K Number
K201562
Device Name
Spirotrac
Date Cleared
2020-10-14

(126 days)

Product Code
Regulation Number
868.1840
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vitalograph Spirotrac Model 7000 is a PC-based software application 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. The product is designed for use on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers under the supervision of a healthcare provider.
Device Description
The Vitalograph Spirotrac Model 7000 provides 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 integrates and reads / displays information from compatible Pulse Oximetry devices, Blood Pressure and Weight measurements devices, and ECG test devices. Its primary functions are: 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 its 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). 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. Navigation is allowed via the use of a standard PC keyboard and mouse or touchscreen.
More Information

Not Found

No
The summary describes a software application for acquiring, viewing, storing, and printing spirometry data and data from other compatible devices. It focuses on standard spirometry measurements and data management, with no mention of AI or ML algorithms for analysis, interpretation, or prediction. The performance testing is based on established spirometry standards (ATS/ERS, ISO) and software validation, not AI/ML model performance metrics.

No
The device is a spirometer used for diagnostic measurements of lung function, not for providing therapy.

Yes

The device performs spirometry measurements to assess pulmonary function, which involves collecting and analyzing physiological data to help diagnose and monitor respiratory conditions.

No

The device is described as a "PC-based software application" but its intended use and device description explicitly state it is intended to be used "as a spirometer" or connect to compatible Vitalograph or third-party devices to acquire, view, store, and print device output. While it is software, it is designed to function in conjunction with hardware (spirometers, pulse oximeters, blood pressure devices, ECG devices) to perform its intended medical function of measuring and displaying physiological data. The performance studies also include bench testing related to spirometry standards (ATS/ERS, ISO 23747, ISO 26782), which are hardware-related performance standards. Therefore, it is not a standalone software-only medical device.

Based on the provided information, the Vitalograph Spirotrac Model 7000 is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) to examine specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
  • Spirotrac's Function: The Vitalograph Spirotrac Model 7000 is a software application used in conjunction with spirometers and other devices to measure and display physiological parameters related to lung function (spirometry), as well as integrate data from pulse oximetry, blood pressure, and weight measurements.
  • Nature of Measurements: The measurements taken by the devices connected to Spirotrac (like spirometers) are in vivo measurements, meaning they are taken directly from the living body (e.g., measuring airflow during breathing). They are not analyzing specimens taken from the body.

Therefore, the Vitalograph Spirotrac Model 7000 falls under the category of a medical device used for physiological measurement and data management, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Vitalograph Spirotrac Model 7000 is a PC-based software application 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. The product is designed for use on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers under the supervision of a healthcare provider.

Product codes

BZG

Device Description

The Vitalograph Spirotrac Model 7000 provides 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 integrates and reads / displays information from compatible Pulse Oximetry devices, Blood Pressure and Weight measurements devices, and ECG test devices.

Its primary functions are:

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 its 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).

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.

Navigation is allowed via the use of a standard PC keyboard and mouse or touchscreen.

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 pediatrics, 5 years and older

Intended User / Care Setting

professional healthcare environments, e.g. primary care, hospitals and occupational health centers under the supervision of a healthcare provider.

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)

Non-clinical Testing
Performance testing demonstrated that the subject device met its acceptance criteria. Testing included:

Software
Verification and Validation was performed following Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005 and General Principles of Software Validation Guidance. January 2020.

Bench

  • ATS / ERS (2005) waveform simulator testing
  • ISO 23747:2015- Anaesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
  • ISO 26782:2009 - Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans.

Note that this testing was performed to demonstrate that the data displayed along with any limits set by user or by default, are aligned with these performance standards.

There is no hardware so electrical safety, electromagnetic compatibility, biocompatibility, and cleaning testing were not required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K141546

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

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October 14, 2020

Vitalograph Ireland Ltd. % Paul Dryden Consultant ProMedic. LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704

Re: K201562

Trade/Device Name: Vitalograph Spirotrac Model 7000 Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: September 10, 2020 Received: September 11, 2020

Dear Paul Dryden:

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

1

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 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 (QS) 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 medical devices and radiation-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,

for Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

K201562

Device Name

Vitalograph Spirotrac Model 7000

Indications for Use (Describe)

The Vitalograph Spirotrac Model 7000 is a PC-based software application 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. The product is designed for use on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers under the supervision of a healthcare provider.

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

XX Prescription Use (Part 21 CFR 801 Subpart D)

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

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FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301)

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K201562

510(k) Summary Page 1 of 5

Date Prepared:13-Oct-2020
-----------------------------

I Submitter

| Vitalograph Ireland Ltd.
Gort Road Business Park
Ennis Co Clare V95 HFT4 Ireland

Tel - +353-65-6864100
-----------------------------------------------------------------------------------------------------------------

| Submitter Contact: | Tony O'Hanlon
Regulatory Affairs / Quality Assurance Manager |
|---------------------------|-----------------------------------------------------------------|
| Submission Correspondent: | Paul Dryden
ProMedic, LLC |

II Device

Proprietary or Trade Name:Vitalograph Spirotrac Model 7000
Common/Usual Name:Diagnostic spirometer
Classification Name:Diagnostic spirometer (21 CFR 868.1840)
Regulatory Class:II
Product Code:BZG

III Predicate Device:

Vitalograph Model 7000, K141546
-----------------------------------

IV Device Description:

The Vitalograph Spirotrac Model 7000 provides 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 integrates and reads / displays information from compatible Pulse Oximetry devices, Blood Pressure and Weight measurements devices, and ECG test devices.

Its primary functions are:

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 its 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).

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.

Navigation is allowed via the use of a standard PC keyboard and mouse or touchscreen.

4

510(k) Summary Page 2 of 5

V Indications for Use:

The Vitalograph Spirotrac Model 7000 is a PC-based software application 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. The product is designed for use on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers under the supervision of a healthcare provider.

Environments of use: Professional healthcare environments, e.g. primary care, hospitals and occupational health centers.

VI Modifications

A new code base, rewrite of the application, use of interfacing with latest Windows technology, User Interface etc. There were no changes to the algorithm.

Mechanical:

None, this is a software only device

Electrical:

None, this is a software only device

Materials:

None, this is a software only device

Software:

A new code base, rewrite of the application, use of interfacing with latest Windows technology, User Interface etc.

VII Comparison of Technological Characteristics and Performance with the Predicate

Table 1 is a comparison - Subject Device vs. the Predicate, K141546 including technological characteristics and performance.

5

510(k) Summary

Table 1: Comparison of the Model 7000 Spirotrac vs. the Predicate

PredicateSubjectComparison
Model 7000 SpirotracVitalograph Spirotrac Model 7000
K#K141546K201562
Product CodeBZGBZGSame
CFR868.1840868.1840Same
ClassificationSpirometer, diagnosticSpirometer, diagnosticSame
Indications for UseThe 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.The Vitalograph Spirotrac Model 7000 is a
PC-based software application 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. The
product is designed for use on adults and
pediatrics, 5 years and older, in a variety of
professional healthcare environments, e.g.
primary care, hospitals and occupational
health centers under the supervision of a
healthcare provider.The indications for use
have been updated from
the predicate K141546
which was not specific
regarding the type of
testing performed,
patient population or
environments of use.
Otherwise the indications
for use are the same.
Fundamental scientific technologyDigital data communicationDigital data communicationSame
Spirometry - acquire, view,
store and print measures and
waveforms of pulmonary
functionYesYesSame
ECG waveforms -
view, store, printYesYesSame
ECG waveforms - acquireYes, From compatible device.Yes, From compatible device.Same
ECG waveform- view, store, printYesYesSame
ECG Interpretation via
algorithmsYesYesSame
Ambulatory Blood Pressure -
retrieve, view, store and print
patient ambulatory blood
pressure historyYes, from compatible device.Yes, from compatible device.Same
PredicateSubjectComparison
Model 7000 SpirotracVitalograph Spirotrac
Model 7000
K#K141546K201562
Spot Oximetry download, view.
WeightYes, From compatible device.
Manual entry or download via connection to
compatible deviceYes, From compatible device.
Manual entry or download via connection
to compatible deviceSame
Microsoft windows Operating
Systems Supported:Yes, Windows 7 and 8Yes, Windows 7, 8 and 10Support for newer
operating system
Database:MS SQL ServerMS SQL ServerSame
Where usedHospital, Health center, primary care practices
and clinicsHospital, Health center, primary care
practices and clinicsSame
Networked operationYesYesSame
Subject Management:
Demographic Entry, Maintenance
and DeletionYesYesSame
Report PrintingYesYesSame
Spirometry testingYesYesSame
Trending Graphs for Spirometry
ResultsYesYesSame
Spirometry Predicted Value
EquationsYesYesSame
Population Group ManagementYesYesSame
Data Import/ExportYesYesSame
Subject and Spirometry Data
ExportYesYesSame
Manual data entry of resultsYesYesSame
Data export via EmailYesYesSame
Database ManagementYesYesSame
Color DisplayYesYesSame
Population groupsAdult, PediatricAdult, Pediatric (5 years and above)Same
CommunicationBluetooth, USB,Bluetooth, USB,Same
StorageDependent on storage mediaDependent on storage mediaSame
BiocompatibilityNo patient contactNo patient contactSame

6

K201562

510(k) Summary

7

VIII Performance Data

Non-clinical Testing

Performance testing demonstrated that the subject device met its acceptance criteria. Testing included:

Software

Verification and Validation was performed following Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005 and General Principles of Software Validation Guidance. January 2020.

Bench

  • ATS / ERS (2005) waveform simulator testing
  • ISO 23747:2015- Anaesthetic and respiratory equipment -- Peak expiratory flow meters ● for the assessment of pulmonary function in spontaneously breathing humans
  • ISO 26782:2009 - Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans.

Note that this testing was performed to demonstrate that the data displayed along with any limits set by user or by default, are aligned with these performance standards.

There is no hardware so electrical safety, electromagnetic compatibility, biocompatibility, and cleaning testing were not required.

Substantial Equivalence Conclusion

The performance testing has demonstrated that the subject devise met the applicable standard performance requirements. The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device are substantially equivalent.