(161 days)
The Resuscitation Unit 105 PV and Resuscitation Unit 105 EV are intended to remove secretions from the neonatal / infant airways and to provide blended air and oxygen at a desired oxygen concentration in the range of 21-100% to a respiratory assist device connected to the patient such as a ventilator (including a manually operated one) and an oxygen tent.
Environment of use - Hospitals, delivery suites, NICU
There are two (2) models of the Resuscitation Unit 105 air / oxygen blender with suction.
- Resuscitation Unit 105PV .
- . Resuscitation Unit 105EV
They have the same basic design. Table 1 outlines the basic features and differences of each model.
The Atom Medical Corporation Resuscitation Unit 105EV and 105PV are medical devices intended to remove secretions from neonatal/infant airways and to provide blended air and oxygen at a desired concentration (21-100%) to respiratory assist devices. The devices underwent performance testing to demonstrate substantial equivalence to predicate devices.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from predicate devices) | Reported Device Performance (Resuscitation Unit 105EV/PV) |
|---|---|
| Air/O₂ blender: |
- Range: 21-100%
- Accuracy: ±3%O₂ | Achieved 21-100% oxygen concentration with ±3%O₂ accuracy (implied by substantial equivalence to predicates like Bio-Med Devices BMD air/oxygen blender K925982 and Precision Medical Precision Blender K053232). |
| Airway pressure manometer: - Range: -20 to 80cmH₂O
- Accuracy: ±1% of full scale | Achieved -20 to 80cmH₂O range with ±1% of full scale accuracy (implied by substantial equivalence to Atom V-505 Infant Warmer K060461, which features an airway pressure manometer). |
| Relieving valve: - Set to 5.9 kPa (60 cmH₂O) for preventing excessive airway pressure | The device has a relieving valve with a default setting of 5.9kPa (60cmH₂O), which is a feature not present in some predicates, indicating it meets or exceeds this safety aspect. |
| Gas sources input pressure: - Air/O₂: 206-517kPa | Achieved 300-500kPa (which falls within the predicate's range of 206-517kPa and implies compliance). |
| Gas flow rate range (blender): - ≥ 30 lpm (for certain predicates) |
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).