technical specifications and standards.

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:

• No. This device is a mechanical ventilator, not an AI-powered diagnostic tool for human readers.

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

• Not applicable. This is a standalone mechanical ventilator, whose performance is inherently "standalone" in its function. It does not involve an algorithm providing outputs for human interpretation.

7. The type of ground truth used:

• The ground truth was based on:
  • Device Performance Specifications: The device's internal design parameters and intended operational ranges.
  • Recognized International and National Standards: Compliance with established medical device safety, performance, and environmental standards (e.g., ASTM, AHA, MIL STD, ISO).
  • FDA Reviewer Guidance for Ventilators: Adherence to FDA-specific requirements for ventilators.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not an AI system that undergoes "training" on a dataset.

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

• Not applicable. See point 8.

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