(285 days)
The intended use for this device is to provide emergency respiratory support for Adult, Child and Infant.
The device is a disposable, single patient use manual resuscitator that includes a compression bag, intake and patient valve, and a closed vinyl oxygen reservoir bag, (options: open corrugated tubing or open expandable tubing in lieu of closed vinyl oxygen reservoir bag), and an optional peep valve and/or face mask.
Here's an analysis of the provided text regarding the acceptance criteria and study for the BriGam Manual Resuscitator (K963848):
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes tests performed on components of the manual resuscitator, rather than overall device performance metrics like efficacy in ventilation. The tests are focused on biocompatibility and physicochemical characteristics of materials in indirect contact with the patient.
| Item | Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Rubber Compression Bag (A) | 1. Cytotoxicity | Minimal or no cytotoxicity | "slight" cytotoxic |
| Rubber Compression Bag (A) | 2. Physiochemical (Elastomeric Closures) | Appropriate physicochemical extraction characteristics (implied for safety/material integrity) | Performed, but specific results not quantified beyond "pertinent" characteristics |
| Rubber Compression Bag (A) | 3. ASTM Protein Analysis | Protein levels below a safe threshold |
§ 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).