(245 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found". While the device performs automatic analysis and interpretation suggestions for ECGs, the summary does not indicate that these functions utilize AI or ML technologies.
No.
The device is intended for measurements, data collection, and analysis for diagnosis, not for therapy or treatment. The text explicitly states that "no therapy or drugs can be administered based solely on the interpretation statements."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "aiding in the diagnosis of related conditions." It also mentions automatic analysis of 12-lead ECGs and suggestions for interpretation, which are components of a diagnostic process.
No
The device description mentions "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 strongly implies the presence of hardware components for gas measurement and delivery, making it more than just software. Additionally, the performance studies mention testing for "Basic Safety (IEC 60601-1)" and "Biocompatibility (ISO 10993-1)", which are typically associated with hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Vyntus/SentrySuite Product Line measures lung function (PFT) and cardio-pulmonary (CPET) parameters, and the Vyntus ECG measures surface electrocardiograms. These are physiological measurements taken directly from the patient's body, not tests performed on samples in vitro (in a lab setting).
- Intended Use: The intended use describes the device as aiding in the diagnosis of related conditions by measuring these physiological parameters. This aligns with the function of a medical device used for physiological monitoring and assessment, not an IVD.
Therefore, while this device is a medical device used for diagnostic purposes, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
BZC, DPS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
4 years and older
Intended User / Care Setting
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.
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests conducted for determination of substantial equivalence:
- Basic Safety, Standard/Test: IEC 60601-1, Results Summary: The proposed device passes the applicable tests and standards
- EMC Compatibility, Standard/Test: IEC 60601-1-2, Results Summary: The proposed device passes the applicable tests and standards
- Risk Management, Standard/Test: ISO 14971, Results Summary: The proposed device passes the applicable tests and standards
- Usability, Standard/Test: EN 62366, Results Summary: The proposed device passes the applicable tests and standards
- Software life cycle, Standard/Test: ISO 62304, Results Summary: The proposed device passes the applicable tests and standards
- Biocompatibility, Standard/Test: ISO 10993-1, Results Summary: The proposed device passes the applicable tests and standards
- Accuracy Testing, Standard/Test: Accuracy of measurement, Results Summary: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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
1
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
2
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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3
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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 GmbH | |
| Leibnizstrasse 7, 97204 Hoechberg | ||
| Germany | 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
4
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 ●
5
XIV. 5.14 Summary Table of Comparison
| Comparison to predicate devices SentrySuite Product Line Predicate K150810 &
| Reference Device Oxycon Pro K992214 | |||
|---|---|---|---|
| Oxycon Pro | |||
| K992214 | |||
| Reference Device | Vyntus/SentrySuite Product Line | ||
| K150810 | |||
| Predicate | Vyntus/SentrySuite Product | ||
| Line | |||
| (with Hi/Lo FiO2) | |||
| Indication for | |||
| Use | Oxycon Pro is a software-driven | ||
| medical device for exercise | |||
| measurements, including | |||
| ECG ST Segment Analysis and/or | |||
| ECG Stress Analysis. It measures | |||
| the human response to increasing | |||
| workloads with emphasis on the gas | |||
| exchange parameters. | |||
| Measurements include ventilation, | |||
| oxygen uptake, carbon dioxide | |||
| excretion, heart rate and derived | |||
| parameters. The results of the tests, | |||
| including the ECG wave forms, can | |||
| be viewed on the computer screen | |||
| and can be printed during the test. | |||
| The test results can be saved on the | |||
| computer hard disk for further | |||
| referral or report generation | |||
| purposes. | |||
| The Oxycon Pro interfaces to a test | |||
| subject via mouthpiece or a face | |||
| mask and ECG electrodes. The | |||
| Oxycon Pro interfaces to a | |||
| peripheral ergometer or treadmill. | |||
| The patient population is 4 years | |||
| and older. | |||
| The Oxycon Pro is capable of | |||
| performing computerized ECG | |||
| interpretation during resting | |||
| condition. | |||
| The intended use locations are | |||
| either in a physician office, hospital | |||
| exercise rehabilitation facilities, or | |||
| similar areas. It is intended to be | |||
| used by or on the order of a | |||
| physician or similar qualified health | |||
| care professional. This device is | |||
| intended for use in the hospital | |||
| environment, physician's office, or | |||
| similar settings. This device is not | |||
| intended for home 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 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 electro- | |||
| cardiogram (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 cardiovas-cular | |||
| 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. | Identical | ||
| (to Predicate K150810) | |||
| 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. | |||
| Intended | |||
| Patient | |||
| population | The patient population is 4 years | ||
| and older. | 4 years and older and a weight of 20 kg | ||
| or higher | Identical | ||
| (to Predicate K150810) | |||
| Software | |||
| Platform | JLab Software | SentrySuite Software | Identical |
| (to Predicate K150810) | |||
| Software | |||
| Version | JLab version 5.7 | SentrySuite version 2.13 | SentrySuite version 3.0 |
| Perfor-mance | |||
| (measuring | |||
| programs) | 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 data | |||
| and accuracy) | Flow measurement | ||
| Range: 0 - 15 L/s | |||
| Accuracy: 70 mL/s or 3% | |||
| Volume measurement | |||
| Range: 0 - 10 L | |||
| Accuracy: 50 mL or 2% | |||
| Ventilation | |||
| Range: 0 - 300 L/min | |||
| Accuracy: 0.05 L/min or 2% | |||
| V'O2, V'CO2 | |||
| Range: 0 - 7 L/min | |||
| Accuracy: 0.05 L/min or 3% | |||
| RER | |||
| Range: 0.6 - 2.0 | |||
| Accuracy: 4% | Flow measurement | ||
| Range: 0 - 15 L/s | |||
| Accuracy: 70 mL/s or 3% | |||
| Volume measurement | |||
| Range: 0 - 10 L | |||
| Accuracy: 50 mL or 2% | |||
| Ventilation | |||
| Range: 0 - 300 L/min | |||
| Accuracy: 0.5 L/min or 2% | |||
| V'O2, V'CO2 | |||
| Range: 0 - 7 L/min | |||
| Accuracy: 0.05 L/min or 3% | |||
| RER | |||
| Range: 0.6 - 2.0 | |||
| Accuracy: 4% | Identical | ||
| Hi/Lo Fi O2 | |||
| Premixed inspiratory gases up to | |||
| 100% O2 from manually filled bag | Identical | ||
| (to Reference K992214) | |||
| Sterilization | The device along with its | ||
| accessories is neither supplied | |||
| sterile nor intended to be sterilized | The device along with its accessories is | ||
| neither | |||
| supplied sterile nor intended to be | |||
| sterilized | Identical |
Comparison to predicate devices SentrySuite Product Line Predicate K150810 &
6
7
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.