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510(k) Data Aggregation
(375 days)
Servo Guard
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 |
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(474 days)
SERVO GUARD, MODEL 64 81 290 EH88E
The Servo Guard is a disposable single-use device that provides filtration for reducing possible cross contamination between patient and equipment. The device is intended for adult, pediatric and infant populations. The device is indicated for use by qualified medical personnel only.
The Servo Guard is an efficient bacterial and viral filter for applications in respiratory care and anesthesia. The Servo Guard is a disposable single-use device that provides filtration for reducing possible cross contamination between patient and equipment.
This document is a 510(k) summary for the Servo Guard bacterial and viral filter. It does not contain information about acceptance criteria or a study proving that the device meets such criteria in the format requested. The document describes the device, its intended use, and claims substantial equivalence to predicate devices, but lacks details on performance studies with specific statistical metrics.
Therefore, I cannot extract the requested information from the provided text.
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