(264 days)
No
The summary describes a pulmonary function testing device that uses sensors to measure physiological parameters and does not mention any AI or ML components for data analysis or interpretation.
No.
The device is described as a pulmonary function testing device used for measurements and screening, not for treatment.
Yes
The device is designed for "conducting lung function measurements" and performs "Spirometry and Single Breath CO Diffusion (DLCO) tests including Lung Volume Parameters" which are diagnostic procedures to assess lung health.
No
The device description explicitly details various hardware components, including sensors (ultrasonic flow, molar mass, CO/CO2, temperature, humidity), and mentions the use of test gases and single-patient use accessories. This indicates it is a hardware-based medical device with accompanying software.
Based on the provided information, the EasyOne Pro/LAB device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The EasyOne Pro/LAB measures lung function directly from the patient's breathing, not from a sample taken from the body.
- The device description focuses on measuring physiological parameters like flow velocity, volume, molar mass of gases, and gas concentrations in inhaled and exhaled air. These are direct measurements of bodily function, not analysis of a biological sample.
- The intended use describes performing lung function measurements and screenings. This is a direct assessment of a physiological process.
While the device uses sensors to analyze the composition of gases, this analysis is performed on the air being breathed by the patient in real-time, not on a collected biological specimen. Therefore, it falls under the category of a diagnostic device that measures physiological parameters, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
BTY
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 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.
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 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.
Intended User / Care Setting
physicians, respiratory therapists or nurses in general or specialist practices or in hospitals. The EasyOne Pro Respiratory Analysis System can also be used in clinical settings in occupational medicine for performing lung function screenings or measurements in occupational medicine.
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
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.
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.
Key Metrics
Not Found
Predicate Device(s)
EasyOne Pro Respiratory Analysis System, model EasyOne Pro K091428, EasyOne Pro Respiratory Analysis System, model EasyOne Pro LAB K120635
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
1
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
2
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)
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
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
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 AG
Technoparkstrasse 1
8005 Zurich, Switzerland |
|----------------------------------|---------------------------------------------------------------------------|
| United States
contact person: | Mr. Jerry Masiello
Operations Manager
ndd 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
4
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 device
Primary predicate device | Currently marketed device
Secondary predicate device | Subject device |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Device
identification | EasyOne Pro Respiratory
Analysis System
Model:
EasyOne Pro
K091428 | EasyOne Pro Respiratory
Analysis System
Model:
EasyOne Pro LAB
K120635 | EasyOne Pro Respiratory
Analysis System
Models:
EasyOne Pro
EasyOne Pro LAB
K161534 |
| Product code | BTY | BTY | BTY |
| Description | Currently marketed device
Primary predicate device | Currently marketed device
Secondary predicate
device | Subject device |
| Intended Use
(incl. target
population) | System for pulmonary
function testing on adults
and children (over the age
of 4 for spirometry lung
function measurements
and over the age of 6 for
DLCO testing). | Identical | Identical |
| Target users | The EasyOne Pro
Respiratory Analysis
System is used by
physicians, respiratory
therapists or nurses in
general or specialist
practices or in hospitals.
The EasyOne Pro
Respiratory Analysis
System can also be used in
clinical settings in
occupational medicine for
performing lung function
screenings or
measurements in
occupational medicine. | Identical | Identical |
| User interface | Resistive touch screen for
data entry and display | Identical | Capacitive touch screen for
data entry and display |
| Patient interface | EasyOne Pro:
• Disposable breathing
tube Spirette
• Disposable barrier shield
DLCO Barriette | EasyOne Pro LAB:
• All identical
In addition:
• Disposable barrier
shield FRC Barriette | Identical |
| Components | EasyOne Pro :
• Main Unit (embedded
computer, touch screen
and monitor)
• Handheld flow sensor
• Breathing valve
assembly (for DLCO and
FRC tests)
• DLCO gas mix supply
• 100-240 VAC, 50/60 Hz
power supply | EasyOne Pro LAB:
• All identical
In addition:
• 100% O2 gas supply | Identical |
| Operating
system | Microsoft Windows XP
Embedded
Microsoft Access database | Identical | Microsoft Windows 8
Embedded
SQLite/Microsoft SQL
server database |
| Description | Currently marketed device
Primary predicate device | Currently marketed device
Secondary 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 identical
In 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 identical
In 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 mix
CO: 0.3 %
Helium: 10 %
Oxygen: 18 % - 25 %
Nitrogen: balance | Identical | Identical |
| Description | Currently marketed device
Primary predicate device | Currently marketed device
Secondary predicate
device | Subject device |
| Test gas
requirements for
MBW test | (not applicable for EasyOne
Pro) | Oxygen 100 % | Identical |
| Flow sensor
specification | ±16 L/s
Greater of ±2 % or 0.050 L
Greater of ±2 % or 0.020 L/s