(77 days)
The T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with patients weighing greater than 10kg (>22lb).
The Mercury T-Piece Resuscitator is manually operated, gas powered resuscitator for use with patients greater than 10 kg (>22 lb).
It is a simple T-piece, with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve for excessive pressure.
The T-Piece Resuscitator can be connected to the patient via a face mask, Supraglottic airway or endotracheal tube.
The provided document describes the Mercury T-Piece Resuscitator and its substantial equivalence to predicate devices, focusing on non-clinical testing for performance. This is a 510(k) premarket notification summary, which means the device is being compared to an already legally marketed device (predicate device) and does not involve AI or complex analytical studies in the way modern AI/ML medical devices would.
Therefore, many of the requested categories in the prompt are not applicable to this document. I will focus on the information that can be extracted directly from the provided text.
Here's the breakdown based on the provided document:
Acceptance Criteria and Device Performance
The acceptance criteria are generally aligned with the performance requirements outlined in ISO 10651-5 - Particular Requirements for Basic Safety and Essential Performance for Gas Powered Resuscitators. The "Reported Device Performance" column reflects the specifications of the proposed Mercury Medical T-Piece Resuscitator as presented in comparison tables with its predicate devices.
| Acceptance Criteria (Derived from Predicate & ISO 10651-5) | Reported Device Performance (Mercury Medical T-Piece Resuscitator) |
|---|---|
| Indications for Use: Provide emergency respiratory support by face mask or tube; patients > 10kg (>22lbs). | The T-Piece Resuscitator is a gas-powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with patients weighing greater than 10kg (>22lb). |
| Environment of Use: Hospital, sub-acute facilities, and pre-hospital (EMS). | Hospital, sub-acute facilities, and pre-hospital (EMS). |
| Patient Population: Patients greater than 10 Kg (>22 lbs.). | Patients greater than 10 Kg (>22 lbs.) |
| Ventilation Frequency: Manually delivered by the user up to 60 BPM. | Manually delivered by the user up to 60 BPM. |
| Maximum Pressure Relief: Factory set at 40 cm H2O (predicate range 5-80 cm H2O). | 60 cm H2O (Factory set at 40 cm H2O). |
| Delivered Pressure: Up to 60 cm H2O (predicate range 5-80 cm H2O). | Up to 60 cm H2O. |
| Delivered Volume: (Predicate range 190 - 675 ml with flow rates between 4 - 36 lpm). | 60 - 700 ml with flow rates between 5 - 35 lpm. |
| Inspiratory Resistance: (Predicate: Less than - 5 cm H2O). | 2 cm H2O at minimum PEEP setting @ 60 lpm. |
| Expiratory Resistance: (Predicate: Less than + 5 cm H2O). | 2.4 cm H2O at minimum PEEP setting @ 60 lpm. |
| Oxygen Concentration with optional blender: (Predicate range: 21-100%). | 21 - 98% based upon blender setting. |
| Manometer Range: (Predicate range: -20 to 80 cm H2O). | Up to 60 cmH2O (Cleared under K954486). |
| Manometer Accuracy: (Predicate: +/- 2 cm H2O). | +/- 3 cm H2O up to 15 cm H2O; +/- 5 cm H2O > 15 cm H2O. |
| Peak Inspiratory Pressure (PIP): (Predicate range: 5-80 cm H2O). | 0-60 cm H2O. |
| Positive End-Expiratory Pressure (PEEP): (Predicate uses CPAP instead; reference NeoTee has PEEP). | 0 to 60 cm H2O. |
| Operational Gas Flow Rate: (Predicate range: 0-60 lpm). | 0 - 35 lpm. |
| Operational time with 400 L cylinder: (Predicate @ 36 lpm - 10 minutes). | @ 35 lpm - 11 minutes. |
| Dead space of circuit: (Predicate: |
§ 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).