(264 days)
EasyOne Pro/LAB is designed for conducting lung function measurements in general or specialist practices or in hospitals.
EasyOne Pro/LAB can also be used in clinical settings in occupational medicine for performing lung function screenings or measurements.
EasyOne Pro/LAB is used to conduct lung function measurements on adults and children starting at age 4, except measurements of diffusing capacity of the lung based on CO (DLCO), which can be performed on adults and children starting at age 6.
The EasyOne Pro Respiratory Analysis System consists of two different device models: EasyOne Pro and EasyOne Pro LAB.
The EasyOne Pro Respiratory Analysis System devices are pulmonary function testing devices. Both EasyOne Pro Respiratory Analysis System device models provide Spirometry and Single Breath CO Diffusion (DLCO) tests including Lung Volume Parameters. The device model EasyOne Pro LAB additionally provides the Nitrogen Multiple Breath Washout (MBW) method. The EasyOne Pro Respiratory Analysis System devices meet the ATS recommendations for accuracy and precision for Spirometry, DLCO and MBW tests.
The EasyOne Pro Respiratory Analysis System devices can be used as a stand-alone system and can be connected to a network.
The EasyOne Pro Respiratory Analysis System devices use the following sensors: An ultrasonic flow sensor to measure flow velocity, volume and molar mass of the gases that the patient inhales and exhales; a molar mass sensor which determines the helium content of the respired air for the DLCO test and the nitrogen concentration for the multiple-breath washout (MBW) test; a CO sensor (EasyOne Pro) or a combined CO/CO₂ sensor (EasyOne Pro LAB) to determine CO and CO2 content in breathing gas; a temperature and humidity sensor to collect environmental data.
The EasyOne Pro Respiratory Analysis System devices are used in combination with test gases (DLCO gas for DLCO tests and O2 for MBW tests).
The EasyOne Pro Respiratory Analysis System devices are used in combination with the single-patient use breathing tube ndd Spirette. For DLCO and MBW tests, the additional single-patient use accessories, the ndd DLCO or FRC Barriettes, are used.
The single-patient use accessories prevent cross-contamination between patients. The Spirette prevents the passage of microorganisms into the inside of the flow sensor; the Barriettes prevent the passage of microorganisms into gas supply tubing.
The provided document is a 510(k) premarket notification for the EasyOne Pro Respiratory Analysis System. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence. The document summarizes the testing performed to ensure the modified device meets performance and safety standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the EasyOne Pro Respiratory Analysis System devices "meet the ATS recommendations for accuracy and precision for Spirometry, DLCO and MBW tests." While specific numerical acceptance criteria (e.g., ±X% accuracy) for each parameter are not explicitly listed in the provided text, the general acceptance criterion is compliance with ATS recommendations.
| Parameter/Test | Acceptance Criteria (ATS Recommendations) | Reported Device Performance |
|---|---|---|
| Spirometry | ATS recommendations for accuracy and precision (specific numerical values not provided in this document, but typically involve thresholds for flow and volume measurements, e.g., ±3% or 50mL for FEV1/FVC, etc.) | "The EasyOne Pro Respiratory Analysis System devices meet the ATS recommendations for accuracy and precision for Spirometry...""Simulated Spirometry, DLCO and MBW testing, as well as testing with humans, confirmed that the modified EasyOne Pro Respiratory Analysis System devices meet the recommendations for accuracy and precision for Spirometry..." |
| DLCO (Single Breath CO Diffusion) | ATS recommendations for accuracy and precision (specific numerical values not provided in this document) | "...and Single Breath CO Diffusion (DLCO) tests... The EasyOne Pro Respiratory Analysis System devices meet the ATS recommendations for accuracy and precision for... DLCO...""Simulated Spirometry, DLCO and MBW testing, as well as testing with humans, confirmed that the modified EasyOne Pro Respiratory Analysis System devices meet the recommendations for accuracy and precision for... DLCO..." |
| MBW (Nitrogen Multiple Breath Washout) | ATS recommendations for accuracy and precision (specific numerical values not provided in this document) | "...The device model EasyOne Pro LAB additionally provides the Nitrogen Multiple Breath Washout (MBW) method. The EasyOne Pro Respiratory Analysis System devices meet the ATS recommendations for accuracy and precision for... MBW tests.""Simulated Spirometry, DLCO and MBW testing, as well as testing with humans, confirmed that the modified EasyOne Pro Respiratory Analysis System devices meet the recommendations for accuracy and precision for... MBW tests." |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests) | "The modified devices were tested to demonstrate conformance with the requirements for medical electrical equipment basic safety and essential performance of standards IEC 60601-1 and IEC 60601-1-2." |
| Basic Safety & Essential Performance | IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | "The modified devices were tested to demonstrate conformance with the requirements for medical electrical equipment basic safety and essential performance of standards IEC 60601-1 and IEC 60601-1-2." |
| Software Verification & Validation | IEC 62304 (Medical device software - Software life cycle processes) | "Software verification and validation in accordance with IEC 62304 confirmed that the modified EasyOne Pro Respiratory Analysis System meets the specified criteria." |
| Biocompatibility | ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process | "Biocompatibility was evaluated in accordance with ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process." |
Note: The document states that "For the modified devices, some of the labelled specifications were updated to reflect the technical capabilities. No changes were made to the components the specifications relate to." This implies there might be specific numerical specifications in other documentation not provided here.
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document mentions "testing with humans" for Spirometry, DLCO, and MBW, but does not specify the numerical sample size for the human test set. It also mentions "Simulated Spirometry, DLCO and MBW testing."
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth (Test Set)
Not applicable / Not specified in the provided text. This device is a measurement system and its "ground truth" would generally be established by calibrated reference standards and established physiological measurements, rather than expert consensus on interpretive tasks.
4. Adjudication Method for Test Set
Not applicable / Not specified in the provided text. As noted above, the "ground truth" for this type of device (a physiological measurement system) is based on reference standards and calibrated instruments, not on human interpretation or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers improve with AI assistance, which is not relevant for a device that measures lung function clinically. The EasyOne Pro is a diagnostic measurement device, not an AI-based interpretive aid for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, the testing described appears to be a standalone performance evaluation of the device's measurement capabilities. The "Simulated Spirometry, DLCO and MBW testing" would assess the algorithm and hardware performance independently, and the "testing with humans" would validate its clinical measurement accuracy against the ATS recommendations. The device itself is designed to provide direct physiological measurements.
7. Type of Ground Truth Used
The ground truth for the EasyOne Pro Respiratory Analysis System is established by technical standards and physiological recommendations, specifically the "ATS recommendations for accuracy and precision for Spirometry, DLCO and MBW tests." This would involve:
- Calibrated reference standards: For simulated testing (e.g., known flow and volume signals, known gas concentrations).
- Established physiological measurement methods: When testing with human subjects, the device's measurements would be compared against expected values or other validated methods to confirm compliance with ATS standards.
8. Sample Size for Training Set
Not applicable / Not specified. This device is a measurement system, not a machine learning algorithm that requires a "training set" in the conventional sense of AI models. Its underlying principles are based on known physics and physiological models, not data-driven learning from previous cases.
9. How Ground Truth for Training Set Was Established
Not applicable. As explained above, the device does not use a "training set" in the context of an AI/ML model. Its design and calibration are based on established scientific principles and engineering practices to meet specific performance standards.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2017
Ndd Medizintechnik Ag % Jerry Masiello Operations Manager Ndd Medical Technologies Inc. 300 Brickstone Square, Suite 604 Andover, Massachusetts 01810
Re: K161534
Trade/Device Name: Easyone Pro Respiratory Analysis System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: BTY Dated: January 13, 2017 Received: January 23, 2017
Dear Jerry Masiello:
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. 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.
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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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) 161534
Device Name
EasyOne Pro Respiratory Analysis System
Indications for Use (Describe)
EasyOne Pro/LAB is designed for conducting lung function measurements in general or specialist practices or in hospitals.
EasyOne Pro/LAB can also be used in clinical settings in occupational medicine for performing lung function screenings or measurements.
EasyOne Pro/LAB is used to conduct lung function measurements on adults and children starting at age 4, except measurements of diffusing capacity of the lung based on CO (DLCO), which can be performed on adults and children starting at age 6.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(k) Summary 8
In accordance with 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter Information
| Submitter name: | ndd Medizintechnik AGTechnoparkstrasse 18005 Zurich, Switzerland |
|---|---|
| United Statescontact person: | Mr. Jerry MasielloOperations Managerndd Medical Technologies, Inc |
| Phone: | (877) 904.0090 x11 |
| Fax: | (978) 824.3853 |
| Email: | jmasiello@nddmed.com |
| Type of Submission: | Traditional 510(k) |
| Date prepared: | July 20, 2016 |
Device Name
| Proprietary name: | EasyOne Pro Respiratory Analysis System |
|---|---|
| Common name: | Pulmonary function testing device |
| Class: | Class II according to 21 CFR 868.1890 |
| Classification name: | Predictive pulmonary-function value calculator |
| Product code: | BTY |
| Regulation number: | 868.1890 |
Predicate Device
Primary Predicate: EasyOne Pro Respiratory Analysis System, model EasyOne Pro K091428 Secondary Predicate:
EasyOne Pro Respiratory Analysis System, model EasyOne Pro LAB K120635
Device Description
The EasyOne Pro Respiratory Analysis System consists of two different device models: EasyOne Pro and EasyOne Pro LAB.
The EasyOne Pro Respiratory Analysis System devices are pulmonary function testing devices. Both EasyOne Pro Respiratory Analysis System device models provide Spirometry and Single Breath CO Diffusion (DLCO) tests including Lung Volume Parameters. The device model EasyOne Pro LAB additionally provides the Nitrogen Multiple Breath Washout (MBW) method. The
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EasyOne Pro Respiratory Analysis System devices meet the ATS recommendations for accuracy and precision for Spirometry, DLCO and MBW tests.
The EasyOne Pro Respiratory Analysis System devices can be used as a stand-alone system and can be connected to a network.
The EasyOne Pro Respiratory Analysis System devices use the following sensors: An ultrasonic flow sensor to measure flow velocity, volume and molar mass of the gases that the patient inhales and exhales; a molar mass sensor which determines the helium content of the respired air for the DLCO test and the nitrogen concentration for the multiple-breath washout (MBW) test; a CO sensor (EasyOne Pro) or a combined CO/CO₂ sensor (EasyOne Pro LAB) to determine CO and CO2 content in breathing gas; a temperature and humidity sensor to collect environmental data.
The EasyOne Pro Respiratory Analysis System devices are used in combination with test gases (DLCO gas for DLCO tests and O2 for MBW tests).
The EasyOne Pro Respiratory Analysis System devices are used in combination with the singlepatient use breathing tube ndd Spirette. For DLCO and MBW tests, the additional single-patient use accessories, the ndd DLCO or FRC Barriettes, are used.
The single-patient use accessories prevent cross-contamination between patients. The Spirette prevents the passage of microorganisms into the inside of the flow sensor; the Barriettes prevent the passage of microorganisms into gas supply tubing.
Intended Use:
EasyOne Pro/LAB is designed for conducting lung function measurements in general or specialist practices or in hospitals.
EasyOne Pro/LAB can also be used in clinical settings in occupational medicine for performing lung function screenings or measurements.
EasyOne Pro/LAB is used to conduct lung function measurements on adults and children starting at age 4, except measurements of diffusing capacity of the lung based on CO (DLCO), which can be performed on adults and children starting at age 6.
Comparison of Technological Characteristics:
The modified device models of the EasyOne Pro Respiratory Analysis System have the same technological characteristics with regards to Spirometry, DLCO and MBW testing as the predicate devices.
| Description | Currently marketed devicePrimary predicate device | Currently marketed deviceSecondary predicate device | Subject device |
|---|---|---|---|
| Deviceidentification | EasyOne Pro RespiratoryAnalysis SystemModel:EasyOne ProK091428 | EasyOne Pro RespiratoryAnalysis SystemModel:EasyOne Pro LABK120635 | EasyOne Pro RespiratoryAnalysis SystemModels:EasyOne ProEasyOne Pro LABK161534 |
| Product code | BTY | BTY | BTY |
| Description | Currently marketed devicePrimary predicate device | Currently marketed deviceSecondary predicatedevice | Subject device |
| Intended Use(incl. targetpopulation) | System for pulmonaryfunction testing on adultsand children (over the ageof 4 for spirometry lungfunction measurementsand over the age of 6 forDLCO testing). | Identical | Identical |
| Target users | The EasyOne ProRespiratory AnalysisSystem is used byphysicians, respiratorytherapists or nurses ingeneral or specialistpractices or in hospitals.The EasyOne ProRespiratory AnalysisSystem can also be used inclinical settings inoccupational medicine forperforming lung functionscreenings ormeasurements inoccupational medicine. | Identical | Identical |
| User interface | Resistive touch screen fordata entry and display | Identical | Capacitive touch screen fordata entry and display |
| Patient interface | EasyOne Pro:• Disposable breathingtube Spirette• Disposable barrier shieldDLCO Barriette | EasyOne Pro LAB:• All identicalIn addition:• Disposable barriershield FRC Barriette | Identical |
| Components | EasyOne Pro :• Main Unit (embeddedcomputer, touch screenand monitor)• Handheld flow sensor• Breathing valveassembly (for DLCO andFRC tests)• DLCO gas mix supply• 100-240 VAC, 50/60 Hzpower supply | EasyOne Pro LAB:• All identicalIn addition:• 100% O2 gas supply | Identical |
| Operatingsystem | Microsoft Windows XPEmbeddedMicrosoft Access database | Identical | Microsoft Windows 8EmbeddedSQLite/Microsoft SQLserver database |
| Description | Currently marketed devicePrimary predicate device | Currently marketed deviceSecondary predicate device | Subject device |
| Physical dimensions | 270 mm x 335 mm x 270 mm (h x w x d) | Identical | Identical |
| Pulmonary Function Testing | EasyOne Pro :Spirometry tests: FVC, FVL, SVC, MVV, Pre-post Bronchodilator Single Breath CO Diffusion (DLCO) test including Lung Volume | EasyOne Pro LAB:All identical In addition: Nitrogen Multiple Breath Washout (MBW) test | Identical |
| Principle of operation | EasyOne Pro:All test types -measurement of patient air flow via ultrasonic transit time flow sensor.DLCO test - determination of in- and exhaled gas concentrations:CO gas concentration measured by infrared absorption with CO sensor.Helium tracer gas concentration measured by molar mass sensor. | EasyOne Pro LAB:All identicalIn addition:MBW test - determination of in- and exhaled gas concentrations:Nitrogen tracer gas concentration determined by a combination of molar mass measurement (molar mass sensor) and CO2 measurement (CO/CO2 sensor). | Identical |
| Reported Spirometry parameters | FVC, FEV0.5, FEV1, FEV3, FEV6, FEV1/FVC, FEV3/FVC, FEV1/FEV6, FEF25%, FEF50%, FEF75%, FEF25-75%, FEF75-85%, PEF, FIVC, FIV0.5, FIF50%, PIF, FET, Vext, MVV, MTV, RR, AT, VC, ERV, IRV, TV | Identical | Identical |
| Reported Lung Volume parameters | EasyOne Pro:DLCO test:FRC, TLC, RV, RV/TLC, VT, f | EasyOne Pro LAB:All identicalIn addition - MBW test:FRC, TLC, RV, RV/TLC, LCI, VT, f | Identical |
| Reported DLCO parameters | DLCO, TLCO, DLadj, DLCO/VA, DLCO/VAadj, VA, VCin, BHT | Identical | Identical |
| Test gas requirements for DLCO test | Medical grade gas mixCO: 0.3 %Helium: 10 %Oxygen: 18 % - 25 %Nitrogen: balance | Identical | Identical |
| Description | Currently marketed devicePrimary predicate device | Currently marketed deviceSecondary predicatedevice | Subject device |
| Test gasrequirements forMBW test | (not applicable for EasyOnePro) | Oxygen 100 % | Identical |
| Flow sensorspecification | ±16 L/sGreater of ±2 % or 0.050 LGreater of ±2 % or 0.020 L/s<1.5 cm H2O/L/s (at 12 L/s) | IdenticalIdenticalIdenticalIdentical | IdenticalIdenticalIdentical~0.3 cm H2O/L/s (at 12 L/s) |
| Molar masssensorspecification | Ultrasonic transit time9 - 50 g/mol0.02 g/mol±0.01 g/mol | IdenticalIdenticalIdenticalIdentical | IdenticalIdentical0.005 g/molIdentical |
| CO Sensorspecification | Infrared absorption0 - 0.35 %0.0001 %±0.001 % | IdenticalIdenticalIdenticalIdentical | IdenticalIdenticalIdenticalIdentical |
| CO2 Sensorspecification | (not applicable for EasyOnePro) | Infrared absorption0 - 7 %0.01 %±0.1 % | Identical0 - 15%0.005%±0.05% |
| Tracer GasAnalysis forDLCO | HeliumMolar mass sensor0 - 50% He0.01% He±0.05% He | Identical | Identical |
| Tracer GasAnalysis forMBW | (not applicable for EasyOnePro) | NitrogenMolar mass sensor0 – 100 % N20.1 % N2±0.2 % N2 | Identical |
Side-by-side comparison of technological characteristics
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The same single-patient use accessories – Spirette, DLCO Barriette and FRC Barriette – are used with the modified devices than with the predicate devices. The same materials in the patient gas path are used with the modified devices and the predicate devices.
Differences between the modified and the predicate EasyOne Pro Respiratory Analysis System devices:
- • The modified devices differ in appearance from the predicate devices in that they have a different color scheme of the device housing, a different on/off button and a different design of the software user interface.
- A capacitive touch screen is used for the modified devices in comparison to the resistive touch screen used for the predicate devices.
- A different PC-board but providing the same functionalities is used for the modified devices.
- In the modified devices, a metal box around the CO or CO/CO₂ sensor provides improved EMC protection.
- . A power supply of higher efficiency but identical environmental specifications is used for the modified devices.
- An internal USB stick instead of a CF card for internal back-up data storage is used for the modified devices.
- . DISS gas hose connectors are used in the modified devices instead of the Quick Connectors used in the predicate devices.
- • The board used for data acquisition is modified compared to the predicate device, but keeping the same functions.
- • The outer geometry of the MMss sensor is modified compared to the predicate devices, but without modifying the operating principle and functionality of the sensor.
- . For the modified EasyOne Pro LAB device model, a modified combined CO/CO2 sensor is used; the modified combined CO/CO₂ sensor contains an additional reference path but has the same performance specifications as the combined CO/CO2 sensor used in the predicate device.
- The modified devices use Windows 8 instead of Windows XP embedded operating system and SQLite/Microsoft SQL server as database technology instead of Microsoft Access.
- . For the modified devices, some of the labelled specifications were updated to reflect the technical capabilities. No changes were made to the components the specifications relate to.
Design verification and validation demonstrated that the performance of the modified EasyOne Pro Respiratory Analysis System is the same as for the predicate EasyOne Pro Respiratory Analysis System. The modified as well as the predicate EasyOne Pro Respiratory Analysis System meet the ATS recommendations for accuracy and precision for spirometry, DLCO and MBW tests. The modified EasyOne Pro Respiratory Analysis System is therefore substantially equivalent to the predicate EasyOne Pro Respiratory Analysis System.
Summary of Testing:
Simulated Spirometry, DLCO and MBW testing, as well as testing with humans, confirmed that the modified EasyOne Pro Respiratory Analysis System devices meet the recommendations for accuracy and precision for Spirometry, DLCO and MBW tests of the American Thoracic Society (ATS).
The modified devices were tested to demonstrate conformance with the requirements for medical electrical equipment basic safety and essential performance of standards IEC 60601-1 and IEC 60601-1-2.
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Software verification and validation in accordance with IEC 62304 confirmed that the modified EasyOne Pro Respiratory Analysis System meets the specified criteria.
Biocompatibility was evaluated in accordance with ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process.
Conclusion:
Based on the above, ndd Medical Technologies concluded that the modified EasyOne Pro Respiratory Analysis System is substantially equivalent to the legally marketed predicate devices and is as safe and as effective for their intended use.
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).