(371 days)
This device is intended for monitoring PEF (Peak Expiratory Flow) for patient home use. The device is designed for children 5 years of age or older, adolescent and adult subjects.
The device is made up of two elements – the Electronic Peak Flow Meter and a Mobile Medical Application for smartphones that communicate via Bluetooth. The device is a portable device that can measure the Peak Expiratory Flow (PEF). The Electronic Peak Flow Meter consists of the main unit, turbine, and blowing mouthpiece.
Electronic Peak Flow Meter software is embedded in the main control unit, which is used to control the whole system of operation. After compiling, the program is solidified into the hardware. The combination of software and hardware realizes the functions for electronic peak flow meter.
When Electronic Peak Flow Meter connected to APP of communication devices (such as a mobile) through Bluetooth. The changes of the patient's PEF data within one week can be monitored by APP, so that it is more convenient to monitor the respiratory health status.
This document is a 510(k) premarket notification for an Electronic Peak Flow Meter (model DL-DF01). It states that performance testing was conducted according to the ATS/ERS Task Force: "Standardisation of lung function testing - Standardisation of spirometry 2005" to evaluate accuracy and repeatability of PEF measurements.
Here's a breakdown of the requested information based on the provided text, recognizing that some details directly related to the study's execution and ground truth might not be explicitly stated in this high-level summary:
- 1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (from predicate) | Reported Device Performance (Proposed Device DL-DF01) |
|---|---|---|
| Accuracy | ±10 L/min or ±10%, whichever is greater | PEF ± 20 L/min or PEF ± 10% of the reading |
| Repeatability |
§ 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).