(147 days)
Flexicare Single Use Manometer is attached to the manometer port on Flexicare resuscitation bags to provide visual indication of the patient's airway pressure during ventilation. The device is intended to be used by trained personnel only within a hospital and/or pre-hospital environment.
Flexicare's Single Use Manometer is a single use device that can be attached to the manometer port on resuscitation bags to provide visual indication of the patient's airway pressure during manual ventilation. Flexicare's Single Use Manometer consists of end cap, clear housing with printed pressure scale, concertina seal, slider and stainless steel spring. When pressure rises, the spring is compressed raising the blue concertina seal and showing the pressure via markings on the manometer housing has calibrated marking at 20 cmH2O intervals between 0 through 60 cmH2O. The measured pressures are accurate to ± 1cmH2O. Flexicare's Single Use Manometer is supplied non-sterile and are for use by CPR-trained personnel only within a hospital and/or pre-hospital environments.
The document provided is a 510(k) Premarket Notification for the Flexicare Single Use Manometer. It describes the device, its intended use, and compares it to a legally marketed predicate device (Ambu Disposable Pressure Manometer, K040991) to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria / Standard | Reported Device Performance |
|---|---|---|
| Accuracy | ± 1 cm H₂O at 20, 40, 60 cm H₂O | Pass |
| Repeatability | Within accuracy tolerance (Graduation print and manometer slider overlap at each marked pressure graduation) | Pass |
| Leak Testing | No standard criteria available; Test for comparative use only ( |
§ 868.2600 Airway pressure monitor.
(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).