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510(k) Data Aggregation
(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.
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(126 days)
The babyPAC 100 is a portable gas powered transport ventilator, suitable for use in an MRI environment up to 3 Testa, which features a battery powered integrated electronic pressure alarm unit. It is designed for use by qualified medical caregivers, paramedics and other trained personnel, for ambulance, hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency. It can be used on neonates and infants up to a bodyweight of 44lb (20 kg).
The babyPAC ventilator consists of a control module with a disposable conventional Y patient circuit. The babyPAC ventilator is a pressure generator which depends solely on the pressure of the supply gas for its operation. The babyPAC 100 additionally incorporates an integrated electronic pressure alarm unit which becomes operational during Controlled Mandatory Ventilation. This unit provides a warning of significant changes which may occur in the patient's ventilation. Loss of battery power for the alarm is signaled to the user but will have no effect on the ventilation performance of the babyPAC ventilator, nor affect the mechanically operated alarms and performance on the babyPAC ventilator (K970158) already on the market.
The babyPAC 100 portable ventilator is designed for use as an emergency and transport ventilator in ambulances and hospitals, and can be used in an MRI environment up to 3 Teslas. It is intended for transportation and for resuscitation of infants (above approx 11lb [5 kg]) and neonates up to 44 lb (20 kg).
The control module of the babyPAC ventilator is rugged by virtue of its thick section structural foam plastic case and the controls for the gauge and internal pneumatics are recessed to minimise the possibilities of damage and inadvertent operation.
The babyPAC 100 portable ventilator consists of a control module and the following items: 22mm disposable Polyethylene respirator hose/ 22mm OD female connector and Paediatric 'Y' piece connector
The module weighs 8.25 lb (3.75 kilograms)
The module control panel has the following features:
- Adjustable Relief Pressure Control, range 12 to 80 cm H2O.
- Inspiratory Time Control, range 0.25 to 2.0 seconds.
- Expiratory Time Control, range 0.25 to 4.0 seconds
- Inspiratory Pressure Control, range 12 to 70 cm H2O, with click action warning at and above 40 cm H2O.
- PEEP/ CPAP Control, range 0 to 20 cm H2O with click action warning at and above 10 cm H2O.
- IMV Control, range Expiratory time 2.5 to 40 seconds with CPAP Pressure level and oxygen concentration as selected.
- Patient Inflation Pressure Manometer, range -10 to +100 cm H2O.
- Variable Oxygen Concentration, range 45 (approx) to 100% with oxygen only as supply, 21 to 70 % with oxygen and air supplies
- Supply Gas Failure Alarm indicators- One for air, the other for oxygen, these mechanically operated visual alarms give a warning that the supply gas has dropped to a pressure at which the ventilator will no longer be operating to specification (< 35 psi). With low pressure they show red, with adequate pressure they show white. Any visible red indicates that the supply should be changed. As the pressure falls the display will begin to oscillate from white to partial red as the supply pressure falls to the lower threshold level.
The visual indication will be accompanied by an electronically generated medium priority (to EN 475: 1995) audible warning.
- Electronic alarm bezel indicating
- High Pressure/ Constant Positive Inflation Pressure Indicator Flashes Red LED with audible alarm at set relief pressure and with continuous positive pressure
- Inflation Indicator Flashes Green LED every time inflation pressure rises through 10 cm H2O.
- Low Pressure/ Disconnect Indicator Flashes Yellow LED with audible alarm if pressure does not rise through 10 cm H2O within eight seconds
- Silence button silences audible alarm for 60 seconds. Flashes Orange LED to indicate to the operator that the audible alarm is silenced.
- Single Gas Use Indicator Flashes a Green LED as a burst of 3 flashes every 30 seconds, whenever the ventilator is being used with only a single gas input (ie oxygen or air only). In the event that the single gas fails (ie. where the audible gas failure alarm has activated) the Low Pressure/ Disconnect Indicator will activate together with the audible alarm.
- Low battery indicator Flashes Yellow LED with audible alarm.
Here's an analysis of the provided text to extract the requested information about acceptance criteria and the study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety Testing | Compliance with EN794-3 (Lung Ventilators - Part 3 Particular requirements for emergency and transport ventilators) 1999 | "The ventilator passes all of these tests and met all requirements of the standards." |
| Compliance with EN60601-1 (Medical Electrical Equipment - Part 1 General requirements for safety) 1990 | "The ventilator passes all of these tests and met all requirements of the standards." | |
| Environmental Testing | Compliance with EN 60601-1-2: 1993 | "The results demonstrated that the babyPAC 100 complied with the guidelines and standards and that they performed within their specifications and functional requirements." |
| Compliance with EN794-3: 1999 | "The results demonstrated that the babyPAC 100 complied with the guidelines and standards and that they performed within their specifications and functional requirements." | |
| Performance (Functional Equivalence to Predicate K970158) | Delivered Tidal Volume, Frequency, Inspiration times, and Expiration time parameters are the same as the predicate (babyPAC K970158). | "All measurements were within the specified tolerances of the ventilators," indicating "no functional difference." |
| Performance (Functional Equivalence to Predicate K020899) | Safe for use in an MRI environment up to 3 Teslas, and the performance of the electronic integrated alarms system is the same as the predicate (paraPAC 'medic' P200 K020899). | "No functional difference... for safe use in an MRI environment up to 3 Teslas and operation of the integrated electronic alarms." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a 'sample size' in terms of patient data or a specific number of devices tested for each parameter. The testing described is typically design verification and validation testing rather than a clinical trial with a patient test set.
- Test Set Sample Size: Not explicitly stated in terms of patient numbers or specific device units. The wording suggests testing of the ventilator's entire range and across its parameters.
- Data Provenance: The document does not specify the country of origin of the data. Given the "Submitter" and "Address" information (Smiths Medical International Ltd., UK), it is highly probable the testing was conducted in the UK or a region complying with the cited European standards (EN). The data is part of a submission for regulatory clearance (510(k)), implying it is prospective with respect to the regulatory approval process, but the detailed testing itself would have been retrospective if conducted on existing manufactured units as part of the product development lifecycle.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts for ground truth determination) is not applicable or provided in this document. The "ground truth" for the device's performance is established by direct measurement against engineering specifications and regulatory standards, not by expert consensus on clinical data. The tests refer to objective measurements (e.g., Tidal Volume, Frequency, alarm activation) against defined tolerances and compliance with standards.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation where adjudication would be necessary. Performance is measured against objective technical standards and predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is a ventilator, and the testing focuses on its engineering performance and safety compliance, not on human interpretation of medical images or data where MRMC studies are typically employed.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance study was done. The entire "Performance Data" section describes the device's performance in isolation (e.g., meeting EN standards, comparison of physical output parameters like tidal volume). The device itself is not an "algorithm" in the modern AI sense, but its functional performance was tested standalone without human intervention affecting the measurement of its core parameters. The electronic alarm unit's operation was also tested standalone in its comparison to the predicate.
7. Type of Ground Truth Used
The ground truth used is primarily based on:
- Engineering Specifications and Tolerances: For parameters like Tidal Volume, Frequency, Inspiration/Expiration times, relief pressure, PEEP/CPAP, etc.
- Regulatory and International Standards: E.g., EN794-3, EN60601-1, EN60601-1-2. Compliance with these standards forms the ground truth for safety and environmental performance.
- Predicate Device Performance: For demonstrating substantial equivalence, the performance of the babyPAC (K970158) and paraPAC 'medic' P200 (K020899) served as the established ground truth for comparison.
8. Sample Size for the Training Set
Not applicable. This device is a medical ventilator, not an AI/ML algorithm that requires a "training set" in the computational sense. The design and validation are based on engineering principles and regulatory testing, not statistical learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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