The Vitalograph Model 6600 COMPACT 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 adults and paediatrics, 5 years and older. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC or connected to compatible Vitalograph or third party devices to acquire, view, store and print the device output.

Device Description

Vitalograph Model 6600 Compact, running Vitalograph Model 7000 Spirotrac software, ref 510(k) K141546, shall provide a mains-powered desktop spirometer for creating, adding and recalling subjects and performing Spirometry testing on those subjects to aid in the measuring the effect of lung disease on pulmonary function. Model 6600 Compact will also, via the Spirotrac software, connect to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject. All connected compatible third party devices are those cleared via Model 7000 510(k) K141546. The intended use of the Compact is in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry. Its primary functions are: 1. Interaction will be via the touch Screen interface. 2. Running the Spirotrac software, as cleared in K141546, The model 6600 Compact performs spirometric measurements using the established fleisch Pneumotachograph, using single breath and multiple-breath testing techniques, to display and record lung volumes and flow rates (including FVC, FEV1, FEV6, PEF, MVV and VC) and their sub-divisions to aid in the measuring the effect of lung disease on pulmonary function 3. Record subject demographic data. 4. Produce printed reports to external printers.

AI/ML Overview

This document describes a 510(k) premarket notification for the Vitalograph Model 6600 Compact, a diagnostic spirometer. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy, as might be seen for AI/ML devices. Instead, the acceptance criteria for this spirometer are based on adherence to established international performance and safety standards, and equivalency to predicate devices.

Acceptance Criteria (Standards Adherence & Equivalency)	Reported Device Performance
Performance Standards: - 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) - ISO 23747 (Anaesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans) - EN13826:2003 (for PEF, now ISO 23747:2009) - EN ISO 26782:2009	"All tests and validations demonstrated satisfactory results." "The Model 6600 Compact successfully passed the performance requirements of these tests."
Safety Standards: - IEC / EN 60601 (inclusive of EN 60601-1-1 and EN 60601-1-2)	"Yes" (in comparison table) for Model 6600 and predicate Model 2120. "Yes, for connected compatible devices" for predicate Spirotrac Model 7000. (Implies Model 6600, using Spirotrac software, also meets this).
Mechanical Shock Testing: - Drop test of packaged device (specified height, all corners/edges) - Random Vibration, Sinusoidal Vibration, and Bump Tests - Storage conditions testing - Operating temperature limits testing	"All tests and validations demonstrated satisfactory results." "Evidence of successful completion of tests and validations has been provided with this submission."
Equivalence to Predicate Devices (Model 7000 Spirotrac, K141546 and Model 2120, K100687): - Identical user interface and software - Same indications for use (including pediatric population clarification) - Same operating principle and flow measurement principles - Same parameters calculation - Same method of use - Same performance (bench tested) - Same patient interface accessories - "No new issues of safety or effectiveness have been introduced"	The document asserts "The characteristics of the Model 6600 Compact are similar to those of the predicate devices listed." The detailed comparison table throughout pages 7-10 highlights these similarities.

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

The document refers to "performance testing against international standards" (ISO 26782, ATS/ERS 2005, ISO 23747) and "Mechanical shock testing". However, it does not specify the sample size (e.g., number of spirometry maneuvers, number of devices tested for mechanical shock) used for these tests.
The data provenance is internal testing performed by Vitalograph Ireland Ltd. It implies prospective testing conducted for regulatory submission, rather than retrospective analysis of patient data.

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

This information is not provided in the document. For a diagnostic spirometer, "ground truth" typically refers to accurately generated airflow and volume signals from a calibration syringe or a mechanical lung simulator, which are then compared to the device's measurements. The document mentions "bench tested against performance standards," suggesting such methods were used, but details on expert involvement in setting these "ground truths" or validating the testing methodology are absent.

4. Adjudication Method for the Test Set:

This information is not provided. Given that the testing involves adherence to objective performance standards for measuring physiological parameters (airflow, volume), typical "adjudication" in the sense of resolving discrepancies between human readers or algorithm outputs is not directly applicable. The device's measurements are compared against the known, controlled inputs from the test equipment.

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

A MRMC comparative effectiveness study is not applicable to this device. This is a standalone diagnostic spirometer, not an AI/ML-driven interpretive system that would assist human readers in, for example, image interpretation. The device's function is to objectively measure lung parameters, not to provide interpretations that human readers would then review or augment.

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

Yes, a standalone performance assessment was done. The entire submission focuses on the device's (Vitalograph Model 6600 Compact) ability to accurately measure respiratory parameters (FVC, FEV1, FEV6, PEF, MVV and VC) independently, against international performance standards described in point 1. The device itself performs the measurements; it's not described as having an AI algorithm requiring human interaction for its primary function.

7. The Type of Ground Truth Used:

The ground truth used for performance testing (bench testing) would have been precisely known, controlled flow and volume inputs generated by calibration equipment (e.g., a calibration syringe, flow generator, or mechanical lung simulator) that comply with the requirements of the mentioned ISO and ATS/ERS standards. This is an objective, physical ground truth.

8. The Sample Size for the Training Set:

This information is not applicable as the Vitalograph Model 6600 Compact is a hardware device based on established physical measurement principles (Fleisch Pneumotachograph) and software logic, not a machine learning or AI algorithm that typically requires a "training set." The software (Spirotrac Model 7000) was previously cleared (K141546), implying its development and validation occurred prior, but no training set for an AI model is mentioned for this device.

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

This information is not applicable for the same reason as point 8.

Summary

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

June 30, 2015

Vitalograph Ireland Ltd. Tom J. Healy Regulatory Affairs/OA Manager Gort Road Business Park Ennis, Co Clare Ireland

Re: K142642

Trade/Device Name: Vitalograph Model 6600 Compact Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: May 25, 2015 Received: May 27, 2015

Dear Mr. Healy:

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 - Tom J. Healy

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

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

Erin I. Keith, M.S. Division 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

510(k) Number (if known) K142642

Device Name

Vitalograph Model 6600 Compact

Indications for Use (Describe)

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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510K Summary

as required by 21 CFR 807.92

1. 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: 29th June 2015.
1. Device Trade Name: Vitalograph Model 6600 Compact
1. Common / Usual name: Diagnostic Spirometer, Vitalograph Compact Expert
1. Classification number:

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

7. Predicate Device:

Manufacturer	: Vitalograph
Device Name	: Model 7000 Spirotrac
510(k) No	: K141546, Class 2, Product Code BZG.

8. Description of Device:

Model 6600 Compact will also, via the Spirotrac software, connect to compatible third party devices to read and display the output from these devices to allow the

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information to be retained with the subject. All connected compatible third party devices are those cleared via Model 7000 510(k) K141546.

Compatible third party devices are:

Nonin iPod
. A&D Blood Pressure
Corscience BT12 ●
A&D weighing scales ●

The intended use of the Compact is in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry.

Its primary functions are:

1. Interaction will be via the touch Screen interface.
1. Running the Spirotrac software, as cleared in K141546, The model 6600 Compact performs spirometric measurements using the established fleisch Pneumotachograph, using single breath and multiple-breath testing techniques, to display and record lung volumes and flow rates (including FVC, FEV1, FEV6, PEF, MVV and VC) and their sub-divisions to aid in the measuring the effect of lung disease on pulmonary function
1. Record subject demographic data.
1. Produce printed reports to external printers.
1. Indications for Use:

The Vitalograph Model 6600 COMPACT 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 adults and paediatrics. 5 years and older. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC or connected to compatible Vitalograph or third party devices to acquire, view, store and print the device output.

1. Technological Characteristics
  The differences between the Model 6600 Compact and the predicate devices are the software which is being used as the primary interface with the user. This software was previously cleared, ref K141546. The profile and weight of the Model 6600 Compact also differs where the Model 6600 is larger.

These differences do not pose any risks to the intended use of the device. The Model 7000 Spirotrac software (K141546) to be used independently of a PC within a controlled environment with all of the functions of a PC still available.

For performance, the same flow measurement and operating principles are used on the predicate devices as are on the Vitalograph Model 6600 Compact device. The flow circuit will use the same exact circuit and transducer as used in the Vitalograph Model 2120 {ref K100687 }. While, a new industrial design has been created, this has the

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same touchscreen input mechanism, interface and functionality as was cleared for the Model 7000 Spirotrac, {ref K141546}.

The indications for use for the Vitalograph Pneumotrac now include pediatric population in line with the updated FDA guidance. The Model 6600 has the same indications for use, including pediatric population, as the Model 7000 as cleared under K141546. No new testing was required for this revised indication for use. No new risks have been introduced as a result of pediatric population inclusion. The device complies with the existing international performance standards to cater for all population groups.

Materials used continue to be those materials that have been previously used and do not introduce any new risks in relation to safety and effectiveness.

In relation to Patient interface accessories the Model 6600 will use the established Model 2820 and Model 2020 mouthpieces which have their own previous clearances and active device listings. See comparison table below.

The characteristics of the Model 6600 Compact are similar to those of the predicate devices listed in comparison table below. The similarities are

Identical user interface, and software, as cleared via model 7000 Spirotrac, ref . 510(k) K141546.
Same indications for use (Clarification of pediatric population and parameters ● measured)
Some operating principle and flow measurement principles.
Same parameters calculation.
Same method of use ●
Same performance when bench tested against performance standards. ●
Same patient interface accessories ●

Risks have been evaluated and the performance has been validated. This validation is on file for all devices.

	Compact Model6600	K141546Spirotrac Model7000 {predicate}	K100687 Model2120 {predicate}
Spirometry -acquire, view,store and printmeasures andwaveforms ofpulmonaryfunction	Yes	Yes	Yes
ECG waveforms -view, store, print	Yes	Yes	No
ECG waveforms -acquire	Yes, Fromcompatible device.	Yes, Fromcompatible device.	No
ECG waveform-view, store, print	Yes	Yes	No
ECGInterpretation viaalgorithms	Yes	Yes	No
Ambulatory BloodPressure -retrieve, view,store and printpatientambulatory bloodpressure history	Yes, from compatibledevice.	Yes, fromcompatible device.	No
Spot Oximetrydownload, view.	Yes, Fromcompatible device.	Yes, Fromcompatible device.	No
Weight(measurement)	Manual entry ordownload viaconnection tocompatible device	Manual entry ordownload viaconnection tocompatible device	No
MicrosoftwindowsOperatingSystemsSupported:	Yes	Yes	No
Database:	MS SQL Server	MS SQL Server	MS SQL whendownloaded toSpirotrac {K100687& K141546}
Where used	Hospital, Healthcentre, primarycare practices and clinics	Hospital, Healthcentre, primary carepractices and clinics	Hospital wards,health centres andhomes
Networkedoperation	Yes	Yes	No
SubjectManagement:DemographicEntry,Maintenance andDeletion	Yes	Yes	Yes
Report Printing	Yes	Yes	Yes
Spirometrytesting	Yes	Yes	Yes
Trending Graphsfor SpirometryResults	Yes	Yes	Yes, whendownloaded toSpirotrac {K100687& K141546}
SpirometryPredicted ValueEquations	Yes	Yes	Yes

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Population Group Management
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, when downloaded to Spirotrac {K100687 & K141546}
Database Management	Yes	Yes	Yes, when downloaded to Spirotrac {K100687 & K141546}
Colour Display	Yes	Yes	No
Target Population	Adult & Paediatric	Adult & Paediatric	Adult, Paediatric
Communication	Bluetooth, USB,	Bluetooth, USB,	USB, Micro SD card
Storage	Dependent on storage media	Dependent on storage media	Non-volatile data storage
Sterile	No	No	No
Regulatory (USA):	FDA - 510(k) Class 2	FDA - 510(k) Class 2. K141546	FDA - 510(k) Class 2 K100687
Performance standards	ATS/ERS 2005ISO 26782,ISO 23747,	ATS/ERS 2005ISO 26782,ISO 23747,	ATS/ERS 2005ISO 26782,ISO 23747,
Safety Standards IEC / EN 60601 {EN 60601-1-1 and EN 60601-1-2}	Yes	Yes, for connected compatible devices	Yes
Performance Standards {incl bench tests}:	ATS ERS 2005, ISO 23747:2009 for PEF {formerly EN13826:2003}. EN ISO 26782:2009	ATS ERS 2005, ISO 23747:2009 for PEF {formerly EN13826:2003}. EN ISO 26782:2009	ATS ERS 2005, ISO 23747:2009 for PEF {formerly EN13826:2003}. EN ISO 26782:2009
	Drop test.Vibration testingBump Tests.		Drop test.

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	Operatingtemperature		Operatingtemperature
Device materials	ABS plastic Body,Silicone Rubber,Stainless Steel,Aluminium, TPXplastic	N/A. Software	ABS plastic Body,Silicone Rubber,Stainless Steel,Aluminium, TPXplastic
Device weight	2.5KG	N/A. Software	0.230Kg
Dimensions	375235110mm	N/A. Software	160x100x45mm
Patient interfaceaccessories	Model 2820 BVFMouthpiece,Singe; patient use.510(k) K942779.Product Code BZG	Dependent onconnectingcompatible thirdparty device.	Model 2820 BVFMouthpiece,Singe; patient use.510(k) K942779.Product Code BZGModel 2020SafeTwayMouthpiece.Singe; patient use{Class 1, 510(k)exempt, with anactive device listing.Device listing:D141382. ProductCode BYP,Vitalograph NoseClip, Singe; patientuse {Class 1, 510(k)exempt, with anactive device listing.Device listingD130170. ProductCode BXJ
Product Code,Class, CFR	BZG, Class 2,868.1840	BZG, Class 2,868.1840	BZG, Class 2,868.1840
Indications forUse	The VitalographModel 6600COMPACT isintended for use byor on the order of aphysician in ahospital or clinicsetting. The productis designed for useon adults andpaediatrics, 5 yearsand older. Thedevice is intended tobe used as a	The VitalographModel 7000Spirotrac isintended for useby or on the orderof a physician in ahospital or clinicsetting. Theproduct isdesigned for useon both adult andpediatric patients.The device is a PCbased software	The device is abattery operatedspirometer whichmeasures threebasic patientrespiratoryparameters {FVC,MVV and VC}. Themodel 2120 is ahand heldspirometerdesigned for lungfunction testing in avariety of

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	spirometer whichmeasures patientrespiratoryparameters includingFVC, FEV1, FEV6,PEF, MVV and VC orconnected tocompatibleVitalograph or thirdparty devices toacquire, view, storeand print the deviceoutput.	application whichis intended to beused as aspirometer orconnect tocompatibleVitalograph orthird party devicesto acquire, view,store and print thedevice output.	environments suchas hospital wards,health centres andprivate homes. Themodel 2120 can beconfigured as astand-alonespirometer orconnected to aprinter.
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The Vitalograph Model 6600 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}.

Mechanical shock testing was also performed to evaluate the effects on the device during transport.

These tests included:

Drop test of the packaged device from a specified height onto all corners and edges.
Random Vibration, sinusoidal Vibration, and Bump Tests. ●
Storage conditions testing. ●
Operating temperature limits testing. ●

All tests and validations demonstrated satisfactory results.

As with the predicate device the Model 6600 Compact successfully passed the performance requirements of these tests. Evidence of successful completion of tests and validations has been provided with this submission.

11. Conclusion:

The characteristics of the Model 6600 Compact 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).