The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Vitalograph Pneumotrac is a desktop spirometer designed for lung function testing for use on adults and pediatrics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healthcare provider.

Device Description

The intended use of the Vitalograph Pneumotrac desktop spirometer, which connects to Vitalograph Model 7000 Spirotrac software, ref 510(k) K141546, shall provide a USB-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. Spirometry is in the simple assessment of respiratory function through the measurement of dynamic lung volumes. Its primary functions are; 1. Standalone spirometric measures using single breath or multiple-breath testing techniques, display and record lung volumes and flow rates (including FVC, MVV, VC) and it's subdivisions, Display a single subject's demographic data entered by the user. 2. Produce reports In a clinical setting, the measurements obtained from a lung function test form part of the various findings of a physician in the detection, diagnosis and monitoring of chest diseases.

AI/ML Overview

The Vitalograph Model 6800 Pneumotrac is a diagnostic spirometer. The device was studied through validation bench testing against several international standards to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance:

Parameter	Acceptance Criteria	Reported Device Performance
Volume Range	0-10 Liters (Predicate)	0-10 Liters
Max Flow Range	0-16 Liters/second (Predicate)	0-16 Liters/second
Back Pressure	<= 0.1 kPa/L/s (Predicate)	< 0.1 kPa/L/s
Accuracy FEV1	+/- 3% (Predicate)	+/- 3%
Accuracy FEV6	+/- 3% (Predicate)	+/- 3%
Accuracy PEF	+/- 5% (Predicate)	+/- 5%
Operating Temp	10-40°C (At least 17-37°C required per ATS 2005)	10-40°C (At least 17-37°C required per ATS 2005)
Storage Temp	0-50°C (Predicate)	0-50°C
Humidity	10-95% relative humidity (Predicate)	10-95% relative humidity
Performance Standards	ATS ERS 2005, ISO 23747:2009 for PEF, EN ISO 26782:2009, ISO 10993-1 Fourth Edition	ATS ERS 2005, ISO 23747:2009 for PEF, EN ISO 26782:2009, ISO 10993-1 Fourth Edition
Compliance	IEC / EN 60601 (EN 60601-1-1 and EN 60601-1-2)	IEC / EN 60601 (EN 60601-1-1 and EN 60601-1-2)
Biocompatibility	All materials previously cleared	All materials previously cleared in K100687 & K925085
Connectivity/Communication	Validation with Vitalograph Model 7000 Spirotrac software to maintain integrity and successful download/storage	Validation with Model 7000 Spirotrac (K141546) performed and deemed satisfactory

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample size of a "test set" for data provenance in terms of patient data. The study primarily involved validation bench testing against international performance standards. This implies controlled laboratory testing rather than a clinical study with patient data. Therefore, the data provenance would be from laboratory experiments rather than patient data from a specific country or collected retrospectively/prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the described study is a series of bench tests against engineering standards, not a study involving human interpretation of data where "ground truth" would be established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable as the study did not involve expert adjudication of results. The performance was assessed against predefined numerical and technical standards.

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:

This is not applicable. The device is a spirometer, which measures physiological parameters. It is not an AI-assisted diagnostic tool that would be evaluated in a MRMC study involving human readers and AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is a measurement instrument. The "standalone" performance was assessed through bench testing against international standards (ISO, ATS/ERS). This is the functional equivalent of standalone performance for such a device, ensuring its accuracy and precision in measuring respiratory parameters independent of human interpretation during the measurement process.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the bench tests, the "ground truth" was established by the international performance standards themselves (e.g., ISO 26782, ATS/ERS 2005, ISO 23747) which define acceptable ranges and accuracy for spirometry measurements. These standards are developed through scientific consensus and extensive validation.

8. The sample size for the training set:

This is not applicable as the device is not an AI/machine learning algorithm requiring a training set in the conventional sense. Its functionality is based on established physiological measurement principles.

9. How the ground truth for the training set was established:

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

Summary

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

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

June 29, 2015

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

Re: K142812

Trade/Device Name: Vitalograph Model 6800 Pneumotrac Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic spirometer Regulatory Class: II Product Code: BZG Dated: May 27, 2015 Received: May 29, 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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 vours.

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

Enclosure

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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) K142812

Device Name

Vitalograph Model 6800 Pneumotrac

Indications for Use (Describe)

The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, MVV and VC. The Vitalograph Pneumotrac is a desktop spirometer designed for luse on adults and pediatics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healtheare provider.

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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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"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

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: 19th June 2015.
1. Device Trade Name: Vitalograph Model 6800 Pneumotrac
1. Common / Usual name: Vitalograph Pneumotrac,
1. Classification number:

Classified per 21 CFR 868.1840. Part 868 - Anesthesiology Devices, Subpart B--Diagnostic Devices Class 2 Diagnostic Spirometer Product Code BZG.

1. Predicate Device:

Manufacturer	:	Vitalograph
Device Name	:	Model 2120
510(k) No	:	K100687, Class 2, Product Code BZG.

8. Description of Device:

Spirometry is in the simple assessment of respiratory function through the measurement of dynamic lung volumes.

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Its primary functions are;

1. Standalone spirometric measures using single breath or multiple-breath testing techniques, display and record lung volumes and flow rates (including FVC, MVV, VC) and it's subdivisions,
Display a single subject's demographic data entered by the user. 2.
ന്ന് Produce reports

In a clinical setting, the measurements obtained from a lung function test form part of the various findings of a physician in the detection, diagnosis and monitoring of chest diseases.

9. Indications for Use:

10. Technological Characteristics

The characteristics of the Pneumotrac are similar to those of the predicate device listed in comparison table below. The similarities are:

· Identical operating principle
Identical spirometry parameters measured
Both the subject and predicate devices comply with international performance standards including electrical safety {IEC 60601-1}, EMC {IEC 60601-1-2} and performance bench tests {ISO 23747, ISO 26782, ATS/ERS}
Sharing of Identical patient interface accessories

The primary differences between the Vitalograph Model 6800 and the predicate devices is that the predicate operates as a portable spirometer and the Model 6800 is a desktop spirometer.

The indications for use for the Vitalograph Pneumotrac now include pediatric population in line with the updated FDA guidance. The Model 6800 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.

All of the device materials were previously cleared in the predicate (K100687) and create no new risk profiles. The Model 7000 Spirotrac which connects to the Pneumotrac device was previously cleared. Materials used in the Vitalograph 6800 Pneumotrac are identical to those used in previously cleared devices. Thus separate biocompatibility testing was not performed for the subject device.

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Risks have been evaluated and the connectivity / communication by model 6800 Pneumotrac has been validated with the Vitalograph Model 7000 Spirotrac software. This validation is on file.

The operating principle, measuring range, application and use are unchanged. Packaging and labelling has been updated to conform to current regulatory requirements but otherwise remains substantially unchanged. Precautions, warnings, contra-indications and software functionality remain unchanged.

Parameter	Vitalograph model 6800Pneumotrac	Predicate Device – VitalographModel 2120 (K100687)
Volume Range	0-10 Liters	0-10Litres
Max Flow Range	0-16 Liters / second	0-16 Liters / second
Back Pressure	Less than 0.1kPa/L/s	0.1kPa/L/s
Accuracy FEV1	+/- 3%	+/- 3%
Accuracy FEV6	+/- 3%	+/- 3%
Accuracy PEF	+/-5%	+/-5%
Calibration	Using calibration syringe	Using calibration syringe
Technology	FleischPneumotachograph	Fleisch Pneumotachograph
Set Predicted /reference values	Yes	Yes
Memory Type /Storage:	Uses Spirotrac database.{K141546}	On-board or connection toSpirotrac database {K141546}
Sounds	Audible beeps emittedwhilst performing a test,for incentives.	Audible beeps emitted whilstperforming a test, for incentives.
Communication	USB	USB
Download to P.C	Yes. Downloads toSpirotrac {K141546}	Yes. Downloads to Spirotrac{K141546}
To be serviced	Yes, Has Service Manual.	Yes. Has Service Manual.
Connection toexternal printer	Yes, via Spirotrac{K141546}	Yes. Direct or via Spirotrac{{K141546}}
Internal printer	No	No
Battery Type	USB Power	USB Power and 3.7V Li-ion
power		Battery.
Dimensions	183x105x70mm	160x100x45mm
Weight	0.45Kg	0.23Kg
Material Type	ABS plastic Body, SiliconeRubber, Stainless Steel,Aluminum, TPX plastic	ABS plastic Body (identical),Silicone Rubber(identical),Stainless Steel(identical),
Biocompatibility	No new testing required.All materials previouslycleared in K100687 &K925085.
Operating Temp:	10-40°C.{At least 17-37°C requiredper ATS 2005}	10 to 40°C{At least 17-37°C required perATS 2005}
Storage Temp	0 - 50 °C	0 - 50°C
Humidity	10 - 95% relativehumidity	10 - 95% relative humidity
PerformanceStandards{bench tests}	ATS ERS 2005, ISO23747:2009 for PEF{formerly EN13826:2003}.EN ISO 26782:2009ISO 10993-1 FourthEdition	ATS ERS 2005, ISO 23747:2009for PEF {formerlyEN13826:2003}. EN ISO26782:2009ISO 10993-1 Fourth Edition
Compliance:	IEC / EN 60601 {EN60601-1-1 and EN 60601-1-2}	IEC / EN 60601 {EN 60601-1-1and EN 60601-1-2}
Interface withuser	Spirotrac {K141546}	On-board Button Keypad /touchscreen display or viaSpirotrac {{K141546}}
Regulatory	FDA - 510(k)CE {0086} Class 2a	FDA - 510(k)CE {0086} Class 2a
Product Code,Class, CFR	BZG, Class 2, 868.1840	BZG, Class 2, 868.1840
Warranty	1 Year	1 Year
Patient interfaceaccessories	Model 2820 BVFMouthpiece (K942779){Class 2 with an activedevice listing}.	Model 2820 BVF Mouthpiece(K942779) {Class 2 with an activedevice listing}.Model 2020 SafeTwayMouthpiece {Class 1 with anactive device listing}.
Indications forUse	The device is aspirometer whichmeasures patientrespiratory parametersincluding FVC, FEV1,FEV6, PEF, MVV andVC. The VitalographPneumotrac is adesktop spirometerdesigned for lungfunction testing foruse on adults andpediatrics, 5 years andolder, in a variety ofenvironments such ashospital wards, healthcenters and privatehomes under thesupervision of ahealthcare provider.	The device is a battery operatedspirometer which measuresthree basic patient respiratoryparameters {FVC, MVV and VC}.The model 2120 is a hand heldspirometer designed for lungfunction testing in a variety ofenvironments such as hospitalwards, health centers andprivate homes. The model 2120can be configured as a stand-alone spirometer or connectedto a printer.

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The Vitalograph Model 6800 Spirotrac underwent validation bench testing to ensure performance according to its specifications against current standards. These tests included performance testing against international standards such as

ISO 26782{Anesthetic and respiratory equipment -- Spirometers intended ● for the measurement of time forced expired volumes in humans},
ATS/ERS 2005 {ATS/ERS Task Force: Standardization of Lung Function Testing} and
. ISO 23747 {Anesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans}.
IEC 60601-1 ●

Biocompatibility was reviewed during the risk management process. Separate biocompatibility testing was not carried out as all materials we previously cleared in earlier submissions including K100687 and K925085.

Validation of the interfaces with model 7000 Spirotrac {K141546} was performed to ensure that the integrity of the information is maintained and that the information 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:

Based on the above, including the successful completion of all device testing Vitalograph conclude that Vitalograph model 6800 Pneumotrac 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).