(157 days)
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No
The summary describes a device that collects and transmits pulse oximetry data during a 6MWT. There is no mention of AI or ML being used for data analysis, interpretation, or any other function. The data is transmitted for "further data evaluation and diagnosis" by a physician.
No
The device is a software application that collects and collates data for diagnostic purposes, not a device that provides therapy.
Yes
The "Intended Use / Indications for Use" section states that the mobile platform provides "access to a host computer with SQL database (SentrySuite) via a wireless network for further data evaluation and diagnosis." The "Device Description" also mentions that the data is transmitted "for diagnosis purposes."
No
The device description explicitly states that Vyntus WALK includes "wearable, wireless sensors connected to a tablet PC". This indicates the device includes hardware components beyond just software.
Based on the provided information, the Vyntus Walk is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Vyntus Walk collects pulse oximetry data (heart rate and SpO2) directly from a patient during a walk test. It does not analyze blood, urine, tissue, or any other bodily fluid or substance.
- The intended use and device description clearly state it collects and collates physiological data. The data is then transmitted for further evaluation and diagnosis, but the device itself is not performing the diagnostic test on a specimen.
The Vyntus Walk is a medical device that aids in the collection and management of physiological data during a specific clinical test (6MWT). It is not performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
DQA
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.
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
Patients as young as 4 years of age and older
Intended User / Care Setting
Measurements are 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
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Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests conducted for determination of substantial equivalence:
- Risk Management: ISO 14971, Results Summary: The proposed device passes the applicable tests and standards
- Usability: EN 62366, Results Summary: The proposed device passes the applicable tests and standards
- Software life cycle: ISO 62304, Results Summary: The proposed device passes the applicable tests and standards
- 6 Minute Walk Test: ATS (6MWT), Results Summary: The proposed device passes the applicable tests and standards
- Accuracy Testing: Comparison bench testing with predicate device, Results Summary: 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 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.
Clinical Performance Data/Information:
Clinical test document: Validation Summary – Accuracy of Measures Document ID: 671113 86.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 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).
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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 seal 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, representing the department's focus on people and health.
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:
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).
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/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 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 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:
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.
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
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).
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 for | ||
| Use | The SpiroPro is a portable, battery operated | |
| device and can be used by physicians in the | ||
| office or | ||
| hospital, in occupational medicine or by patients | ||
| in the home. The SpiroPro measures inspiratory | ||
| and expiratory lung function parameters in adults | ||
| and children 4 years and older. In addition to the | ||
| pulmonary function measurements, oxygen | ||
| saturation and heart rate can be recorded. | 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). | ||
| Target | ||
| population | Adults and children 4 years and older | similar |
| Place of use | by physicians in the office or hospital, | |
| in occupational medicine or by | ||
| patients in the home | similar | |
| Energy | ||
| used | Battery operated device | similar |
| Design | Medical device with firmware and | |
| Software | Medical APP operated on a tablet PC | |
| Interface | RS232 & Bluetooth interface | WLAN & Bluetooth interface |
| Performance | ||
| (measuring | ||
| programs) | • 6 Minute Walk Test | similar |
| • Slow Spirometry | ||
| • Forced Spirometry | not applicable | |
| Biocompatibility | ||
| (Patient | ||
| contacting | ||
| parts) | • finger clip sensor | |
| • nose clip pad | ||
| • single use mouthpiece | not applicable | |
| Sterility | The device along with its | |
| accessories is neither supplied | ||
| sterile 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 bench | |
| testing with predicate | |||
| device | 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.