The Vyntus ONE / SentrySuite product line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardio-pulmonary (CPET) parameters, aiding in the diagnosis of related conditions. The results of the test can be viewed online with the help of a computer screen and can be printed after the test results can be saved for future reference or report generation purposes.

The products can be utilized with patients aged 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists.

Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities).

A qualified physician has to reassess all Vyntus / SentrySuite measurements. An interpretation by Vyntus ONE / SentrySuite is only significant if it is considered in connection with other clinical findings. Additional for Vyntus ECG:

The Vyntus ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on the screen or printed on paper. 12-lead ECGs are analyzed automatically and suggestions for the interpretation of the resting ECG can be made by the software.

ECG interpretation statements made by the Vyntus / SentrySuite represent partial qualitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.

The Vyntus ECG can be used for non-interpretive applications in patients age 4 years and older and a weight of 20 kg or higher. The Vyntus ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor's office or hospital). The Vyntus ECG is not intended for intracranial use. The Vyntus ECG is not intended for use in an EMS environment (Emergency Medical Services Environment). The Vyntus ECG is not intended for use in home healthcare environments. Automatic interpretation of the ECG is not possible for pediatric and adolescent patients below 16 years of age and for patients with pacemakers.

Device Description

The Vyntus ONE is a full pulmonary function test (PFT) system, consisting of a main unit with the gas analyzers and electronics inside, a patient interface with a Flow Path Valve eDemand and an electronic demand valve inside and an ultrasound flow sensor (USS). The entire equipment is mounted on a cart which includes the isolation transformer and the support arm for the patient interface and the USS.

The Vyntus ONE is connected via USB interface to the desktop PC and enables the following standard measurements:

Diffusion SB Realtime
Diffusion SB Intra-breath
FRC N2 washout
Slow/forced spirometry and MVV

The Vyntus ONE also supports cardiopulmonary exercise testing (CPET). The specific hardware consists of the light-weight digital volume transducer (DVT) and an optional SpO2 pulse oximeter. It enables the following standard measurement features:

Breath-by-breath (BxB) gas exchange
Workload control for bicycle ergometer or treadmills
Automatic workload protocols

Further optional hardware and software include:

Vyntus ECG: 12-lead Electrocardiogram (ECG) recording (resting and stress ECG)
ROcc, P0.1, MIP / MEP measurements

AI/ML Overview

The Vyntus ONE device, a full pulmonary function test (PFT) system, was evaluated through non-clinical tests to determine its substantial equivalence to predicate devices. No clinical tests were performed.

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Standard/Test	Acceptance Criteria	Reported Device Performance
Risk Management	ISO 14971	Pass applicable tests and standards	The proposed device passes the applicable tests and standards
Usability	EN 62366 (IEC 60601-1-6 and related IEC 62366)	Pass applicable tests and standards; Usability Engineering File & Usability report	The proposed device passes the applicable tests and standards
Software Life Cycle	ISO 62304	Pass applicable tests and standards	The proposed device passes the applicable tests and standards
Basic Safety	IEC 60601-1	Pass applicable tests and standards	The proposed device passes the applicable tests and standards
EMC Compatibility	IEC 60601-2	Pass applicable tests and standards	The proposed device passes the applicable tests and standards
Biocompatibility	ISO 10993	Pass applicable tests and standards	The proposed device passes the applicable tests and standards
Accuracy Testing	Measurement effectiveness & accuracy	Pass applicable tests and standards	The proposed device passes the applicable tests and standards
Climatic Chamber Test	Environmental testing according specifications (Temperature: +10° to 34°C, Relative humidity: 20 to 80%, Barometric pressure: 700 to 1060 hPa)	Pass applicable tests and standards	The proposed device passes the applicable tests and standards
ATS / ERS	Standard for lung function testing	Fulfill ATS/ERS standard	The proposed device passes the applicable tests and standards
Flow Accuracy (exh.)	Ultrasonic Flow Sensor	0 to 14 L/S: 1.5% or 0.05 L/S (whichever is greater)	Actual performance met or exceeded this, as the new device is stated to be "more accurate in flow and volume".
Flow Accuracy (inh.)	Ultrasonic Flow Sensor	0 to 14 L/S: 2.5% or 0.05 L/S (whichever is greater)	Actual performance met or exceeded this, as the new device is stated to be "more accurate in flow and volume".
Flow Range	Ultrasonic Flow Sensor	0 to 18 L/S bidirectional	The document states the new technology improved the maximum ranges slightly. "insignificant difference as the ranges are higher than a patient can breathe."
Flow Resolution	Ultrasonic Flow Sensor	1ml/s	Actual performance met or exceeded this, as the new device is stated to have a "higher flow resolution."
Volume Accuracy (exh.)	Ultrasonic Flow Sensor	0 to 14L: 1.5% or 0.05L (whichever is greater)	Actual performance met or exceeded this, as the new device is stated to be "more accurate in flow and volume".
Volume Accuracy (inh.)	Ultrasonic Flow Sensor	0 to 14L: 2.5% or 0.05L (whichever is greater)	Actual performance met or exceeded this, as the new device is stated to be "more accurate in flow and volume".
Volume Range	Ultrasonic Flow Sensor	+/- 30 L (software limited)	The document states the new technology improved the maximum ranges slightly. "insignificant difference as the ranges are higher than a patient can breathe."
Volume Resolution	Ultrasonic Flow Sensor	1ml	Actual performance met or exceeded this, as the new device is stated to have a "higher flow resolution."
Patient Interface Material	Biocompatibility (ISO 10993)	Tested completely according to ISO 10993	New FPV (Flow Path Valve) uses new material tested for Cytotoxiticity, sensitization, irritation, intracutaneous reactivity, acute systemic toxicity, material mediated pyrogenicity, and Chemical Characterization (Exaggerated Extraction FTIR HPLC-MS / UPLC-MS GC-MS Headspace GC-MS ICP-MS ICP-OES).

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

The document does not explicitly state the numerical sample size for the test set used in the non-clinical studies. However, the study involved various technical tests (risk management, usability, software life cycle, basic safety, EMC, biocompatibility, accuracy, climatic, and ATS/ERS standards).
The data provenance is not explicitly stated as retrospective or prospective, but given the nature of the testing (device performance, safety, and function tests against standards), it would typically be prospective testing conducted as part of the device development and validation process. The manufacturer is Vyaire Medical, Inc. based in Germany, implying the tests were conducted or overseen by German entities.

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

This information is not provided within the document. The ground truth for these non-clinical tests would typically be established by comparing the device's performance against recognized international standards (e.g., ISO, IEC, ATS/ERS). Therefore, the "experts" would be the technical committees and bodies responsible for defining these standards.

4. Adjudication method for the test set:

This information is not explicitly mentioned. For non-clinical validation studies against international performance standards, adjudication often involves documented verification and validation processes by the manufacturer and third-party testing labs, where results are compared against predefined criteria set by the standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, an effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was conducted or mentioned in this document. The device is a "Pulmonary-Function Data Calculator" and "Electrocardiograph," which perform measurements and analysis of lung function and ECGs, but there is no indication of AI assistance to human readers or interpretation within the scope of this submission. The device's ECG interpretation statements are explicitly mentioned as "partial qualitative information" and "no therapy or drugs can be administered based solely on the interpretation statements," implying human oversight is always required.

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

Yes, a standalone performance evaluation was done for the device. The non-clinical tests assess the device's functional performance, safety, and accuracy (e.g., flow, volume, and ECG measurements) independently against established technical standards, without human interpretation in the loop influencing the measurement accuracy itself. The device is intended for use by trained healthcare professionals under the direction of a physician, who then reassesses the measurements.

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

The ground truth for the non-clinical tests used for the Vyntus ONE device is based on established international and national standards and specifications. This includes:

ISO 14971 (Risk Management)
EN 62366 / IEC 60601-1-6 (Usability)
ISO 62304 (Software Life Cycle)
IEC 60601-1 (Basic Safety)
IEC 60601-2 (EMC Compatibility)
ISO 10993 (Biocompatibility)
ATS/ERS Standardisation of Lung Function Testing

The performance characteristics (e.g., flow and volume accuracy/range/resolution) are also compared against the specifications defined by these standards, particularly the ATS/ERS standard.

8. The sample size for the training set:

This information is not applicable and not provided. The Vyntus ONE device is a medical device for measuring and analyzing physiological parameters, not an AI or machine learning model that requires a "training set" in the traditional sense for learning. Its functionality is based on established engineering principles and algorithms, validated against physical measurements and known standards.

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

This information is not applicable. As explained above, the device does not use a "training set" in the context of machine learning. Its internal algorithms and logic are developed and verified against known physical laws and validated measurement techniques, with performance assessed against established medical and engineering standards.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" and the words "U.S. FOOD & DRUG ADMINISTRATION".

November 30, 2018

Vyaire Medical, Inc. Elmar Niedermeyer Manager, Regulatory Affairs Leibnizstrasse 7 Hoechber, 97204 De

Re: K181524

Trade/Device Name: Vyntus ONE Regulation Number: 21 CFR 868.1880 Regulation Name: Pulmonary-Function Data Calculator Regulatory Class: Class II Product Code: BZC, DPS Dated: October 31, 2018 Received: November 2, 2018

Dear Elmar Niedermeyer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

James J. Lee -S

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

510(k) Number (if known) K181524

Device Name Vyntus ONE

Indications for Use (Describe)

The products can be utilized with patients aged 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists.

Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities).

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)

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Image /page/3/Picture/1 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is in a large, bold, blue font. Below that, the word "MEDICAL" is in a smaller, light blue font. The letters in "MEDICAL" are spaced out.

510(k) Summary

GENERAL INFORMATION

5.1 Type of Submission

Traditional 510(k) Submission

Submission date: 2018/05/24

5.2 Submitter

Name:	Vyaire Medical, Inc.
	(Doing business as CareFusion Germany 234 GmbH)

Address: Leibnizstrasse 7 D-97204 Hoechberg Germany

Contact person in Germany:

(Official Correspondent)	Elmar Niedermeyer
Address:	CareFusion Germany 234 GmbH
	Leibnizstrasse 7, 97204 Hoechberg
	Germany
Phone:	+49 931 49 72 - 361
FAX:	+49 931 49 72 - 62361
E-mail	elmar.niedermeyer@vyaire.com

Contact person in the U.S.:

(U.S. Agent) Address

Phone:

E-mail:

Fax:

Colleen Watson

Vyaire Medical Inc. 26125 N. Riverwoods Blvd. Mettawa, IL 60045, USA 224-7066818 847-8473629 Colleen.Okeeffe@vyaire.com

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5.3 Establishment Registration Number 9615102

5.4 Common Name or Classification Name Pulmonary function data calculator (Primary) (CFR 868.1880, Product Code BZC) Electrocardiograph (Secondary) (CFR 870.2340, Product Code DPS)

5.5 Trade Name Vyntus ONE
5.6 Device Classification This is a Class II device

5.7 Classification Panel 73 Anesthesiology Part 868 (Primary) 74 Cardiovascular Part 870 (Secondary)

5.8 Reason for Premarket Notification

. new medical device

5.9 Legally predicate marketed devices

Vyntus / SentrySuite Product Line . K150810 Code BZC, DPS
Predicate Device Company: Vyaire Medical, Inc. (Doing business as CareFusion Germany 234 GmbH)

5.10 Reference Devices

SentrySuite Product line
MasterScreen Pneumo USS .
. Vmax Series

K122699 Code BZC, JEH, BZG, BTY K071753 Code BTY K942211 Code BTY

Reference Device Company: Vyaire Medical, Inc. (Doing business as CareFusion Germany 234 GmbH)

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5.11 Device Description

Description & function:

The Vyntus ONE is connected via USB interface to the desktop PC and enables the following standard measurements:

· Diffusion SB Realtime
Diffusion SB Intra-breath
FRC N2 washout
Slow/forced spirometry and MVV

Breath-by-breath (BxB) gas exchange
· Workload control for bicycle ergometer or treadmills
· Automatic workload protocols

Further optional hardware and software include:

• Vyntus ECG: 12-lead Electrocardiogram (ECG) recording (resting and stress ECG)

· ROcc, P0.1, MIP / MEP measurements

5.12 Intended Use Statement

The Vyntus ONE / SentrySuite product line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardiopulmonary (CPET) parameters, aiding in the diagnosis of related conditions. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for future reference or report generation purposes.

The products can be utilized with patients aged 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists.

Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities).

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suggestions for the interpretation of the resting ECG can be made by the software.

ECG interpretation statements made by the Vyntus / SentrySuite represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.

The Vyntus ECG is not intended for use in an EMS environment (Emergency Medical Services Environment). The Vyntus ECG is not intended for use in home healthcare environments. Automatic interpretation of the ECG is not possible for pediatric and adolescent patients below 16 years of age and for patients with pacemakers.

5.13 Required Components

PC o
CART 3.0N / 3.1N O
Vyntus ONE main unit O
USS module o
FPV (Flow Path Valve) O
Control Unit FPV eDemand o
Vyntus ECG O
o SentrySuite Software
Instruction for Use o
Accessories o

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5.14 Summary Table of Comparison

	Vyntus / SentrySuiteProduct LineK150810(Predicate device)	SentrySuiteProduct LineK122699(Reference device)	VmaxK942211(Reference device)	MasterScreenPneumoK071753(Reference device)	Vyntus ONE(new device)
Indicationfor Use	Pulmonary function testing	----------------	----------------	----------------	Identical
Targetpopulation	4 years on and older	----------------	----------------	----------------	Identical
Softwareused	SentrySuite(Version 2.13)	----------------	----------------	----------------	SentrySuite(Version 2.21)
SoftwareNetworkoptions	Use as Workstation Use as Server Online connection Vlink connection GDT connection Sentry.NET(mobile Review) Data integration Database handling JINET server	----------------	----------------	----------------	Identical
Performance(measuringprograms)	Slow Spirometry Incentive Spirometry Forced Spirometry MVV	Slow Spirometry Incentive Spirometry Forced Spirometry MVV	----------------	----------------	Identical
		Diffusion SB Realtime Diffusion SBIntrabreath R Occlusion Respiratory Drive P0.1 MIP / MEP	----------------	----------------	Identical
	Vyntus / SentrySuiteProduct LineK150810(Predicate device)	SentrySuiteProduct LineK122699(Reference device)	VmaxK942211(Reference device)	MasterScreenPneumoK071753(Reference device)	Vyntus ONE(new device)
Performance(measuringprograms)	• Breath-by-breath (BxB)• Resting ECG• Stress ECG• Indirect Calorimetry	----------------	----------------	----------------	Identical
	----------------	----------------	• Functional ResidualCapacity (FRC) byNitrogen (N2)washout	----------------	Identical
Patient directcontactingparts	• Full face CPETmasks• Single Usemouthpiece• Silicone mouthpiece• Nose clip• Nose clip pad• Head gear	----------------	----------------	----------------	Identical
	----------------	• Single Usemouthpiece• Silicone mouthpiece• Nose clip• Nose clip pad• MicroGard II Filter	----------------	----------------	Identical
Biocompati-bility	Patient user interface• Digital VolumeTransducer• Full face CPET mask	----------------	----------------	----------------	Identical
	----------------	----------------	----------------	Patient user interface• ultrasonic flow sensor• Shutter	Patient user interface• ultrasonic flow sensor(new material)• Flow Path Valve(new material)
Sterilization	The device along with its	----------------	----------------	----------------	Identical
	Vyntus / SentrySuiteProduct LineK150810(Predicate device)accessories is neithersupplied sterile norintended to be sterilized	SentrySuiteProduct LineK122699(Reference device)	VmaxK942211(Reference device)	MasterScreenPneumoK071753(Reference device)	Vyntus ONE(new device)
CleaningValidation	Validation of Instrumentdisinfection & Surfacedisinfection	----------------	----------------	----------------	Validation according FDAGuidance: ReprocessingMedical Devices in HealthCare Settings: ValidationMethods and Labeling
Humanfactors	Usability testing acc.IEC 60601-1-6 andrelated IEC 62366;Usability Engineering File& Usability report	----------------	----------------	----------------	Usability testing acc.IEC 60601-1-6 andrelated IEC 62366;Usability EngineeringFile & Usability report
Energy used	100 – 240V / 50 – 60Hz	----------------	----------------	----------------	Identical
Patent userInterfacetechnique	• Digital VolumeTransducer technique	----------------	----------------	----------------	Identical
		----------------	----------------	• ultrasonic flow sensortechnique	Identical
Patient userInterfaceSpecification	Digital Volume Transducer• Flow: 0 – 15 L/s (3%)• Volume: 0 – 10 L (2%)• Resolution: 3ml• Resistance: <0.1kPa/L/s at 15 L/s• ATS compliant	----------------	----------------	----------------	Identical
	Vyntus / SentrySuiteProduct LineK150810(Predicate device)	SentrySuiteProduct LineK122699(Reference device)	VmaxK942211(Reference device)	MasterScreenPneumoK071753(Reference device)	Vyntus ONE(new device)
		Pneumotachograph• Flow Accuracy (exhalation)0,2 to 12 L/S: +/- 2% or +/-0,2 L/S (whichever is greater)• Flow Accuracy (inhalation)0,1 to 14 L/S: +/- 5% or+/- 0,2 L/S (whichever is greater)• Flow Range0 to +/- 20 L/S• Flow Resolution10ml/s• Volume Accuracy0,5 to 8L: +/- 3% or +/-0,05L (whichever is greater)• Volume Range+/- 20 L• Volume Resolution1ml			Ultrasonic Flow Sensor• Flow Accuracy (exhalation)0 to 14 L/S: 1,5% or0,05 L/S (whichever is greater)• Flow Accuracy (inhalation)0 to 14 L/S: 2,5% or0,05 L/S (whichever is greater)• Flow Range0 to 18 L/S bidirectional• Flow Resolution1ml/s• Volume Accuracy (exhalation)0 to 14L: 1,5% or 0,05L(whichever is greater)• Volume Accuracy (inhalation)0 to 14L: 2,5% or 0,05L(whichever is greater)• Volume Range+/- 30 L (software limited)• Volume Resolution1ml
ElectricalSafety	Protection class I				Identical
EnvironmentalSpecification	• Temperature: +10° to 34°C• Relative humidity: 15 to 95%, non condensing• Barometric pressure: 700 to 1060 hPa				• Temperature: +10° to 34°C• Relative humidity: 20 to 80%, non condensing• Barometric pressure:700 to 1060 hPa
	Vyntus / SentrySuiteProduct LineK150810(Predicate device)	SentrySuiteProduct LineK122699(Reference device)	VmaxK942211(Reference device)	MasterScreenPneumoK071753(Reference device)	Vyntus ONE(new device)
Accessorieslisted in UserManual	892102Silicone mouthpiece forchildren
	892100Silicone mouthpiece
	720254Manual calibration syringe 3l
	852740Silicone sleeve, 60 mm formanual calibration syringe 3l
	S773470Silicone mouthpieceFreeFlowTM, 12 pieces
	V-892894Mouthpiece (disp.mouthpiece blue), 180pieces
	892120Nose-clip "plastic"
	892121Nose-clip pad "foammaterial", 100 pieces				Identical
	S42101Nose-clip disposable, 10pieces
	S761889Nose-clip disposable, 100pieces
	V-707326Volume sensor DVT (digitalvolume transducer)complete
	982094Volume sensor insert
	V-707725Volume sensor insert
	923015O2 fuel cell
	992582Ear clip sensor for SpO2
Vyntus / SentrySuiteProduct Line	SentrySuiteProduct Line	Vmax	MasterScreenPneumo	Vyntus ONE(new device)
K150810	K122699	K942211	K071753
(Predicate device)	(Reference device)	(Reference device)	(Reference device)
(Nonin Model 8000Q2)(applied part)992506SpO2 Flex sensor with cablefor adults (Nonin Model8000J-3) (applied part)992578Adult Flexi Wrap adhesivetape for Flex Sensor (pack of25 pcs.) (Nonin Model8000JFW) (applied part)V-992528SpO2 Reflectance ForeheadSensor (Nonin Model8000R)V-992529SpO2 Reflect Sensor holder(Nonin Model 8000H)(applied part)
	892103Plastic mouthpiece, singleuse, 25 pieces720252Manual calibration syringe 1lV-861449Silicone adapter "Oval" forMicroGard IIB852353Adapter ID 30V-892384MicroGard IIC, 50 piecesV-892381MicroGard IIB withintegrated mouthpiece, 50piecesV-892391Filter kit MicroGard type IIB,80 piecesV-892392Filter kit MicroGard type IIC	----------------	----------------	Identical
Vyntus / SentrySuiteProduct LineK150810(Predicate device)	SentrySuiteProduct LineK122699(Reference device)	VmaxK942211(Reference device)	MasterScreenPneumoK071753(Reference device)	Vyntus ONE(new device)
	80 pieces			AdditionalAccessories"International Items"V-892895Nose Clip (reusable), 5pieces (applied part)V-892900Nose Clip (disposable), 10pieces (applied part)
Vyntus / SentrySuiteProduct Line	SentrySuiteProduct Line	Vmax	MasterScreenPneumo	Vyntus ONE(new device)
K150810(Predicate device)	K122699(Reference device)	K942211(Reference device)	K071753(Reference device)	AdditionalAccessories “PFTtests”
----------------	----------------	----------------	----------------	V-707377USS Module with adapterand prot. Cover
				V-707380USS MicroGard Adapter
				V-707381USS MicroGard Adapterfor gas sampling
				V-707722Sample line Vyntus ONE
				V-707384Cable port protectivecover, 5 pieces
				V-707721FPV block eDemand
				V-707388FPV shutter mechanism
				V-707390FPV silicone valves, 5pieces
				V-707383USS Module holder
				V-707393FPV block holder
				V-707394Disinfection tray insert
Vyntus / SentrySuiteProduct LineK150810(Predicate device)	SentrySuiteProduct LineK122699(Reference device)	VmaxK942211(Reference device)	MasterScreenPneumoK071753(Reference device)	Vyntus ONE(new device)
----------------	----------------	----------------	----------------	AdditionalAccessories "CPETtests"V-861078Adapter Jaeger cone forDVT Vyntus ONEV-841188Calibration gas holder(0.8/0.38L)706183Gas bottle wall mountV-992512Nonin XPOD 3011 LP w.ODU
V-982181Headgear Oro Nasal Mask7450 V2 Size L (appliedpart)V-892180Headgear Oro Nasal Mask 7450V2 Size M (applied part)	----------------	----------------	----------------	AdditionalAccessories "CPETmasks"Identical
Vyntus / SentrySuiteProduct LineK150810(Predicate device)	SentrySuiteProduct LineK122699(Reference device)	VmaxK942211(Reference device)	MasterScreenPneumoK071753(Reference device)	Vyntus ONE(new device)
--------------------	--------------------	--------------------	--------------------	V-982186CPET Mask 7450 V2, SizeL, Complete (applied part)V-982185CPET Mask 7450 V2, SizeM, Complete (applied part)V-892184CPET Mask 7450 V2, SizeS, Complete (applied part)V-982187CPET Mask 7450 V2, SizeXS, Complete (appliedpart)V-982188CPET Mask 7450 V2, SizePetite, Complete (appliedpart)V-982192Flexible mask adapterV-982189Headgear Oro Nasal Mask7450 V2 Size ES andPetite (applied part)V-982195Brace Set, Size L, forCPET Mask 7450 V2V-982196Brace Set, Size M, forCPET Mask 7450 V2V-982197Brace Set, Size S, forCPET Mask 7450 V2V-982198Brace Set, Size XS, forCPET Mask 7450 V2V-982199Brace Set, Size Petite, forCPET Mask 7450 V2V-982179Oro Nasal 6450 V2 DISP
Vyntus / SentrySuite	SentrySuite	Vmax	MasterScreenPneumo	Vyntus ONE(new device)
Product Line	Product Line
K150810	K122699	K942211	K071753
(Predicate device)	(Reference device)	(Reference device)	(Reference device)
				with HG Size L 18ea/bx(disposable mask) (appliedpart)V-982178Oro Nasal 6450 V2 DISPwith HG Size M 18ea/bx(disposable mask) (appliedpart)V-982177Oro Nasal 6450 V2 DISPwith HG Size S 18ea/bx(disposable mask) (appliedpart)V-982182Oro Nasal 6450 V2 DISPwith HG Size ES 18ea/bx(disposable mask) (appliedpart)V-982183Oro Nasal 6450 V2 DISPwith HG Size Petite18ea/bx (disposable mask)(applied part)
Additional Accessories"Vyntus ECG"992368Disposable electrodes(Rest), 50 pieces (appliedpart)892205Disposable electrodes(Stress), 25 pieces (appliedpart)8065021.5V AA battery "VartaIndustrial"V-806520NiMH rechargeable battery	--------------------	--------------------	--------------------	Identical
Vyntus / SentrySuiteProduct Line	SentrySuiteProduct Line	Vmax	MasterScreenPneumo	Vyntus ONE(new device)
K150810	K122699	K942211	K071753
(Predicate device)	(Reference device)	(Reference device)	(Reference device)
1.2 V AA $\geq$ 2500 mAhV-996146NiMH battery chargerV-841234Bag for the Vyntus ECG, 25pieces				AdditionalAccessories "Other"S760707Power line US AWG16acc. To UL and CSA918100Power line EU H05 VV-F3G acc. to IEC 227 andIEC 245845117Instrument tub with lid, 210x 110 x 35 mm
				AdditionalAccessories "ITcomponents"V-991090DELL Monitor 24"V-991093Monitor 24"V-991091Monitor 34"V-994185Dell Optiplex 3040MFFV-994187Dell Optiplex 3050MFFV-994225
Vyntus / SentrySuiteProduct LineK150810	SentrySuiteProduct LineK122699	VmaxK942211	MasterScreenPneumoK071753	Vyntus ONE(new device)
(Predicate device)	(Reference device)	(Reference device)	(Reference device)
				Dell Optiplex 7050MFFV-991481HP Printer 6230eV-994191Notebook E5570V-994205Notebook E5580

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Summary of technological characteristics compared to the predicate device to the table above:

The software platform used for the Vyntus ONE is equivalent to the predicate ● device Vyntus/SentrySuite Product line K150810. The software which is used is the SentrySuite software only with a different version.
The Biocompatibility for the patient interface for Vyntus ONE and the . reference device K071753 is equivalent as the new Vyntus ONE patient interface material has been tested completely according ISO 10993 standard. The following testing was done.

Biocompability:

Cytotoxiticity, sensitization, irritation, intracutaneous reactivity, acute systemic toxicity, material mediated pyrogenicity

Chemical Characterization:

Exaggerated Extraction FTIR HPLC-MS / UPLC-MS GC-MS Headspace GC-MS ICP-MS ICP-OES

. The specification for the patient user interface is equivalent to the reference device K122699. There is an insignificant difference in flow accuracy, flow resolution, volume accuracy. There is also an insignificant difference in flow range and volume range. The proposed device is more accurate in flow and volume and has a higher flow resolution. The difference in flow range and volume range is insignificant as the ranges are higher than a patient can breathe. The shift of the ranges and the improvements in the measurement details are caused in the technology improvement by using an ultrasonic flow measurement. The new technology improved the accuracy and maximum ranges slightly, as the flow resistance is lower in the subject device compared to the predicate device. Both systems fulfill the ATS/ERS standard "ATS/ERS TASK FORCE: STANDARDISATION OF LUNG FUNCTION TESTING". The Vyntus ONE works as intended.
The environmental conditions are nearly equivalent to the predicate device . Vyntus/SentrySuite Product line. The testing supported that the subject device is as safe and effective as the predicate device.
. The accessories for the Vyntus ONE are in partially new compared to the predicate and reference devices.

The new accessories which come into direct or indirect contact are:

V-892895 Nose clip (reusable)

V-892900 Nose clip (disposable)

V-707377 USS module with adapter

V-707380 USS MicroGard adapter

V-707381 USS MicroGard adapter for gas sampling

V-707721 FPV block eDemand
V-707388 FPV shutter mechanism

V-707390 FPV silicone valves, 5 pieces

V-861078 Adapter Jaeger cone for DVT Vyntus ONE

Performance testing supported that the subject device is as safe and effective as the predicate device.

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Summary of Device Testing 5.15

1. Non-clinical tests conducted for determination of substantial equivalence:

	Characteristic	Standard/Test	Results Summary
1.	Risk Management	ISO 14971	The proposed device passes the applicable tests and standards
2.	Usability	EN 62366	The proposed device passes the applicable tests and standards
3.	Software life cycle	ISO 62304	The proposed device passes the applicable tests and standards
4.	Basic Safety	IEC 60601-1	The proposed device passes the applicable tests and standards
5.	EMC Compatibility	IEC 60601-2	The proposed device passes the applicable tests and standards
6.	Biocompatibility	ISO 10993	The proposed device passes the applicable tests and standards
7.	Accuracy Testing	Measurement effective-ness & accuracy	The proposed device passes the applicable tests and standards
8.	Climatic Chamber test	Environmental testingaccording specifications	The proposed device passes the applicable tests and standards
9.	ATS / ERS	Standard for lungfunction testing	The proposed device passes the applicable tests and standards
Summary Discussion of Bench Performance Data

The Vyntus ONE passed all specified test requirements.

The validation and verification testing confirmed this device meets user needs and design inputs for a pulmonary function testing system.

Testing also confirmed physical attributes and device performance meet the requirements of the standards listed in the performance testing summary above. These standards address risk management, usability, software life cycle, electrical safety, emc. biocompatibility, accuracy testing, climatic chamber testing and ATS / ERS. All testing which have been performed demonstrate substantial equivalence to the predicate devices.

2. Clinical tests conducted for determination of substantial equivalence and/or of clinical information:

Clinical Performance Data/Information:

Clinical testing was not performed with this device.

3. Conclusion drawn from non-clinical and clinical data:

The Vyntus ONE meets the functional claims and intended use as described in the product labeling. The Vynuts ONE is substantially equivalent to the predicate device described in the submission.

5.16 Conclusion

Based on the above, Vyaire Medical concludes that the Vyntus ONE is substantially equivalent to the legally marketed predicate device and as safe as effective as the predicate.

Regulation Number and Section

§ 868.1880 Pulmonary-function data calculator.

(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).