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510(k) Data Aggregation
(250 days)
HepaShield Bacterial Viral Breathing System Filter
Flexicare's HepaShield Bacterial Viral Breathing System Filters are intended to reduce the transmission of bacteria and viruses to/from a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are single patient for use on a single patient for up to 24hrs and are available in Adult size. FlepaShield Bacterial Viral Breathing System Filters are designed to be used in hospital environments by trained personnel.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are designed to reduce the transmission of bacteria and viruses to and from a patient who requires aesthesia, artificial respiration or other types of assisted respiration
Flexicare's HepaShield Bacterial Viral Breathing System Filters consist of a top/bottom housing, pleated paper filter pack and a luer port cap. The Female luer-lock port allows connection of a luer-terminating monitoring line for monitoring of patient exhaled CO2 & is supplied with a tethered cap to seal port when not in use.
The patient side of the Flexicare's HepaShield Bacterial Viral Breathing System Filters feature a 22mm Male and a 15mm Female conical. The machine side features a 22mm Female and a 15mm Male conical.
All conical connectors comply with dimensions stated within BS EN ISO 5356-1 standard.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in Adult sizes.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in a both Sterile and non-sterile state, packaged in individually sealed polybags, or blister trays (if sterile).
The provided text describes the acceptance criteria and study results for the Flexicare HepaShield Bacterial Viral Breathing System Filter, which is a medical device.
1. Table of acceptance criteria and the reported device performance:
| Test | Standard / Pre-Determined Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Visual Inspection | Product packaging must remain sealed & undamaged. All components of devices must be free of flash, cracking, warping, discoloration or contamination. | Pass |
| Compliance testing (Internal Volume/dead space) | BS EN ISO 9360: 2009 (Methodology only, no pass criteria) | Methodology only, no pass criteria - Comparable performance outcome between Flexicare's new devices and the predicate devices (47ml vs 35ml for predicate) |
| Pressure drop | BS EN ISO 23328-2 (Refers to: BS EN ISO 9360: 2009) - Methodology only, no pass criteria | Methodology only, no pass criteria - Comparable performance outcome between Flexicare's new devices and the predicate devices (1.70 cmH2O @ 30LPM; 3.92 cmH2O @ 60LPM; 6.56 cmH2O @ 90LPM) |
| Gas Leakage (for comparison only, HME aspects not applicable) | Pre-determined Acceptance Criteria* (implies visual inspection criteria for gas leakage if unspecified) | methodology only, no pass criteria |
| Conical Connector compliance | BS EN ISO 5356-1 2004 | Pass |
| Leak testing | Not explicitly stated (likely internal specification) | Pass |
| Drop testing | Not explicitly stated (likely internal specification) | Pass |
| Cytotoxicity, Irritation, Sensitization, Systemic toxicity, Material Mediated | BS EN ISO 10993-10:2010, BS EN ISO 10993-5:2009 | Pass |
| Pyrogenicity | BS EN ISO 10993-11:2009 | Pass |
| Bacterial Endotoxin | (USP) guidelines and , ANSI/AAMI ST72:2011 | Pass |
| Particulate emissions (gas pathway) | EN ISO 18562-2:12017 | Pass |
| VOC emissions (gas pathway) | EN ISO 18562-3:2017 | Pass |
| Gauging tests on luer | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Liquid leakage from luer | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Air leakage from luer | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Luer separation force | BS EN ISO 80369-7:2016 | Pass |
| Luer unscrewing torque | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Luer ease of assembly | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Luer resistance to overriding | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Luer testing for stress cracking | Not explicitly stated (likely internal specification or part of ISO 80369-7) | Pass |
| Shelf life testing | Standards included within this table (implying all relevant performance criteria are met over shelf life) | Pass |
| Filter integrity | Based on ASTM F2101 (Nelson Labs Protocol), BS EN ISO 23328-1 (2008) (Methodology only, no pass criteria within standard) | Methodology only, no pass criteria within standard (Reported BFE - 99.99999%, VFE - 99.9999%, Salt Method filtration efficiency - 99.89%) |
| Pressure Drop (as part of Filter integrity or separate measurement) | BS EN ISO 23328-2 (2009) (Methodology only, no pass criteria within standard) | Methodology only, no pass criteria within standard |
| Housing Leakage | BS EN ISO 23328-2(2009) (Methodology only, no pass criteria within standard) | Methodology only, no pass criteria within standard (Reported |
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