(203 days)
The Pal® Ultipor® U55/U55N Filter is a single use bacterial/viral filter and heat and moisture exchanger (HME) for patient side or machine side installation in breathing systems. It is designed to reduce bacterial/viral transmissions between the patient, the equipment and the environment and to reduce the loss of patient heat and humidity. The Ultipor® U55/U55N breathing circuit filter has >99.999% bacterial and >99.995% viral efficiency.
The filter is for single patient use for adult patients, and is intended for use within breathing systems in healthcare and home environments where ventilation is required and for a maximum duration of 24 hours.
The Pall® Ultipor®U55/U55N Breathing Circuit Bacterial Filter and Heat and Moisture Exchanger is a disposable, highly efficient, bi-directional bacterial/viral filter for patient ventilation solutions and is comprised of the following components:
- . Filter housing - Is comprised of two molded halves, an inlet housing and an outlet housing that are joined and sealed together. The finished filter housing holds the pleated hydrophobic filter media and provides conical (tapered) fittings on opposing sides of the finished housing to provide connection to the conventional equipment used in the breathing circuit. One side of the finished housing has a coaxial conical fitting, with a conical fitting located on the opposing side.
- Hydrophobic filter media Provides airborne bacterial removal efficiency of >99.999%, . airborne viral removal efficiency of >99.995% and waterborne microbial contaminant removal efficiency of 100%. If the filter is used at the patient end, the filter media also acts as a heat and moisture exchanger (HME) by conserving a proportion of the heat and humidity present in the patient's exhaled air and returning it to the patient on the next inspiration.
The provided text is a 510(k) summary for a medical device called the Pall® Ultipor® U55/U55N Breathing Circuit Bacterial Filter and Heat and Moisture Exchanger. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive comparative effectiveness study against human readers or specific clinical outcomes in the way an AI diagnostic device might.
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1. Table of Acceptance Criteria and Reported Device Performance
| Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Evaluate device's biological safety for the intended use, in accordance with ISO 10993-1 and FDA's corresponding guidance document | • Cytotoxicity (L929 MEM elution) per ISO 10993-5; | |
| • Sensitization and intracutaneous injection per ISO 10993-10; | |||
| • Acute systemic toxicity per ISO 10993-11 with both polar and non-polar solvents (in lieu of testing to ISO 18562-4); and | |||
| • Material-mediated pyrogenicity per ISO 10993-11. | All results were acceptable. | ||
| Microbial retention (aerosol bacterial and viral) | Evaluate aerosol bacterial and viral removal | >99.999% effectiveness for bacteria removal and >99.995% for virus removal | Unaged and aged (5 years) filters demonstrated bacterial effectiveness of >99.999% and viral effectiveness of >99.995%. |
| Microbial retention (liquid bacterial) | Evaluate liquid bacterial removal | 100% retention | No bacteria were recovered from the water placed on the machine side following the challenge for any unaged or aged (3 & 5 years) filters. This testing also supports filter media integrity and hydrophobicity. |
| Poly-alpha-olefin (PAO) Removal | Evaluate filtration efficiency | Penetration of ≤0.09% | All unaged and 5-year aged filters had a penetration of 0.09%. |
| Sodium Chloride Particulate Removal | Evaluate filtration efficiency | Pre- and post-conditioning penetrations of |
§ 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).