(171 days)
Filter only - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired. Use up to 24 hours.
HME / Filter - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. Use up to 24 hours.
Environment of use - clinical setting including hospital, sub-acute, pre-hospital and home
For patient with Tidal Volumes > 300 ml.
The subject device is provided in two (2) configurations.
- Filter only ●
- . HME / Filter combination
- The common features are:
- Standard conical 15 mm / 22 mm fittings for connections
- Female luer lock port for gas sampling for end-tidal CO2 ●
The provided text describes a 510(k) premarket notification for a medical device called "Altera Filter and HME/Filter". It details the device's characteristics, indications for use, and a comparison with a predicate device, including performance data from nonclinical testing.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Method (Attribute) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISO 9360-1 (Resistance to Flow) | Equivalent to a predicate | 76 kPa |
| ISO 80369-7 Luer / ISO 5356-1 Conical (Connectors) | Passes Requirements | Meets the Standards |
| ASTM F2101 (Bacterial Filtration Efficiency - BFE) | Equivalent to predicate | >99.998% |
| ASTM F2101 (Viral Filtration Efficiency - VFE) | Equivalent to predicate | >99.96% |
| ISO 9360-1 (HME Performance - Moisture Output) | Moisture Output equivalent to predicate | 39 mg/L (Vt = 1000 ml @ 24 hours) |
| ISO 10993 and ISO 18562 (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| ISO 10993 and ISO 18562 (Sensitization) | Non-sensitizer | Non-sensitizer |
| ISO 10993 and ISO 18562 (Irritation) | Non-irritant | Non-irritant |
| ISO 10993 and ISO 18562 (Chemical Characterization TRA) | Margin of Safety > 1 | Margin of Safety > 1 |
| ISO 10993 and ISO 18562 (Acute Systemic Toxicity) | Non-systemic | Non-systemic |
| ISO 10993 and ISO 18562 (Volatile Organic Compound) | Identified VOC | Identified VOC |
| ISO 10993 and ISO 18562 (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).