The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Vitalograph micro is a handheld spirometer designed for lung function 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

Vitalograph Model 6300 micro is a handheld portable spirometer for performing Spirometry testing to aid in measuring the effect of lung disease on pulmonary function. The device may be used in hospital, healthcare facilities and homes under the supervision of a healthcare provider.

The intended use of the 6300 micro is in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry.

The proposed device consists of a main body which incorporates an LCD, a touch panel, pressure transducer and flow circuitry as well as a detachable flow head. The device is used with a pulmonary function filter. Reports may be printed using the USB cable provided.

Principles of Operation: The Vitalograph micro measures a subject's lung ventilation by using a flowhead containing a Fleisch Pneumotachograph capable of giving linear signals throughout the entire physiological range. During testing, the airflow through the flowhead produces a pressure differential. Internally this pressure is applied to a pressure transducer, which produces an electric signal. This signal is converted into digital form so that the unit can perform calculations and display the results.

Primary functions are:

Interaction will be via the touch screen interface.
The model 6300 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
Record subject demographic data.
Produce printed reports to external printers.

AI/ML Overview

The provided text describes the Vitalograph Model 6300 micro, a diagnostic spirometer, and its substantial equivalence to predicate devices, rather than a clinical study establishing AI performance. Therefore, many of the requested elements for AI/ML device studies, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable.

However, I can extract information related to the acceptance criteria (performance standards) and the study that proves the device meets these criteria in the context of this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Vitalograph Model 6300 micro are primarily based on international performance standards for spirometers. The reported device performance indicates successful compliance with these standards.

Acceptance Criteria (Standards Met)	Reported Device Performance
Performance Standards:
ISO 26782: Spirometers for measurement of time forced expired volumes in humans	Successfully passed
ATS/ERS 2005: Standardisation of Lung Function Testing	Successfully passed
ISO 23747: Peak expiratory flow meters for assessment of pulmonary function	Successfully passed
IEC/EN 60601 (EN 60601-1-1 and EN 60601-1-2)	Successfully passed

Mechanical/Environmental Standards:
Drop test of packaged device from specified height	Satisfactory results
Storage conditions testing	Satisfactory results
Operating temperature limits testing	Satisfactory results
Cleaning method validation	Satisfactory results

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

This is a non-clinical, bench testing study. Therefore, there is no "sample size" in the context of patient data. The testing involves the device itself undergoing various physical and performance evaluations against established standards. The data provenance is from non-clinical testing conducted by the manufacturer, Vitalograph Ireland Ltd., in Ireland.

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

Not applicable for this type of non-clinical device testing. Ground truth is established by the international performance standards themselves, which are developed by expert consensus within their respective standardization bodies. The tests evaluate the device's adherence to these predefined criteria.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements against specified performance limits outlined in the standards. There is no human adjudication in the sense of reviewing results to establish ground truth for individual cases.

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

Not applicable. This is not an AI/ML device, nor is it a comparative effectiveness study involving human readers.

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

Not applicable. This is a standalone medical device (spirometer) designed for direct measurement, not an algorithm. Its performance is measured as a standalone instrument.

7. The type of ground truth used

The ground truth for this device's performance claims is defined by the international and national performance standards (e.g., ISO 26782, ATS/ERS 2005, ISO 23747, IEC/EN 60601). The device's measurements are compared against the specifications and tolerances outlined in these standards.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a traditional medical device, not an AI/ML algorithm.

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

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

August 26, 2016

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

Re: K160253

Trade/Device Name: Vitalograph Model 6300 micro Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic spirometer Regulatory Class: II Product Code: BZG Dated: July 25, 2016 Received: July 27, 2016

Dear Mr. Tom J. 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.

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

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Page 2 - Tom J. Healy

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 yours.

Tejashri Purohit-Sheth, M.D.

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

Tina Kiang, Ph.D. Acting 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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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) K160253

Device Name Vitalograph Model 6300 micro

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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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

1. Company Information: Contact Person / Official Correspondent: Mr. Tom J Healy Regulatory Affairs / Quality Assurance Manager
  Name: Vitalograph (Ireland) Ltd Address: Gort Road Business Park, Ennis, Co Clare, Ireland.

Tel: +353656864100 Fax: +353656829289.

Date prepared: 15th January 2016.

1. Common / Usual name (s):
  Vitalograph Model 6300 micro

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

1. Predicate Device:
  Manufacturer : Vitalograph Device Name : Model 2120 : K100687, Class 2, Product Code BZG. 510(k) No Classified per 21 CFR 868.1840

Manufacturer	Vitalograph
Device Name	Model 6800 Pneumotrac
510(k) No	K142812, Class 2, Product Code BZG.Classified per 21 CFR 868.1840

1. Description of Device:
  Vitalograph Model 6300 micro is a handheld portable spirometer for performing Spirometry testing to aid in measuring the effect of lung disease on pulmonary function. The device may be used in hospital, healthcare facilities and homes under the supervision of a healthcare provider.

The intended use of the 6300 micro is in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry.

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Primary functions are:

Interaction will be via the touch screen interface. .
. The model 6300 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
Record subject demographic data.
Produce printed reports to external printers. ●
1. Indications for Use:

The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Vitalograph micro is a handheld 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.

1. Technological Characteristics

Differences:

The differences between the Model 6300 device and the predicate Model 2120, K100687 revolve around the Model 6300 has a touchscreen for navigation only while the predicate device Model 2120 is used with touchscreen or button navigation. The profile and weight of the devices are also similar as outlined below where the model 6300 is lighter and dimensionally smaller. The model 6300 employs a colour display and has USB and Bluetooth options where the model 2120 allowed USB and SD card. For power the model 6300 uses USB power or replaceable batteries where the predicates, model 2120 is rechargeable and the model 6800 uses USB power only.

Similarities:

The proposed device uses scientific concepts, operating principles and materials already cleared in the predicate devices submissions. As such the differences outlined are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and do not affect the safety and effectiveness of the device when used as labelled.

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For performance, the same flow measurement and operating principles are used on the predicate devices and the Vitalograph Model 6300 device.

The flow circuit in the model 6300 is identical to the circuit and transducer as the Vitalograph Model 2120 {ref K100687} and has the same touchscreen input mechanism, interface and functionality as cleared model 2120.

The indications for use for the Vitalograph 6300 micro now include pediatric population in line with the updated FDA guidance. The Model 6300 has the same indications for use, including pediatric population, as the Model 6800 as cleared under K142812. No new testing was required for this revised indication for use. The proposed device complies with the existing international performance standards to cater for all population groups. The micro device includes new parameters in the indications for use.

Materials used have been previously cleared in the predicate. No new biocompatibility testing was required to use these materials.

In relation to Patient interface accessories the Model 6300 will use the previously cleared Model 2820 mouthpieces and Nose clips which have their active device listings.

The characteristics of the Model 6300 are similar to those of the predicate devices listed in comparison table below. The similarities are

Non-sterile device, components and accessories. ●
Touchscreen user interface, ●
Same indications for use ●
Same 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.
. Same cleaning method.

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

Clinical testing was not carried out on the 6300 micro. The Vitalograph Model 6300 underwent non-clinical 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

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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.
Storage conditions testing.
Operating temperature limits testing. ●
. Cleaning method validation was completed.

All tests and validations demonstrated satisfactory results. The Model 6300 Micro successfully passed the performance requirements of these tests and compliance to the requirements of the standards was achieved.

As such, the model 6300 performance is substantially equivalent to the legally marketed predicate devices.

Evidence of successful completion of tests and validations has been provided with this submission.

	Micro 6300	K100687 Model2120 {predicate}	Vitalograph model6800 PneumotracK142812.
Spirometry -acquire, view,store and printmeasurementsand waveforms ofpulmonaryfunction	Yes	Yes	Yes
Environment ofCare	Hospital wards,health centres andhomes	Hospital wards,health centres andhomes	Hospital wards,health centres andhomes
Volume Range:	0-10 Litres	0-10 Litres	0-10 Litres
Report Printing(via VitalographReports)	Yes	Yes	Yes, via Spirotrac{K141546}
Spirometrytesting	Yes	Yes	Yes
Colour Display	Yes	Yes	Yes, via Spirotrac{K141546}
Interface	Touchpanel (plusOn/Off button)	Touchpanel &Buttons	On/Off switch.Power button.Navigation viaSpirotrac (K141546)
Target Population	Adult & Pediatric(5yrs and over)	Adult, Pediatric	Adult & Pediatric(5yrs and over)
Communication	USB, Bluetooth	USB, Micro SD card	USB
Storage	Non-volatile datastorage	Non-volatile datastorage	via Spirotrac{K141546}
Sterile device orcomponents	No	No	No
Regulatory (USA):	FDA - 510(k) Class 2	FDA - 510(k) Class 2K100687	FDA - 510(k) Class 2K142812
Device weight	0.250Kg	0.230Kg	0.450Kg
Dimensions	83 x 91x 32 mm	160x100x45mm	183x105x70mm
Power	5V USB /6V AAAAlkaline Batteries	3V AAA AlkalineBatteries	5V USB
Operating Temp:	10-40°C.{At least 17-37°Crequired per ATS2005}	10 to 40°C{At least 17-37°Crequired per ATS2005}	10 to 40°C{At least 17-37°Crequired per ATS2005}
Storage Temp:	0 - 50 °C	0 - 50 °C	0 - 50°C
Humidity:	10 - 95% relativehumidity	10 - 95% relativehumidity	10 - 95% relativehumidity
Non-ClinicalTesting toPerformanceStandards{incl bench tests}:	ATS ERS 2005, ISO23747:2009 for PEF.EN ISO 26782:2009IEC / EN 60601 {EN60601-1-1 and EN60601-1-2}	ATS ERS 2005, ISO23747:2009 for PEF.EN ISO 26782:2009IEC / EN 60601 {EN60601-1-1 and EN60601-1-2}	ATS ERS 2005, ISO23747:2009 for PEF.EN ISO 26782:2009IEC / EN 60601 {EN60601-1-1 and EN60601-1-2}
	Drop tests.Storage conditions.OperatingtemperatureCleaning validation	Drop tests.Storage conditions.Operatingtemperature	Drop tests.Storage conditions.Operatingtemperature.Cleaning validation
Device materials	ABS plastic Body,Silicone Rubber,Stainless Steel,Aluminium,	ABS plastic Body,Silicone Rubber,Stainless Steel,Aluminium,	ABS plastic Body,Silicone Rubber,Stainless Steel,Aluminium, TPXplastic
Biocompatibility	No new testingrequired. Allmaterials previouslycleared in K100687(same duration ofexposure and usage)	No new testingrequired. No newtesting required. Allmaterials previouslycleared in K073155(same duration ofexposure and usage)	No new testingrequired. Allmaterials previouslycleared in K100687 &K925085.
Patient interfaceaccessories	Model 2820 BVFMouthpiece,Single; patient use.	Model 2820 BVFMouthpiece,Single; patient use.	Model 2820 BVFMouthpiece(K942779) {Class 2
	510(k) K942779.Product Code BZG	510(k) K942779.Product Code BZG	with an active devicelisting}.
Patient interfaceaccessoriescontacting the gaspathway	Vitalograph NoseClip, Single; patientuse {Class 1, 510(k)exempt, with anactive device listing.Device listingD130170. ProductCode BXJ. Previouslycleared in K100687,	Model 2020SafeTwayMouthpiece.Single; patient use{Class 1, 510(k)exempt, with anactive device listing.Device listing:D141382. ProductCode BYP,Vitalograph NoseClip, Single; patientuse {Class 1, 510(k)exempt, with anactive device listing.Device listingD130170. ProductCode BXJ	Model 2820 BVFMouthpiece,Single; patient use.510(k) K942779.Product Code BZG
FDA ProductCode,Device Class,21 CFR section	BZG,Class 2,868.1840	BZG,Class 2,868.1840	BZG,Class 2,868.1840
Indications forUse	The device is aspirometer whichmeasures patientrespiratoryparameters includingFVC, FEV1, FEV6,PEF, MVV and VC.The Vitalographmicro is a handheldspirometer designedfor lung functiontesting for use onadults andpediatrics, 5 yearsand older, in avariety ofenvironments suchas hospital wards,health centers andprivate homes under	The device is abattery operatedspirometer whichmeasures patientrespiratoryparameters. Themodel 2120 is a handheld spirometerdesigned for lungfunctiontesting in a variety ofenvironments suchas hospital wards,health centres andprivate homes. Themodel 2120 can beconfigured as astand-alonespirometer or	The device is aspirometer whichmeasures patientrespiratoryparameters includingFVC, FEV1, FEV6,PEF, MVV and VC.TheVitalographPneumotrac is adesktop spirometerdesigned for lungfunction testing foruse on adults andpediatrics, 5 yearsand older,in a variety ofenvironments suchas hospital wards,health centers and
	the supervision of ahealthcare provider.	connected to aprinter.	private homes underthe supervision of ahealthcare provider.

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11. Conclusion:

The characteristics of the Model 6300 Micro 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 substantially equivalent to 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).