(204 days)
No
The device is a physical filter and the summary describes its mechanical and filtration properties, with no mention of software, algorithms, or data processing that would involve AI/ML.
No
The device is described as a viral and bacterial filter intended to reduce particulates from exhaled air during spirometry tests, primarily for environmental protection, not for directly treating a disease or condition.
No
The EasyOne Filter is a filter accessory for spirometry tests, designed to reduce bacteria, viruses, and particulates from exhaled air for infection control, not to diagnose medical conditions itself. It does not provide any diagnostic output or interpretation of patient data.
No
The device description clearly states it is a physical filter composed of injection molded polymeric parts and a filter medium. It is a hardware accessory.
Based on the provided information, the EasyOne Filter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to reduce bacteria, viruses, and other particulates from exhaled air during flow measurements (spirometry). This is a physical filtration function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description reinforces that it's a filter designed to be used with breathing mouthpieces during flow measurements. It's an accessory for a diagnostic device (the spirometer), but it doesn't perform a diagnostic test itself.
- Lack of Diagnostic Function: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The EasyOne Filter does not analyze any biological sample.
- Performance Studies: The performance studies focus on the filter's physical properties (filtration efficiency, dead space, connector) and its impact on the performance of the spirometer, not on the accuracy of a diagnostic test performed by the filter itself.
The EasyOne Filter is an accessory designed to improve the hygiene and safety of a diagnostic procedure (spirometry), but it is not an IVD device in its own right.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CAH
Device Description
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.
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
Adults and children over age of 4 years (users of ndd pulmonary lung function testing devices).
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility
- Purpose: Evaluate device's biological safety for the intended use, in accordance with ISO 10993-5, ISO 10993-10 and FDA's corresponding guidance document. Assess if airborne particulate is emitted into the gas stream in accordance with ISO 18562. Assess if airborne VOCs are emitted from the filter into the gas stream per ISO 18562.
- Acceptance Criteria: Biological Evaluation per ISO 10993-5 and ISO 10993-10. 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. Gas path emissions of volatile organic compounds per ISO 18562-3. Risk assessment per ISO 10993-17 and ISO 18562-1.
- Result: 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). 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.
Filtration Efficiency
- Purpose: Evaluate aerosol bacterial and viral removal. The BFE / VFE at an Increased Challenge Level test procedure was adapted from ASTM F2101.
- Acceptance Criteria: Bacterial filtration 99.999% (BFE). Viral filtration 99.999% (VFE).
- Result: All results were acceptable.
Dead space
- Purpose: Determination of dead space According to ATS/ERS standard 2005.
- Acceptance Criteria: Dead space is within the ATS/ERS recommendation of 90%.
- Result: Calibration check of NDD spirometers can be performed with EasyOne Filter.
Configuration
- Purpose: Configuration of NDD spirometers for use with optional EasyOne Filter.
- Acceptance Criteria: 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.
- Result: Passed.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial filtration 99.999% (BFE)
Viral filtration 99.99% (VFE)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
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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
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) | ||
|---|---|---|
| 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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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: 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
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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).