(242 days)
No
The description focuses on standard physiological measurements and calculations, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is used for measurement, data collection, and analysis to aid in diagnosis, not to provide therapy.
Yes.
Explanation: The "Intended Use / Indications for Use" section explicitly states that the product line "aids in the diagnosis of related conditions." This directly indicates its role as a diagnostic device.
No
The device description clearly outlines hardware components such as a stationary, mains powered ergospirometry system, facemask or mouth-piece, cable connection, digital volume transducer (DVT), Nafion tubes, and gas analyzers. While software is used for calculations and data management, it is integral to and dependent on this hardware.
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. They are used to examine these samples outside of the body.
- Device Function: The Vyntus/SentrySuite product line measures lung function and cardio-pulmonary parameters by analyzing gases breathed in and out by the patient. While it analyzes gas samples, these samples are taken directly from the patient's breath during the test, not from a collected bodily fluid or tissue sample.
- Intended Use: The intended use describes measurements, data collection, and analysis of physiological parameters (lung function and cardio-pulmonary). This is a direct measurement of the body's function, not an analysis of a sample taken from the body.
- Device Description: The description details the measurement of gas volume and analysis of O2 and CO2 content in the breath. This is a measurement of respiratory gas exchange, not an analysis of a bodily fluid or tissue sample.
Therefore, while the device performs analysis, it does so on gases directly involved in the patient's physiological process during the test, not on a sample collected for in vitro examination.
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. 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).
Product codes (comma separated list FDA assigned to the subject device)
BZC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung, cardio-pulmonary
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).
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: IEC 60601-1, The proposed device passes the applicable tests and standards
- EMC Compatibility: IEC 60601-1-2, The proposed device passes the applicable tests and standards
- Risk Management: ISO 14971, The proposed device passes the applicable tests and standards
- Usability: EN 62366, The proposed device passes the applicable tests and standards
- Software life cycle: ISO 62304, The proposed device passes the applicable tests and standards
- Biocompatibility: ISO 10993-1, The proposed device passes the applicable tests and standards
- ATS / ERS: Standard of lung function testing, The proposed device passes the applicable tests and standards
- Climatic Chamber test: Environmental testing according specifications, The proposed device passes the applicable tests and standards
- 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.
Clinical Performance Data/Information: Clinical testing was not performed with this device.
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.
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.
Not Found
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).
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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 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 ____________________________________________________________________________________________________________________________________________________________________
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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 GmbH |
| Leibnizstrasse 7, 97204 Hoechberg | |
| Germany | |
| Phone: | +49 931 49 72 - 361 |
| FAX: | +49 931 49 72 - 62361 |
| 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:
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: