(204 days)
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 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.
The provided text is a 510(k) summary for the EasyOne Filter, a breathing circuit bacterial filter. It details the device's characteristics, comparison to predicate devices, and the results of non-clinical, and usability tests. However, it does not describe a study involving an AI/algorithm or human readers for diagnostic purposes (e.g., radiologists interpreting images). The device itself is a physical filter for spirometry, not a diagnostic AI tool.
Therefore, many of the requested points, such as MRMC studies, standalone algorithm performance, number of experts for ground truth, and training set details, are not applicable to this type of medical device submission.
Here's an attempt to answer the applicable points based on the provided text, and explicitly state when information is not present or not relevant to this specific device:
1. A table of acceptance criteria and the reported device performance
| 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). |
| Gas Path Emissions (Particulate Matter) | Assess if airborne particulate is emitted into the gas stream in accordance with ISO 18562 | 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. |
| Gas Path Emissions (Volatile Organic Compounds) | 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 | Exposure of the individual VOCs released are unlikely to result in toxicological effects. (Implicitly passed) |
| Filtration Efficiency | Evaluate aerosol bacterial and viral removal | Bacterial filtration 99.999% (BFE); Viral filtration 99.999% (VFE) | All results were acceptable. |
| 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. |
| 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 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Filtration Efficiency: Not explicitly stated, but implies lab testing.
- Human Test (System test): The document mentions "Human subjects performed a FVL test session". The number of subjects is not specified.
- Data Provenance: Not specified, but given the manufacturer is based in Switzerland, it's likely to be European or internationally sourced lab/human data. The tests are general performance tests for a physical device, not tied to specific patient populations or retrospective/prospective clinical data in the way an AI diagnostic would be.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a physical filter, not a diagnostic tool requiring expert interpretation or ground truth establishment in the context of diagnostic accuracy. The tests are based on established engineering and medical device standards (e.g., ISO, ATS/ERS).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- Not applicable. This is not an AI-assisted diagnostic device. Its function is to filter exhaled air. The "human test" was to confirm the device doesn't negatively impact spirometry measurements, not to assess human diagnostic performance with/without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical filter, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device exists in the form of established engineering and medical standards (e.g., ISO 10993 for biocompatibility, ISO 18562 for gas path emissions, ATS/ERS standards for spirometry). The performance of the filter is measured against specified physical and biological parameters. Not ground truth from medical diagnoses.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
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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
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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
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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) | ||
|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 filterdesigned to be used with NDD breathing mouthpieces. |
| Submitter | NDD Medizintechnik AGTechnoparkstrasse 1CH-8005 ZürichNote: NDD stands for New Diagnostic Design |
| Official Contact | Andreas SennDirector Quality, RA & CANdd Medizintechnik AG, SwitzerlandPhone : +41 44 512 65 41e-mail : ase@ndd.ch |
| Alternative Contact | Roman EicherRegulatory Affairs Manager & Safety OfficerNdd Medizintechnik AG, SwitzerlandPhone : +41 44 512 65 24e-mail : rei@ndd.ch |
| US agent | Robert WeismanNDD MEDICAL TECHNOLOGIES, INC.300 Brickstone Sq Ste 604ANDOVER, MA US 01810Phone: 978 4700923 ExtEmail: Rweisman@Nddmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade name: | EasyOne Filter |
|---|---|
| Variants, types: | EasyOne Filter SPEasyOne Filter FT |
| Common name: | Breathing circuit bacterial filter |
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| 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 PredicateDevice | Reference Device | Predicatecomparisonresults |
| 510(k) number | K221250 | K000654 | K051712 | Different |
| Predicate device comparison table | ||||
| Criteria | Subject Device | Primary PredicateDevice | Reference Device | Predicatecomparisonresults |
| Device | EasyOne Filter | VBMax PFT Filter | Air Safety Model2800 | Different |
| Manufacturer | ndd Medizintechnik AG | A-M Systems | GVS FilterTechnology | Different |
| Regulationnumber | 868.5260 | 868.5260 | 868.1840 | Same aspredicate,different toreferencedevice |
| Regulation name | Filter, Bacterial, Breathing-Circuit | Filter, Bacterial,Breathing-Circuit | Spirometer,Diagnostic | Same aspredicate,different toreferencedevice |
| Product Code(s) | CAH | CAH | BZG | Same aspredicate,different toreferencedevice |
| Regulatory Class | II | II | II | Same |
| Intended use | The EasyOne Filter isintended to be used incombination with NDDbreathing mouthpieces toreduce bacteria, virusesand other particulatesfrom the patient's exhaledair while performing flowmeasurements, such asspirometry tests. | The VBMax filter is adisposable, single-patient session filterfor spirometric andpulmonary functiontesting. The VBMaxfilter is designed topreventbacterial/viralcontamination fromentering thepulmonary functionequipment. Thefilter is to be usedwith children andadults subjects, butit is not indicated foruse with neonatalsubjects. It is to be | For use withpulmonary functiontesting equipment,to filter air betweenthe patient'sexhaled air and thetesting equipment. | Same |
| Predicate device comparison table | ||||
| Criteria | Subject Device | Primary PredicateDevice | Reference Device | Predicatecomparisonresults |
| used under thedirection of aphysician. | ||||
| Indications foruse | The EasyOne Filter isintended to be used incombination with NDDbreathing mouthpieces toreduce bacteria, virusesand other particulatesfrom the patient's exhaledair while performing flowmeasurements, such asspirometry tests.The EasyOne Filter is asingle-use device andintended for single-patientuse only. | The VBMax filter is adisposable, single-patient session filterfor spirometric andpulmonary functiontesting. The VBMaxfilter is designed topreventbacterial/viralcontamination fromentering thepulmonary functionequipment. Thefilter is to be usedwith children andadults subjects, butit is not indicated foruse with neonatalsubjects. It is to beused under thedirection of aphysician. | Model 2800 isindicated for usewith pulmonaryfunction testingequipment, to filterair between thepatient's exhaled airand the testingequipment. Singlepatient use | Same |
| Contraindications | None | None | None | Same |
| Single patientuse | Yes | Yes | Yes | Same |
| Intendedpopulation | Adults and children overage of 4 years (users ofndd pulmonary lungfunction testing devices). | Any patientexcept neonates | Any patient | Similar |
| Prescription use | Yes | Yes | Yes | Same |
| Models | EasyOne Filter SPEasyOne Filter FT | VBMax PFT Filter | Model 2800 | Different |
| Materials | Housing: styreneacrylonitrile (SAN)Filter media: electrostatic | Housing: styreneacrylonitrile (SAN)Free of latex, PVC, | Housing:polystyreneFilter media: | Same aspredicate,similar to |
| Predicate device comparison table | ||||
| Criteria | Subject Device | Primary PredicateDevice | Reference Device | Predicatecomparisonresults |
| polypropyleneSame filter pad as used inthe primary predicatedevice | DEHP, BPAFilter media:electrostaticpolypropylene | electrostaticpolypropylene | referencedevice | |
| Mouthpiece | Custom fitting to NDDmouthpiecesSpirette SPFlowTube FT | VBMax Standard:Straight ports with apapermouthpiece or anoptionalpediatric adapterVBMax E-Series:Oval-shapedmouthpiece withoptional, disposablerubbermouthpiece.VBMax S-Series:Smaller mouthpiecewithridges for pediatricuse or foradults with smalleraperture | Filters can besupplied withaccessories, such asnose clip,mouthpiece and bitegrip. | Similar |
| Can be used withseveral PFTdevices | No, custom fitting to NDDmouthpiecesSpirette (SP) whenused with Easy-on PCSpirometer (Referencedevice)FlowTube (FT) whenused with EasyOne AirSpirometer (Referencedevice) | Yes, fits most PFTequipment in usetodayCustom sizesavailable to fit PFTequipment | Yes, various endfittings | Different |
| Compact housing | Yes | Yes | Yes | Same |
| Weight | 24 grams | 38 grams | 40 grams | Similar |
| Predicate device comparison table | ||||
| Criteria | Subject Device | Primary PredicateDevice | Reference Device | Predicatecomparisonresults |
| 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 mmlength | Ø 97 x 93 mm length | Similar |
| Bacterialfiltration | 99.999% | 99.999% | 99.9999% | Same |
| Viral filtration | 99.99% | 99.99% | 99.999+% | Same aspredicate,similar toreferencedevice |
| Dead space | 48 mL EasyOne Filter SP54 mL EasyOne Filter FT | 45 mL | 75 mL | Similar |
| Sterility | non-sterile, single use | non-sterile, singleuse | non-sterile, singleuse | Same |
| Shelf-life | 4 years | n/a | 5 years | Similar |
| Resistance toflow at 720 lpmper ATS standard | - | 0.75 cm H2O | 0.7 cm H2O | Different |
| Resistance toflow at 60 lpm | - | 0.55 cm H2O | 0.5 cm H2O | Different |
| Resistance toflow at 840 lpmper 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
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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.
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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 biologicalsafety for the intended use,in accordance with ISO10993-5, ISO 10993-10 andFDA's correspondingguidance document. | Biological Evaluation per ISO10993-5 and ISO 10993-10 | Justification for cytotoxicity,sensitization, and irritationtests based on results ofViroMax filter (K063526),same filter body and filtercap materials used forEasyOne Filter as well asVBMax filter (K000654). |
| Assess if airborneparticulate is emitted intothe gas stream inaccordance with ISO 18562 | Gas path emissions ofparticulate matter: Measuredconcentrations of particulatematter ≤ 2.5 µm and ≤ 10 µmwere compared to air qualityguidelines in ISO 18562-2. | The minimum, maximum,and average particulateconcentrations are allbelow acceptable limits.Exposure of the individualVOCs released are unlikelyto resultin toxicological effects. | |
| Assess if airborne VOCs areemitted from the filter intothe gas stream per ISO18562 | Gas path emissions of volatileorganic compounds per ISO18562-3Risk assessment per ISO10993-17 and ISO 18562-1 | ||
| FiltrationEfficiency | Evaluate aerosol bacterialand 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 anIncreased Challenge Leveltest procedure was adaptedfrom ASTM F2101. | |||
| Dead space | Determination of deadspaceAccording to ATS/ERSstandard 2005 | Dead space is within theATS/ERS recommendation of< 300ml | Passed |
| Connector | Verify that the connectionbetween EasyOne Filter andthe breathing mouthpiecesSpirette and EasyOneFlowTube | Mechanical force is within 6 -55NHold in place during forcedexpiration (18L/s)Resistance higher4800hPa*s/L | Passed |
| (ATS)Standardizationof SpirometryCompliance(System test withEasyOne Filterand referencedevices) | Performance testing andcomparative testing of NDDspirometers used with andwithout EasyOne Filterdemonstratedcompliance with spirometrystandards ISO 26782 andATS/ERS 2019. | Test scenario according to ISO26782 Annex BResistance ≤ 1.5 cm H2O/L/sat 14L/s | NDD spirometers complywith ISO 26782 when usedwith the optional EasyOneFilter. |
| Human test(System test withEasyOne Filterand referencedevices) | Human subjects performeda FVL test session usingNDD spirometers with andwithout use of the EasyOneFilter. For each subject, thedifference between the testsession with and withoutfilter were calculated forthe following parameters:FVC, FIVC, FEV1, PEFAccording to ATS/ERSstandard 1994 | FVC & FIVC: 6% or 200 mlwhichever is greaterFEV1: 6% or 200 ml whicheveris greaterPEF: 15% or 0.50 L/minwhichever is greater | NDD spirometers providethe same spirometry testresults when used with orwithout EasyOne Filter. |
| Calibrationchecks(System test withEasyOne Filterand referencedevices) | Confirm that theimplemented calibrationcheck meets specificationswhen NDD spirometers areused with EasyOne Filter. | Pass rate > 90% | Calibration check of NDDspirometers can beperformed with EasyOneFilter. |
| Test | Purpose | Acceptance Criteria | Result |
| Configuration | Configuration of NDDspirometers for use withoptional EasyOne Filter | EasyOne Air firmware V1.18or higher and EasyOneConnect V3.9.3 or higherallows setup of spirometerytesting with or withoutEasyOne Filter. | Passed |
SUMMARY OF NON-CLINICAL TESTS
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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).
§ 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).