(60 days)
Not Found
No
The summary describes a software user interface for displaying physiological data and does not mention any AI/ML capabilities or related concepts like training/test sets.
No
The device is described as a "secondary, adjunct patient monitor" and is "not intended to replace existing standard-of-care patient monitoring practices." Its primary function is to display physiological data, not to directly treat or manage a disease or condition.
No
Explanation: The "Intended Use / Indications for Use" section states that VitalWatch is intended to "display physiological data collected by the VitalConnect Platform" and explicitly says it "is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices." This indicates it is for monitoring, not for diagnosing conditions.
Yes
The device is described as a "software user interface" and "software user intended for use by healthcare professionals to display physiological data". While it relies on a "Relay device" for execution, the description focuses solely on the software's function of displaying data and mentions only software verification and validation testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that VitalWatch is a software user interface to display physiological data collected by a wireless remote monitoring system. It is a secondary, adjunct patient monitor.
- Device Description: The description reinforces that it's a software interface for displaying data from a monitoring system.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a physiological state, health, or disease based on the analysis of samples.
- Any laboratory or in vitro testing procedures.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. VitalWatch's function is to display data collected from the body, not to analyze samples from the body.
N/A
Intended Use / Indications for Use
VitalWatch is a software user intended for use by healthcare professionals to display physiological data collected by the VitalConnect Platform wireless remote monitoring system in home and healthcare is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices.
Product codes (comma separated list FDA assigned to the subject device)
DRG
Device Description
VitalWatch is a software user interface designed to be manufacturer-installed and user-executed on a validated Relay device, which serves as a graphical user interface that displays physiological data provided by the VitalConnect wireless remote monitoring system.
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
Not Found
Intended User / Care Setting
healthcare professionals / home and healthcare settings
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)
Software verification and validation testing was conducted and documentation is provided in accordance with the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Applying Human Factors and Usability Engineering to Medical Devices, and Postmarket Management of Cybersecurity in Medical Devices. VitalWatch software has a "Moderate" Level of Concern.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2017
VitalConnect, Inc. Kevin Potgieter Senior Manager, Regulatory Affairs 224 Airport Parkway, Suite 300 San Jose, California 95110
Re: K170973
Trade/Device Name: VitalWatch Software User Interface Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG Dated: March 31, 2017 Received: April 3, 2017
Dear Kevin Potgieter:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
M.A. Hilleman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170973
Device Name VitalWatch Software User Interface
Indications for Use (Describe)
VitalWatch is a software user intended for use by healthcare professionals to display physiological data collected by the VitalConnect Platform wireless remote monitoring system in home and healthcare is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY - VitalWatch™ Software User Interface
510(k) Owner's Name, Address, and Telephone Number
VitalConnect, Inc. 224 Airport Parkway, Suite 300 San Jose. CA 95110 (408) 963-4600
Contact Person
Kevin Potgieter, MS, RAC Senior Manager, Regulatory Affairs Office: (408) 963-4603 Cell: (424) 263-8484 Fax: (408) 963-2828 Email: kpotgieter@vitalconnect.com
510(k) Number: K170973
Date Prepared: 31 May 2017
Trade Name of Device: VitalWatch Software User Interface
Common or Usual Name: User Interface for Wireless Remote Monitoring System
Classification Name: 21 CFR 870.2910 - Transmitters and Receivers, Physiological Signal, Radiofrequency
Product Code: DRG
Predicate Device(s) VitalConnect Platform by VitalConnect, Inc. (K152139)
Intended Use
VitalWatch is a software user interface intended for use by healthcare professionals to display physiological data collected by the VitalConnect wireless remote monitoring system in home and healthcare settings. VitalWatch is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices.
Device Description
VitalWatch is a software user interface designed to be manufacturer-installed and user-executed on a validated Relay device, which serves as a graphical user interface that displays physiological data provided by the VitalConnect wireless remote monitoring system.
4
Technological Characteristics
This 510(k) does not involve any changes to the technological characteristics of the VitalConnect Platform.
Performance Data
Software verification and validation testing was conducted and documentation is provided in accordance with the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Applying Human Factors and Usability Engineering to Medical Devices, and Postmarket Management of Cybersecurity in Medical Devices. VitalWatch software has a "Moderate" Level of Concern.
Substantial Equivalence
The VitalConnect Platform, modified to include the VitalWatch software user interface, has the same intended use and technological characteristics as the predicate device and is therefore substantially equivalent to the predicate device.
Conclusions
The VitalConnect Platform is substantially equivalent to the predicate device. The modifications described in this 510(k) do not raise different questions of safety and effectiveness.
| Topic | Predicate Device
K152139 | Modified Device
VitalWatch |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II |
| Classification
Name | Transmitters and Receivers,
Physiological Signal,
Radiofrequency | Transmitters and Receivers,
Physiological Signal, Radiofrequency |
| Product Code | DRG | DRG |
| Trade Name | VitalConnect Platform®,
HealthPatch® MD, VitalPatch® | VitalConnect Platform®,
HealthPatch® MD, VitalPatch®,
VitalWatchTM |
| Physiological
Data
Monitored | Heart rate, electrocardiography
(ECG), heart rate variability, R-R
interval, respiratory rate, skin
temperature, activity (including step
count), and posture (body position
relative to gravity including fall) | Heart rate, electrocardiography
(ECG), heart rate variability, R-R
interval, respiratory rate, skin
temperature, activity (including step
count), and posture (body position
relative to gravity including fall) |
| Principles of
Operation | Display of data from validated Relay
device using third-party developed
Graphical User Interface and
optional transmission of data to
Secure Server. | Display of data from validated Relay
device using third-party developed
Graphical User Interface, or
VitalWatch, and optional
transmission of data to Secure Server. |