(51 days)
The EAGLE is intended to be used for diagnostic use in the treatment of pulmonary illnesses with an intended use and indication for use as a configurable, non-invasive pulmonary function tester (PFT) testing system. The EAGLE is indicated for use in: pulmonary function testing.
The Collins EAGLE (Diffusion Spirometer)is a Pulmonary Function Test System. is intended as a configurable, non-invasive pulmonary function tester (PFT) testing system. These tests are suitable for both pediatric and adult patient testing.
The EAGLE is a configurable, non-invasive pulmonary function tester (PFT) testing system. It includes a pneumotach (single-screen bi-directional device), commercially available pressure transducers, and gas analyzers (fast-response Infrared analyzer for CO, CO2, and CH4, and an electrochemical sensor for O2). It operates on 115-240 VAC 50-60 Hz.
The Collins Medical, Inc.'s EAGLE is a diffusion spirometer intended for diagnostic use in the treatment of pulmonary illnesses as a configurable, non-invasive pulmonary function tester (PFT) testing system for both pediatric and adult patients.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The given document does not explicitly present a table of acceptance criteria for the overall device directly alongside its performance. Instead, it lists performance specifications for key components and indicates conformity to recognized standards. I will extract these performance specifications for the core components that would typically have acceptance criteria.
| Component / Parameter | Acceptance Criteria (Stated Performance) | Reported Device Performance (Same as criteria as these are specifications) |
|---|---|---|
| Spirometer | ||
| Pneumotach Resistance |
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).