(172 days)
No
The summary mentions "automatic analysis" and "suggestions for interpretation" for the ECG, but does not use terms like AI, ML, or describe any training or test sets, which are typical indicators of AI/ML implementation in medical devices.
No.
The device is intended for measurements, data collection, and analysis to aid in diagnosis, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product line is "aiding in the diagnosis of related conditions."
No
The device description explicitly details multiple hardware components, including a main unit with gas analyzers, a patient interface, an ultrasound flow sensor, a cart, a digital volume transducer, and an optional SpO2 pulse oximeter and ECG hardware. While software is mentioned for analysis and interpretation, it is integrated with and dependent on this physical hardware.
Based on the provided information, the Vyntus ONE / SentrySuite product line is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Vyntus ONE / SentrySuite Function: The Vyntus ONE / SentrySuite product line measures physiological parameters directly from the patient's body (lung function and electrical activity of the heart). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "measurements, data collection and analysis of lung function (PFT) and cardio-pulmonary (CPET) parameters," and "measuring the surface electrocardiogram (ECG)." These are direct physiological measurements, not analysis of in vitro samples.
Therefore, the Vyntus ONE / SentrySuite product line falls under the category of medical devices that perform physiological measurements, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Vyntus ONE / 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 aged 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 ONE / 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 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 ONE is a full pulmonary function test (PFT) system, consisting of a main unit with the gas analyzers and electronics inside, a patient interface with a Flow Path Valve eDemand and an electronic demand valve inside and an ultrasound flow sensor (USS). The entire equipment is mounted on a cart which includes the isolation transformer and the support arm for the patient interface and the USS.
The Vyntus ONE is connected via USB interface to the desktop PC and enables the following standard measurements:
- Diffusion SB Realtime
- Diffusion SB Intra-breath
- FRC N2 washout
- Slow/forced spirometry and MVV
The Vyntus ONE also supports cardiopulmonary exercise testing (CPET). The specific hardware consists of the light-weight digital volume transducer (DVT) and an optional SpO2 pulse oximeter. It enables the following standard measurement features:
- Breath-by-breath (BxB) gas exchange
- Workload control for bicycle ergometer or treadmills
- Automatic workload protocols
Further optional hardware and software include:
- Vyntus ECG: 12-lead Electrocardiogram (ECG) recording (resting and stress ECG)
- ROcc, P0.1, MIP / MEP measurements
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). The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.q. the doctor's office or hospital).
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 included: Risk Management (ISO 14971), Usability (EN 62366), Software life cycle (ISO 62304), Basic Safety (IEC 60601-1), EMC Compatibility (IEC 60601-2), Biocompatibility (ISO 10993), Accuracy Testing (Measurement effectiveness & accuracy), Climatic Chamber test (Environmental testing according specifications), and ATS / ERS (Standard for lung function testing).
All tests passed, indicating the device meets user needs and design inputs for a pulmonary function testing system and that physical attributes and device performance meet the requirements of the listed standards. All performed testing demonstrates substantial equivalence to the predicate devices.
Clinical Performance Data/Information: Clinical testing was not performed with this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" and the words "U.S. FOOD & DRUG ADMINISTRATION".
November 30, 2018
Vyaire Medical, Inc. Elmar Niedermeyer Manager, Regulatory Affairs Leibnizstrasse 7 Hoechber, 97204 De
Re: K181524
Trade/Device Name: Vyntus ONE Regulation Number: 21 CFR 868.1880 Regulation Name: Pulmonary-Function Data Calculator Regulatory Class: Class II Product Code: BZC, DPS Dated: October 31, 2018 Received: November 2, 2018
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
James J. Lee -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181524
Device Name Vyntus ONE
Indications for Use (Describe)
The Vyntus ONE / 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 aged 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 ONE / 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 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is in a large, bold, blue font. Below that, the word "MEDICAL" is in a smaller, light blue font. The letters in "MEDICAL" are spaced out.
510(k) Summary
GENERAL INFORMATION
5.1 Type of Submission
Traditional 510(k) Submission
Submission date: 2018/05/24
5.2 Submitter
| Name: | Vyaire Medical, Inc. |
|---|---|
| (Doing business as 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@vyaire.com |
Contact person in the U.S.:
(U.S. Agent) Address
Phone:
E-mail:
Fax:
Colleen Watson
Vyaire Medical Inc. 26125 N. Riverwoods Blvd. Mettawa, IL 60045, USA 224-7066818 847-8473629 Colleen.Okeeffe@vyaire.com
4
5.3 Establishment Registration Number 9615102
5.4 Common Name or Classification Name Pulmonary function data calculator (Primary) (CFR 868.1880, Product Code BZC) Electrocardiograph (Secondary) (CFR 870.2340, Product Code DPS)
- 5.5 Trade Name Vyntus ONE
- 5.6 Device Classification This is a Class II device
5.7 Classification Panel 73 Anesthesiology Part 868 (Primary) 74 Cardiovascular Part 870 (Secondary)
5.8 Reason for Premarket Notification
- . new medical device
5.9 Legally predicate marketed devices
- Vyntus / SentrySuite Product Line . K150810 Code BZC, DPS
Predicate Device Company: Vyaire Medical, Inc. (Doing business as CareFusion Germany 234 GmbH)
5.10 Reference Devices
- SentrySuite Product line
- MasterScreen Pneumo USS .
- . Vmax Series
K122699 Code BZC, JEH, BZG, BTY K071753 Code BTY K942211 Code BTY
Reference Device Company: Vyaire Medical, Inc. (Doing business as CareFusion Germany 234 GmbH)
5
5.11 Device Description
Description & function:
The Vyntus ONE is a full pulmonary function test (PFT) system, consisting of a main unit with the gas analyzers and electronics inside, a patient interface with a Flow Path Valve eDemand and an electronic demand valve inside and an ultrasound flow sensor (USS). The entire equipment is mounted on a cart which includes the isolation transformer and the support arm for the patient interface and the USS.
The Vyntus ONE is connected via USB interface to the desktop PC and enables the following standard measurements:
- · Diffusion SB Realtime
- Diffusion SB Intra-breath
- FRC N2 washout
- Slow/forced spirometry and MVV
The Vyntus ONE also supports cardiopulmonary exercise testing (CPET). The specific hardware consists of the light-weight digital volume transducer (DVT) and an optional SpO2 pulse oximeter. It enables the following standard measurement features:
- Breath-by-breath (BxB) gas exchange
- · Workload control for bicycle ergometer or treadmills
- · Automatic workload protocols
Further optional hardware and software include:
• Vyntus ECG: 12-lead Electrocardiogram (ECG) recording (resting and stress ECG)
- · ROcc, P0.1, MIP / MEP measurements
5.12 Intended Use Statement
The Vyntus ONE / SentrySuite product line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardiopulmonary (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 aged 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 ONE / 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
6
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.q. 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.
5.13 Required Components
- PC o
- CART 3.0N / 3.1N O
- Vyntus ONE main unit O
- USS module o
- FPV (Flow Path Valve) O
- Control Unit FPV eDemand o
- Vyntus ECG O
- o SentrySuite Software
- Instruction for Use o
- Accessories o
7
5.14 Summary Table of Comparison
| | Vyntus / SentrySuite
Product Line
K150810
(Predicate device) | SentrySuite
Product Line
K122699
(Reference device) | Vmax
K942211
(Reference device) | MasterScreen
Pneumo
K071753
(Reference device) | Vyntus ONE
(new device) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication
for Use | Pulmonary function testing | ---------------- | ---------------- | ---------------- | Identical |
| Target
population | 4 years on and older | ---------------- | ---------------- | ---------------- | Identical |
| Software
used | SentrySuite
(Version 2.13) | ---------------- | ---------------- | ---------------- | SentrySuite
(Version 2.21) |
| Software
Network
options | Use as Workstation Use as Server Online connection Vlink connection GDT connection Sentry.NET
(mobile Review) Data integration Database handling JINET server | ---------------- | ---------------- | ---------------- | Identical |
| Performance
(measuring
programs) | Slow Spirometry Incentive Spirometry Forced Spirometry MVV | Slow Spirometry Incentive Spirometry Forced Spirometry MVV | ---------------- | ---------------- | Identical |
| | | Diffusion SB Realtime Diffusion SB
Intrabreath R Occlusion Respiratory Drive P0.1 MIP / MEP | ---------------- | ---------------- | Identical |
| | Vyntus / SentrySuite
Product Line
K150810
(Predicate device) | SentrySuite
Product Line
K122699
(Reference device) | Vmax
K942211
(Reference device) | MasterScreen
Pneumo
K071753
(Reference device) | Vyntus ONE
(new device) |
| Performance
(measuring
programs) | • Breath-by-breath (BxB)
• Resting ECG
• Stress ECG
• Indirect Calorimetry | ---------------- | ---------------- | ---------------- | Identical |
| | ---------------- | ---------------- | • Functional Residual
Capacity (FRC) by
Nitrogen (N2)
washout | ---------------- | Identical |
| Patient direct
contacting
parts | • Full face CPET
masks
• Single Use
mouthpiece
• Silicone mouthpiece
• Nose clip
• Nose clip pad
• Head gear | ---------------- | ---------------- | ---------------- | Identical |
| | ---------------- | • Single Use
mouthpiece
• Silicone mouthpiece
• Nose clip
• Nose clip pad
• MicroGard II Filter | ---------------- | ---------------- | Identical |
| Biocompati-
bility | Patient user interface
• Digital Volume
Transducer
• Full face CPET mask | ---------------- | ---------------- | ---------------- | Identical |
| | ---------------- | ---------------- | ---------------- | Patient user interface
• ultrasonic flow sensor
• Shutter | Patient user interface
• ultrasonic flow sensor
(new material)
• Flow Path Valve
(new material) |
| Sterilization | The device along with its | ---------------- | ---------------- | ---------------- | Identical |
| | Vyntus / SentrySuite
Product Line
K150810
(Predicate device)
accessories is neither
supplied sterile nor
intended to be sterilized | SentrySuite
Product Line
K122699
(Reference device) | Vmax
K942211
(Reference device) | MasterScreen
Pneumo
K071753
(Reference device) | Vyntus ONE
(new device) |
| Cleaning
Validation | Validation of Instrument
disinfection & Surface
disinfection | ---------------- | ---------------- | ---------------- | Validation according FDA
Guidance: Reprocessing
Medical Devices in Health
Care Settings: Validation
Methods and Labeling |
| Human
factors | Usability testing acc.
IEC 60601-1-6 and
related IEC 62366;
Usability Engineering File
& Usability report | ---------------- | ---------------- | ---------------- | Usability testing acc.
IEC 60601-1-6 and
related IEC 62366;
Usability Engineering
File & Usability report |
| Energy used | 100 – 240V / 50 – 60Hz | ---------------- | ---------------- | ---------------- | Identical |
| Patent user
Interface
technique | • Digital Volume
Transducer technique | ---------------- | ---------------- | ---------------- | Identical |
| | | ---------------- | ---------------- | • ultrasonic flow sensor
technique | Identical |
| Patient user
Interface
Specification | Digital Volume Transducer
• Flow: 0 – 15 L/s (3%)
• Volume: 0 – 10 L (2%)
• Resolution: 3ml
• Resistance: