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510(k) Data Aggregation
(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.
Therefore, many of the requested categories are not applicable to the information contained in this document.
Here's the information extracted from the provided text, addressing your questions where applicable:
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 <1% | Unaged and 5-year aged filters had acceptable performance for pre-conditioning and post-conditioning penetration. |
| Filter Media Integrity with 50 cm hydrostatic head | Evaluate hydrophobicity (resistance to penetration by a measured column of liquid) | No water breakthrough of the filter media for 60 seconds after application of a 50 cm head of sterile water | No unaged or 3-year aged filter showed water breakthrough. |
| Air Flow Resistance (Pressure Drop) Pre- and Post-hydrostatic head | Evaluate any changes in the filter's resistance to air flow before and after being subjected to a 15 cm hydrostatic head. | At 60 L/min, average inspiratory/expiratory flow resistance should be <2.5 cm H2O pre-hydrostatic head and ≤6.0 cm H2O post-hydrostatic head, and no evidence of water breakthrough within 60 seconds of the 15 cm hydrostatic head. | The pre-hydrostatic head and post-hydrostatic maximum flow resistance were passing across all unaged, 3-year aged, and 5-year aged filters. |
| Heat and Moisture Exchange efficiency | Evaluate moisture loss for tidal volumes of 250 mL, 500 mL, 750 mL, and 1000 mL | <12 mg/L (10-12 mg H2O/L) at 250 ml tidal volume;<16 mg/L (13-16 mg H2O/L) at 500 ml tidal volume;<20 mg/L (19 mg H2O/L) at 750 ml tidal volume;<22 mg/L (19-22 mg H2O/L) at 1000 ml tidal volume. | The average moisture loss met the acceptance criteria for the specified tidal volumes for unaged, and aged (1, 3, & 5 years filters. |
| Pressure drop pre and post moisture loss testing | Evaluate pressure drop pre and post moisture loss testing | The inspiratory/expiratory flow resistance should be <2.5 cm H2O at 60 L/min | For unaged as well as 1, 3 & 5 year aged filters, the maximum inspiratory and expiratory flow resistance were passing, showing that the pressure drop does not increase when conditioned for the length of filter use or when challenged with liquid. |
| Leakage (pressure decay) pre and post moisture loss testing | Evaluate leakage (pressure decay) under an applied pressure pre and post moisture loss testing | ISO 9360-1 Section 6.4 does not specify acceptance criteria, only to record the volume of air required; however, Pall has specified an internal acceptance criteria for leakage of <25 mL/min at 7 ± 0.5 kPa. | The maximum leakage values for unaged as well as for 1, 3 & 5 year aged filters met predefined criteria both pre- and post-moisture loss. |
| Compliance in accordance with ISO 9360 pre- and post-moisture loss testing | Evaluate compliance in accordance with ISO 9360 pre- and post- moisture loss testing | ISO 9360-1 Section 6.5 does not specify an acceptance criterion, only to record the volume of air required. | There was no significant increase in flow rate following filter conditioning. All test values for unaged and aged (1, 3, & 5 years) filters were acceptable. |
| Housing Integrity (for pressure decay) | Evaluate filter leakage at two different pressures | Leakage <4 ml/min for unaged filters at 70 mbar (7 kPa) and 150 mbar (15 kPa); leakage <25 ml/min at 70 mbar (7 kPa) for aged filters. | Unaged as well as 1 & 3 year aged filters had leakage values meeting the predefined acceptance criteria at the evaluated pressures. |
| Connector Compliance | Demonstrate inlet and outlet ports comply with ISO 5356-1 | All ports must comply with ISO 5356-1 | For both 15 mm and 22 mm connectors, axial force and rotation for unaged and 1 & 3 year aged filters were in accordance with the standard. |
| Nebulization | Evaluate changes in air flow resistance across filter when used with nebulized drugs at patient and machine ends of breathing circuit | Air flow resistance <6 cm H2O at 60 L/min airflow after 24 hours of nebulization | Unaged & 3 year aged filters: Highest flow resistance values were within specification for both filter locations and for drugs delivered by air-driven and ultrasonic nebulizers as well as drugs delivered by metered dose inhalers, as applicable. |
| Particulate Analysis | Assess if airborne particulate is emitted into the gas stream in accordance with ISO 18562 | Particulate category PM2.5 and PM10 acceptable concentrations: 12 µg/m3 and 150 µg/m3, respectively | The minimum, maximum, and average particulate concentrations are all below acceptable limits. |
| Volatile Organic Compounds (VOCs) Analysis | Assess if airborne VOCs are emitted from the filter into the gas stream per ISO 18562 | Threshold of Toxicological Concern (TTC) of 360 µg/d for the first 24 hours and a limit of 120 µg/d for the remaining 24 hours | Exposure of the individual VOCs released are all below pre-defined TTC. |
| Shelf life (stability / maintained performance) | Evaluate shelf life | 3 years from the date of manufacture based on the stability testing | Stability of device confirmed from performance testing conducted on 3-year real-time aged and 5-year accelerated aged devices. |
2. Sample size used for the test set and the data provenance
The document states, "Testing was performed on the subject device or on representative filters reflecting the same fundamental design and materials, and the same manufacturing methods." It mentions testing unaged and aged filters (e.g., 1, 3, or 5 years aged). However, it does not specify the exact number of filters (sample size) used for each test. The data provenance is related to the manufacturing process of the device itself and aging protocols, not clinical patient data from a specific country.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The tests performed are laboratory-based, non-clinical performance evaluations of the device's physical and biological properties (e.g., filtration efficiency, pressure drop, biocompatibility). These do not involve human readers establishing a "ground truth" for interpretations like in a medical imaging study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable, as the tests are non-clinical laboratory evaluations and do not involve human interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. This submission is for a breathing circuit filter, not an AI-assisted diagnostic device. Therefore, no MRMC comparative effectiveness study was performed, nor is there any AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. As explained above, this is not an AI algorithm but a physical medical device (filter).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is defined by standardized test methodologies and established performance specifications for medical filters (e.g., ISO standards for biocompatibility, filtration efficiency, pressure drop, moisture exchange, connector compliance, VOC emissions). The results are quantitative measurements against these criteria.
8. The sample size for the training set
This question is not applicable. As this is not an AI device, there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no "training set" for this device.
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