(203 days)
Not Found
No
The device description and performance metrics focus on the physical filtration and heat/moisture exchange properties of the filter, with no mention of AI or ML.
No.
The device acts as a filter and heat/moisture exchanger, primarily preventing transmission of bacteria/viruses and conserving heat/humidity, which are supportive functions for ventilation rather than direct treatment of a disease or condition.
No
The device is a bacterial/viral filter and a heat and moisture exchanger. Its purpose is to filter out bacteria and viruses from breathing systems and to conserve heat and humidity for the patient, not to diagnose medical conditions.
No
The device description clearly outlines physical components (filter housing, hydrophobic filter media) and its function is based on physical filtration and heat/moisture exchange, not software processing.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to filter bacteria and viruses from breathing systems and to act as a heat and moisture exchanger. This is a function performed in vivo (within the patient's breathing circuit), not in vitro (outside the body, typically on biological samples).
- Device Description: The description details a physical filter and housing designed to be integrated into a breathing circuit. It does not involve the analysis of biological samples.
- Performance Studies: The performance studies focus on the physical and filtration properties of the device (bacterial/viral efficiency, pressure drop, HME efficiency, etc.), not on the analysis of biological markers or substances.
IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such a function.
N/A
Intended Use / Indications for Use
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.
Product codes
CAH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
healthcare and home environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical tests were performed to demonstrate the performance of the Ultipor® U55/U55N Filter.
- Biocompatibility: Evaluate device's biological safety for the intended use, in accordance with ISO 10993-1 and FDA's corresponding guidance document. All results were acceptable.
- Microbial retention: Evaluate aerosol bacterial and viral removal. Unaged and aged (5 years) filters demonstrated bacterial effectiveness of >99.999% and viral effectiveness of >99.995%.
- Microbial retention: Evaluate liquid bacterial removal. 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. All unaged and 5-year aged filters had a penetration of 0.09%.
- Sodium Chloride Particulate Removal: Evaluate filtration efficiency. 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 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. 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. The average moisture loss met the acceptance criteria for the specified tidal volumes for unaged, and aged (1, 3, & 5 years filters.
- Heat and Moisture Exchange efficiency: Evaluate pressure drop pre and post moisture loss testing. 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.
- Heat and Moisture Exchange efficiency: Evaluate leakage (pressure decay) under an applied pressure pre and post moisture loss testing. 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.
- Heat and Moisture Exchange efficiency: Evaluate compliance in accordance with ISO 9360 pre- and post- moisture loss testing. 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. 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. 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. 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. 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. Exposure of the individual VOCs released are all below pre-defined TTC.
- Shelf life (stability / maintained performance): Evaluate shelf life. Stability of device confirmed from performance testing conducted on 3-year real-time aged and 5-year accelerated aged devices.
Key Metrics
- Bacterial removal efficiency: >99.999%
- Viral removal efficiency: >99.995%
- Waterborne microbial contaminant removal efficiency: 100%
- Heat and moisture exchanger loss H2O @ 500 mL tidal volume: 15 mg/L
- Compressible volume (dead space): 50 mL approx.
- Gas Leakage (mL/min):
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
November 16, 2021
Pall Corporation % Randy Prebula Partner Hogan Lovells U.S. LLP 555 Thirteenth Street NW Washington, District of Columbia 20004
Re: K211286
Trade/Device Name: Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II Product Code: CAH Dated: October 18, 2021 Received: October 18, 2021
Dear Randy Prebula:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
K211286
Device Name
Ultipor® U55/U55N Breathing Circuit Bacterial Filter and Heat and Moisture Exchanger
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
図 Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY - K211286
Pall Corporation's Ultipor® U55/U55N Breathing Circuit Bacterial Filter and Heat and Moisture Exchanger
| Submitter: | Pall Corporation
25 Harbor Park Drive
Port Washington, NY 11050, USA |
|----------------------------|-----------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Brian Goetz
Senior Manager, Regulatory Affairs
Telephone Number: 516-801-9267
Fax Number: 516-801-9643 |
| Date Prepared: | November 2, 2021 |
| Trade Names: | Pall® Ultipor® U55/U55N Filter |
| Common Name: | Filter, Bacterial, Breathing-Circuit |
| Classification Regulation: | 21 C.F.R. § 868.5260, Breathing circuit bacterial filter |
| Regulatory Class: | Class II |
| FDA Product Code: | CAH |
| Predicate Device: | Intersurgical, Inc. Hydro-Guard Mini Breathing Filter and Heat
and Moisture Exchanger (Model 1745) (K092409) |
Intended Use/Indications for Use
The Pall® 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.
Device Description
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.
4
- 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.
Summary of Technological Characteristics
The subject and predicate devices have the same fundamental design, consisting of the filter media and housing. In addition, the subject and predicate filters both operate based on size exclusion (direct interception filtration) as the primary filtration mechanism, supplemented by effects of inertial impaction, and diffusion impaction, to prevent certain particles from passing through the filter to the other side.
| Subject Device | Predicate Device | |
|---|---|---|
| Element | Pall® Ultipor® U55 and U55N | |
| Breathing Circuit Bacterial Filter and | ||
| Heat and Moisture Exchanger | Intersurgical 1745 Hydro-Guard | |
| Mini Breathing Filter and Heat | ||
| and Moisture Exchanger | ||
| (K092409) | ||
| Indications for Use | The Pall® 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 Intersurgical Hydro-Guard Mini
Filter and Heat and Moisture
Exchanger is for use at the patient
and equipment connections. It is
designed to reduce bacterial/viral
transmissions between the patient
and equipment and to reduce the
loss of patient heat and humidity.
The filter is for single patient use
for an adult target population, is
intended for use within breathing
systems in healthcare and home
environments where ventilation is
required and a maximum duration
of 24 hours. |
| Installation positions | Patient and machine ends | Patient and machine ends |
| Filtration efficiency
(%) | >99.999% bacterial; >99.995% viral | >99.999% |
| Filtration efficiency -
waterborne bacterial
removal (%) | 100 | Not available |
| Minimum tidal
volume (mL) | 150 (See Note 1 below) | >200 |
| Maximum tidal
volume (mL) | 1000 | 1000 |
| Pressure drop
(cmH2O) @ 60 L/min | 2.5 | 2.9 |
| Heat and moisture
exchanger loss H2O
@ 500 mL tidal
volume (mg/L) | 15 | 23 |
5
| Compressible volume
(dead space) (mL)
| approx. | 50 | 63 |
|---|---|---|
| Gas Leakage | ||
| (mL/min) | 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 | 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)
Removal1 | 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