The Vitalograph Model 7000 Spirotrac is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediatric patients. The device is a PC based software application which is intended to be used as a spirometer or connect to compatible Vitalograph or third party devices to acquire, view, store and print the device output.

Device Description

Spirotrac shall provide a secure PC based medical device software application for creating, adding and recalling subjects and performing Spirometry testing on those subjects. Spirotrac will also link to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject. Spirotrac will integrate and read / display information from Pulse Oximetry devices, Blood Pressure and Weight measurements devices, and ECG test devices. Its primary functions are: 1. Spirometry measurements using single breath and multiple-breath testing techniques, the display and recording of measured lung volumes and flow rates (including VC, FIVC, FVC) and it's subdivisions, The unit also allows for the measurements of Inspiratory and Expiratory Flow rates (PEF, FEFx, etc), indirect measures (e.g. MVV) and Pre-post testing (e.g. Challenge, work shift). 2. Record subject demographic data as input. Interact with existing Vitalograph and compatible third party devices via standard PC communication methods for download of data for storage within the Spirotrac database. 3. Navigation is allowed via the use of a standard PC keyboard and mouse or touchscreen.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Vitalograph Model 7000 Spirotrac, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not typically a detailed clinical study report proving device performance against specific, pre-defined acceptance criteria in the same way a PMA or de novo submission might. Therefore, some information, especially regarding detailed sample sizes, expert qualifications, and specific "reported device performance" metrics against acceptance criteria (beyond general compliance checks), is not explicitly stated in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device underwent validation testing to ensure performance according to its specifications against current standards. The mentioned standards serve as the de-facto acceptance criteria. The "Reported Device Performance" is generally stated as "All tests and validations demonstrated satisfactory results." Specific numerical performance metrics against each standard are not provided in this summary.

Acceptance Criterion (Standard)	Reported Device Performance (as per document)
ISO 26782: Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time forced expired volumes in humans	Satisfactory results demonstrated
ATS/ERS 2005: ATS/ERS Task Force: Standardisation of Lung Function Testing	Satisfactory results demonstrated
ISO 23747: Anaesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function	Satisfactory results demonstrated
Integrity of information maintained during interface with compatible third-party devices	Satisfactory results demonstrated (validation on file for all devices)
Successful download and storage of information from third-party devices within the Spirotrac database	Satisfactory results demonstrated (validation on file for all devices)

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

The document does not specify a sample size for any clinical test set. The validation appears to be primarily engineering and bench testing against international standards, rather than a clinical study with a patient cohort.

Sample Size (Test Set): Not specified.
Data Provenance: Not specified, but likely from laboratory testing and calibration rather than patient data from a specific country or retrospective/prospective study type, given it's a spirometer software.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided as the validation described is against established international technical standards for spirometry. There wasn't a ground truth established by human experts in the typical sense of a diagnostic imaging study.

4. Adjudication Method for the Test Set

Since the validation is described as performance testing against international standards, an "adjudication method" in the context of expert review for ground truth determination is not applicable or described. The standards themselves define the criteria for "correctness" or acceptable performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not mentioned or performed. The device is a spirometer software application; its performance is typically evaluated for measurement accuracy and consistency, rather than its impact on human reader interpretation.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance evaluation was done. The document explicitly states: "The Vitalograph Model 7000 Spirotrac underwent validation testing to ensure performance according to its specifications against current standards." This refers to the software's ability to accurately acquire, process, and display spirometry measurements as determined by the listed ISO and ATS/ERS standards.

7. Type of Ground Truth Used for the Test Set

The ground truth for the test set was defined by international technical standards and norms for spirometry (ISO 26782, ATS/ERS 2005, ISO 23747). This implies that the device's measurements were compared against established reference values or methods defined by these standards, likely using simulated lung functions or calibrated devices.

8. Sample Size for the Training Set

The document does not mention a training set size. This device is a spirometer software, and its primary function is measurement and data handling. While it might include algorithms for interpretation (e.g., predicted values, flagging out-of-range results), these are typically based on well-established physiological models and clinical guidelines, not necessarily a machine learning model that requires a "training set" in the modern AI sense.

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

Since a "training set" in the machine learning sense is not mentioned, the method for establishing its ground truth is not applicable or described. The algorithms and computations within the spirometer software would be based on established physiological principles and clinical guidelines rather than learned from a labeled dataset.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

September 3, 2014

Vitalograph (Ireland) Ltd. C/O Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313

Re: K141546

Trade/Device Name: Vitalograph Model 7000 Spirotrac Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: August 15, 2014 Received: August 19, 2014

Dear Mr. Job:

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}------------------------------------------------

Page 2 - Mr. Job

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

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/ResourcesforYou/Industry/default.htm.

of Surveillance and Biometrics/Division of Postmarket Surveillance.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K141546

Device Name

Vitalograph Model 7000 Spirotrac

Indications for Use (Describe)

The Vitalograph Model 7000 Spirotrac is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediativ patients. The device is a PC based software application which is intended to be used as a spirometer or connect to compatible Vitalograph or third party devices to acquire, view, store and print the device output.

Type of Use (Select one or both, as applicable)

X 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)

Image /page/2/Picture/14 description: The image contains text that appears to be a timestamp or record of some kind. The text includes a name, "Anya C. Harry -S", followed by a date and time stamp: "2014.09.03 12:12:31". There is also a time zone offset indicated as "-04'00'". The text is presented in a clear, sans-serif font, making it easily readable.

FORM FDA 3881 (1/14)

{3}------------------------------------------------

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510K Summary as required by 21 CFR 807.92

Company Information: Name: Vitalograph (Ireland) Ltd Address: Gort Road Business Park, Ennis, Co Clare, Ireland.

Tel: +353656864100 Fax: +353656829289.

1. Contact Person / Official Correspondent: Mr. Tom J Healy Regulatory Affairs / Quality Assurance Manager
1. Date prepared: 2nd July 2014.
1. Device Trade Name: Vitalograph Model 7000 Spirotrac
1. Common / Usual name: Vitalograph Spirotrac,
1. Classification number:

Class 2 Spirometer as classified per 21 CFR 868.1840. Product Code BZG.

1. Predicate Device:

Manufacturer	: Welch Allyn
Device Name	: CardioPerfect Workstation Software
510(k) No	: K082478, Class 2, Product Code BZG

Manufacturer	: MIR
Device Name	: Spirodoc
510(k) No	: K103530, Class 2, Product Code BZG

1. Description of Device:
  Spirotrac shall provide a secure PC based medical device software application for creating, adding and recalling subjects and performing Spirometry testing on those subjects. Spirotrac will also link to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject

{5}------------------------------------------------

Spirotrac will integrate and read / display information from Pulse Oximetry devices, Blood Pressure and Weight measurements devices, and ECG test devices.

Its primary functions are:

1. Spirometry measurements using single breath and multiple-breath testing techniques, the display and recording of measured lung volumes and flow rates (including VC, FIVC, FVC) and it's subdivisions, The unit also allows for the measurements of Inspiratory and Expiratory Flow rates (PEF, FEFx, etc), indirect measures (e.g. MVV) and Pre-post testing (e.g. Challenge, work shift).
1. Record subject demographic data as input. Interact with existing Vitalograph and compatible third party devices via standard PC communication methods for download of data for storage within the Spirotrac database.
1. Navigation is allowed via the use of a standard PC keyboard and mouse or touchscreen.

9. Indications for Use:

1. Technological Characteristics
  The primary difference between the revised Vitalograph Model 7000 Spirotrac and the predicate devices is the inclusion of the weighing scales as a compatible third party devices. The predicates all measure spirometry with optional ECG, Blood Pressure, Weight and Pulse Oximetry connectivity.

The connectivity to other compatible devices is to allow data to be downloaded from the other devices via a cable or wireless connection, in lieu of manual data entry which can still be performed within Spirotrac.

Connectivity includes a wired / wireless connection to devices to allow downloading of data into the Spirotrac database. Risks have been evaluated and the connectivity / communication with other devices have been validated with the Vitalograph Model 7000 Spirotrac software. This validation is on file for all devices.

{6}------------------------------------------------

	Welch AllynCardioPerfectWorkstation	Spirotrac Model7000	MIR Spirodoc,K103530
	Software,K082478
Spirometry -acquire, view, storeand printmeasures andwaveforms ofpulmonary function	Yes	Yes	Yes
ECG waveforms -view, store, print	Yes	Yes	No
ECG waveforms -acquire	Yes	Yes, Fromcompatible device.	No
ECG waveform-view, store, print	Yes	Yes	No
ECG Interpretationvia algorithms	Yes	Yes	No
Ambulatory BloodPressure - retrieve,view, store and printpatient ambulatoryblood pressurehistory	Yes	Yes, fromcompatible device.	No
Spot Oximetrydownload, view.	No	Yes, Fromcompatible device.	Yes
Weight	Manual entry	Manual entry ordownload viaconnection tocompatible device	No
Microsoft windowsOperating SystemsSupported:	Yes	Yes	Yes
Database:	MS SQL Server	MS SQL Server	MS SQL Server
Where used	Hospital, Clinic	Hospital, Healthcentre, primarycare practices andclinics	Physician or patientunder prescribed usof a physician
Networkedoperation	Yes	Yes	Yes
SubjectManagement:Demographic Entry,Maintenance andDeletion	Yes	Yes	Yes
Report Printing	Yes	Yes	Yes
Spirometry testing	Yes	Yes	Yes
Trending Graphs forSpirometry Results	Yes	Yes	Yes
SpirometryPredicted ValueEquations	Yes	Yes	Yes
Population GroupManagement	Yes	Yes	Yes
Data Import/Export	Yes	Yes	Yes
Subject andSpirometry DataExport	Yes	Yes	Yes
Manual data entryof results	Yes	Yes	Yes
Data export viaEmail	Yes	Yes	Yes
DatabaseManagement	Yes	Yes	Yes
Colour Display	Yes	Yes	Yes
Population groups	Adult, PaediatricAdult & Paediatric	Adult, Paediatric	YesSpirometry - Adult &paediatric
Target Population		Adult & Paediatric	Oximetry - All ages
Communication	Wireless, USB,Serial,Dependent onstorage media	Bluetooth, USB,Dependent onstorage media	Bluetooth, USB
Storage
Sterile	No	No	No
Regulatory (USA):	FDA - 510(k)Class 2 { K082478}	FDA - 510(k) Class2	FDA - 510(k) Class 2{K103530}
Indications for Use	The CardioPerfectWorkstation softwareand associatedaccessories areindicated for theacquisition, analysis,formatting, display,printing and storage ofcertain physiologicsignals, as identifiedbelow, for the purposeof assisting theclinician in thediagnosis andmonitoring of variousdiseases and/ortreatment regimens.The CardioPerfectWorkstation softwarealso provides non-diagnostic functionssuch as patientmanagement, datasecurity, search toolsfor patient and/or testrecords and supportfor exporting data toElectronic Medical	The Vitalograph Model7000 Spirotrac isintended for use by oron the order of aphysician in a hospitalor clinic setting. Theproduct is designed foruse on both adult andpediatric patients. Thedevice is a PC basedsoftware applicationwhich is intended to beused as a spirometer orconnect to compatibleVitalograph or thirdparty devices to acquire,view, store and print thedevice output.	The Spirodoc Spirometerand pulse oximeter isintended to be used bya physician or by apatient under theprescribed use of aphysician.The device is intended totest lung function and canperform spirometrytesting in adult andpediatric patients,excluding infants andneonates, and oximetryreadings in patients of allages.

{7}------------------------------------------------

{8}------------------------------------------------

The CardioPerfectWorkstation andassociated accessoriesare intended for useby or on the order of aphysician in a hospitalor clinic setting. Theproduct is designed foruse on both adult andpediatric patients,subject to any specificcontraindicationsidentified below.
StressElectrocardiograph -Intended UseUsing the optional ECGmodule andassociated accessoriesthe user can acquire,view, store and printECG waveforms.
RestingElectrocardiograph -Intended UseThe same as definedfor stress ECG plus theability to use optionalalgorithms (MEANS) togeneratemeasurements, datapresentations,graphicalpresentations andinterpretivestatements on anadvisory basis. Theseare presented forreview andinterpretation by theclinician.
Spirometry - IntendedUseUsing the optionalspirometry moduleand associatedaccessories to acquire,view, store and printmeasures andwaveforms ofpulmonary function.The spirometer should	only be used withpatients able tounderstand theinstructions forperforming the test.
Ambulatory BloodPressure - Intended

{9}------------------------------------------------

Use
Using the optional ABPmodule andassociated accessoriesthe user can acquire,retrieve, view, storeand print patientambulatory bloodpressure history.

The Vitalograph Model 7000 Spirotrac underwent validation testing to ensure performance according to its specifications against current standards. These tests included performance testing against international standards such as

ISO 26782{ Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time forced expired volumes in humans},
. ATS/ERS 2005 { ATS/ERS Task Force: Standardisation of Lung Function Testing} and
ISO 23747 { Anaesthetic and respiratory equipment -- Peak expiratory flow . meters for the assessment of pulmonary function in spontaneously breathing humans}.

Validation of the interfaces with compatible third party devices is to ensure the integrity of the information is maintained and that the information on the third party devices may be successfully downloaded and stored within the Spirotrac database.

All tests and validations demonstrated satisfactory results. Evidence of successful completion of tests and validations has been provided with this submission.

11. Conclusion:

The characteristics of the Model 7000 Spirotrac are similar to those of the predicate devices listed.

Based on the above, including the successful completion of all device testing Vitalograph conclude that this device is as safe and as effective as the predicate devices. No new issues of safety or effectiveness have been introduced as a result.

Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).