(87 days)
Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg in hospital, transport, emergency and post hospital care environments.
Single patient use medical device, which temporarily augment ventilation insufficiency or ventilatory failure.
The document provided outlines the A Plus Medical Babi.Plus™ Neonatal Resuscitation Bag and its substantial equivalence to a predicate device. The primary study presented relates to comparative technological characteristics rather than a clinical study involving human patients or complex AI algorithms.
Here's a breakdown of the requested information based on the provided text, noting where information is not applicable or not present:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the ISO 10651-4:2002 standard ("Lung ventilators - Part 4: Particular requirements for opered resuscitators") and the predicate device's performance. The "Babi.Plus™" column shows the reported device performance.
| Item | Acceptance Criteria (Implied by Predicate/ISO) | Reported Device Performance (Babi.Plus™) |
|---|---|---|
| Patient Connector: | 15 mm I.D. / 22 mm O.D. (Predicate) | 15 mm I.D. |
| Face Mask: | Option offered, 15 mm O.D. (Predicate) | Option offered, 15 mm O.D. |
| Pressure Gauge Connector: | None (Predicate) | 4.0 mm O.D. tapered |
| Supplemental oxygen delivery: | (Predicate values given) | VT-20 mls, Rate – 60 BPM: |
| @ 2 LPM – 91%, @ 10 LPM – 99+% | ||
| VT-20 mls, Rate – 120 BPM: | ||
| @ 2 LPM – 91%, @ 10 LPM – 99+ % | ||
| VT-50 mls, Rate – 30 BPM: | ||
| @ 2 LPM – 75%, @ 10 LPM – 99+% | ||
| VT-50 mls, Rate – 60 BPM: | ||
| @ 2 LPM – 66%, @ 10 LPM – 99+% | ||
| Expiratory resistance: |
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, 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).