Who is the manufacturer of EasyOne Filter?

Ndd Medizintechnik AG filed the 510(k) submission for EasyOne Filter (K221250).

What is the FDA product code for EasyOne Filter?

CAH. It is classified under 21 CFR 868.5260 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for EasyOne Filter?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like EasyOne Filter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EasyOne Filter

Q: What are the predicate devices for EasyOne Filter?

VBmax Viral and Bacterial Filter (K000654).

K221250 · Ndd Medizintechnik AG · CAH · Nov 22, 2022 · Anesthesiology

Device Facts

Record ID	K221250
Device Name	EasyOne Filter
Applicant	Ndd Medizintechnik AG
Product Code	CAH · Anesthesiology
Decision Date	Nov 22, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5260
Device Class	Class 2
Attributes	Pediatric

Indications for Use

The EasyOne Filter is intended to be used in combination with NDD breathing mouthpieces to reduce bacteria, viruses and other particulates from the patient's exhaled air while performing flow measurements, such as spirometry tests. The EasyOne Filter is a single-use device and intended for single-patient use only.

Device Story

EasyOne Filter is a single-use, non-sterile viral/bacterial filter accessory for NDD spirometers. Device consists of injection-molded polymeric housing (styrene acrylonitrile) enclosing an electrostatic polypropylene filter medium. It attaches to NDD breathing mouthpieces (Spirette or FlowTube) at the distal end of the spirometer. During spirometry, patient exhaled air passes through the filter, which captures bacteria, viruses, and particulates to prevent environmental contamination. Device is operated by clinicians or technicians in clinical settings. Output is filtered air; device does not alter diagnostic spirometry endpoints. Benefits include reduced risk of cross-contamination in the test environment. System configuration requires specific firmware/software versions to account for filter presence during flow measurements.

Clinical Evidence

No clinical investigations performed. Evidence consists of bench testing (biocompatibility per ISO 10993, gas path emissions per ISO 18562, filtration efficiency per ASTM F2101, dead space, mechanical force, and system-level spirometry compliance per ISO 26782/ATS/ERS) and a summative usability study. Human testing confirmed that spirometry parameters (FVC, FIVC, FEV1, PEF) remain equivalent when using the filter.

Technological Characteristics

Housing: Styrene acrylonitrile (SAN). Filter media: Electrostatic polypropylene. Dimensions: ~76.6mm diameter, 77.6-83.0mm length. Dead space: 48-54 mL. Bacterial filtration: 99.999%. Viral filtration: 99.99%. Non-sterile, single-use. Connectivity: Custom mechanical interface for NDD spirometers. Standards: ISO 10993 (biocompatibility), ISO 18562 (gas path), ISO 26782 (spirometry), ASTM F2101 (filtration).

Indications for Use

Indicated for adults and children over age 4 years undergoing spirometry or pulmonary function testing using NDD devices. Not indicated for neonates.

Regulatory Classification

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.

Predicate Devices

VBmax Viral and Bacterial Filter (K000654)

Reference Devices

Air Safety Model 2800 PFT Filter (K051712)
Easy-On PC Spirometer (K090034)
EasyOne Air Spirometer (K161536)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text. November 22, 2022 NDD Medizintechnik AG Andreas Senn Director Quality, RA & QA Technoparkstrasse 1 Zurich, 8005 Switzerland Re: K221250 Trade/Device Name: EasyOne Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II Product Code: CAH Dated: October 17, 2022 Received: October 21, 2022 Dear Andreas Senn: 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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 (OS) 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 mediation-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, # Allan Guan -S For Bifeng Qian, M.D., Ph.D. 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221250 Device Name EasyOne Filter # Indications for Use (Describe) The EasyOne Filter is intended to be used in combination with NDD breathing mouthpieces to reduce bacteria, viruses and other particulates from the patient's exhaled air while performing flow measurements, such as spirometry tests. The EasyOne Filter is a single-use device and intended for single-patient use only. | Type of Use (Select one or both, as applicable) | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | <table><tr><td><div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div></td><td><div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div></td></tr></table> | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | 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 In accordance with 21 CFR 807.92 the following information is provided for the EasyOne Filter. # ADMINISTRATIVE INFORMATION | Date prepared | November 21, 2022 | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submission type: | Traditional 510(k) | | Purpose of 510(k): | Introduction of a new device. The new EasyOne Filter is a viral, bacterial filter designed to be used with NDD breathing mouthpieces. | | Submitter | NDD Medizintechnik AG Technoparkstrasse 1 CH-8005 Zürich Note: NDD stands for New Diagnostic Design | | Official Contact | Andreas Senn Director Quality, RA & CA Ndd Medizintechnik AG, Switzerland Phone : +41 44 512 65 41 e-mail : ase@ndd.ch | | Alternative Contact | Roman Eicher Regulatory Affairs Manager & Safety Officer Ndd Medizintechnik AG, Switzerland Phone : +41 44 512 65 24 e-mail : rei@ndd.ch | | US agent | Robert Weisman NDD MEDICAL TECHNOLOGIES, INC. 300 Brickstone Sq Ste 604 ANDOVER, MA US 01810 Phone: 978 4700923 Ext Email: Rweisman@Nddmed.com | # DEVICE NAME AND CLASSIFICATION | Trade name: | EasyOne Filter | |------------------|----------------------------------------| | Variants, types: | EasyOne Filter SP EasyOne Filter FT | | Common name: | Breathing circuit bacterial filter | {4}------------------------------------------------ | Regulation number: | 21 CFR 868.5260 | |----------------------|------------------------------------| | Classification name: | Breathing circuit bacterial filter | | Regulatory class: | Class II | | Product Code: | CAH | #### PREDICATE DEVICE | Subject Device: | EasyOne Filter | |---------------------------|-------------------------------------------| | Primary Predicate Device: | VBmax Viral and Bacterial Filter, K000654 | | Reference Devices: | Air Safety Model 2800 PFT Filter, K051712 | | | Easy-On PC Spirometer, K090034 | | | EasyOne Air Spirometer, K161536 | #### INDICATIONS FOR USE The EasyOne Filter is intended to be used in combination with NDD breathing mouthpieces to reduce bacteria, viruses and other particulates from the patient's exhaled air while performing flow measurements, such as spirometry tests. The EasyOne Filter is a single-use device and intended for single-patient use only. ## DEVICE DESCRITION The EasyOne Filter is a viral, bacterial filter designed to be used with NDD breathing mouthpieces during flow measurements, e.g. for spirometry testing with NDD spirometers. The EasyOne Filter exists in two variants which differ in the connection interface to enable mounting on the EasyOne FlowTube. The EasyOne Filter is composed of two injection molded polymeric parts which enclose a filter medium. The EasyOne Filter is an optional accessory and reduces viruses, bacteria, and other particles that may be released by the patient and thus contaminate the test environment. The EasyOne Filter is non-sterile and for single use. | Predicate device comparison table | | | | | |------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------| | Criteria | Subject Device | Primary Predicate Device | Reference Device | Predicate comparison results | | 510(k) number | K221250 | K000654 | K051712 | Different | | Predicate device comparison table | | | | | | Criteria | Subject Device | Primary Predicate Device | Reference Device | Predicate comparison results | | Device | EasyOne Filter | VBMax PFT Filter | Air Safety Model 2800 | Different | | Manufacturer | ndd Medizintechnik AG | A-M Systems | GVS Filter Technology | Different | | Regulation number | 868.5260 | 868.5260 | 868.1840 | Same as predicate, different to reference device | | Regulation name | Filter, Bacterial, Breathing- Circuit | Filter, Bacterial, Breathing-Circuit | Spirometer, Diagnostic | Same as predicate, different to reference device | | Product Code(s) | CAH | CAH | BZG | Same as predicate, different to reference device | | Regulatory Class | II | II | II | Same | | Intended use | The EasyOne Filter is intended to be used in combination with NDD breathing mouthpieces to reduce bacteria, viruses and other particulates from the patient's exhaled air while performing flow measurements, such as spirometry tests. | The VBMax filter is a disposable, single- patient session filter for spirometric and pulmonary function testing. The VBMax filter is designed to prevent bacterial/viral contamination from entering the pulmonary function equipment. The filter is to be used with children and adults subjects, but it is not indicated for use with neonatal subjects. It is to be | For use with pulmonary function testing equipment, to filter air between the patient's exhaled air and the testing equipment. | Same | | Predicate device comparison table | | | | | | Criteria | Subject Device | Primary Predicate Device | Reference Device | Predicate comparison results | | | | used under the direction of a physician. | | | | Indications for use | The EasyOne Filter is intended to be used in combination with NDD breathing mouthpieces to reduce bacteria, viruses and other particulates from the patient's exhaled air while performing flow measurements, such as spirometry tests. The EasyOne Filter is a single-use device and intended for single-patient use only. | The VBMax filter is a disposable, single- patient session filter for spirometric and pulmonary function testing. The VBMax filter is designed to prevent bacterial/viral contamination from entering the pulmonary function equipment. The filter is to be used with children and adults subjects, but it is not indicated for use with neonatal subjects. It is to be used under the direction of a physician. | Model 2800 is indicated for use with pulmonary function testing equipment, to filter air between the patient's exhaled air and the testing equipment. Single patient use | Same | | Contraindications | None | None | None | Same | | Single patient use | Yes | Yes | Yes | Same | | Intended population | Adults and children over age of 4 years (users of ndd pulmonary lung function testing devices). | Any patient except neonates | Any patient | Similar | | Prescription use | Yes | Yes | Yes | Same | | Models | EasyOne Filter SP EasyOne Filter FT | VBMax PFT Filter | Model 2800 | Different | | Materials | Housing: styrene acrylonitrile (SAN) Filter media: electrostatic | Housing: styrene acrylonitrile (SAN) Free of latex, PVC, | Housing: polystyrene Filter media: | Same as predicate, similar to | | Predicate device comparison table | | | | | | Criteria | Subject Device | Primary Predicate Device | Reference Device | Predicate comparison results | | | polypropylene Same filter pad as used in the primary predicate device | DEHP, BPA Filter media: electrostatic polypropylene | electrostatic polypropylene | reference device | | Mouthpiece | Custom fitting to NDD mouthpieces Spirette SPFlowTube FT | VBMax Standard: Straight ports with a paper mouthpiece or an optional pediatric adapter VBMax E-Series: Oval-shaped mouthpiece with optional, disposable rubber mouthpiece. VBMax S-Series: Smaller mouthpiece with ridges for pediatric use or for adults with smaller aperture | Filters can be supplied with accessories, such as nose clip, mouthpiece and bite grip. | Similar | | Can be used with several PFT devices | No, custom fitting to NDD mouthpieces Spirette (SP) when used with Easy-on PC Spirometer (Reference device)FlowTube (FT) when used with EasyOne Air Spirometer (Reference device) | Yes, fits most PFT equipment in use today Custom sizes available to fit PFT equipment | Yes, various end fittings | Different | | Compact housing | Yes | Yes | Yes | Same | | Weight | 24 grams | 38 grams | 40 grams | Similar | | Predicate device comparison table | | | | | | Criteria | Subject Device | Primary Predicate Device | Reference Device | Predicate comparison results | | Dimensions | Ø 76.6 x 77.6 mm length (SP) Ø 76.6 x 83.0 mm length (FT) | Ø 89.7 x 89.5 mm length | Ø 97 x 93 mm length | Similar | | Bacterial filtration | 99.999% | 99.999% | 99.9999% | Same | | Viral filtration | 99.99% | 99.99% | 99.999+% | Same as predicate, similar to reference device | | Dead space | 48 mL EasyOne Filter SP 54 mL EasyOne Filter FT | 45 mL | 75 mL | Similar | | Sterility | non-sterile, single use | non-sterile, single use | non-sterile, single use | Same | | Shelf-life | 4 years | n/a | 5 years | Similar | | Resistance to flow at 720 lpm per ATS standard | - | 0.75 cm H2O | 0.7 cm H2O | Different | | Resistance to flow at 60 lpm | - | 0.55 cm H2O | 0.5 cm H2O | Different | | Resistance to flow at 840 lpm per ATS standard | Filter SP: <1.2 cmH2O/(L/s) Filter FT: <1.4 cmH2O/(L/s) | - | - | Different | ## SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ The subject device EasyOne Filter has similar indications, intended use, target populations, technological characteristics, and materials as the predicate device. The subject and predicate/reference devices have the same fundamental design, consisting of the filter pad and housing. All three filters are intended to filter the patient's exhaled air during spirometry tests. The primary filtration mechanism of the subject and predicate/reference device prevents certain particles from passing through the filter to the other side and have the same bacterial and viral filter pad used in the EasyOne Filter is the same as used in the primary predicate device. The dead space and resistance of all three filters is withing the ATS Standardization of Spirometry recommendation. The filters are made of similar materials and are all provided non-sterile and are intended for single patient use only. {9}------------------------------------------------ The EasyOne Filter has the following different technological characteristics compared to the predicate/reference device. The EasyOne Filter connected to the Spirette or EasyOne FlowTube and therefore dedicated for use with NDD spirometers only. The predicate/reference device has standardized connectors and may be used with different devices. The EasyOne Filter is connected at the distal end of the spirometer, i.e. away from the patient, whereby the predicate device is connected at the patient side. The EasyOne Filter is not intended to protect the test equipment itself but to prevent transmission of bacteria and viruses from the patient's exhaled air to the ambience. The introduction of the EasyOne Filter and use with the NDD spirometers has an impact on the overall system performance. Comparative testing has been performed with the reference devices NDD spirometers when used with or without EasyOne Filter. Based on the results, it has been confirmed that the diagnostic endpoints remain the same. Furthermore, the NDD spirometers when used with and without EasyOne Filter comply with ATS Standardization of Spirometry. The intended uses, materials and bacterial / viral efficiency are the same. Any differences between the EasyOne Filter and the predicate do not raise questions concerning safety and effectiveness. Performance testing in accordance with applicable standards demonstrates that the EasyOne Filter is adequate for its intended use. The EasyOne Filter is therefore similar to the predicate device. | Test | Purpose | Acceptance Criteria | Result | |-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility | Evaluate device's biological safety for the intended use, in accordance with ISO 10993-5, ISO 10993-10 and FDA's corresponding guidance document. | Biological Evaluation per ISO 10993-5 and ISO 10993-10 | Justification for cytotoxicity, sensitization, and irritation tests based on results of ViroMax filter (K063526), same filter body and filter cap materials used for EasyOne Filter as well as VBMax filter (K000654). | | | Assess if airborne particulate is emitted into the gas stream in accordance with ISO 18562 | Gas path emissions of particulate matter: Measured concentrations of particulate matter ≤ 2.5 µm and ≤ 10 µm were compared to air quality guidelines in ISO 18562-2. | The minimum, maximum, and average particulate concentrations are all below acceptable limits. Exposure of the individual VOCs released are unlikely to result in toxicological effects. | | | Assess if airborne VOCs are emitted from the filter into the gas stream per ISO 18562 | Gas path emissions of volatile organic compounds per ISO 18562-3 Risk assessment per ISO 10993-17 and ISO 18562-1 | | | Filtration Efficiency | Evaluate aerosol bacterial and viral removal | Bacterial filtration 99.999% (BFE) Viral filtration 99.999% (VFE) | All results were acceptable. | | Test | Purpose | Acceptance Criteria | Result | | | The BFE / VFE at an Increased Challenge Level test procedure was adapted from ASTM F2101. | | | | Dead space | Determination of dead space According to ATS/ERS standard 2005 | Dead space is within the ATS/ERS recommendation of < 300ml | Passed | | Connector | Verify that the connection between EasyOne Filter and the breathing mouthpieces Spirette and EasyOne FlowTube | Mechanical force is within 6 - 55N Hold in place during forced expiration (18L/s) Resistance higher 4800hPa*s/L | Passed | | (ATS) Standardization of Spirometry Compliance (System test with EasyOne Filter and reference devices) | Performance testing and comparative testing of NDD spirometers used with and without EasyOne Filter demonstrated compliance with spirometry standards ISO 26782 and ATS/ERS 2019. | Test scenario according to ISO 26782 Annex B Resistance ≤ 1.5 cm H2O/L/s at 14L/s | NDD spirometers comply with ISO 26782 when used with the optional EasyOne Filter. | | Human test (System test with EasyOne Filter and reference devices) | Human subjects performed a FVL test session using NDD spirometers with and without use of the EasyOne Filter. For each subject, the difference between the test session with and without filter were calculated for the following parameters: FVC, FIVC, FEV1, PEF According to ATS/ERS standard 1994 | FVC & FIVC: 6% or 200 ml whichever is greater FEV1: 6% or 200 ml whichever is greater PEF: 15% or 0.50 L/min whichever is greater | NDD spirometers provide the same spirometry test results when used with or without EasyOne Filter. | | Calibration checks (System test with EasyOne Filter and reference devices) | Confirm that the implemented calibration check meets specifications when NDD spirometers are used with EasyOne Filter. | Pass rate > 90% | Calibration check of NDD spirometers can be performed with EasyOne Filter. | | Test | Purpose | Acceptance Criteria | Result | | Configuration | Configuration of NDD spirometers for use with optional EasyOne Filter | EasyOne Air firmware V1.18 or higher and EasyOne Connect V3.9.3 or higher allows setup of spirometery testing with or without EasyOne Filter. | Passed | # SUMMARY OF NON-CLINICAL TESTS {10}------------------------------------------------ {11}------------------------------------------------ ## SUMMARY OF CLINICAL AND USABILITY TESTS Based on a clinical evaluation including literature review and the results of verification activities it has been concluded that clinical investigations were not required. A summative usability study confirmed that users understand the configuration and setup of the EasyOne Filter and how to perform spirometry tests when the filter is applied. # CONCLUSION The conclusions drawn from the nonclinical and usability tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed devices, VBMax PFT Filter (K000654).

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