Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 20, 2020 VitalConnect, Inc. Cynthia Merrell Vice President, QA & RA 224 Airport Parkway. Suite 300 San Jose, California 95110 Re: K193343/S001 Trade/Device Name: Vista Solution Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG Dated: December 3, 2019 Received: December 3, 2019 Dear Cynthia Merrell: 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 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 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Jennifer Shih Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193343 Device Name Vista Solution Indications for Use (Describe) Vista Solution 2.1 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 settings. Vista Solution 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) | <span style="font-size:100%;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size:100%;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | |-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) SUMMARY This summary of 510(k) substantial equivalence information is submitted in accordance with the requirements of 21 CFR §807.92: 1. SUBMITTER VitalConnect, Inc. Address 224 Airport Parkway, Suite 300 City San Jose, CA, 95110 USA Tel: 1-408-963-4600 Fax: 1-408-963-2828 | Contact Person: | Cynthia Merrell | |-----------------|-----------------| | Date Prepared: | March 19, 2020 | | II. DEVICE | | |------------------------------|------------------------------------------------------------------| | Name of Device: | Vista Solution | | Classification Name: | Transmitters and Receivers, Physiological Signal, Radiofrequency | | Regulation: | 21 CFR § 870.2910 | | Regulatory Class: | Class II | | Product Classification Code: | DRG | 111. PREDICATE DEVICE Predicate Manufacturer: Predicate Trade Name: Predicate 510(k): VitalConnect, Inc. VitalWatch Software User Interface K170973 No reference devices were used in this submission. #### IV. DEVICE DESCRIPTION The VitalConnect Platform, Vista Solution is a wireless remote monitoring system consisting of the VitalPatch biosensor (K190916) and the VistaCenter and VistaPoint software (formally branded as VitalWatch in K170973). This submission is a catch-up 510(k) for changes made to the software since K170973 was cleared. The principles of operation, mechanism of action, and proposed environment of use are unchanged from the predicate device (K170973). Image /page/3/Figure/12 description: The image shows a diagram of a vital patch biosensor system. The system includes a vital patch biosensor, a VistaPoint app on a Vista tablet device, and a VistaCenter app. The vital patch biosensor is worn by a patient in an inpatient or outpatient environment. The VistaPoint app is used to collect data from the vital patch biosensor and display it on a tablet device. The VistaCenter app is used by nurses or other healthcare providers to monitor patients in a nurse station or virtual care center. The data is stored in the VitalCloud. {4}------------------------------------------------ ## VistaCenter Application A web application that interfaces with the VCI Cloud and displays live and historical data for multiple patients and supports download of historical data for multiple patients. The application also supports the user entry of criteria for triggering notifications based on data values and for displaying notifications generated from such criteria. ### VistaPoint Application The VistaTablet 2.0 App is a stand-alone Android Application which is delivered pre- installed on an off-the-shelf tablet and the combination called VistaTablet 2.0. It incorporates within a single distributable application the functionality of the Relay App, and VistaPoint. The VistaTablet runs a single application that is a combination of Relay App, Configuration App, VistaPoint, and a product wrapper to make it run like a native application. The user interface on VistaTablet is substantially equivalent to the previously commercialized VistaTablet 1.0 product with the following major additions: - Support for third-party devices for collecting additional vital signs SpO2, Blood ● Pressure, and Weight - . Data management by patient instead of patch (i.e. multiple patches and devices supply data for one patient) - . Support for VitalPatch 3.0 features including body temperature, 30 degree calibration, and LED blinking. The following changes were made previously as letters to file: 1. ### RGD-007 - a. Add support for four 3rd party devices - b. Support body temperature, 30-degree supine posture calibration, and on-command LED blinking - Each vital sensor will be assigned a patient ID based upon the actual patient C. - Add support for SPO2 and weight scale and NIBP (related to "a" above) d. - Display graphical ECG streaming data e. - Add combination heart rate / respiratory rate as a new notification; add no data f. uploading and low battery as error conditions - 2. RGD-008 - VitalTablet changes Add support for four (4) third party pulse oximeter (Sp02), nona. invasive blood pressure (NIBP) and weight scale devices. - b. VitalCenter changes Add support for Sp02, NIBP and weight scale device data displays. Add NEWS calculated with patient vitals, and observer input for consciousness and supplemental oxygen. RGD-006 - Add new relay hardware (Samsung Galaxy Tab E 8.0 Android OS) New functionality incorporated which are extensions of previously existing functionality include manual entry of data, notifications on 3rd party devices and body temperature, and universal notifications. {5}------------------------------------------------ #### V. INDICATIONS FOR USE Vista Solution 2.1 is a software user interface intended for use by healthcare professionals to display physiological data collected by the VitalConnect Platform wireless remote monitoring system in home and healthcare settings. Vista Solution is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence: | Feature | Subject Device | Predicate Device (K170973) | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Vista Solution 2.1 is a software<br>user interface intended for use by<br>healthcare professionals to display<br>physiological data collected by the<br>VitalConnect Platform wireless<br>remote monitoring system in home<br>and healthcare settings. Vista<br>Solution is a secondary, adjunct<br>patient monitor and is not intended<br>to replace existing standard-of-care<br>patient monitoring practices. | VitalWatch is a software user<br>interface intended for use by<br>healthcare professionals to display<br>physiological data collected by the<br>VitalConnect Platform wireless<br>remote monitoring system in home<br>and healthcare settings.<br>VitalWatch is a secondary, adjunct<br>patient monitor and is not intended<br>to replace existing standard-of-care<br>patient monitoring practices. | | Classification | Class II | Class II | | Classification<br>Name | Transmitters and Receivers,<br>Physiological Signal,<br>Radiofrequency | Transmitters and Receivers,<br>Physiological Signal,<br>Radiofrequency | | Product Code | DRG | DRG | | Trade Name | Vista Solution | VitalConnect Platform®,<br>HealthPatch® MD,<br>VitalPatch®,<br>VitalWatch TM | | Physiological<br>Data Monitored | Heart rate, electrocardiography<br>(ECG), heart rate variability, R-R<br>interval, respiratory rate, body<br>temperature, activity (including<br>step count), and posture (body<br>position relative to gravity<br>including fall)<br>Pulse oximeter, Weight and Blood<br>Pressure via 3rd Party Devices.<br>NEWS score calculated with above<br>patient vitals, and observer input for<br>consciousness and supplemental<br>oxygen. | Heart rate,<br>electrocardiography<br>(ECG), heart rate variability, R-R<br>interval, respiratory rate, skin<br>temperature, activity (including step<br>count), and posture (body position<br>relative to gravity including fall) | | Principles of<br>Operation | Display of data from validated<br>Relay device using Graphical<br>User Interface (VistaPoint) and<br>transmission of data to Secure<br>Server (VCI Cloud). | Display of data from<br>validated Relay device<br>using third-party<br>developed Graphical<br>User Interface, or<br>VitalWatch, and<br>optional transmission<br>of data to Secure<br>Server. | {6}------------------------------------------------ ### Electrical safety and electromagnetic compatibility (EMC) Not Applicable (Standalone Software) ### Software Verification and Validation Testing Software validation was performed in accordance with IEC 62304. ### Benchtop Testing Usability testing was performed in accordance with IEC 62366. ### Animal Study Animal performance testing was not required to demonstrate substantial equivalence to the predicate device. ### Clinical Studies Clinical testing was not required to demonstrate the substantial equivalence of The Proposed Vista Solution Software User Interface. Instead, substantial equivalence is based upon benchtop performance testing. ### VII. CONCLUSIONS The Proposed Vista Solution Software User Interface is substantially equivalent to the predicate device. The modifications described in this 510(k) do not raise different questions of safety and effectiveness.