The Vyntus/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. The test results can be saved for future reference or report generation purposes. The products can be utilized with patients age 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).

Device Description

The Vyntus CPX system is an accurate and reliable system that allows the determination of a subjects' metabolic response while exercising. It is a stationary, mains powered ergospirometry system. The system records the data breath-by-breath. The breath-by-breath data is collected through a facemask or mouth-piece and is sent to a host computer system via cable connection. The digital volume transducer (DVT) measures the gas volume in- and expired. Gas samples are continuously drawn from a location very close to the mouth (between DVT and the face-mask or mouth-piece). The gas samples are dryed by Nafion tubes and analyzed for O2 and CO2 content. From the breathing volume and the differences between inspiratory and expiratory O2 and CO2 concentrations the oxygen uptake and the CO2 production (V'O2 and V'CO2) are calculated by the software. The workload protocol selected by the user will control the ergometer device accordingly and the changes in the above vital signs due to the change in workload are recorded. All data is stored together with the patient and test data in the database for later evaluation and printing.

AI/ML Overview

The provided document is a 510(k) Summary for the Vyntus/SentrySuite product line, a pulmonary-function data calculator. This type of document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than providing a detailed study report of accuracy relative to a specific ground truth.

Therefore, many of the typical acceptance criteria and study details for AI/device performance metrics (like sample size for training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance of an algorithm, or specific types of ground truth like pathology) are not applicable or not explicitly stated in this document.

However, based on the information provided, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are implied by the "Accuracy" column for each parameter, representing the desired performance. The reported device performance is presented as meeting these desired accuracies.

Parameter	Acceptance Criteria (Accuracy)	Reported Device Performance (Accuracy)
Ergospirometry
Ventilation (V'E)	2% or 0,5 L/min	2% or 0,5 L/min
O2 uptake (V'O2)	3% or 0,05 L/min	3% or 0,05 L/min
CO2 output (V’CO2)	3% or 0,05 L/min	3% or 0,05 L/min
RER	4% or 0.04	4% or 0.04
Volume Sensor
Volume	2% or 50 mL	2% or 50 mL
Flow	3% or 70 mL/s	3% or 70 mL/s
O2 Analyzer
O2 Accuracy	0,05%	0,05%
CO2 Analyzer
CO2 Accuracy	0,05% or 1% (for proposed)	0,05% or 1% (for proposed)

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

Test Set Sample Size: The document does not specify a sample size for the accuracy testing. It refers to "Measurement effectiveness & accuracy according golden standard 'Douglas bag'" which indicates the method of testing, but not the number of tests or subjects.
Data Provenance: Not specified. The company (CareFusion Germany 234 GmbH) is based in Germany, suggesting testing might have been done there. The testing is non-clinical bench testing.

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

Number of Experts: Not applicable. The ground truth for the performance parameters (like O2 uptake, CO2 output, flow, volume) is established through a "golden standard 'Douglas bag'" and other calibrated measurement techniques, not expert review of images or data.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. This device measures physiological parameters, and accuracy is determined by comparison to a "golden standard" reference, not through human adjudication of differing interpretations.

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:

MRMC Study: No, an MRMC study was not done. This device is a measurement system, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

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

Standalone Performance: Yes, the accuracy testing described in the tables (Ergospirometry and Volume Sensor parameters) represents the standalone performance of the device's measurement capabilities. The device's software calculates these parameters.
- The "Summary Discussion of Bench Performance Data" states: "The CareFusion Vyntus CPX cardio pulmonary exercise system passed all specified test requirements. The validation and verification testing confirmed this device meets user needs and design inputs for a CPET system. Testing also confirmed physical attributes and device performance meet the requirements of the standards listed in the performance testing summary above."
- This confirms the device, including its algorithms, performs according to the specified accuracies.

7. The type of ground truth used:

Type of Ground Truth: The ground truth for the accuracy testing was established using a "golden standard 'Douglas bag'" method for measurement effectiveness and accuracy. This refers to a highly accurate reference method for collecting and analyzing breathed gases. Other parameters (volume, flow) would be compared against calibrated reference instruments.

8. The sample size for the training set:

Training Set Sample Size: Not applicable/not stated. This document describes a medical device for measuring physiological parameters, whose core functionality relies on physical sensors and established scientific principles for calculation. It is not an AI/Machine Learning model that typically requires a discrete training set in the way a diagnostic AI would. The "software life cycle" according to ISO 62304 is mentioned, implying robust software development and verification, but not a "training set" in the context of data-driven AI.

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

Ground Truth for Training Set: Not applicable. As explained above, the concept of a "training set" and its associated ground truth establishment is not typically relevant in the context of this type of device's regulatory submission where the focus is on sensor accuracy and calculation validity against known physical standards.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background.

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

August 22,2014

CareFusion Germany 234 GmbH Elmar Niedermeyer Leibnizstrasse 7 Hoechberg, Bavaria, Germany 97204

Re: K133925

Trade/Device Name: Vyntus / SentrySuite Product line Regulation Number: 868.1880 Regulation Name: Pulmonary-function data calculator Regulatory Class: II Product Code: BZC Dated: July 22nd, 2014 Received: July 25th, 2014

Dear Mr. 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. 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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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,

Mary S. Runner -S

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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Indications for Use

510(k) Number (if known): K

Device Name:

Vyntus/SentrySuite product line

Indications for Use:

The products can be utilized with patients age 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).

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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Image /page/3/Picture/1 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. The shield has a small orange section in the upper right corner. The logo is simple and modern.

510(k) Summary

GENERAL INFORMATION

Type of Submission 5.1

Traditional 510(k) Submission

Submission date: 12/13/2013

5.2 Submitter

Name: CareFusion Germany 234 GmbH

Address: Leibnizstrasse 7 D-97204 Hoechberg Germany

Contact person in Germany:

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

Contact person in the U.S.:
(U.S. Agent)	Donald Sherratt
Address	CareFusion
	22745 Savi Ranch Parkway
	Yorba Linda, CA 92887
Phone:	714-919-3349
Fax:	714-283-8420
E-mail:	donald.sherratt@carefusion.com

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5.3 Establishment Registration Number 9615102

5.4 Common Name or Classification Name Pulmonary-function data calculator (CFR 868.1880, Product Code BZC)

5.5 Trade Name Vyntus/SentrySuite Product line
5.6 Device Classification This is a Class II device

5.7 Classification Panel

73 Anesthesiology Part 868 Code BZC

5.8 Reason for Premarket Notification

New device
(The CareFusion CPET devices K072323 & K992214 have been revised with new hardware. The software platform SentrySuite has been taken over from SentrySuite Product line with 510(k) K122699)

5.9 Legally predicate marketed devices

. MasterScreen CPX K072323 Code BZC . Oxycon Pro K992214 Code 73 BZC, 74 MWI, MLC, DPS
SentrySuite Product line K122699 Code BTY, BZG, BZC, JEH .

5.10 Predicate Device Company

CareFusion Germany 234 GmbH ●

Device Description 5.11

Description & function:

Scientific Concepts that form the basis of the device:

The digital volume transducer (DVT) measures the gas volume in- and expired. Gas samples are continuously drawn from a location very close to the mouth (between DVT and the face-mask or mouth-piece).

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The gas samples are dryed by Nafion tubes and analyzed for O2 and CO2 content. From the breathing volume and the differences between inspiratory and expiratory O2 and CO2 concentrations the oxygen uptake and the CO2 production (V'O2 and V'CO2) are calculated by the software.

The workload protocol selected by the user will control the ergometer device accordingly and the changes in the above vital signs due to the change in workload are recorded.

All data is stored together with the patient and test data in the database for later evaluation and printing.

Significant performance characteristics:

Ergospirometry

Parameter	Measurement range	Accuracy
Ventilation(V'E)	0 to 300 L/min	2% or 0,5 L/min
O2 uptake (V'O2)	0 to 7 L/min	3% or 0,05 L/min
CO2 output (V’CO2)	0 to 7 L/min	3% or 0,05 L/min
RER	0,6 to 2.0	4% or 0.04

Volume Sensor

Parameter	Measurement range	Accuracy
Volume	0 to 10 L	2% or 50 mL
Flow	0 to 15 L/s	3% or 70 mL/s

Resolution: 3 mL Resistance: <0.1 kPa/L/s at 15 L/s ATS-compliant

Device Design:

Vynuts CPX has been designed according CareFusion Standard Working Instruction 0301-5001-000-SWI (Design Control) into two configurations. This is the table top version and the cart version.

Material used:

Vyntus CPX front panel [aluminium alloy 3.2315 EN-AW 6082] O
Vyntus CPX rear panel [aluminium alloy 3.3535 EN-AW5754] O
Vyntus CPX housing [babyblend FR3010 UL94V0] O
o Vyntus CPX cart/corpus [steel panel alloy EN10130 DC01A]
Vyntus CPX cart/spine [aluminium alloy AlMgSi 0,5 F22 (6066)] O

Physical properties:

size Vyntus CPX (31,94cm x 29,40cm x 13,57cm) O
weight Vyntus CPX (3995 gram) O
size cart (140cm x 70,90cm x 71,90cm) O
weight cart (86,4 kg) O

5.12 Intended Use Statement

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

5.13 Required Components

PC or Notebook ●
Vyntus CPX unit (table version)
Vyntus table top power module ●
DVT (Digital Volume Transducer) ●
Ambient module ●
USB cable (PC / Vyntus CPX unit) ●
SentrySuite Software ●
Instruction for Use
Accessories
Vyntus cart with power supply (optional) ●
Polar receiver/belt for heart rate (optional)
SpO2 Nonin Xpod pulse oximeter (optional) ●
External PC-based 8 Channel / 12 lead ECG (optional) ●
Treadmill or bicycle ergometer (optional)

5.14 Summary Table of Comparison

Comparison with MasterScreen CPX K072323& Oxycon Pro K992214
	Predicate CareFusionMasterScreen CPXK072323	Predicate CareFusionOxycon ProK992214	Vyntus CPX(proposed device)
Indicationfor Use	The MasterScreen CPX stationarypulmonary function test system is adevice which monitors the cardio-respiratory functions during stresstesting, rehabilitation, sportsmedicine and other relatedactivities. The MasterScreen CPXsystem allows the monitoring ofmetabolic parameters. TheMasterScreen CPX system isintented to use with adults andchildren over the age of 14 years.	The Oxycon Pro is a software-driven, medical device for exercisemeasurements, including ECG STsegment analysis and/or ECGstress analysis. It measures thehuman response to increasingworkloads with emphasis on thegas exchange parameters.Measurements include ventilation,oxygen uptake, carbon dioxideexcretion, heart rate and derivedparameters. The results of thetests, including the ECG waveforms, can be viewed on thecomputer screen and can beprinted during the test. The testresults can be saved on thecomputer hard disk for furtherreferral or report generationpurposes.The Oxycon Pro interfaces to a testsubject via a mouthpiece or a facemask and ECG electrodes. TheOxycon Pro interfaces to aperipheral ergometer or treadmill.The patient population is 4 age and	The Vyntus/SentrySuite product lineis intended to be used formeasurements, data collection andanalysis of lung function (PFT) andcardio-pulmonary (CPET)parameters, aiding in the diagnosis ofrelated conditions. The results of thetest can be viewed online with thehelp of a computer screen and canbe printed after the test. The testresults can be saved for futurereference or report generationpurposes.The products can be utilized withpatients age 4 years and older aslong as they can cooperate in theperformance - no special limit topatient's sex or height exists.Measurements will be performedunder the direction of a physician in ahospital environment, physician'soffice or similar setting (professionalhealthcare facilities).
		older.The Oxycon Pro is capable ofperforming computerized ECGinterpretation during restingcondition.The intended use locations areeither in a physician office, hospitalexercise rehabilitation facilities, orsimilar areas. It is intended to beused by or on the order of aphysician or similar qualified healthcare professional. This device isintended for use in the hospitalenvironment, physician's office, orsimilar settings. This device is notintended for home use.
Intendedpatientpopula-tion	Adults and children over theage of 14 years	4 years and older	similar to K992214
Perfor-mancespecifica-tion	Flow: 0 - 15 L/s (3% or 70 ml)Volume: 0 - 10 L (2% or 50 ml)Ventilation:0 - 300 L/m (2% or 0,5 L/min)O2 uptake:0 - 7 L/min (3% or 0,05 L/min)CO2 output:0 - 7 L/min (3% or 0,05 L/min)RER: 0,6 - 2,0 (+4% or 0,04)	Flow: 0 – 15 L/s (3% or 70 ml)Volume: 0 - 10 L (2% or 50 ml)Ventilation:0 - 300 L/m (2% or 0,5 L/min)O2 uptake:0 - 7 L/min (3% or 0,05 L/min)CO2 output:0 – 7 L/min (3% or 0,05 L/min)RER: 0,6 - 2,0 (+4% or 0,04)	similar
Gassamplingtechnique	Breath-by-breath	Breath-by-breath	similar
Patientcontac-tingaccessory	• Face Mask• Head strap for facemask• Mouthpiece• Nose clip• ECG electrodes• SpO2 finger probe• Polar sensor	• Face Mask• Head strap for facemask• Mouthpiece• Nose clip• ECG electrodes• SpO2 finger probe• Polar sensor	similar
Steriliza-tion	The device along with itsaccessories is neithersupplied sterile norintended to be sterilized	The device along with itsaccessories is neithersupplied sterile norintended to be sterilized	similar
O2analyzer	Electro-chemicalRange: 0 - 25%Resolution: 0,01%Accuracy: 0,05%Response time: 80 msLife time: 2 years	Differential-paramagneticprinciple high speedRange: 0 - 25%Resolution: 0,01%Accuracy: 0,05%Response time: 40 msLife time: 2 years	Electro-chemical high speedanalyzerRange: 0 - 25%Resolution: 0,01%Accuracy: 0,05%Response time: 80 msLife time: 100 h or 1,5 years
CO2analyzer	Thermal conductiveRange: 0 - 10%	Infrared absorption principleRange: 0 - 15%	Infrared absorption highspeed analyzer
	Resolution: 0,01%Accuracy: 0,05%Response time: 80 msLife time: infinite	Resolution: 0,01%Accuracy: 0,05%Response time: 40 msLife time: infinite	Range: 0 - 15%Resolution: 0,01%Accuracy: 0,05% or 1%Response time: 80 msLife time: infinite
Options	Nonin Xpod pulse oximetry with oximeter probe intended to be clipped onto a finger or ear Polar heart rate receiver External PC-based 8-Channel/12 lead ECG Treadmill or bicycle ergometer	Nonin Xpod pulse oximetry with oximeter probe intended to be clipped onto a finger or ear Polar heart rate receiver External PC-based 8-Channel/12 lead ECG Treadmill or bicycle ergometer	similar to K072323
Environmentalspecifications	Operating:+10 to +34 °C30% to 95% RH700 to 1060 hPaStorage:-30 to +50 °C10% to 95% RH600 to 1200 hPa	Operating:+10 to +40 °C15% to 95% RH500 to 1150 hPaStorage:-20 to +50 °C10% to 95% RH600 to 1200 hPa	Operating:+10 to +34 °C20% to 80% RH800 to 1060 hPaStorage:-20 to +50 °C15% to 95% RH600 to 1200 hPa
Measuringprograms	Slow Spirometry Forced Spirometry MVV Breath-by-Breath Indirect Calorimetry	Slow Spirometry Forced Spirometry MVV Breath-by-Breath Indirect Calorimetry Cardiac Output Cardiac Output High/Low FiO2 Intrabreath End Tidal Respiratory drive P0.1 Mixing Chamber Resting ECG Stress ECG	similar
Comparison with SentrySuite Product Line K122699
	SentrySuite Product LineK122699		Vyntus CPX(proposed device)
Software	SentrySuite Software 2.x		similar
Softwareplatformmainfeatures	can be installed on workstations in a network or stand alone can be used as a server in a network equipped with powerful SQL database connection to HIS complete seamless interfacing to hospital electronic medical record with VLINK with SentrySuite connectivity, patient data and measurement data can be exchanged between JAEGER JLAB, SensorMedics Vmax, Medical Graphics and nSpire software application for remote access with Sentry.NET like view, interpret and sign is possible data exchange via GDT to praxis systems and via HL7 for hospital systems remote applications with iPad / tablet like questionnaire	similar

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

The Vyntus CPX is similar in indication for use compared to the predicate . devices. The patient population is similar to the predicate CareFusion devise Oxycon Pro. It is 4 years and older and thereby the proposed device is substantial equivalent to the predicate device Oxycon Pro.
The new high speed O2 analyzer has a shorter life time compared to both . predicate devices and also has a higher response time compared to the predicate Oxycon Pro K992214. The O2 analyzer technique used for the Oxycon Pro is the differential-paramagnetic principle whereby the predicate MasterScreen CPX and the proposed device Vyntus CPX use electrochemical analyzer technique. The advantage for exchanging the analyzers is that the O2 analyzer in the proposed device Vyntus CPX can be exchanged by the user itself. With these insignificant changes the proposed device is substantial equivalent to the predicate devices.
The new high speed CO2 sensor works with infrared absorption technique ● and has an extended measuring range when compared to the predicate MasterScreen CPX K072323. Whereupon the predicate Oxycon Pro K992214 works with the similar infrared absorption technique as the proposed device but has a shorter response time. With this insignificant change the proposed device is substantial equivalent to the predicate devices.
The environmental conditions are nearly similar to the predicate devices ● MasterScreen CPX and Oxycon Pro. There are only insignificant differences which will not have any influence on the device functions. The Vyntus CPX operates as intended in user environments. The proposed device is substantial equivalent to the predicate devices.
The measuring programs of the proposed device are similar to the predicate ● device MasterScreen CPX and Oxycon Pro. The only difference is that Oxycon Pro has the possibility to do some more measurements. The Vyntus CPX measurements are substantial equivalent to the measurements of the predicate devices.
The software platform for the Vyntus CPX is the powerful SentrySuite ● software from the predicate device "SentrySuite Product Line" K122699.

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5.15 Summary of Device Testing

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

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

The CareFusion Vyntus CPX cardio pulmonary exercise system passed all specified test requirements.

The validation and verification testing confirmed this device meets user needs and design inputs for a CPET 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 basic safety, emc, risk, usability, software life cycle, biocompatibility and environment. 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 Carefusion CPET system meets the functional claims and intended use as described in the product labeling. The Vynuts CPX is substantially equivalent to the K072323 MasterScreen CPX, K122699 SentrySuite Product line and K992214 Oxycon Pro described in the submission.

5.16 Conclusion

Based on the above, CareFusion concludes that the Vyntus CPX is substantially equivalent to the legally marketed predicate device and performs at least as well or even better as the predicate devices.

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).