(245 days)
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 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).
A qualified physician has to reassess all Vyntus/SentrySuite measurements. An interpretation by Vyntus/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 ECC 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.
Option Hi/Lo FiO2: The High/low FiO2 option of the Vyntus CPX is designed to measure the ventilation and the gas exchange (02 uptake, CO2 production) of a subject with varying inspiratory concentrations of O2.
This document primarily details a 510(k) premarket notification for the Vyntus/SentrySuite Product Line, specifically focusing on the addition of an option for High/Low FiO2. The submission aims to demonstrate substantial equivalence to previously cleared devices.
Here's an analysis of the provided text with respect to your requested information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a numerical or target performance metric for each characteristic. Instead, it refers to passing "applicable tests and standards" and meeting "user needs and design inputs." The performance data section focuses on demonstrating the device meets the technical specifications and accuracy of its predecessors.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Flow measurement | Range: 0 - 15 L/s, Accuracy: 70 mL/s or 3% | Passed applicable tests and standards; Identical to predicate device |
| Volume measurement | Range: 0 - 10 L, Accuracy: 50 mL or 2% | Passed applicable tests and standards; Identical to predicate device |
| Ventilation | Range: 0 - 300 L/min, Accuracy: 0.5 L/min or 2% | Passed applicable tests and standards; Identical to predicate device |
| V'O2, V'CO2 | Range: 0 - 7 L/min, Accuracy: 0.05 L/min or 3% | Passed applicable tests and standards; Identical to predicate device |
| RER | Range: 0.6 - 2.0, Accuracy: 4% | Passed applicable tests and standards; Identical to predicate device |
| Hi/Lo FiO2 Capability | Premixed inspiratory gases up to 100% O2 from manually filled bag | Passed applicable tests and standards; Identical to reference device (K992214) |
| Basic Safety | Compliance with IEC 60601-1 | Passed the applicable tests and standards |
| EMC Compatibility | Compliance with IEC 60601-1-2 | Passed the applicable tests and standards |
| Risk Management | Compliance with ISO 14971 | Passed the applicable tests and standards |
| Usability | Compliance with EN 62366 | Passed the applicable tests and standards |
| Software life cycle | Compliance with ISO 62304 | Passed the applicable tests and standards |
| Biocompatibility | Compliance with ISO 10993-1 | Passed the applicable tests and standards |
| Accuracy Testing | Accuracy of measurement (specifics not detailed for this general criteria) | Passed the applicable tests and standards |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench performance data and compliance with standards. It does not mention a specific "test set" in terms of patient data or a clinical study for the new High/Low FiO2 option. The testing appears to be centered on engineering and regulatory compliance rather than clinical performance data from a patient sample. Therefore, there is no information provided regarding sample size, country of origin, or retrospective/prospective nature of data for a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Given that clinical testing was not performed (stated explicitly), there is no information about experts used to establish ground truth for a clinical test set. The performance data is based on engineering tests against established technical specifications for pulmonary function devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical test set is described, there is no information on an adjudication method for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This submission is for a pulmonary function and cardio-pulmonary exercise testing device, not an AI-assisted diagnostic or interpretive system in the context of "human readers." While the Vyntus ECG component does offer automatic analysis and "suggestions for the interpretation," the document states these are "partial qualitative information" and "no therapy or drugs can be administered based solely on the interpretation statements." Furthermore, for the new option, no MRMC comparative effectiveness study is mentioned, nor is any AI assistance or effect size on human readers discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
While the device includes software with automated analysis for ECG, the focus of this submission is on the added High/Low FiO2 option for the CPX system and the overall compliance of the product line. No specific standalone performance study of an algorithm independent of the device's measurement capabilities is detailed. The performance testing section refers to "Accuracy Testing" as a general item but does not specify a standalone algorithm performance study.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the technical performance tests discussed (flow, volume, ventilation accuracy), the ground truth would typically be established by reference standards or highly accurate calibration devices that measure these physical parameters precisely. The document refers to "applicable tests and standards" for accuracy testing. For the non-clinical tests (safety, EMC, risk management, usability, software life cycle, biocompatibility), the ground truth is simply compliance with the respective international standards (e.g., IEC 60601-1, ISO 14971). There is no mention of ground truth based on expert consensus, pathology, or outcomes data, as clinical testing was not performed for this submission.
8. The sample size for the training set
The document states, "Clinical testing was not performed with this device." Therefore, there is no information on a training set or its sample size as no clinical data appears to have been used for an algorithm development for this specific submission's context.
9. How the ground truth for the training set was established
As no clinical training set is mentioned, there is no information provided on how ground truth for a training set was established.
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August 23, 2019
Vyaire Medical Elmar Niedermeyer Cnstl. Regulatory Affairs Leibnizstrasse 7 Hoechberg, 97204 De
Re: K183567
Trade/Device Name: Vyntus/SentrySuite Product Line Regulation Number: 21 CFR 868.1880 Regulation Name: Pulmonary-Function Data Calculator Regulatory Class: Class II Product Code: BZC, DPS Dated: July 23, 2019 Received: July 25, 2019
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for James J. Lee, PhD Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183567
Device Name
Vyntus/SentrySuite Product Line
Indications for Use (Describe)
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 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).
A qualified physician has to reassess all Vyntus/SentrySuite measurements. An interpretation by Vyntus/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 ECC 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.
Type of Use (Select one or both, as applicable)
| 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/0 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is in a dark blue, sans-serif font, with the "TM" symbol in the upper right corner. Below "Vyaire" is the word "MEDICAL" in a smaller, light blue, sans-serif font.
510(k) Summary
Colleen Watson
847-8473629
Vyaire Medical Inc.
26125 N. Riverwoods Blvd. Mettawa, IL 60045, USA + 847-786-5998 x110070
I. Type of Submission
Traditional 510(k) Date Prepared: August 21, 2019
| II. | Submitter |
|---|---|
| Name: | Vyaire Medical GmbH |
| Address: | Leibnizstrasse 7 |
| D-97204 Hoechberg | |
| Germany |
| Official Correspondent | Elmar Niedermeyer | US Agent |
|---|---|---|
| Address: | CareFusion Germany 234 GmbHLeibnizstrasse 7, 97204 HoechbergGermany | Address |
| Phone: | +49 931 49 72 - 361 | Phone: |
| FAX: | +49 931 49 72 - 62361 | Fax: |
| elmar.niedermeyer@vyaire.com | E-mail: |
| III. | Establishment Registration Number |
|---|---|
| 9615102 |
IV. Common Name or Classification Name
Pulmonary function data calculator (Primary) (CFR 868.1880, Product Code BZC) Electrocardiograph (Secondary) (CFR 870.2340, Product Code DPS)
V. Trade Name
Vyntus/SentrySuite Product Line
VI. Device Classification
This is a Class II device
VII. Classification Panel
73 Anesthesiology Part 868 (Primary) 74 Cardiovascular Part 870 (Secondary)
VIII. Reason for Premarket Notification
New medical device, new option Hi/Lo FiO2, Software SentrySuite 3.0 (update)
IX. Legally predicate marketed devices
Vyntus / SentrySuite Product Line K150810 Code BZC, DPS Predicate Device Company: Vyaire Medical GmbH
X. Reference Devices
K992214 Code BZC, DPS, MWI, MLC Oxycon Pro Reference Device Company: Vyaire Medical GmbH
XI. Device Description
Option Hi/Lo FiO2: The High/low FiO2 option of the Vyntus CPX is designed to measure the ventilation and the gas exchange (02 uptake, CO2 production) of a subject with varying inspiratory concentrations of O2.
Vyaire Medical GmbH
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XII. 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). A qualified physician has to reasess all Vyntus/SentrySuite measurements. An interpretation by Vyntus/SentrySuite is only significant if i 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 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 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.
XIIII. Required Components
- Vyntus CPX / ECG with SentrySuite Software ●
- Instruction for Use
- Option Hi/Lo FiO2
- HR-valve 2730 complete ●
- Breathing bag
- DVT complete for High / Low FiO2 ●
- Hans-Rudolph inhaler adapter ●
- Filling assembly for bag ●
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XIV. 5.14 Summary Table of Comparison
| Comparison to predicate devices SentrySuite Product Line Predicate K150810 &Reference Device Oxycon Pro K992214 | |||
|---|---|---|---|
| Oxycon ProK992214Reference Device | Vyntus/SentrySuite Product LineK150810Predicate | Vyntus/SentrySuite ProductLine(with Hi/Lo FiO2) | |
| Indication forUse | Oxycon Pro is a software-drivenmedical device for exercisemeasurements, includingECG ST Segment Analysis and/orECG Stress Analysis. It measuresthe human response to increasingworkloads with emphasis on the gasexchange parameters.Measurements include ventilation,oxygen uptake, carbon dioxideexcretion, heart rate and derivedparameters. The results of the tests,including the ECG wave forms, canbe viewed on the computer screenand can be printed during the test.The test results can be saved on thecomputer hard disk for furtherreferral or report generationpurposes.The Oxycon Pro interfaces to a testsubject via mouthpiece or a facemask and ECG electrodes. TheOxycon Pro interfaces to aperipheral ergometer or treadmill.The patient population is 4 yearsand 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. | The Vyntus/SentrySuite product line isintended to be used for measurements,data collection and analysis of lungfunction (PFT) and cardio-pulmonary(CPET) parameters, aiding in thediagnosis of related conditions. Theresults of the test can be viewed onlinewith the help of a computer screen andcan be printed after the test. The testresults can be saved for future referenceor report generation purposes.The products can be utilized withpatients age 4 years and older as long asthey can cooperate in the performance -no special limit to patient's sex or heightexists. Measurements will be performedunder the direction of a physician in ahospital environment, physician's officeor similar setting (professionalhealthcare facilities). A qualifiedphysician has to reassess allVyntus/SentrySuite measurements. Aninterpretation by Vyntus/SentrySuite isonly significant if it is considered inconnection with other clinical findings.Additional for Vyntus ECG:The Vyntus ECG is intended formeasuring the surface electro-cardiogram (ECG) of a patient. Theacquired ECG can be recorded anddisplayed on the screen or printed onpaper. 12-lead ECGs are analyzedautomatically and suggestions for theinterpretation of the resting ECG can bemade by the software. ECGinterpretation statements made by theVyntus/SentrySuite represent partialqualitative and quantitative informationon the patient's cardiovas-cularcondition and no therapy or drugs can beadministered based solely on theinterpretation statements. The VyntusECG can be used for non-interpretiveapplications in patients age 4 years andolder and a weight of 20 kg or higher.The Vyntus ECG is intended to be usedfor routine ECG collection, recordingboth under resting and stress conditions. | Identical(to Predicate K150810) |
| trained healthcare professionals underthe direction of a physician in healthcarefacilities (e.g. the doctor's office orhospital). The Vyntus ECG is notintended for intracranial use. The VyntusECG is not intended for use in an EMSenvironment (Emergency MedicalServices Environment). The VyntusECG is not intended for use in homehealthcare environments. Automaticinterpretation of the ECG is not possiblefor pediatric and adolescent patientsbelow 16 years of age and for patientswith pacemakers. | |||
| IntendedPatientpopulation | The patient population is 4 yearsand older. | 4 years and older and a weight of 20 kgor higher | Identical(to Predicate K150810) |
| SoftwarePlatform | JLab Software | SentrySuite Software | Identical(to Predicate K150810) |
| SoftwareVersion | JLab version 5.7 | SentrySuite version 2.13 | SentrySuite version 3.0 |
| Perfor-mance(measuringprograms) | Slow Spirometry Forced Spirometry MVV Breath-by-Breath Indirect Calorimetry Resting ECG Stress ECG | Slow Spirometry Forced Spirometry MVV Breath-by-Breath Indirect Calorimetry Resting ECG Stress ECG | Identical |
| High/Low FiO2 | Identical(to Reference K992214) | ||
| Intrabreath Respiratory Drive P0.1 Mixing Chamber | |||
| Perfor-mance(technical dataand accuracy) | Flow measurementRange: 0 - 15 L/sAccuracy: 70 mL/s or 3%Volume measurementRange: 0 - 10 LAccuracy: 50 mL or 2%VentilationRange: 0 - 300 L/minAccuracy: 0.05 L/min or 2%V'O2, V'CO2Range: 0 - 7 L/minAccuracy: 0.05 L/min or 3%RERRange: 0.6 - 2.0Accuracy: 4% | Flow measurementRange: 0 - 15 L/sAccuracy: 70 mL/s or 3%Volume measurementRange: 0 - 10 LAccuracy: 50 mL or 2%VentilationRange: 0 - 300 L/minAccuracy: 0.5 L/min or 2%V'O2, V'CO2Range: 0 - 7 L/minAccuracy: 0.05 L/min or 3%RERRange: 0.6 - 2.0Accuracy: 4% | Identical |
| Hi/Lo Fi O2Premixed inspiratory gases up to100% O2 from manually filled bag | Identical(to Reference K992214) | ||
| Sterilization | The device along with itsaccessories is neither suppliedsterile nor intended to be sterilized | The device along with its accessories isneithersupplied sterile nor intended to besterilized | Identical |
Comparison to predicate devices SentrySuite Product Line Predicate K150810 &
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Summary of technological characteristic compared to the predicate / reference device to the table above:
- The new Vyntus/SentrySuite Product Line with option Hi/Lo FiO2 is identical in indication for use compared to the ● predicate Vyntus/SentrySuite Product Line K150810.
- The patient population for the proposed device is identical to the predicate device Vyntus/SentrySuite Product Line with K150810.
- . The Software platform for the proposed device is identical to the predicate Vyntus/SentrySuite Product Line K150810. Both devices use the software SentrySuite and differ only in software version for the proposed device is the SentrySuite version 3.0.
- . The measuring programs & accuracy of the proposed device are identical to the predicate device. Except the new measurement Hi/Lo FiO2 is identical to the reference device Oxycon Pro K992214.
XV. Summary of Device Testing
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. | Accuracy Testing | Accuracy of measurement | The proposed device passes the applicable tests and standards |
Summary Discussion of Bench Performance Data
The Vyaire Medical GmbH Vyntus SentrySuite Product Line with the option Hi/Lo FiO2 passed all specified test requirements. The validation and verification testing confirmed this device with the option Hi/Lo FiO2 meets user needs and design inputs for PFT and CPET.
Testing also confirmed physical attributes and device performance meet the standards listed in the performance testing summary above. These standards address basic safety, EMC compatibility, software life cycle and biocompatibility. All testing which have been performed demonstrate substantial equivalence to the predicate devices.
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.
Conclusion drawn from non-clinical and clinical data:
The Vyaire Medical GmbH CPET system with the new option HilLo FiO2 meets the functional claims and intended in the product labeling. The Vyntus/SentrySuite Product Line is substantially equivalent to the predicate devices described in the submission.
XVI. Conclusion
Based on the above. Vyaire Medical GmbH concludes that the Vyntus/SentrySuite Product Line with the new option Hi/Lo FiO2 is substantially equivalent to the legally marketed predicate devices.
§ 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).