(431 days)
Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10Kg. Child: less than or equal to 23 Kg. Adult: greater than 23 Kg
This manual resuscitator may be supplied with a single patient use positive end expiratory pressure (PEEP) valve and / or disposable Airway Pressure Manometer.
The PEEP Valve is a single patient use positive end expiratory pressure (PEEP) valve for use hospital. transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. Intended for patients that the clinician has determined need PEEP.
The Disposable Manometer is a single patient use manometer intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems.
Foremount Disposable PVC Resuscitators are portable medical devices used to temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure. They consist of Ventilation Bag, Patient Valve, Intake Valves, Reservoir Bag, Oxygen Tubing, Cushion Mask, and optional Diverter Ring, PEEP Valve and Manometer. Foremount Disposable PVC Resuscitators come in three sizes along with a ventilation bag:
- . Infant - Less than or equal to 10 kg
- Child less than or equal to 23 kg ●
- Adult Greater than 23 kg. ●
The ventilation bags are available in three sizes based upon the intended patient population. They are provided with masks in three sizes (#1 - Infant, #3 - Child, and #5 - Adult). The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 40 cmH2O pop off valve for Child and Infant models. The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 60 cmH2O pop off valve for Adult models.
This is a 510(k) premarket notification for the Foremount Disposable PVC Resuscitator Model A1, A2, B1, B2 and Accessories, including a PEEP valve and a disposable manometer. The submission aims to demonstrate substantial equivalence to previously cleared devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define "acceptance criteria" in a dedicated table for each device component with specific numerical targets. Instead, it demonstrates performance by comparing the Foremount devices to their respective predicates or by stating that the device meets relevant ISO standards.
We can infer the acceptance criteria are met if the Foremount device's specifications and performance fall within acceptable limits defined by the predicate devices and applicable ISO standards.
Inferred Acceptance Criteria and Reported Device Performance (Resuscitator)
| Characteristic | Acceptance Criteria (Inferred from Predicate/Standard) | Reported Device Performance (Foremount) |
|---|---|---|
| General | ||
| Indications for Use | Single patient use manual resuscitator for hospital, transport, emergency, and post-hospital care to temporarily ventilate in given body mass ranges. | Same as predicate: Infant ≤ 10Kg, Child ≤ 23 Kg, Adult > 23 Kg (for Models A1, B1); Adult > 23 Kg (for Models A2, B2) |
| Patient Population | Infant ≤ 10Kg, Child ≤ 23 Kg, Adult > 23 Kg | Same as predicate |
| Environment of Use | Hospital, transport, emergency, post-hospital care | Same as predicate |
| Duration of Use | Single patient, disposable |
§ 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).