(371 days)
The spirometer (LA104, LA105) is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (5 to 21 years and older) patients in hospitals, physician's offices, laboratories, and occupational health environments.
The spirometer is used to detect the ventilatory conditions of patients using a flow sensor. Basic test items include: Forced Vital Capacity (FVC), Slow Vital Capacity (SVC), Maximum Ventilator Volume (MVV), and Minute ventilation (MV). The device also provides bronchial diastolic and bronchial provocation tests comparison before and after medication along with time-volume and time-flow curves of the above tests.
The device comes in two models: LA104 and LA105. There are no differences between the two models apart from a minor software function. LA104 includes software incentive animations to encourage children to follow breathing instructions. The spirometer (model: LA104, LA105) consists of the main body, handle, power adapter and a single-use flow sensor. In order to conduct simple spirometry testing, the spirometer is used with a commercially available single-use disposable filter with integrated mouthpiece. This device is compatible with 30mm diameter filters.
The fundamental technology to measure flow is differential pressure. While the patient breathes, the air flows through both ends of the flow probe and produces different pressures. Then the sensor detects the pressure gap between both ends and converts it to electrical signals. The electrical signals are converted into digital signals of the pressure gap. Then digital signals are input into the computer system, which outputs values of pulmonary function related parameters after digital signal processing and data analysis.
The provided document is a 510(k) summary for a Spirometer (models LA104, LA105). It outlines the device's technical specifications, comparison to a predicate device, and performance data to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document primarily focuses on demonstrating equivalence to the predicate device (CardioTech Spirometry Model System, K090646) and compliance with recognized standards. The acceptance criteria are implicit in these standards and the predicate comparison.
| Acceptance Criteria / Specification | Device Performance (Spirometer LA104, LA105) |
|---|---|
| Spirometry Performance: | |
| Flow range | ±16 L/s |
| Flow accuracy | Comply with ATS/ERS 2005 |
| Flow 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).