(167 days)
Filter CareStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in pediatric (with a tidal volume between 100 and adult patients, depending on the respective device. Filter SafeStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in adult patients. Filter/HME TwinStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and for respiratory use, as well as heat and moisture exchanger for humidifying respired gases for the patient. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in adult, pediatric and neonatal patients, depending on the respective device.
The devices are breathing circuit filters used to filter the inhaled and/or the exhaled air of the patient against microbiological and particulate matter from the gases in the breathing circuit. They enclose a filter material in a housing that fits to standard breathing system connectors. Additionally, there are breathing system filters combined with a foam to function as HME (Heat and Moisture Exchangers) for passively humidifying the inspired air. The portfolio contains the following types of breathing circuit filters: - Filter CareStar Plus are electrostatic filters for use against contamination with microorganisms - . Filter SafeStar Plus are mechanical filters for use against contamination with microorganisms - Filter/HME TwinStar Plus are filters for use against contamination with microorganisms and for passive humidification of breathing gases
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document describes three devices: Filter CareStar Plus, Filter SafeStar Plus, and Filter/HME TwinStar Plus. The table below compiles the acceptance criteria and reported performance for these devices based on the "Summary of non-clinical testing" section (pages 18-19).
| Test Method & Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|
| ISO 9360-1:2000 - Determination and Evaluation of Pneumatic Compliance | Compliance is less than or equal to 1mL/kPa at 15, 30, 60, and 70 hPa | PASSED |
| ISO 9360-1:2000 - Determination and Evaluation of Pneumatic Leakage | Pneumatic leakage is less than or equal to 50mL/min at 70hPa. | PASSED |
| ISO 9360-1:2000 - Determination and Evaluation of Pressure Drop (Pneumatic Resistance) | Pneumatic resistance/pressure drop is acc. to IfU value | PASSED |
| ISO 5356-1:2015 - Evaluation of Conical Connectors (ISO 5356-1) | Cone dimensions comply with ISO 5356-1. | PASSED |
| ISO 80369-7:2021 - Luer Lock Connector (ISO 80369-7) | Luer-Lock connector fulfills the requirements laid out in ISO 80369-7. | PASSED |
| IEC 60601-1:2005 - Product's Ability to Withstand Damage from Dropping | When dropped, the product should not suffer any damage which influences its function. | PASSED |
| ISTA 3A - Product Durability During Transport, Mechanical Aspects | - The packaging shows no or minor damage |
- The DUT (Device Under Test) shows no signs of damage and retains functionality after simulated transport. | PASSED |
| ISO 23328-1:2003 - Filtration Efficiency (Particulate Matter) incl. Usage Time | - Adult and pediatric electrostatic filters achieve a filtration efficiency of >90% before and after the specified usage time - Neonatal filters achieve a filtration efficiency of >75% before and after the specified usage time
- Mechanical filters achieve a filtration efficiency of >99% before and after the specified usage time
- Mechanical filters achieve a HEPA classification ≥ class H13 | PASSED |
| ASTM F2101:2019 - Filtration Efficiency (Viral and Bacterial) | - Electrostatic filters achieve 99.99% (bacterial) and 99.9% (viral) filtration efficiency - Electrostatic filters for neo applications achieve 99.98% (bacterial) and 99.9% (viral) filtration efficiency. | PASSED |
| ISO 10993:2018 and ISO 18562-1:2017 - Evaluation of Product's Biological Compatibility | Evaluation according to ISO 10993:2018 and/or ISO 18562-1:2017 | PASSED |
| ISO 9360-1:2000 - Evaluation of HME Water Loss, Resistance | · pediatric/neonatal: The moisture loss shall be
§ 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).