(269 days)
The Pneupac paraPAC plus™ Model 300/310 Ventilators are gas-powered emergency and transport portable ventilators that are primarily intended for use in transport applications in vehicles including fixed and rotary winged aircraft. They are suitable for emergency use at the accident scene, intra and inter-hospital transport and within medical facilities including medical imaging systems to 3 Teslas. They should only be used under the constant supervision of trained healthcare professionals. The devices are intended to provide ventilatory support to adults, children and infants (above approx. 10kg).
The devices also provide free flow oxygen therapy and CPAP therapy for spontaneously breathing patients.
The Pneupac® paraPAC plus™ Model 300/310 Ventilators are gas powered portable medical devices intended for the ventilation of adults, children and infants (above approximately 10kg (or 22lb)) during transportation and emergency situations.
These models are the enhanced versions of the Pneupac® Parapac® P200D Medic (K020899) gas powered time cycled emergency and transport ventilator which is also one of the predicate devices. Similar to the Pneupac® Parapac P200D, the Pneupac® paraPAC plus™ Model 300/310 Ventilators depend solely on the pressure of the supply gas for their operation. This enables them to be suitable for use in transport applications in vehicles including fixed and rotary winged aircraft.
As with the Pneupac® Parapac® P200D, these models also incorporate an integrated electronic pressure alarm unit to alert the user of certain significant changes (such as for high or low inflation pressure) that may occur in patient's ventilation. Loss of battery power for the alarm is signaled to the user, but will have no effect on the performance of the ventilator, nor affect the pneumatically operated alarms and the ventilators functioning.
Calibrated frequency and tidal volume controls are color coded to indicate the recommended settings for adults, children and infants.
A Positive End Expiratory Pressure (PEEP) control is provided to set PEEP between 0 and 20 cm H2O. It also has a Continuous Positive Airway Pressure (CPAP) control to provide CPAP therapy for spontaneously breathing patients which is also one of the features of the predicate device, the O Two Carevent Systems (K051469). This is achieved by connecting a Pneupac® paraPAC plus™ Disposable CPAP Circuit to the Pneupac® paraPAC plus™ Model 310 Ventilator.
An air mix control in the Pneupac® paraPAC plus™ Model 300/310 Ventilators gives FiQ2 option of 0.50 or 1.0. This enables the device to provide a combination of air and oxygen.
The Pneupac® paraPAC plus™ Model 300/310 Ventilators use currently available technology found in many legally marketed ventilators. Testing was performed to demonstrate that they are safe and would perform within the environment(s) for which they are to be marketed.
The Pneupac® paraPAC plus™ Model 300 Ventilator consists of a control module with user manual, oxygen gas specific standard input hose and a standard disposable patient circuit.
The Pneupac® paraPAC plus™ Model 310 Ventilator consists of a control module with user manual, oxygen gas specific standard input hose, standard disposable patient circuit, CPAP disposable patient circuit and hyperinflation bag (K970785).
The Pneupac® paraPAC plus™ Disposable CPAP Circuit is an air entrainment device with an attached oxygen and pressure monitoring line for connection solely to the Pneupac® paraPAC plus™ 310 Model Ventilators. The Instructions for Use of the Pneupac® paraPAC plus™ Disposable CPAP Circuit state that it can only be used with the Pneupac® paraPAC plus™ Model 310 Ventilator. As the Pneupac® paraPAC plus™ Disposable CPAP circuit cannot be used without the Pneupac® paraPAC plus™ Model 310 Ventilator, the Pneupac® paraPAC plus™ Disposable CPAP circuit is considered as an integral part of the Pneupac® paraPAC plus™ Model 310 Ventilator for the purposes of this Premarket Notification.
The disposable patient circuits provided with the Pneupac® paraPAC plus™ Model 300/310 Ventilators are specifically designed for use with the Pneupac® paraPAC plus™ Model 300/310 Ventilators and the Instructions for Use state that these are the only circuits to be used with the Pneupac® paraPAC plus™ Model 300/310 Ventilators. As the Pneupac® paraPAC plus™ Model 300/310 Ventilators cannot be used without the patient circuit, the patient circuit is considered an integral part of Pneupac® paraPAC plus™ Model 300/310 Ventilators for the purposes of this Premarket Notification.
The provided text describes a 510(k) summary for the Pneupac® paraPAC plus™ Model 300/310 Ventilators. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical characteristics, rather than clinical efficacy studies with specific acceptance criteria related to a disease outcome or human reader performance.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types) are not applicable to the information contained within this document. The document primarily details the device characteristics and the non-clinical testing performed to show that the device performs as intended and is safe.
Here's an analysis of the provided information based on the request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the format of a performance target with a corresponding measured result for specific clinical metrics. Instead, it describes compliance with various standards and satisfactory performance in non-clinical tests. The "reported device performance" is a general statement that the device performed within its specifications and functional requirements and complied with guidelines and standards.
| Acceptance Criteria (Implied from Standards/Guidelines) | Reported Device Performance (Summary) |
|---|---|
| Mechanical durability (vibration, bump, drop) per BS EN 60601-1:1990 clause 21, EN794-3:1999 clause 21, ISO 10651-3:1997, ISO 10651-5:2006 | Passed series of tests; complied with guidelines and standards for durability. |
| Temperature and humidity per EN 60601-1:1990 clause 10, BS EN 794-3:1999 clause 10, ISO 10651-5:2006 | Passed series of tests; complied with guidelines and standards for environmental conditions. |
| Electromagnetic compatibility (EMC) per EN60601-1-2:2002, ISO 10651-3:1997 clause 5.8 (radiated immunity test field strength 30V/m across 80MHz to 2.5GHz) | Examined in accordance with standards; will not interfere electromagnetically. |
| Prevent ingress of objects per BS EN 60529:1992 (Ingress protection and Salt Fog testing) | Complied with guidelines and standards. |
| Suitability for use in air ambulance aircraft per BS EN 13718-1:2008, RTCA DO 160F:2007 | Complied with guidelines and standards. |
| Oxygen consumption, accessories output, rigidity, cleaning and sterilization, storage, life testing of electronic alarm battery | Performed within specifications and functional requirements (based on in-house engineering tests). |
| Usability per FDA guidance, IEC/ISO 62366:2007, ANSI/AAMI HE75:2009 | Overall success of usability in the intended environment (based on HFE Study). |
| Biocompatibility of materials per ISO 10993-1.2009 | Found to be biocompatible. |
2. Sample size used for the test set and the data provenance
Not applicable. The "testing" primarily refers to non-clinical bench testing, environmental testing, and human factors validation, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of clinical studies, is not established for this type of non-clinical device testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving adjudication of interpretations.
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 device is a ventilator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a ventilator, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the clinical sense. For mechanical and environmental testing, the "ground truth" (or reference standard) would be the performance requirements set forth in the cited international and national standards (e.g., specific force for drop test, temperature range, EMC levels, etc.).
8. The sample size for the training set
Not applicable. This is a medical device approval based on substantial equivalence and non-clinical engineering testing, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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).