← Product Code [BZC](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC) · K133925 # VYNTUS/ SENTRYSUITE PRODUCT LINE (K133925) _Carefusion Germany 234 GmbH · BZC · Aug 22, 2014 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K133925 ## Device Facts - **Applicant:** Carefusion Germany 234 GmbH - **Product Code:** [BZC](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC.md) - **Decision Date:** Aug 22, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.1880 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Pediatric ## Intended Use 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 Story Vyntus CPX is a stationary, mains-powered ergospirometry system for metabolic response determination during exercise. Inputs: breath-by-breath gas samples (O2, CO2) via facemask/mouthpiece and digital volume transducer (DVT); optional inputs include SpO2, ECG, and ergometer workload data. Operation: gas samples dried via Nafion tubes; O2/CO2 concentrations and breathing volume processed by SentrySuite software to calculate oxygen uptake (V'O2) and CO2 production (V'CO2). Used in hospitals/clinics by physicians or qualified healthcare professionals. Output: real-time display of metabolic/respiratory parameters, printed reports, and database storage. Clinical utility: aids diagnosis of pulmonary/cardio-pulmonary conditions by monitoring physiological response to exercise. Benefits: provides accurate, reliable, and standardized lung function and exercise testing data for clinical decision-making. ## Clinical Evidence No clinical data. Substantial equivalence established via bench testing, including basic safety (IEC 60601-1), EMC (IEC 60601-1-2), risk management (ISO 14971), usability (EN 62366), software life cycle (ISO 62304), biocompatibility (ISO 10993-1), and accuracy validation against the 'Douglas bag' gold standard. ## Technological Characteristics Stationary ergospirometry system. Materials: Aluminum alloys (3.2315, 3.3535, 6066), babyblend FR3010 housing, steel panel (EN10130). Sensing: Digital volume transducer, electrochemical O2 analyzer, infrared CO2 sensor. Connectivity: USB to host PC. Software: SentrySuite platform. Sterilization: Not supplied sterile, not intended for sterilization. ## Regulatory 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. ## Predicate Devices - MasterScreen CPX ([K072323](/device/K072323.md)) - Oxycon Pro ([K992214](/device/K992214.md)) - SentrySuite Product line ([K122699](/device/K122699.md)) ## Related Devices - [K150888](/device/K150888.md) — Shape-HF Cardiopulmonary Testing System · Shape Medical Systems, Inc. · Jan 21, 2016 - [K040698](/device/K040698.md) — MASTERSCREEN CPX AND OXYCON CPX · Viasys Healthcare GmbH · Apr 7, 2004 - [K070858](/device/K070858.md) — EXPRESS SERIES · Medical Graphics Corp. · Apr 16, 2007 - [K993641](/device/K993641.md) — METALYZER, MODEL 2; METALYZER, MODEL 3 · Cortex Biophysik GmbH · Dec 14, 2000 - [K020280](/device/K020280.md) — PULMOLAB EX671 EXERCISE TESTING SYSTEM · Morgan Medical , Ltd. · Sep 24, 2002 ## Submission Summary (Full Text) {0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known): K Device Name: Vyntus/SentrySuite product line Indications for Use: 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). 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 ____________________________________________________________________________________________________________________________________________________________________ {3}------------------------------------------------ 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 GmbH<br>Leibnizstrasse 7, 97204 Hoechberg<br>Germany | | 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 | {4}------------------------------------------------ ### 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: 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. 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). {5}------------------------------------------------ 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 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 {6}------------------------------------------------ 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<br>& Oxycon Pro K992214 | | | | |------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Predicate CareFusion<br>MasterScreen CPX<br>K072323 | Predicate CareFusion<br>Oxycon Pro<br>K992214 | Vyntus CPX<br>(proposed device) | | Indication<br>for Use | The MasterScreen CPX stationary<br>pulmonary function test system is a<br>device which monitors the cardio-<br>respiratory functions during stress<br>testing, rehabilitation, sports<br>medicine and other related<br>activities. The MasterScreen CPX<br>system allows the monitoring of<br>metabolic parameters. The<br>MasterScreen CPX system is<br>intented to use with adults and<br>children over the age of 14 years. | The Oxycon Pro is a software-<br>driven, medical device for exercise<br>measurements, including ECG ST<br>segment analysis and/or ECG<br>stress analysis. It measures the<br>human response to increasing<br>workloads with emphasis on the<br>gas exchange parameters.<br>Measurements include ventilation,<br>oxygen uptake, carbon dioxide<br>excretion, heart rate and derived<br>parameters. The results of the<br>tests, including the ECG wave<br>forms, can be viewed on the<br>computer screen and can be<br>printed during the test. The test<br>results can be saved on the<br>computer hard disk for further<br>referral or report generation<br>purposes.<br>The Oxycon Pro interfaces to a test<br>subject via a mouthpiece or a face<br>mask and ECG electrodes. The<br>Oxycon Pro interfaces to a<br>peripheral ergometer or treadmill.<br>The patient population is 4 age and | The Vyntus/SentrySuite product line<br>is intended to be used for<br>measurements, data collection and<br>analysis of lung function (PFT) and<br>cardio-pulmonary (CPET)<br>parameters, aiding in the diagnosis of<br>related conditions. The results of the<br>test can be viewed online with the<br>help of a computer screen and can<br>be printed after the test. The test<br>results can be saved for future<br>reference or report generation<br>purposes.<br>The products can be utilized with<br>patients age 4 years and older as<br>long as they can cooperate in the<br>performance - no special limit to<br>patient's sex or height exists.<br>Measurements will be performed<br>under the direction of a physician in a<br>hospital environment, physician's<br>office or similar setting (professional<br>healthcare facilities). | | | | older.<br>The Oxycon Pro is capable of<br>performing computerized ECG<br>interpretation during resting<br>condition.<br>The intended use locations are<br>either in a physician office, hospital<br>exercise rehabilitation facilities, or<br>similar areas. It is intended to be<br>used by or on the order of a<br>physician or similar qualified health<br>care professional. This device is<br>intended for use in the hospital<br>environment, physician's office, or<br>similar settings. This device is not<br>intended for home use. | | | Intended<br>patient<br>popula-<br>tion | Adults and children over the<br>age of 14 years | 4 years and older | similar to K992214 | | Perfor-<br>mance<br>specifica-<br>tion | Flow: 0 - 15 L/s (3% or 70 ml)<br>Volume: 0 - 10 L (2% or 50 ml)<br>Ventilation:<br>0 - 300 L/m (2% or 0,5 L/min)<br>O2 uptake:<br>0 - 7 L/min (3% or 0,05 L/min)<br>CO2 output:<br>0 - 7 L/min (3% or 0,05 L/min)<br>RER: 0,6 - 2,0 (+4% or 0,04) | Flow: 0 – 15 L/s (3% or 70 ml)<br>Volume: 0 - 10 L (2% or 50 ml)<br>Ventilation:<br>0 - 300 L/m (2% or 0,5 L/min)<br>O2 uptake:<br>0 - 7 L/min (3% or 0,05 L/min)<br>CO2 output:<br>0 – 7 L/min (3% or 0,05 L/min)<br>RER: 0,6 - 2,0 (+4% or 0,04) | similar | | Gas<br>sampling<br>technique | Breath-by-breath | Breath-by-breath | similar | | Patient<br>contac-<br>ting<br>accessory | • Face Mask<br>• Head strap for face<br>mask<br>• Mouthpiece<br>• Nose clip<br>• ECG electrodes<br>• SpO2 finger probe<br>• Polar sensor | • Face Mask<br>• Head strap for face<br>mask<br>• Mouthpiece<br>• Nose clip<br>• ECG electrodes<br>• SpO2 finger probe<br>• Polar sensor | similar | | Steriliza-<br>tion | The device along with its<br>accessories is neither<br>supplied sterile nor<br>intended to be sterilized | The device along with its<br>accessories is neither<br>supplied sterile nor<br>intended to be sterilized | similar | | O2<br>analyzer | Electro-chemical<br>Range: 0 - 25%<br>Resolution: 0,01%<br>Accuracy: 0,05%<br>Response time: 80 ms<br>Life time: 2 years | Differential-paramagnetic<br>principle high speed<br>Range: 0 - 25%<br>Resolution: 0,01%<br>Accuracy: 0,05%<br>Response time: 40 ms<br>Life time: 2 years | Electro-chemical high speed<br>analyzer<br>Range: 0 - 25%<br>Resolution: 0,01%<br>Accuracy: 0,05%<br>Response time: 80 ms<br>Life time: 100 h or 1,5 years | | CO2<br>analyzer | Thermal conductive<br>Range: 0 - 10% | Infrared absorption principle<br>Range: 0 - 15% | Infrared absorption high<br>speed analyzer | | | Resolution: 0,01%<br>Accuracy: 0,05%<br>Response time: 80 ms<br>Life time: infinite | Resolution: 0,01%<br>Accuracy: 0,05%<br>Response time: 40 ms<br>Life time: infinite | Range: 0 - 15%<br>Resolution: 0,01%<br>Accuracy: 0,05% or 1%<br>Response time: 80 ms<br>Life 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 | | Environmental<br>specifications | Operating:<br>+10 to +34 °C<br>30% to 95% RH<br>700 to 1060 hPa<br>Storage:<br>-30 to +50 °C<br>10% to 95% RH<br>600 to 1200 hPa | Operating:<br>+10 to +40 °C<br>15% to 95% RH<br>500 to 1150 hPa<br>Storage:<br>-20 to +50 °C<br>10% to 95% RH<br>600 to 1200 hPa | Operating:<br>+10 to +34 °C<br>20% to 80% RH<br>800 to 1060 hPa<br>Storage:<br>-20 to +50 °C<br>15% to 95% RH<br>600 to 1200 hPa | | Measuring<br>programs | 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 Line<br>K122699 | | Vyntus CPX<br>(proposed device) | | Software | SentrySuite Software 2.x | | similar | | Software<br>platform<br>main<br>features | 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 | | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ ### 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. {10}------------------------------------------------ ### 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. --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K133925](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K133925) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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