Vyntus Walk is a mobile medical application which is intended to be used on a mobile platform to collect and collate sequential pulse oximetry data during six minute walk tests (6MWT). Pulse oximetry data are collected from an external pulse oximeter, using Bluetooth connection. The mobile platform has access to a host computer with SQL database (SentrySuite) via a wireless network for further data evaluation and diagnosis. Patients as young as 4 years of age and older can be tested providing they can cooperate with the test instructions. Measurements are performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities).

Device Description

The Vyntus Walk is a tablet based software mobile application that collects and collates pulse oximeter data from an external pulse oximeter during a 6 Minute Walk Test and remotely transmits to the SentrySuite for access to physicians for diagnosis purposes. Vyntus WALK includes wearable, wireless sensors connected to a tablet PC running Android Operating System with a workflow driven 6MWT application. Vyntus WALK integrates seamlessly in today's mobile healthcare environment through the new Sentry CIS™ service landscape for central data management and reporting.

AI/ML Overview

The provided document describes the Vyntus Walk, a mobile medical application designed for collecting and collating pulse oximetry data during Six Minute Walk Tests (6MWT). The document includes a 510(k) summary, which outlines the device's characteristics, intended use, and comparison to a predicate device (SpiroPro K092324). It also summarizes testing performed to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with numerical thresholds for performance metrics. Instead, it refers to passing applicable tests and standards and demonstrating substantial equivalence to the predicate device. The performance characteristics of the Vyntus Walk and how they relate to the Nonin Oximeter (which it connects to) are listed.

Parameter	Acceptance Criteria (Implied)	Reported Device Performance
SpO2	Accuracy according to Nonin Oximeter specifications	"acc. Nonin Oximeter" (implies meeting Nonin's accuracy)
Heart rate (HR)	Accuracy according to Nonin Oximeter specifications	"acc. Nonin Oximeter" (implies meeting Nonin's accuracy)
Manual entered data	Correct collection and display (implied)	Passed all specified test requirements
Lap distance	Correct recording (implied)	Passed all specified test requirements
Lap count	Correct recording (implied)	Passed all specified test requirements
Duration of pauses	Correct recording (implied)	Passed all specified test requirements
Number of pauses	Correct recording (implied)	Passed all specified test requirements
RPE scale	Correct recording (implied)	Passed all specified test requirements
Overall Functionality	Meets user needs and design requirements	"The CareFusion Vyntus Walk Medical App passed all specified test requirements. The validation and verification testing confirmed this device meets user needs and design. Testing confirmed inputs for a 6 Minute Walk Test. The Vyntus Walk operates as intended."
Substantial Equivalence	Functionally similar to predicate device for 6MWT; differences not critical to safety/effectiveness.	"The Vyntus Walk operates as intended and the results were substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Clinical Test Set: 16 healthy subjects.
Data Provenance: The document does not explicitly state the country of origin. It indicates the clinical test was performed in September 2014, making it prospective in relation to the submission date.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical test. It only states that the 6MWT was performed "according to ATS criteria," implying standard clinical practice, but not involving independent expert adjudication for ground truth.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method for the clinical test set. The focus was on the direct measurement and recording of data by the Vyntus Walk compared to an external pulse oximeter (Nonin) and the overall successful operation of the device during the ATS-compliant 6MWT.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. The Vyntus Walk is a data collection and collation tool, not an AI-driven interpretive device that assists human readers in making diagnoses. It facilitates the 6MWT by integrating external pulse oximeter data into a mobile platform.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The document does not specifically describe a "standalone" performance test in the context of an algorithm's diagnostic accuracy. The Vyntus Walk's primary function is as a data collection and display tool for an external oximeter. Its performance evaluation focuses on its ability to accurately collect, collate, and transmit data from the Nonin oximeter. The accuracy of the SpO2 and Heart Rate measurements themselves relies on the connected Nonin Oximeter. The "Accuracy Testing" mentioned was bench testing comparing the proposed device with the predicate device, likely focusing on data handling and display, rather than inherent measurement accuracy as a standalone sensor. The clinical test confirmed the device operated as intended and collected data during a 6MWT successfully.

7. The Type of Ground Truth Used:

For the clinical testing, the ground truth was essentially the real-time physiological data (Heart Rate and SpO2) from an external pulse oximeter (Nonin) during a 6MWT performed according to ATS criteria, and the proper collection and display of this data by the Vyntus Walk. There is no mention of a separate "ground truth" established by experts or pathology for the data itself, as the device is a data handler.

8. The Sample Size for the Training Set:

The document does not provide any information about a training set size. The Vyntus Walk is described as a "mobile medical application," and while software typically undergoes development and internal testing, there's no mention of a "training set" in the context of machine learning or AI algorithm development for a diagnostic task.

9. How the Ground Truth for the Training Set Was Established:

As no training set is discussed or implied for an AI algorithm, there is no information on how ground truth for a training set was established.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 20, 2015

CareFusion Germany 234 GmbH Mr. Elmar Niedermeyer Regulatory Affairs Leibnizstrasse 7 Hoechberg, Bavaria 97204 GERMANY

Re: K142959

Trade/Device Name: Vyntus Walk Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: February 11, 2015 Received: February 18, 2015

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

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.

of Surveillance and Biometrics/Division of Postmarket Surveillance.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Attachment 3

(revised Indication for Use) Next Page

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Indications for Use

510(k) Number (if known): K142959

Device Name:

Vyntus Walk

Indications for Use:

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)

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Image /page/4/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.

510(k) Summary

GENERAL INFORMATION

5.1 Type of Submission

Traditional 510(k) Submission

Submission date: 26/09/2014

5.2 Submitter

CareFusion Germany 234 GmbH Name:

Address: Leibnizstrasse 7 D-97204 Hoechberg Germany

Contact person in Germany:

(Official Correspondent)	Elmar Niedermeyer
Address:	CareFusion Germany 234 GmbHLeibnizstrasse 7, 97204 HoechbergGermany
Phone:	+49 931 49 72 - 361
FAX:	+49 931 49 72 - 62361
E-mail	elmar.niedermeyer@carefusion.com

Contact person in the U.S.:
(U.S. Agent)	Donald Sherratt
Address	CareFusion22745 Savi Ranch ParkwayYorba 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 Oximeter CFR 870.2700, Classification Product Code DQA
5.5 Trade Name Vyntus Walk
5.6 Device Classification This is a Class II device
5.7 Classification Panel 74 Cardiovascular Part 870 Code DQA
5.8 Reason for Premarket Notification . New Medical App
5.9 Legally predicate marketed devices
- SpiroPro K092324 Code DQA, BTY .

Predicate Device Company 5.10

. VIASYS (now CareFusion Germany 234 GmbH)

5.11 Device Description

Description & function:

Scientific Concept:

The digital pulse oximeter measures both the oxygen saturation level and the heart rate of the patient continuously. This is transferred via Bluetooth to the tablet and is displayed graphically during the test with a date and time stamp. All data is stored together with the patient and test data in the repository database for later evaluation and printing.

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Significant performance characteristics:

Medical APP for displaying, printing and transferring data.

Parameter	Measurement range	Accuracy
SpO2	0 to 100 %	acc. Nonin Oximeter
Heart rate (HR)	18 to 321 pulses per minute	acc. Nonin Oximeter
Manual entered data
Lap distance	30m - 100m	N/A
Lap count	0 - 100	N/A
Duration of pauses	0 - 360s	N/A
Number of pauses	0 - 100	N/A
RPE scale	0 - 10	N/A

5.12 Intended Use Statement

5.13 Required Components

. Android Tablet with Vyntus WALK APP
Charger for Tablet PC
US/AUS, European and UK Power Adapter ●
USB cable ●
Nonin 3150 Bluetooth Oximeter
AAA Batteries for the pulse oximeter
Instruction for Use Vyntus Walk
Accessories

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5.14 Summary Table of Comparison

Comparison Table
	SpiroPro K092324	Vyntus Walk(proposed device)
Indications forUse	The SpiroPro is a portable, battery operateddevice and can be used by physicians in theoffice orhospital, in occupational medicine or by patientsin the home. The SpiroPro measures inspiratoryand expiratory lung function parameters in adultsand children 4 years and older. In addition to thepulmonary function measurements, oxygensaturation and heart rate can be recorded.	Vyntus Walk is a mobile medical application which isintended to be used on a mobile platform tocollect and collate sequential pulse oximetry dataduring six minute walk tests (6MWT). Pulse oximetrydata are collected from an external pulse oximeterusing Bluetooth connection. The mobile platformhas access to a host computer with SQL database(SentrySuite) via a wireless network for further dataevaluation and diagnosis. Patients as young as 4 yearsof age and older can be tested providing they cancooperate with the test instructions. Measurements areperformed under the direction of a physician in ahospital environment, physician's office or similarsetting (professional healthcare facilities).
Targetpopulation	Adults and children 4 years and older	similar
Place of use	by physicians in the office or hospital,in occupational medicine or bypatients in the home	similar
Energyused	Battery operated device	similar
Design	Medical device with firmware andSoftware	Medical APP operated on a tablet PC
Interface	RS232 & Bluetooth interface	WLAN & Bluetooth interface
Performance(measuringprograms)	• 6 Minute Walk Test	similar
	• Slow Spirometry• Forced Spirometry	not applicable
Biocompatibility(Patientcontactingparts)	• finger clip sensor• nose clip pad• single use mouthpiece	not applicable
Sterility	The device along with itsaccessories is neither suppliedsterile nor intended to be sterilized	similar

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Summary of technological characteristics compared to the predicate device to the table above:

The Vyntus Walk is similar in indication for use compared to the predicate . SpiroPro whereby the Vyntus Walk is more described in detail. The difference between SpiroPro and Vyntus Walk is that the predicate in addition can measure inspiratory and expiratory lung function parameters and the Vyntus Walk will only be used on a mobile platform. But for the 6 minute walk test and the subsequent diagnostic use, the Vyntus Walk is similar to the predicate SpiroPro. The Vyntus Walk operates as intended for the 6 minute walk test, is similar compared to the predicate and the differences are not critical to the predicate and do not affect the safety and effectiveness of these devices when used as labeled. The patient population of both devices is similar. It is 4 years and older and thereby the proposed device is substantially equivalent to the predicate device.
The design of both devices is different. The predicate SpiroPro is a medical . device with hardware, firmware and software, whereby the Vyntus Walk is a Medical App which will be operated on a tablet PC.
. The interface of Vyntus Walk is similar to the interface of the predicate SpiroPro. Both devices use a Bluetooth interface. In addition the Vyntus Walk uses WLAN for transferring the data to a workstation. The proposed device is substantially equivalent to the predicate device.
. The measuring program of the proposed device is similar to the predicate device SpiroPro. Both devices are used to collect and collate data during a the 6 Minute Walk Test. The Vyntus Walk is substantially equivalent to the predicate SpiroPro.

5.15 Summary of Device Testing

1. Non-clinical tests conducted for determination of substantial equivalence:

	Characteristic	Standard/Test	Results Summary
1.	Risk Management	ISO 14971	The proposed device passes the applicable tests and standards
2.	Usability	EN 62366	The proposed device passes the applicable tests and standards
3.	Software life cycle	ISO 62304	The proposed device passes the applicable tests and standards
4.	6 Minute Walk Test	ATS (6MWT)	The proposed device passes the applicable tests and standards
5.	Accuracy Testing	Comparison benchtesting with predicatedevice	The proposed device passes the applicable tests and standards
Summary Discussion of Bench Performance Data
The CareFusion Vyntus Walk Medical App passed all specified test requirements.The validation and verification testing confirmed this device meets user needs and design.

testing confirmed inputs for a 6 Minute Walk Test.

Testing also confirmed that device performance meet the requirements of the standards listed in the performance testing summary above. These standards address risk management, usability, software life cycle, ATS and accuracy testing. All testing which have been performed demonstrate substantial equivalence to the predicate device. Performance testing like Basic Safety, EMC Compatibility and Biocompatibility are not applicable as Vyntus Walk is a medical App only.

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2. Clinical tests conducted for determination of substantial equivalence and/or of clinical information:

Clinical Performance Data/Information:

Clinical test document: Validation Summary – Accuracy of Measures Document ID: 671113 86

Summary Discussion of Clinical tests conducted

The device was tested in September 2014. Heart rate and SpO2 data have been obtained from a group of 16 healthy subjects who performed a 6 Minute walk test using the Vyntus Walk. The test was performed according to ATS criteria by walking a length of 30 meters per lap.

. No adverse events or complications were reported during this testing.
. The Vyntus Walk operates as intended and the results were substantially equivalent to the predicate device.

Justification:

The goal of the biological test performed was to receive accurate data for the performance of the device under natural environment.

3. Conclusion drawn from non-clinical and clinical data:

The Carefusion Vyntus Walk meets the functional claims and intended use as described in the product labeling. The Vyntus Walk is substantially equivalent to the predicate device described in the submission.

5.16 Conclusion

Based on the above. CareFusion concludes that the Vyntus Walk is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).