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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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