(141 days)
Not Found
No
The document mentions "Automatic analysis by HES stress/resting algorithm package" and "Arrhythmia detection," which are standard signal processing and algorithmic techniques in ECG analysis, not necessarily indicative of AI/ML. There is no mention of AI, ML, deep learning, or any related terms.
No.
The device is intended for measurements, data collection, and analysis to aid in diagnosis, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section states that the Vyntus/SentrySuite Product Line is "aiding in the diagnosis of related conditions." Specifically, the Vyntus ECG "12-lead ECGs are analyzed automatically and suggestions for the interpretation of the resting ECG can be made by the software." This indicates its role in providing information for diagnostic purposes.
No
The device description explicitly mentions hardware components like a "wireless, battery operated ECG amplifier" and "surface electrodes," which are essential for acquiring the ECG signals. While software is used for analysis and display, the device is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Vyntus/SentrySuite Product Line, including the Vyntus ECG, measures physiological parameters directly from the patient (lung function, cardio-pulmonary parameters, and surface electrocardiogram). It does not analyze samples like blood, urine, or tissue.
- The intended use focuses on measuring and analyzing physiological signals. The description clearly states the device is for "measurements, data collection and analysis of lung function (PFT) and cardio-pulmonary (CPET) parameters" and "measuring the surface electrocardiogram (ECG)".
- The device description details the recording and processing of electrical signals from the body. This aligns with a diagnostic device that interacts directly with the patient, not an IVD that analyzes samples.
Therefore, while this device is a diagnostic tool used in healthcare settings, it falls under the category of a medical device rather than 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. 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 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.
Product codes
BZC, DPS
Device Description
The Vyntus ECG is the perfect 12-Lead PC-ECG extension for the Vyntus CPX via secure Bluetooth® communication. One integrated solution through the SentrySuite platform helps laboratories ease procedures and integration to reduce costs.
The Vyntus ECG records the full 12-lead resting and stress ECG via its wireless, battery operated ECG amplifier. The evaluation and interpretation is using the proven Hannover ECG System (HES).
Scientific Concept:
The surface electrodes of the Vyntus ECG record the electrical signals that are mainly generated by the heart muscle activity and repolarization. The small voltages are amplified and A/D converted. A low frequency high-pass filter is applied and the recorded signals are transmitted to the PC for recording, storing, evaluation, interpretation, display and reporting.
Significant performance characteristics:
- Full 12 lead ECG
- Small, low weight (
§ 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 seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem that resembles an abstract representation of an eagle or a similar bird, with stylized feathers or wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 14, 2015
CareFusion Germany 234 GmbH Elmar Niedermeyer Consult, Regulatory Affairs Leibnizstrasse 7 Hoechberg, Bavaria 97204 Germany
Re: K150810
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 14, 2015 Received: July 17, 2015
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150810
Page 1 of 1
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/1 description: The image contains the CareFusion logo. The logo consists of an orange circle with a white shield inside, with a portion of the shield colored yellow. To the right of the circle is the text "CareFusion" in a dark gray sans-serif font. The logo is simple and modern, with a focus on the company name.
510(k) Summary
GENERAL INFORMATION
Type of Submission 5.1
Traditional 510(k) Submission
Submission date: 16/03/2015
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 |
4
5.3 Establishment Registration Number 9615102
5.4 Common Name or Classification Name
Pulmonary-function data calculator (CFR 868.1880, Product Code BZC) Electrocardiograph (CFR 870.2340, Product Code DPS)
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 (primary) 74 Cardiovascular Part 870 Code DPS (secondary)
5.8 Reason for Premarket Notification
- new medical device .
- additional cart 3.0 to available cart 2.0
5.9 Legally predicate marketed devices
- MasterScope ECG ● K082539 Code BTY, DPS
- Cor12+ K091505 Code DSH ●
- Vyntus / SentrySuite Product line K133925 Code BZC .
5.10 Predicate Device Company
- Cardinal Health Germany 234 GmbH (now CareFusion Germany 234 GmbH)
- . Cardinal Health Germany 234 GmbH (now CareFusion Germany 234 GmbH)
- . CareFusion Germany 234 GmbH
5.11 Device Description
Description & function:
The Vyntus ECG is the perfect 12-Lead PC-ECG extension for the Vyntus CPX via secure Bluetooth® communication. One integrated solution through the SentrySuite platform helps laboratories ease procedures and integration to reduce costs.
The Vyntus ECG records the full 12-lead resting and stress ECG via its wireless, battery operated ECG amplifier. The evaluation and interpretation is using the proven Hannover ECG System (HES).
5
Scientific Concept:
The surface electrodes of the Vyntus ECG record the electrical signals that are mainly generated by the heart muscle activity and repolarization. The small voltages are amplified and A/D converted. A low frequency high-pass filter is applied and the recorded signals are transmitted to the PC for recording, storing, evaluation, interpretation, display and reporting.
Significant performance characteristics:
- Full 12 lead ECG O
- Small, low weight (