Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard spirometry measurements and data management, with no mention of AI or ML algorithms for analysis or interpretation.

Therapeutic

No
The device is a spirometer used to acquire, view, store, and print diagnostic data related to lung function, but it does not provide therapy.

Diagnostic

Yes

The device performs spirometry measurements, analyzes lung volumes and flow rates, and records subject demographic data, all of which are diagnostic functions used to assess respiratory health and identify potential medical conditions.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states it is a "PC based medical device software application" and its primary functions are software-based data acquisition, storage, display, and analysis, even when interacting with external hardware.

IVD (In Vitro Diagnostic)

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

Here's why:

IVDs analyze samples taken from the human body. The description of the Spirotrac focuses on measuring lung volumes and flow rates directly from the patient's breathing. It also integrates data from devices that measure physiological parameters like pulse oximetry, blood pressure, and ECG, which are also direct measurements from the body, not analysis of samples.
The intended use and device description clearly outline its function as a spirometer and a data management system for various physiological measurements. There is no mention of analyzing blood, urine, tissue, or any other biological sample.

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

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

BZG

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:

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).
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

adult and pediatric patients

Intended User / Care Setting

physician in a hospital or clinic setting.

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)

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, ATS/ERS 2005 and ISO 23747. 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.

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

Not Found

Predicate Device(s)

K082478, K103530

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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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.

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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

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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)

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FORM FDA 3881 (1/14)

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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."

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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

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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:

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.

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.

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| | Welch Allyn
CardioPerfect
Workstation | Spirotrac Model
7000 | MIR Spirodoc,
K103530 |
|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Software,
K082478 | | |
| Spirometry -
acquire, view, store
and print
measures and
waveforms of
pulmonary function | Yes | Yes | Yes |
| ECG waveforms -
view, store, print | Yes | Yes | No |
| ECG waveforms -
acquire | Yes | Yes, From
compatible device. | No |
| ECG waveform-
view, store, print | Yes | Yes | No |
| ECG Interpretation
via algorithms | Yes | Yes | No |
| Ambulatory Blood
Pressure - retrieve,
view, store and print
patient ambulatory
blood pressure
history | Yes | Yes, from
compatible device. | No |
| Spot Oximetry
download, view. | No | Yes, From
compatible device. | Yes |
| Weight | Manual entry | Manual entry or
download via
connection to
compatible device | No |
| Microsoft windows
Operating Systems
Supported: | Yes | Yes | Yes |
| Database: | MS SQL Server | MS SQL Server | MS SQL Server |
| Where used | Hospital, Clinic | Hospital, Health
centre, primary
care practices and
clinics | Physician or patient
under prescribed us
of a physician |
| Networked
operation | Yes | Yes | Yes |
| Subject
Management:
Demographic Entry,
Maintenance and
Deletion | Yes | Yes | Yes |
| Report Printing | Yes | Yes | Yes |
| Spirometry testing | Yes | Yes | Yes |
| Trending Graphs for
Spirometry Results | Yes | Yes | Yes |
| Spirometry
Predicted Value
Equations | Yes | Yes | Yes |
| Population Group
Management | Yes | Yes | Yes |
| Data Import/Export | Yes | Yes | Yes |
| Subject and
Spirometry Data
Export | Yes | Yes | Yes |
| Manual data entry
of results | Yes | Yes | Yes |
| Data export via
Email | Yes | Yes | Yes |
| Database
Management | Yes | Yes | Yes |
| Colour Display | Yes | Yes | Yes |
| Population groups | Adult, Paediatric
Adult & Paediatric | Adult, Paediatric | Yes
Spirometry - Adult &
paediatric |
| Target Population | | Adult & Paediatric | Oximetry - All ages |
| Communication | Wireless, USB,
Serial,
Dependent on
storage media | Bluetooth, USB,
Dependent on
storage media | Bluetooth, USB |
| Storage | | | |
| Sterile | No | No | No |
| Regulatory (USA): | FDA - 510(k)
Class 2 { K082478} | FDA - 510(k) Class
2 | FDA - 510(k) Class 2
{K103530} |
| Indications for Use | The CardioPerfect
Workstation software
and associated
accessories are
indicated for the
acquisition, analysis,
formatting, display,
printing and storage of
certain physiologic
signals, as identified
below, for the purpose
of assisting the
clinician in the
diagnosis and
monitoring of various
diseases and/or
treatment regimens.
The CardioPerfect
Workstation software
also provides non-
diagnostic functions
such as patient
management, data
security, search tools
for patient and/or test
records and support
for exporting data to
Electronic Medical | 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. | The Spirodoc Spirometer
and pulse oximeter is
intended to be used by
a physician or by a
patient under the
prescribed use of a
physician.
The device is intended to
test lung function and can
perform spirometry
testing in adult and
pediatric patients,
excluding infants and
neonates, and oximetry
readings in patients of all
ages. |

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| The CardioPerfect
Workstation and
associated accessories
are 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,
subject to any specific
contraindications

identified below.
Stress
Electrocardiograph -
Intended Use
Using the optional ECG
module and
associated accessories
the user can acquire,
view, store and print
ECG waveforms.
Resting
Electrocardiograph -
Intended Use
The same as defined
for stress ECG plus the
ability to use optional
algorithms (MEANS) to
generate
measurements, data
presentations,
graphical
presentations and
interpretive
statements on an
advisory basis. These
are presented for
review and
interpretation by the
clinician.
Spirometry - Intended
Use
Using the optional
spirometry module
and associated
accessories to acquire,
view, store and print
measures and
waveforms of
pulmonary function.
The spirometer should	only be used with
patients able to
understand the
instructions for
performing the test.
Ambulatory Blood
Pressure - Intended

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Use
Using the optional ABP
module and
associated accessories
the user can acquire,
retrieve, view, store
and print patient
ambulatory blood
pressure 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.