The EasyOne Pro Respiratory Analysis System 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.

Device Description

The ndd EasyOne Pro Respiratory Analysis System is a portable device for performing lung function measurements. The device consists of a compact main unit and a hand-held sensor. Spirometry tests can be performed by connecting the hand-held sensor to the main unit. In order to perform DLCO and FRC tests a valve unit must additionally be connected to the handheld sensor. The valve unit is connected with the main unit with a gas supply tube. The spirette respiratory tube is a mouthpiece for single patient use, which is inserted in the sensor. In the valve unit there is also an accessory for single patient use inserted, which is called barriette. The barriette prevents the passage of microorganisms into EasyOne Pro Respiratory Analysis System. A touch screen is integrated in the main unit that provides the user interface. The main power switch, different connections as well as different ports are located on the rear panel of the main unit. The EasyOne Pro can be used as a stand-alone system and can be connected to a network. The device has built-in quality control to assure correct test performance and equipment function.

AI/ML Overview

The provided text describes the ndd EasyOne Pro Respiratory Analysis System and its substantial equivalence to predicate devices, but it does not provide a detailed table of specific acceptance criteria and reported device performance with numerical values or statistical metrics.

However, I can extract the information that is present and highlight what is missing based on your request.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Parameter	Acceptance Criteria (Stated)	Reported Device Performance (Implied that criteria were met)
Spirometry Tests	Meet ATS recommendations for accuracy and precision	Successfully met ATS recommendations (via dynamic waveform testing, comparative measurements)
DLCO Testing	Meet ATS recommendations for accuracy and precision	Successfully met ATS recommendations (via DLCO simulator, comparative measurements)
FRC Testing (N2 Washout)	Not explicitly stated, but "acceptance criteria" for performance	Successfully met "acceptance criteria" (via FRC simulator, patient/healthy subject tests)
Electrical Safety	Conformance with IEC 60601-1 and IEC 60601-1-2	Met IEC 60601-1 and IEC 60601-1-2 requirements
Biocompatibility	Conformance with ISO 10993	Met ISO 10993 requirements
Software Verification/Validation	Meet specified criteria	Met specified criteria

Missing Information: The document states that the device meets ATS recommendations and other specified criteria, but it does not provide the specific numerical thresholds for these criteria (e.g., a specific percentage accuracy, range of precision) or the actual measured performance data from the tests (e.g., measured accuracy values, standard deviations).

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size (Test Set):
- For Spirometry and DLCO: Not explicitly stated. The document mentions "comparative measurements with another DLCO testing device" but doesn't specify the number of measurements or subjects.
- For FRC: "multiple breath washout tests in patients and healthy subjects were performed." The exact number of patients and healthy subjects is not specified.
Data Provenance: Not explicitly stated. The document does not mention the country of origin of the data.
Retrospective or Prospective: Not explicitly stated. Given the nature of performance testing for a new device, it is likely prospective testing on simulators and possibly a cohort of subjects, but this is not explicitly confirmed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The testing described focuses on device performance against simulators and established standards (like ATS recommendations), rather than expert-established ground truth for diagnostic accuracy in a clinical context.

4. Adjudication Method for the Test Set

This information is not provided in the document. As the tests primarily involved comparisons to simulators and existing devices/standards, a human expert adjudication method as typically used for AI-driven diagnostic tools is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided in the document. The ndd EasyOne Pro Respiratory Analysis System is a pulmonary function testing device, not an AI-assisted diagnostic tool designed to be used by human "readers" (like radiologists). Therefore, an MRMC study or an assessment of human improvement with AI assistance is not applicable to this device as described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance testing described (dynamic waveform testing, DLCO simulator, FRC simulator tests) are essentially "standalone" device performance evaluations in a controlled environment, demonstrating the device's ability to accurately measure lung function parameters. The device itself is a measurement tool, not an "algorithm only" in the sense of an interpretive AI system. Its accuracy is evaluated inherently in a standalone manner against known inputs or reference methods.

7. The Type of Ground Truth Used

Spirometry, DLCO, FRC: The ground truth for these tests appears to be based on:
- Simulators: Dynamic waveform testing for spirometry, a DLCO simulator, and an FRC simulator. These simulators provide known, controlled inputs against which the device's measurements are compared.
- ATS Recommendations: The device's performance is gauged against the established accuracy and precision standards set by the American Thoracic Society (ATS) for lung function measurements.
- Comparative Measurements: Comparisons were made with "another DLCO testing device," implying the established accuracy of that device served as a reference.
- Healthy Subjects/Patients: For FRC, tests were also performed in these groups, presumably to assess real-world performance against expected physiological ranges or established clinical standards.

8. The Sample Size for the Training Set

This information is not provided and is likely not applicable in the context of this device. The ndd EasyOne Pro is a measurement device based on known physiological principles and sensor technology, not a machine learning or AI model that requires a "training set" in the traditional sense. Its software verification and validation would refer to standard software engineering practices, not AI model training.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable for the same reasons mentioned in point 8.

Summary

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SEP 27 2012

5 510(k) Summary K120635

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 Manager
	ndd Medical Technologies, Inc
Phone:	(877) 904.0090 x11
Fax:	(978) 824.3853
Mailto:	imasiello@nddmed.com
Date prepared:	February 22, 2012
Device Name:
Proprietary name:	EasyOne Pro Respiratory Analysis System
Common name:	Pulmonary function.testing device
Class	Class II according to 868.1890
Classification name:	Calculator, Predicted Values, Pulmonary Function
Product code:	BTY

Predicate Device:

Substantial Equivalence is claimed with the SensorMedics Vmax 229 Series Pulmonary Function Analysis Instrument, K942211. The ndd Medical Technologies EasyOne Pro Respiratory System consists of two different device models: EasyOne Pro and EasyOne Pro LAB. The EasyOne Pro is currently marketed and cleared under K091428. The EasyOne Pro LAB is an enhanced version of the EasyOne Pro, which uses many of the technological characteristics implemented in the currently marketed EasyOne Pro. Both device models of the EasyOne Pro Respiratory Analysis System provide DLCO (Diffusion Capacity) tests including Lung Volume parameters and Spirometry tests. Compared to the EasyOne Pro the EasyOne Pro LAB includes measurement of the Functional Residual Capacity (FRC) based on the Multiple Breath Nitrogen (N2) Washout method.

Device Description:

Section 5: 510(k) Summary

Page 1 of 2

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barriette. The barriette prevents the passage of microorganisms into EasyOne Pro Respiratory Analysis System. A touch screen is integrated in the main unit that provides the user interface. The main power switch, different connections as well as different ports are located on the rear panel of the main unit. The EasyOne Pro can be used as a stand-alone system and can be connected to a network. The device has built-in quality control to assure correct test performance and equipment function.

Intended Use:

The ndd EasyOne Pro Respiratory Analysis System is designed for conducting lung function measurements in general or specialist practices or in hospitals. The EasyOne Pro Respiratory Analysis System can also be used outside of the laboratory when performing lung function screenings or measurements in occupational medicine. The EasyOne Pro Respiratory Analysis System 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 device has the same technological characteristics as the predicate devices. Testing was conducted to demonstrate that lung function measurements are as accurate and precise as the methods used in predicate devices. The new as well as the predicate devices meet the ATS recommendations for lung function measurements. The EasyOne Pro Respiratory Analysis System is therefore substantially equivalent to the predicate devices.

Summary of Testing:

Dynamic wave form testing was performed regarding the diagnostic spirometry tests. The DLCO performance was tested by using a DLCO simulator. In addition comparative measurements with another DLCO testing device demonstrate that the EasyOne Pro Respiratory Analysis System meets the ATS recommendations for accuracy and precision for DLCO testing and the intended diagnostic spirometry tests.

The multiple breath washout testing was performed using an FRC simulator. In addition to these in-vitro tests multiple breath washout tests in patients and healthy subjects were performed. Performance testing demonstrated that the acceptance criteria were successfully met.

The device was tested to demonstrate conformance with IEC 60601-1 and IEC 60601-1-2 requirements for electrical safety.

The materials used meet the requirements for biocompatibility in accordance with ISO 10993.

Software verification and validation revealed that the EasyOne Pro Respiratory Analysis System meets the specified criteria.

Conclusion:

Based on the above, ndd Medical Technologies concluded that the EasyOne Pro Respiratory , Analysis System is substantially equivalent to the legally marketed predicate devices and is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ndd Medizintechnik AG C/O Mr. Gerard Masiello Operations Manager Ndd Medical Technologies, Incorporated Two Dundee Park Andover, Massachusetts 01810 .

SEP 27 2012

Re: K120635

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: September 12, 2012 Received: September 14, 2012

Dear Mr. 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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Page 2- Mr. Masiello

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

h tor

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

Device Name:

EasyOne Pro Respiratory Analysis System

Indications for Use:

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L Schultheis

esiology, General Hospital

510(k) Number: KC/

Section 4: Indications for Use Statement

EasyOne Pro Respiratory Analysis System

Regulation Number and Section

§ 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).