(268 days)
The paraPAC 200 & 200D are portable, gas powered, time-cycled ventilators that are designed for emergency ventilation of patients who have respiratory distress or insufficiency.
The paraPAC 'Medic' 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 'Medic' ventilator, nor affect the mechanically operated alarms and protection systems, which operate in an identical manner to the predicate device, except for the addition of a mechanically operated gas supply indicator and the addition of a secondary relief valve.
The paraPAC 'Medic' 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 is available as either a non- demand version (P200) or demand version (P200D), and weighs 2.7 kilograms (non-demand version) or 3.1 kilograms (demand version) respectively. The module control panel for both models have the following features: Adjustable Relief Pressure Control, range 20 to 80 cm H2O. Air Mix (45% oxygen) / No Air Mix (100% oxygen) Selector. Tidal Volume Control, range 65 to 1570 ml. Frequency Control, range 8 to 40 b.p.m. with click stop detent at 12 b.p.m. for Cardiopulmonary Resuscitation. Patient Inflation Pressure Manometer, range -10 to +100 cm H2O. 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 (
The provided document is a 510(k) premarket notification for the Pneupac paraPAC 'Medic' models 200 & 200D ventilators. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data for new device performance acceptance criteria.
Based on the information provided, here's a breakdown of what can be answered:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly define a table of acceptance criteria with numerical targets. Instead, it states that the device "passed all of these tests and met all requirements of the standards" and that "All measurements were within the specified tolerances of the ventilators" for the comparison tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with Safety Standards (e.g., EN794-3, EN60601-1) | The ventilator passes all of these tests and met all requirements of the standards. |
| Compliance with Environmental Standards (EN 60601-1-2, EN794-3) | The results demonstrated that the paraPAC 'medic' models 200 & 200D complied with the guidelines and standards and that they performed within their specifications and functional requirements. |
| Electromagnetic Compatibility (EMC) | The results demonstrated that the paraPAC 'medic' models 200 & 200D complied with the guidelines and standards and that they performed within their specifications and functional requirements. |
| Electrical Durability | The results demonstrated that the paraPAC 'medic' models 200 & 200D complied with the guidelines and standards and that they performed within their specifications and functional requirements. |
| Safety (operator and patient) | The results demonstrated that the paraPAC 'medic' models 200 & 200D complied with the guidelines and standards and that they performed within their specifications and functional requirements. |
| Temperature/Humidity | The results demonstrated that the paraPAC 'medic' models 200 & 200D complied with the guidelines and standards and that they performed within their specifications and functional requirements. |
| Equivalent performance of Tidal Volume with predicate device | The performance of the delivered Tidal Volume, Frequency, Inspiration times and Expiration time parameters are the same for each... All measurements were within the specified tolerances of the ventilators. (Comparison between new and predicate devices) |
| Equivalent performance of Frequency with predicate device | The performance of the delivered Tidal Volume, Frequency, Inspiration times and Expiration time parameters are the same for each... All measurements were within the specified tolerances of the ventilators. (Comparison between new and predicate devices) |
| Equivalent performance of Inspiration times with predicate device | The performance of the delivered Tidal Volume, Frequency, Inspiration times and Expiration time parameters are the same for each... All measurements were within the specified tolerances of the ventilators. (Comparison between new and predicate devices) |
| Equivalent performance of Expiration time with predicate device | The performance of the delivered Tidal Volume, Frequency, Inspiration times and Expiration time parameters are the same for each... All measurements were within the specified tolerances of the ventilators. (Comparison between new and predicate devices) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for any test sets. The data provenance is not explicitly mentioned as a country of origin. The nature of the testing described (compliance with standards, comparison to predicate device) suggests laboratory or bench testing rather than clinical data involving human subjects, so "retrospective or prospective" would not typically apply in the same way.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. The testing described is technical and objective (e.g., measuring tidal volume, checking alarm functionality, adherence to standards), not involving subjective expert assessment for ground truth determination.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. The tests described are objective measurements against specified tolerances 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
This is not applicable. The device is a ventilator, not an AI-assisted diagnostic tool that would involve "human readers" or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a mechanical ventilator with electronic alarms, not an algorithm, so "standalone performance" in the context of AI is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance claims appears to be:
- International/European Standards: The device's performance was compared against the requirements specified in standards such as EN 794-3, EN 60601-1, and EN 60601-1-2.
- Predicate Device Performance: For delivered Tidal Volume, Frequency, Inspiration times, and Expiration time, the ground truth was the established and accepted performance of the legally marketed predicate devices (paraPAC 'medic' 2 and 2D). The new device was required to perform "the same."
8. The sample size for the training set
This is not applicable as the device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/machine learning model.
§ 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).