(158 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 (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
| Feature/Standard | Acceptance Criteria (Implied by compliance, performance specification) | Reported Device Performance (Summary from non-clinical testing) |
|---|---|---|
| All functions as listed in specifications | Meets specifications | Validated |
| FDA Reviewer Guidance for Ventilators | Meets all test requirements | Meets all test requirements |
| ASTM F 1100-90 Ventilators Intended for Use in Critical Care | Compliance with standard | Complies with standard |
| AHA Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiac Care (Minimum requirements for Automatic Transport Ventilators) | Compliance with minimum requirements | Complies with minimum requirements |
| MIL STD 810 E Test Method Standard for Environmental Engineering Considerations and Laboratory Tests | Compliance with standard | Complies with standard |
| ISO 10651-3 Lung Ventilators for Medical Use. Particular requirements for emergency and transport ventilators | Compliance with standard | Complies with standard |
| Operating Principle | Pneumatic | Pneumatic |
| Input Gas Pressure | 40 to 70 psi | 40 to 70 psi (equivalent to predicates) |
| Patient Circuit | Standard with external expiratory valve | Standard with external expiratory valve (equivalent to predicates) |
| Enclosure | Rugged, lightweight | Rugged, lightweight (equivalent to predicates) |
| Displays | Manometer | Manometer (equivalent to one predicate) |
| Alarms | Low gas source | Low gas source (Pneuton only device with alarm) |
| Modes of Ventilation | CMV, IMV, CPAP | CMV, IMV, CPAP (substantially equivalent to predicates) |
| Tidal Volume | 360 - 1500 | 360 - 1500 (equivalent to one predicate) |
| Respiratory Rate | 2 - 50 | 2 - 50 (equivalent to one predicate) |
| Flow | 36 | 36 (equivalent to one predicate) |
| PEEP / CPAP | 0 - 20 | 0 - 20 (equivalent to one predicate) |
| Peak Pressure | 10 - 75 | 10 - 75 (equivalent to one predicate) |
| 1:E Ratio | Continuously adjustable | Continuously adjustable (equivalent to one predicate) |
| Internal Oxygen Control | 2 position, 100% or 65% | 2 position, 100% or 65% (Pneuton only unit with internal oxygen mixing) |
| Performance as intended according to its performance specification | Performs as intended | Performs as intended |
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.
§ 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).