(125 days)
SpiroThor spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years.
It is intended to be used by physicians or professional medical personnel for testing in physicians' offices, industrial medical, and hospital settings.
The Cohero Health SpiroThor Spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The proposed device consists of a compact main unit and an ultrasonic flowmeter sensor used with a pulmonary function filter. The device uses an ultrasonic sensor that measures flow. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display.
The provided document is a 510(k) premarket notification for the SpiroThor spirometer, asserting its substantial equivalence to a predicate device, the SDI AstraSonic Spirometer (K092813).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the SpiroThor is identical to the predicate device, the SDI AstraSonic Spirometer (K092813), with minor differences being a name change and the use of a different bacterial filter which was shown through comparative testing to have no performance differences. Therefore, the acceptance criteria and reported device performance are assumed to be the same as the predicate device, which are explicitly listed in Table 1 – Comparison to Predicate.
| Specification | Acceptance Criteria (Predicate K092813 / SpiroThor) | Reported Device Performance (SpiroThor) |
|---|---|---|
| Indications for Use | Basic lung function tests in adults and children over the age of four years | Meets (Identical) |
| Environment of Use | Physicians' offices, industrial medical, and hospital settings | Meets (Identical) |
| Patient Population | Adults and children over the age of four years | Meets (Identical) |
| Temperature Sensor | Semiconductor (-25 °C - +85 °C) | Meets (Identical) |
| Display | Graphic Quarter VGA (320x240 pixels), 262K colors | Meets (Identical) |
| Keyboard | 20-key keyboard | Meets (Identical) |
| Connection Type | USB, BlueTooth | Meets (Identical) |
| Flow Tube Dimensions | Ø30 mm x 150 mm | Meets (Identical) |
| Power Supply | Internal 3.7 V Li-Ion battery (Rechargeable via 5V 500mA mini USB charger) | Meets (Identical) |
| Dimensions | 85x120x35 mm (Flow tube: 26 mm(ID)x150 mm) | Meets (Identical) |
| Weight | 300g | Meets (Identical) |
| Flow/Volume Measurement System | Bidirectional, ultrasound/Ultrasonic technology (WaveFront™ technology) | Meets (Identical) |
| Volume Range | ± 20 L (BTPS) | Meets (Identical) |
| Flow Range | ± 18 L/s (BTPS) | Meets (Identical) |
| Volume Accuracy | ± 3% or 50 mL | Meets (Identical) |
| Flow Accuracy | ± 3% or 20 mL/s | Meets (Identical) |
| Dynamic Resistance at 14 L/s |
§ 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).