Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART

K181524 · Vyaire Medical, Inc. · BZC · Nov 30, 2018 · Anesthesiology

Device Facts

• Record ID: K181524
• Device Name: Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
• Applicant: Vyaire Medical, Inc.
• Product Code: BZC · Anesthesiology
• Decision Date: Nov 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1880
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Vyntus ONE is a pulmonary function test (PFT) and cardiopulmonary exercise testing (CPET) system. Inputs include respiratory gas exchange data via ultrasound flow sensor (USS) and digital volume transducer (DVT), plus optional SpO2 and 12-lead ECG signals. System comprises a main unit, patient interface (Flow Path Valve eDemand), and cart-mounted PC running SentrySuite software. Operated by trained healthcare professionals in hospitals or clinics under physician direction. Software processes inputs to provide PFT/CPET parameters and automated ECG interpretation suggestions. Output displayed on screen or printed for physician review. Device aids diagnosis of lung and cardiovascular conditions; requires physician reassessment of all measurements. Benefits include standardized lung function assessment and integrated diagnostic data collection.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including risk management (ISO 14971), usability (EN 62366), software life cycle (ISO 62304), electrical safety (IEC 60601-1), EMC (IEC 60601-2), biocompatibility (ISO 10993), and performance accuracy testing against ATS/ERS standards.

Technological Characteristics

System includes ultrasonic flow sensor, digital volume transducer, and 12-lead ECG module. Materials tested per ISO 10993. Connectivity via USB to PC. Power: 100–240V, 50–60Hz. Software: SentrySuite (v2.21). Compliance: IEC 60601-1, IEC 60601-2, ISO 14971, ISO 62304.

Indications for Use

Indicated for patients aged 4 years and older (ECG: 20kg+ weight) for lung function (PFT) and cardio-pulmonary (CPET) measurements, and surface ECG recording. Contraindications: ECG interpretation not for patients <16 years or with pacemakers; not for intracranial use, EMS, or home environments.

Regulatory Classification

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.

Predicate Devices

• Vyntus / SentrySuite Product Line (K150810)

Reference Devices

• SentrySuite Product line (K122699)
• MasterScreen Pneumo (K071753)
• Vmax Series (K942211)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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### 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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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: | [phone] - 361 |
| FAX: | [phone] - 62361 |
| E-mail | [e-mail] |

### 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 [e-mail]

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#### 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)

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#### 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

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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

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## 5.14 Summary Table of Comparison

| | Vyntus / SentrySuite<br>Product Line<br>K150810<br>(Predicate device) | SentrySuite<br>Product Line<br>K122699<br>(Reference device) | Vmax<br>K942211<br>(Reference device) | MasterScreen<br>Pneumo<br>K071753<br>(Reference device) | Vyntus ONE<br>(new device) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication<br>for Use | Pulmonary function testing | ---------------- | ---------------- | ---------------- | Identical |
| Target<br>population | 4 years on and older | ---------------- | ---------------- | ---------------- | Identical |
| Software<br>used | SentrySuite<br>(Version 2.13) | ---------------- | ---------------- | ---------------- | SentrySuite<br>(Version 2.21) |
| Software<br>Network<br>options | Use as Workstation Use as Server Online connection Vlink connection GDT connection Sentry.NET<br>(mobile Review) Data integration Database handling JINET server | ---------------- | ---------------- | ---------------- | Identical |
| Performance<br>(measuring<br>programs) | Slow Spirometry Incentive Spirometry Forced Spirometry MVV | Slow Spirometry Incentive Spirometry Forced Spirometry MVV | ---------------- | ---------------- | Identical |
| | | Diffusion SB Realtime Diffusion SB<br>Intrabreath R Occlusion Respiratory Drive P0.1 MIP / MEP | ---------------- | ---------------- | Identical |
| | Vyntus / SentrySuite<br>Product Line<br>K150810<br>(Predicate device) | SentrySuite<br>Product Line<br>K122699<br>(Reference device) | Vmax<br>K942211<br>(Reference device) | MasterScreen<br>Pneumo<br>K071753<br>(Reference device) | Vyntus ONE<br>(new device) |
| Performance<br>(measuring<br>programs) | • Breath-by-breath (BxB)<br>• Resting ECG<br>• Stress ECG<br>• Indirect Calorimetry | ---------------- | ---------------- | ---------------- | Identical |
| | ---------------- | ---------------- | • Functional Residual<br>Capacity (FRC) by<br>Nitrogen (N2)<br>washout | ---------------- | Identical |
| Patient direct<br>contacting<br>parts | • Full face CPET<br>masks<br>• Single Use<br>mouthpiece<br>• Silicone mouthpiece<br>• Nose clip<br>• Nose clip pad<br>• Head gear | ---------------- | ---------------- | ---------------- | Identical |
| | ---------------- | • Single Use<br>mouthpiece<br>• Silicone mouthpiece<br>• Nose clip<br>• Nose clip pad<br>• MicroGard II Filter | ---------------- | ---------------- | Identical |
| Biocompati-<br>bility | Patient user interface<br>• Digital Volume<br>Transducer<br>• Full face CPET mask | ---------------- | ---------------- | ---------------- | Identical |
| | ---------------- | ---------------- | ---------------- | Patient user interface<br>• ultrasonic flow sensor<br>• Shutter | Patient user interface<br>• ultrasonic flow sensor<br>(new material)<br>• Flow Path Valve<br>(new material) |
| Sterilization | The device along with its | ---------------- | ---------------- | ---------------- | Identical |
| | Vyntus / SentrySuite<br>Product Line<br>K150810<br>(Predicate device)<br>accessories is neither<br>supplied sterile nor<br>intended to be sterilized | SentrySuite<br>Product Line<br>K122699<br>(Reference device) | Vmax<br>K942211<br>(Reference device) | MasterScreen<br>Pneumo<br>K071753<br>(Reference device) | Vyntus ONE<br>(new device) |
| Cleaning<br>Validation | Validation of Instrument<br>disinfection & Surface<br>disinfection | ---------------- | ---------------- | ---------------- | Validation according FDA<br>Guidance: Reprocessing<br>Medical Devices in Health<br>Care Settings: Validation<br>Methods and Labeling |
| Human<br>factors | Usability testing acc.<br>IEC 60601-1-6 and<br>related IEC 62366;<br>Usability Engineering File<br>& Usability report | ---------------- | ---------------- | ---------------- | Usability testing acc.<br>IEC 60601-1-6 and<br>related IEC 62366;<br>Usability Engineering<br>File & Usability report |
| Energy used | 100 – 240V / 50 – 60Hz | ---------------- | ---------------- | ---------------- | Identical |
| Patent user<br>Interface<br>technique | • Digital Volume<br>Transducer technique | ---------------- | ---------------- | ---------------- | Identical |
| | | ---------------- | ---------------- | • ultrasonic flow sensor<br>technique | Identical |
| Patient user<br>Interface<br>Specification | Digital Volume Transducer<br>• Flow: 0 – 15 L/s (3%)<br>• Volume: 0 – 10 L (2%)<br>• Resolution: 3ml<br>• Resistance: <0.1<br>kPa/L/s at 15 L/s<br>• ATS compliant | ---------------- | ---------------- | ---------------- | Identical |
| | Vyntus / SentrySuite<br>Product Line<br>K150810<br>(Predicate device) | SentrySuite<br>Product Line<br>K122699<br>(Reference device) | Vmax<br>K942211<br>(Reference device) | MasterScreen<br>Pneumo<br>K071753<br>(Reference device) | Vyntus ONE<br>(new device) |
| | | Pneumotachograph<br>• Flow Accuracy (exhalation)<br>0,2 to 12 L/S: +/- 2% or +/-<br>0,2 L/S (whichever is greater)<br>• Flow Accuracy (inhalation)<br>0,1 to 14 L/S: +/- 5% or<br>+/- 0,2 L/S (whichever is greater)<br>• Flow Range<br>0 to +/- 20 L/S<br>• Flow Resolution<br>10ml/s<br>• Volume Accuracy<…