VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)

K141167 · Vitalconnect, Inc. · DRG · Jul 29, 2014 · Cardiovascular

Device Facts

• Record ID: K141167
• Device Name: VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)
• Applicant: Vitalconnect, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Jul 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K141167 · Jul 29, 2014	VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)	Vitalconnect, Inc.	Field study data (home use setting)	The study was used to assess the usability and long-term wearability of the VitalConnect Platform in a home setting over a 50-day period.	Home use; Usability; Wearability; Field study

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Long-term Field Study for Home Use; Field study; Follow-up/Duration: 50-day study; Study Period: September 2013 to March 2014	General care patients (home setting); Sample Size: 76 participants	Not applicable for this study	Usability of the platform in a home setting; long-term wearability of patches

Indications for Use

The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes 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). Data is transmitted wirelessly to a central location where it is stored for analysis. The Vital Connect Platform can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients.

Device Story

Wireless remote monitoring system; consists of adhesive sensor patch, relay software, and server software. Sensor patch worn on torso; continuously records ECG, HR, HRV, respiratory rate, skin temperature, activity, and posture. Data transmitted via relay to central server for storage and analysis. Healthcare professionals configure notification parameters; system alerts staff if data exceeds thresholds. Used in home and clinical settings; aids diagnosis and treatment. Benefits include continuous patient monitoring outside traditional hospital environments.

Clinical Evidence

50-day prospective home-use field study conducted with 76 participants. Evaluated usability of sensor patch, relay, and server components, and long-term wearability of multiple patches on same participants. Results demonstrated successful system operation in home environment.

Technological Characteristics

Wireless physiological monitor; includes disposable adhesive patch (hydrocolloid or medical-grade silicone) and sensor module. Measures ECG, HR, HRV, respiratory rate, skin temperature, activity, and posture. Data transmitted via Bluetooth to relay, then to central server. Software-based processing and notification. Biocompatibility testing (cytotoxicity, MEM elution, skin irritation, sensitization) performed for silicone adhesive.

Indications for Use

Indicated for general care patients 18+ years old for continuous physiological monitoring (HR, ECG, HRV, respiratory rate, skin temperature, activity, posture/fall detection) in home and healthcare settings. Not for critical care patients.

Regulatory Classification

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.

Predicate Devices

• CareFusion, Wireless Monitoring System (K110809)
• Preventice, BodyGuardian System (K121197)
• Corventis, Mobile Patient Management System (K083287)
• Hidalgo Ltd, Equivalent™ Vital Signs Physiological Monitor EQo2 (K113054)

Submission Summary (Full Text)

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## K141161 JIII 2 9 2014

## 510(k) Summary

The summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. ,

| Submitter: | Vital Connect Inc.<br>900 East Hamilton Avenue<br>Suite 500<br>Campbell, CA 95008 |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sam Mostafavi<br>Vice President of Quality Assurance and Regulatory Affairs<br>E-mail: [e-mail]<br>Phone: [phone]<br>Fax: [phone]<br>Vital Connect Inc.<br>900 East Hamilton Avenue<br>Suite 500<br>Campbell, CA 95008 |
| Date Prepared: | June 03, 2014 |
| Trade name: | VitalConnect Platform (consisting of VitalConnect Sensor,<br>Relay Software Library and Secure Server Software Library) |
| Classification: | Class II |
| Classification: | Classifications presented as part of the VitalConnect<br>Platform cleared 510(k) submission (K132447):<br>21 CFR 870.2910, Product Code: DRG<br>• Transmitters and Receivers, Physiological Signal,<br>Radiofrequency<br>21 CFR 870.1025, Product Code: DSI<br>• Arrhythmia detection and alarm (including ST-segment<br>measurement and alarm)<br>New classification for home use indication:<br>21 CFR 870.1025, Product Code: MHX<br>• Monitor, physiological, patient (with arrhythmia detection<br>or alarm) |
| Predicate Device: | Predicate devices presented as part of the VitalConnect<br>Platform cleared 510(k) submission (K132447):<br>• CareFusion, Wireless Monitoring System, 510(k) #:<br>K110809<br>• Preventice, BodyGuardian System, 510(k) #: K121197<br>• Corventis, Mobile Patient Management System, 510(k) #:<br>K083287 |
| | New predicate device for home use indication: |
| | • Hidalgo Ltd, Equivalent™ Vital Signs Physiological Monitor EQo2, K113054 |
| Classification Panel: | Cardiology |
| Device Description: | The VitalConnect Platform is a wireless data collection system that monitors physiological data and consists of the following sub systems:<br>• VitalConnect Sensor (includes adhesive Patch and Sensor Module)<br>• Relay Software Library<br>• Server Software Library<br><br>VitalConnect Platform sub-system includes:<br>• VitalConnect Sensor<br>a) Adhesive Patch<br>The Patch is designed as a disposable self-adhesive interface to the body.<br>b) Sensor Module<br>Residing within the patch, the sensor module performs processing functions related to capture of physiological data and also performs bi-directional communication with the relay device.<br>• VitalConnect Relay Software Library<br>The Relay Software Library manages bi-directional communication between the Sensor Module and the Server Software Library and is installed on a relay device.<br>• VitalConnect Secure Server Software Library<br>The Server Software Library is installed on a central server, manages the upload, processing and storage of sensor data, as well as configuration of and notifications from the VitalConnect Platform.<br><br>The VitalConnect Sensor continuously gathers physiological data from the person being monitored and then transmits encrypted data via a bi-directional relay to the central server. During normal operation, continuous wireless transmission occurs with a delay or latency of seconds between continuous data collection and transmission. However, for continuous transmission of data to a healthcare professional, a continuous connection is needed between the module, the relay, and the server. Data can be stored on the VitalConnect Sensor for several hours and then transferred once connectivity is reestablished. |
| | The VitalConnect Sensor is a battery-operated adhesive patch<br>with integrated sensors and wireless transceiver module, worn<br>on the torso to record heart rate, electrocardiography (ECG),<br>heart rate variability (R-R interval), respiratory rate, skin<br>temperature, activity (including step count), and posture (body<br>position relative to gravity including fall). |
| Physical<br>Description: | VitalConnect Sensor consisting of Patch and the Sensor<br>Module dimensions are:<br>Patch: approximately 111 mm long x 47mm wide x 6 mm high (without the release liner) Sensor Module: approximately 21 mm long x 12 mm wide x 4 mm high |
| Indication For<br>Use: | The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes 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). Data is transmitted wirelessly to a central location where it is stored for analysis. The Vital Connect Platform can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients. |
| Comparison of<br>Technological<br>Characteristics: | Technological review and comparison to the predicate device,<br>Hidalgo Ltd, EquivalentTM Vital Signs Physiological Monitor<br>EQo2, K113054, has been performed through product testing<br>presented as part of the cleared 510(k) submission K132447.<br><br>The VitalConnect Platform and the predicate device (Hidalgo<br>Ltd, EquivalentTM Vital Signs Physiological Monitor EQo2,<br>K113054) contain small ambulatory monitoring sensors that<br>measure ECG, heart rate, respiration rate, activity, body<br>orientation, body/skin temperature. Both transmit their data to a<br>remote computer server that allows healthcare professionals to<br>access and review the data. There are no fundamental<br>differences between their technological characteristics for<br>home setting environment. Therefore, we claim that<br>VitalConnect Platform is substantially equivalent to Hidalgo Ltd,<br>EquivalentTM Vital Signs Physiological Monitor EQo2<br>(K113054) in this regard. |
| Non-Clinical<br>Testing: | Non-clinical bench testing was presented as part of the<br>VitalConnect Platform cleared 510(k) submission (K132447).<br>This testing is applicable to the indication submitted here in,<br>including testing of:<br>Electrocardiograph (ECG) Heart rate Heart rate variability (R-R interval) Respiration rate Body impedance Activity (including step count) Posture (body position relative to gravity including fall) Bluetooth verification Notification Measurement accuracy Communication, data transmission and storage Reliability Electromagnetic compatibility Electrical safety testing Co-existence testing Software verification and validation testing Biocompatibility verification and testing |
| Clinical Testing: | An IRB-approved "Long-term Field Study for Home Use" was<br>conducted by Vital Connect with the VitalConnect Platform from<br>September 2013 to March 2014, to assess the long-term use of<br>the VitalConnect Platform in a home setting. The assessment<br>includes the usability of the VitalConnect Platform in a home<br>setting, including interaction with the module, patch, and relay. |
| | |
| | In addition, the assessment includes the long-term wearability<br>of a series of patches on the same participants. Results<br>indicate successful use of the VitalConnect Platform over a 50-<br>day home use study on 76 participants. |
| Biocompatibility: | The initial 510k submission, K132447, included biocompatibility<br>data for the hydrocolloid adhesive. In this submission, a<br>medical grade silicone adhesive has been added as a separate<br>option for the patch. The silicone adhesive has been subjected<br>to the following safety evaluation:<br>• In Vitro Cytotoxicity<br>• MEM Elution<br>• Primary Skin Irritation<br>• Guinea Pig Sensitization |
| Conclusion: | The performance results for the VitalConnect Platform included<br>non-clinical and clinical testing already submitted as part of<br>K132447, and the biocompatibility testing data of silicone<br>adhesive and clinical study in a home setting are provided in<br>this 510(k) demonstrate that VitalConnect Platform is safe and<br>effective for its intended use, including use in the home<br>environment. |
| | Based on the intended use and product performance results,<br>VitalConnect Platform has been shown to be substantially<br>equivalent for home use to the currently marketed predicate<br>device, Hidalgo Ltd, EquivalentTM Vital Signs Physiological<br>Monitor EQo2, K113054. |

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July 29, 2014

Vital Connect Inc. Sam Mostafavi VP Quality Assurance & Regulatory Affairs 900 E. Hamilton Ave., Suite 500 Campbell. California 95008

Re: K141167

> Trade/Device Name: Vitalconnect platform (consisting of vitalconnect sensor, relay software library and secure server software library) Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II Product Code: DRG, DSI, MHX Dated: June 3, 2014 Received: June 4. 2014

Dear Sam Mostafavi,

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

Public Health Service

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

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Page 2 - Sam Mostafavi

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 devicerelated 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), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/6/Picture/8 description: The image shows a logo with the text "Ken Skodacek for" below it. The logo consists of the letters K, S, and A, with the A being in the shape of a triangle. The text is in a bold, sans-serif font. The logo and text are black and white.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known): K141167

Device Name: VitalConnect Platform

Indication for use:

- . The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes 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). Data is transmitted wirelessly to a central location where it is stored for analysis. The Vital Connect Platform can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters.
- The device is intended for use on general care patients who are 18 years of age . or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/7/Picture/12 description: The image shows a logo with the letters "KDA" in a stylized, bold font. Below the letters, the name "Ken Skodacek" is written in a smaller, less bold font. The overall design appears to be a logo or emblem, possibly for a person or organization with the initials KDA.

Bram Zuckerman