(375 days)
The Servo Guard is a bacterial/viral filter for applications in respiratory care.The filter is intended to be used in patient circuits to reduce the spread of viruses and bacteria from patient/persomel and to protect the patient circuits and ventilators from contamination. The filter shall only be used with the ventilators Servo-i and Servo-s.
A Breathing Circuit Bacteria Filter is intended to protect from contamination as well as to reduce particles such as dust and microbiological matters from gases used in the patient circuit of a respiratory device. The bacterial/viral filter is a disposable accessory normally used on the expiratory limb of the ventilator breathing system to reduce possible cross contamination between patient and equipment and between patient. It can also be used on the inspiratory pipe, in order to reduce dust particles to the patient.
This document is a 510(k) summary for the Servo Guard bacterial/viral filter. It describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's the information requested based on the provided text, focusing on the study that proves the device meets the acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Type of Study) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISO 23328-1 Filter efficiency | > 99.3 % measured in both flow directions | 99.329 % - 99.93% |
| ASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency | BFE/VFE filter efficiency shall be > 99.999 % | BFE: 99.99951% - 99.999984 % |
| VFE: 99.99960% - 99.999980 % | ||
| ISO 18562-2: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 2: Tests for emissions of particulate matter |
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).