(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 (
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.
§ 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).