(42 days)
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.
| Characteristic | Acceptance Criterion (Implicit) | Reported Device Performance (Pneuton Model A) | Discussion from Document |
|---|---|---|---|
| Intended Use - patient population | Same as predicate (Adult - Pediatric) | Adult - Pediatric | Equivalent |
| Intended Use - application | Same as predicate (Inter and intra-facility transport, MRI) | Inter and intra-facility transport, MRI | Equivalent |
| Operating principle | Same as predicate (Pneumatic) | Pneumatic | Equivalent |
| Input gas pressure | Within range of predicate (37 to 87 psi) | 40 to 70 psi | Substantially equivalent |
| Patient circuit | Same as predicate (Tubing with external expiratory valve) | Tubing with external expiratory valve | Equivalent |
| Enclosure | Same as predicate (Rugged, lightweight) | Rugged, lightweight | Equivalent |
| Displays | Same as predicate (Manometer) | Manometer | Equivalent |
| Safety features | Comparable to predicate | Adjustable high pressure release, internal high pressure release, anti-suffocation valve | Substantially equivalent |
| Alarms | Comparable to predicate (Low gas source, patient disconnect) | Low gas source, patient disconnect | Substantially equivalent |
| Modes of ventilation | Comparable to predicate (CMV, IMV, CPAP/PEEP) | CMV, IMV, CPAP | Substantially equivalent |
| Tidal volume | Comparable to predicate (50-1500) | 360 - 1500 | Substantially equivalent |
| Respiratory rate | Comparable to predicate (7-60) | 3 - 50 | Substantially equivalent |
| Flow (L/min) | Pneuton uses fixed inspiratory flow | 36 | Pneuton uses a fixed inspiratory flow |
| PEEP/CPAP | Comparable to predicate (internal/external) | 0 - 20 (internal) | Pneuton has an internal PEEP/CPAP system |
| Peak pressure | Comparable to predicate (20-80) | 15 - 75 | Substantially equivalent |
| I : E ratio | Continuously adjustable by controlling I time and E time | Continuously adjustable by controlling I time and E time using volume and rate controls | Substantially equivalent |
| Internal oxygen control | Comparable to predicate (2 position, 100% or 50/65%) | 2 position, 100% or 65% | Substantially equivalent |
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.
§ 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).