(99 days)
This AccuTrax EPF840device is intended for monitoring PEF and FEV; for patient home and work use. The EPF840 is designed for pediatric to adult patients. The simple device interface provides ease of use for pediatric patients. When the EPF840 is used to watch lung conditions such as asthma, the user should be under the care of a licensed health care professional. A licensed health care professional's advise is required to understand the meaning and importance of the measures reported by the AccuTrax 840, and how to decide on an appropriate treatment plan. This treatment plan will tell you what action to take when there are changes in your PEF/FEV; numbers.
The EPF840 is an electronic PEF/FEV; monitor. It can store PEF/FEV; test results, symptom scoring, and inhaler usage with a time and date stamp. The physician may retrieve data for analysis and trending using a personal computer. The physician may customize color zone indicators to the patient's needs.
Here's a breakdown of the acceptance criteria and study information for the ACCUTRAX EPF840 Electronic Peak Flow Meter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily compares the ACCUTRAX EPF840 to a predicate device (Vitalograph 2110) against ATS (American Thoracic Society) standards. The acceptance criteria are implicitly the ATS standards for monitoring devices.
| Parameter | Acceptance Criteria (ATS Standard for Monitoring Devices) | ACCUTRAX Model EPF840 Performance | Predicate Device (2110) Performance |
|---|---|---|---|
| Back pressure |
§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).