(231 days)
Single patient use device intended for use with neonates, infants and children under 10 Kg requiring a nasal prong interface during intermittent or continuous gas flow therapy in the hospital critical care unit.
Single patient use nasal cannula offered in 8 different sizes which have been specifically designed for patents ≤ 10 Kg. The device includes a short length of 10 mm corrugated tubing allowing connection to a variety of devices. The device also provides a means to monitor delivered pressure at the nasal prong.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Babi.Plus Infant Nasal Cannula System:
The information provided describes a 510(k) premarket notification for a medical device (Babi.Plus Infant Nasal Cannula System), emphasizing its substantial equivalence to a predicate device. The core of the "study" proving acceptance criteria here is a bench testing and dimensional analysis comparison to a legally marketed predicate device, rather than a clinical trial with human subjects.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria are implicitly defined by demonstrating "substantially equivalent performance" to the predicate device. The performance characteristics compared are "Resistance to gas flow in the inspiratory circuit" and "Resistance to gas flow in the expiratory circuit."
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (Implicit) | Predicate Device Performance (Reported) | Proposed Device Performance (Reported) |
|---|---|---|
| Resistance to gas flow in the inspiratory circuit: | ||
| Gas Flow (L/min) 1 | 0 |
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).