(200 days)
The paraPAC 200D 'Transport' ventilator is a portable, gas powered, time-cycled ventilator that is designed for ventilation during transportation and emergency ventilation of patients who have respiratory distress or insufficiency.
The paraPAC 'Transport' ventilator is a gas powered, time cycled, volume preset, pressure limited ventilator which uses the same technology as existing legally marketed devices. It depends solely on the pressure of the supply gas for its operation. Additionally, it incorporates an integrated electronic pressure alarm unit to alert the user to certain significant changes that may occur in the patient's ventilation. Loss of battery power for the alarm is signalled to the user but will have no effect on the ventilation performance of the paraPAC "Transport" ventilator, nor affect the mechanically operated alarms and protection systems, which operate in an identical manner to the predicate devices.
The paraPAC 'Transport' ventilator consists of a control module and patient circuit comprising the following disposable items: Hose/ Patient Valve/ PEEP Valve/ Exhaust Collector and Mouthpiece.
The module weighs 3.1 kilograms.
The module control panel has the following features:
- Adjustable Relief Pressure Control, range 20 to 80 cm H2O. .
- Air Mix (45% oxygen) / No Air Mix (100% oxygen) Selector. ●
- Inspiratory Time Range 3.0 to 0.5 seconds. .
- . Expiratory Time Range 6.0 to 0.5 seconds.
- Patient Inflation Pressure Manometer, range -10 to +100 cm H2O. .
- Flow Range 0.1 to 1.0 L/sec. .
- Ventilation: Off (Spontaneous breathing)/ On (Spontaneous breathing/ Controlled Mandatory . Ventilation).
- Supply Gas Failure Alarm A mechanically operated visual alarm gives a warning that the . supply gas has dropped to a pressure at which the ventilator will no longer be operating to specification (
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pneupac paraPAC 'Transport' model 200D ventilator:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative "acceptance criteria" alongside specific numerical "reported device performance" values in a neat table format for the paraPAC 'Transport' 200D. Instead, it describes a more general approach based on compliance with standards and comparison to predicate devices.
However, based on the description, we can infer some criteria and the general performance outcome:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Compliance with Draft Reviewer's Guidance for Ventilators, July 1995 | Passes all tests and met all requirements of the standard. |
| Compliance with EN794-3 'Lung Ventilators - Part 3 Particular requirements for emergency and transport ventilators' 1999 | Passes all tests and met all requirements of the standard. |
| Compliance with EN60601-1 'Medical Electrical Equipment - Part 1 General requirements for safety': 1990 | Passes all tests and met all requirements of the standard. |
| Compliance with EN 60601-1-2: 1993 (Environmental testing - EMC) | Complied with the guidelines and performed within specifications and functional requirements. |
| Compliance with EN794-3: 1999 (Environmental testing - Electrical, Mechanical durability, Safety, Temperature/humidity) | Complied with the guidelines and performed within specifications and functional requirements. |
| Performance of Delivered Tidal Volume, Frequency, Inspiration times, and Expiration time parameters | Within the specified tolerances of the ventilators, deemed same as predicate devices. |
| Substantial Equivalence to predicate devices (babyPAC and paraPAC 'medic') | The device is substantially equivalent to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for the test set in terms of number of devices tested or number of test conditions with specific repetitions. It only states that "Testing was performed to ensure that the paraPAC 'Transport' was safe and would perform within the environment(s) for which it is to be marketed."
The data provenance can be inferred as prospective given that the testing was conducted specifically for this new device (paraPAC 'Transport' model 200D) to demonstrate its safety and effectiveness.
The country of origin for the submitter is the United Kingdom (Pneupac Ltd.), suggesting the testing was likely conducted under UK regulatory and manufacturing standards, even though the submission is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for a medical device like a ventilator is established through objective engineering tests against defined performance specifications and regulatory standards, not expert consensus on interpretations of data. There are no human "experts" establishing ground truth in the way described for AI/ML models analyzing medical images, for example.
4. Adjudication Method for the Test Set
This is not applicable as there is no mention of expert interpretation or adjudication panels for the testing of a mechanical ventilator's performance against engineering specifications. The testing involves objective measurements against established technical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study focuses on the diagnostic performance of human readers, sometimes with and without AI assistance, typically in image interpretation. This document describes the testing of a mechanical ventilator, which is a different domain.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable in the context of a mechanical ventilator as described. The "standalone" performance here refers to the device's ability to meet its technical specifications independently, which is what the performance and environmental testing aimed to establish. However, it's not an "algorithm" in the sense of AI/ML. The device's operation is mechanical and electronic, and its performance was tested without human intervention impacting its core function during the tests (though humans operate the device in real-world use).
7. The Type of Ground Truth Used
The ground truth used for the paraPAC 'Transport' 200D was based on objective measurements against established performance specifications and regulatory standards. This includes:
- Engineering specifications for parameters like adjustable relief pressure, inspiratory time, expiratory time, flow range, patient inflation pressure, and alarm thresholds.
- Compliance with international safety and performance standards (e.g., EN794-3, EN60601-1, EN60601-1-2).
- Comparative performance to predicate devices (babyPAC and paraPAC 'medic') for Tidal Volume, Frequency, Inspiration times, and Expiration time, ensuring performance was "within the specified tolerances."
8. The Sample Size for the Training Set
This is not applicable. The paraPAC 'Transport' 200D is a traditional mechanical medical device, not an AI/ML system that utilizes a "training set" of data in the common sense. Its design is based on established engineering principles and technology, not on machine learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as Item 8.
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).