VV330 Continuous ECG Platform, VivaLNK Adhesive Patch

K191870 · VivaLNK, Inc. · DRG · Jan 7, 2020 · Cardiovascular

Device Facts

• Record ID: K191870
• Device Name: VV330 Continuous ECG Platform, VivaLNK Adhesive Patch
• Applicant: VivaLNK, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Jan 7, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

Intended Use

VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data. The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.

Device Story

Wireless, single-channel, rechargeable, ambulatory ECG recorder; uses disposable adhesive patch with hydrogel for skin contact. Collects ECG, accelerometer, R-R interval, and heart rate data. Transmits data via Bluetooth Low Energy (BLE) to mobile devices for storage and display. Used in healthcare settings or home by healthcare professionals; data viewed by professionals on mobile devices. Provides operational alerts (lead on/off, battery, system status); does not provide physiological alarms. Supplements vital signs recording; does not replace standard of care. Benefits patients by enabling continuous, ambulatory monitoring outside of critical care environments.

Clinical Evidence

Bench testing only. No clinical data presented. Verification included software, hardware, mechanical, biocompatibility, packaging, and electromagnetic compatibility testing per FDA-recognized standards (ISO 10993, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-47).

Technological Characteristics

Single-channel ECG recorder; rechargeable battery; tri-axial accelerometer; BLE connectivity. Dimensions: 90mm x 28mm x 7.9mm; weight 7.5g. Biocompatible materials per ISO 10993-1, -5, -10. Conforms to IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home use), and IEC 60601-2-47 (ambulatory ECG).

Indications for Use

Indicated for general care patients 18 years of age or older for ambulatory, continuous recording of ECG, accelerometer data, R-R interval, and heart rate. Not for use on critical care patients. Intended to supplement vital signs recording for later viewing by healthcare professionals.

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

• VitalConnect Platform (K132447)
• VitalConnect Platform (K141167)

Submission Summary (Full Text)

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January 7, 2020

VivaLNK, Inc. Quoi Huynh Vice President of Operations 51 E. Campbell Ave. Suite 160 Campbell, California 95008

Re: K191870

Trade/Device Name: VV330 Continuous ECG Platform. VivaLNK Adhesive Patch Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II Product Code: DRG Dated: December 5, 2019 Received: December 9, 2019

Dear Quoi Huynh:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (QS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Jessica Paulsen Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K191870

Device Name VV330 Continuous ECG Platform

#### Indications for Use (Describe)

VV330 Continuous ECG Platform is a wireless recording system intended for use by healtheare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display.

The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data.

The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients who are 18 years of age or older.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------|--|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |

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# Section 5. 510(k) Summary

# 1. General Information

| 510(k) Sponsor | VivaLNK, Inc. |
|-----------------------|-------------------------------------------------------|
| Address | 51 East Campbell Ave, Suite#160<br>Campbell, CA 95008 |
| Correspondence Person | Quoi Huynh |
| Contact Information | [e-mail]<br>408 205-4202 |
| Date Prepared | July 10th, 2019 |

# 2. Subject device:

| Proprietary Name | VV330 Continuous ECG Platform |
|---------------------|---------------------------------------------------------------------|
| Classification Name | Transmitters and Receivers, Physiological Signal,<br>Radiofrequency |
| Regulation Number | 870.2910 |
| Product Code | DRG |
| Regulatory Class | II |

#### 3. Primary Predicate Device:

| Proprietary Name | VitalConnect Platform |
|------------------------|-------------------------------------------------------------------------------------------------------|
| Premarket Notification | K132447 |
| Classification Name | Transmitters and Receivers, Physiological Signal,<br>Radiofrequency<br>Detector and alarm, arrhythmia |
| Regulation Number | 870.2910<br>870.1025 |
| Product Code | DRG, DSI |
| Regulatory Class | II |

# 4. Secondary Predicate Device:

| Proprietary Name | VitalConnect Platform |
|------------------------|---------------------------------------------------------------------|
| Premarket Notification | K141167 |
| Classification Name | Transmitters and receivers, physiological signal,<br>radiofrequency |

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| | Detector and alarm, arrhythmia |
|-------------------|---------------------------------------------------------------|
| | Monitor, physiological, patient (with arrhythmia detection or |
| | alarm) |
| Regulation Number | 21 C.F.R. 870.2910 |
| | 21 C.F.R. 870.1025 |
| | 21 C.F.R. 870.1025 |
| Product Code | DRG, DSI, MHX |
| Regulatory Class | II |

#### Device Description 5.

The VV330 Continuous ECG Platform is a single-channel, rechargeable, re-usable, ambulatory medical-grade continuous ECG recorder, intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home.

The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording systems intended for use on general care patients and on patients who are 18 years of age or older.

The VV330 Continuous ECG Platform is an ECG acquisition, storage, and transmission devices that utilizes disposable adhesive to maintain contact with the patient's skin and a hydrogel to promote electrical connectivity. The Platform has a re-usable sensor/recorder module allowing collection, storage and transfer of physiological data such as electrocardiogram (ECG), Accelerometer data, R-R Interval (RRI) and Heart Rate (HR). The Platform has a mobile data-display application built from a proprietary Software Library. And it also allows Authorized Persons to build their own applications using the same Software Library.

User's physiological are not transferred to healthcare professionals directly in any way; healthcare professionals can only view the data on the intended device (such as a mobile phone). User may view the physiological data in real time from the smart phone (or similar devices) while it records the data.

The Subject device provides operational alarms such as lead on/off status detection, battery monitoring, Over the Air (OTA) updates, real time clock, and power management. The operational alarms are intended to notify users of any interruption in data and of the overall operation status of the Recorder. The Subject device, being just a Transmitters and Receivers of Physiological Signal, does not provide any alarms based on physiological data setting.

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#### 6. Indications for Use

VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data.

The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.

# 7. Comparison of Indications for Use and Technological Characteristics with the Primary and Secondary Predicates

| Feature/<br>Function | Subject device: | Primary Predicate Device: | Secondary Predicate Device: |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | VV330 Continuous ECG<br>Platform | VitalConnect Platform<br>(K132447) | VitalConnect Platform<br>(K141167) |
| Indications for Use | | | |
| Indications for Use | VV330 Continuous ECG<br>Platform is a wireless recording<br>system intended for use by<br>healthcare professionals for<br>record and display of<br>physiological data within<br>healthcare settings or at home.<br>This includes electrocardiogram<br>(ECG), accelerometer data, R-R<br>interval and heart rate. Data is<br>transmitted wirelessly to a<br>separate location (such as a<br>mobile phone) for storage and<br>display. The VV330 Continuous<br>ECG Platform can be configured<br>by Authorized Persons to modify<br>or merge or ignore any of the<br>operational alerts, but not to set<br>new alerts related to<br>physiological data. | The VitalConnect Platform is a<br>wireless monitoring system<br>intended for use by healthcare<br>professionals for unattended<br>surveillance of physiological data<br>within healthcare settings. This<br>includes heart rate,<br>electrocardiography (ECG), heart<br>rate variability, respiratory rate,<br>skin temperature, activity<br>(including step count), and<br>posture (body position relative to<br>gravity including fall). Data is<br>transmitted wirelessly to a central<br>location where it is stored for<br>analysis.<br><br>The VitalConnect Platform can be<br>configured by Authorized Persons<br>to notify healthcare professionals | The VitalConnect Platform is a<br>wireless remote monitoring system<br>intended for use by healthcare<br>professionals for continuous<br>collection of physiological data in<br>home and healthcare settings. This<br>includes heart rate,<br>electrocardiography (ECG), heart<br>rate variability (R-R interval),<br>respiratory rate, skin temperature,<br>activity (including step count), and<br>posture (body position relative to<br>gravity including fall). Data is<br>transmitted wirelessly to a central<br>location where it is stored for<br>analysis.<br><br>The VitalConnect Platform can be<br>configured by Authorized Persons<br>to notify healthcare professionals<br>when physiological data falls<br>outside selected parameters. |
| Feature/<br>Function | Subject device:<br>VV330 Continuous ECG<br>Platform | Primary Predicate Device:<br>VitalConnect Platform<br>(K132447) | Secondary Predicate Device:<br>VitalConnect Platform<br>(K141167) |
| The device is not intended to be<br>used on critical care patients and<br>is intended to supplement vital<br>signs recording for later viewing<br>by healthcare professionals, not<br>to replace current standards of<br>care. The device is an<br>ambulatory, continuous<br>recording system intended for<br>use on general care patients and<br>on patients who are 18 years of<br>age or older. | when physiological data falls<br>outside selected parameters.<br>The device is not intended to be<br>used on critical care patients and<br>is intended to supplement vital<br>signs monitoring by healthcare<br>professionals, not to replace<br>current standards of care. The<br>device is intended for use on<br>general care patients and on<br>patients who are 18 years of age<br>or older. It is not intended for<br>home use. | The device is intended for use on<br>general care patients who are 18<br>years of age or older as a general<br>patient monitor, to provide<br>physiological information. The data<br>from the VitalConnect Platform is<br>intended for use by healthcare<br>professionals as an aid to diagnosis<br>and treatment. It is not intended for<br>use on critical care patients. | |
| Regulations and<br>Product Code(s) | 21 CFR 870.2910, DRG-<br>Transmitters and Receivers,<br>Physiological Signal,<br>Radiofrequency | 21 CFR 870.2910, DRG-<br>Transmitters and Receivers,<br>Physiological Signal,<br>Radiofrequency<br>21 CFR 870.1025, DSI- Detector<br>and alarm, arrhythmia | 21 CFR 870.2910, DRG-<br>Transmitters and Receivers,<br>Physiological Signal,<br>Radiofrequency<br>21 CFR 870.1025, DSI- Detector<br>and alarm, arrhythmia<br>21 CFR 870.1025, MHX- Monitor,<br>physiological, patient (with<br>arrhythmia detection or alarm) |
| Intended Use | Wireless recording and display<br>of physiological data | Wireless monitoring, recording,<br>and analysis of physiological data | Wireless monitoring, recording, and<br>analysis of physiological data |
| Intended Users | Healthcare Professionals | Healthcare Professionals | Healthcare Professionals |
| Intended Population | General care patients 18 years of<br>age or older | General care patients 18 years of<br>age or older | General care patients 18 years of<br>age or older |
| Intended Use<br>Environment | For home use and healthcare<br>setting | For healthcare setting | For home use and healthcare setting |
| | Hardware | | |
| Device Placement on<br>Human Body | Left upper chest area | Left upper chest area | Left upper chest area |
| Reuse | ECG Recorder: Re-usable<br>Adhesive Patch: Single use | Sensor Module: Single use<br>Adhesive Patch: Single use | Sensor Module: Single use<br>Adhesive Patch: Single use |
| Feature/<br>Function | Subject device:<br>VV330 Continuous ECG<br>Platform | Primary Predicate Device:<br>VitalConnect Platform<br>(K132447) | Secondary Predicate Device:<br>VitalConnect Platform<br>(K141167) |
| Duration of<br>Continuous Use | 3 days of continuous<br>recording once fully charged | 4 days of continuous<br>monitoring. Dispose after<br>single usage | 4 days of continuous monitoring.<br>Dispose after single usage |
| Battery | Rechargeable battery | Single use, non-rechargeable<br>battery | Single use, non-rechargeable<br>battery |
| Accelerometer | Tri-axial accelerometer | Tri-axial accelerometer | Tri-axial accelerometer |
| Size and Weight | Device Size:<br>90mm x 28mm x7.9mm<br>Adhesive Patch Size:<br>110mm x 48mm x 0.9mm<br>(without the release liner)<br>Device Weight: 7.5g | Device Size:<br>~21mm x 12mm x 4mm<br>Adhesive Patch Size:<br>~111mm x 47mm x 6mm<br>(without the release liner)<br>Device Weight: 11g | Device Size:<br>~21mm x 12mm x 4mm<br>Adhesive Patch Size:<br>~111mm x 47mm x 6mm<br>(without the release liner)<br>Device Weight: 11g |
| Relay Server | No | Yes | Yes |
| Signal Transmission | Bluetooth Low Energy (BLE) | Bluetooth Low Energy (BLE) | Bluetooth Low Energy (BLE) |
| Operating<br>Temperature | 10-45 degree C | 10-43 degree C | 10-43 degree C |
| Electrical Safety | Conformed to IEC 60601-1 | Conformed to IEC 60601-1 | Conformed to IEC 60601-1 |
| Electromagnetic<br>Compatibility | Conformed to IEC 60601-1-2 | Conformed to IEC 60601-1-2 | Conformed to IEC 60601-1-2 |
| | | Software | |
| Heart Rate Detection<br>Range | 40-300 Bpm (beats per<br>minute) | 30-200 Bpm (beats per<br>minute) | 30-200 Bpm (beats per minute) |
| Heart Rate Accuracy | 95% accuracy against true<br>heart rate value under<br>ambulatory conditions | < +/- 5 or 10% Beats per<br>minute, whichever is greater…