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 Description

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.

AI/ML Overview

The provided text describes the VV330 Continuous ECG Platform, but it does not contain the specific acceptance criteria or the details of a comparative study proving the device meets these criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria. While it lists recognized standards that the device conforms to, it does not explicitly state performance metrics or the methodology of studies used to prove these metrics.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method for the test set.
MRMC study details or effect size of AI assistance.
Stand-alone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document only provides the following relevant information:

Device Name: VV330 Continuous ECG Platform, VivaLNK Adhesive Patch.
Intended Use/Indications for Use: Wireless recording system for record and display of physiological data (ECG, accelerometer, R-R Interval, heart rate) for healthcare professionals, intended for supplementary use on general care patients 18 years or older, at home or healthcare settings. Not for critical care, not to replace current standards of care.
Performance Claim (Heart Rate Accuracy): 95% accuracy against true heart rate value under ambulatory conditions (this is a claim made in the comparison table, but no study details are provided to support it in terms of methodology or sample size).
Standards Conformed To (listed in "Performance Data" section):
- ISO14971:2007/(R)2010 (Risk Management)
- ANSI AAMI ISO 10993-5:2009/(R)2014 (Cytotoxicity)
- ISO 10993-10 Third Edition 2010-08-01 (Irritation and Skin Sensitization)
- AAMI/ANSI EC-12:2000/(R)2012 (Disposable ECG electrodes)
- ANSI AAMI ES60601-1:2005 (Third Edition) +CORR. 1:2006 + CORR. 2:2007+A1:2012 (General requirements for basic safety and essential performance)
- IEC 60601-1-2 Edition 4.0 2014-02 (Electromagnetic disturbances)
- IEC 60601-1-11:2015 Part 1-11 (Home healthcare environment requirements)
- ANSI AAMI IEC 60601-2-47:2012 (Second Edition) (Ambulatory electrocardiographic systems)
- ANSI IEEE C63.27-2017 (Wireless Coexistence)
- IEC 62304: 2015 (Application of Usability Engineering to Medical Devices)

The "Performance Data" section merely states that "VivaLNK, Inc. ("VivaLNK") completed the appropriate design verification activities... through software, hardware, mechanical, biocompatibility, packaging tests, and electromagnetic compatibility testing." It confirms compliance with recognized standards but does not provide any specific study protocols, results, sample sizes, or ground truth establishment methods for demonstrating the device meets a set of performance acceptance criteria.

In the context of the prompt, the document lacks the detailed information typically found in a clinical study report or a more comprehensive validation test report.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.

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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Section 5. 510(k) Summary

1. General Information

510(k) Sponsor	VivaLNK, Inc.
Address	51 East Campbell Ave, Suite#160Campbell, CA 95008
Correspondence Person	Quoi Huynh
Contact Information	Qh@vivaLNK.com408 205-4202
Date Prepared	July 10th, 2019

2. Subject device:

Proprietary Name	VV330 Continuous ECG Platform
Classification Name	Transmitters and Receivers, Physiological Signal,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,RadiofrequencyDetector and alarm, arrhythmia
Regulation Number	870.2910870.1025
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,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 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.

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6. Indications for Use

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

Feature/Function	Subject device:	Primary Predicate Device:	Secondary Predicate Device:
	VV330 Continuous ECGPlatform	VitalConnect Platform(K132447)	VitalConnect Platform(K141167)
Indications for Use
Indications for Use	VV330 Continuous ECGPlatform is a wireless recordingsystem intended for use byhealthcare professionals forrecord and display ofphysiological data withinhealthcare settings or at home.This includes electrocardiogram(ECG), accelerometer data, R-Rinterval and heart rate. Data istransmitted wirelessly to aseparate location (such as amobile phone) for storage anddisplay. The VV330 ContinuousECG Platform can be configuredby Authorized Persons to modifyor merge or ignore any of theoperational alerts, but not to setnew alerts related tophysiological data.	The VitalConnect Platform is awireless monitoring systemintended for use by healthcareprofessionals for unattendedsurveillance of physiological datawithin healthcare settings. Thisincludes heart rate,electrocardiography (ECG), heartrate variability, respiratory rate,skin temperature, activity(including step count), andposture (body position relative togravity including fall). Data istransmitted wirelessly to a centrallocation where it is stored foranalysis.The VitalConnect Platform can beconfigured by Authorized Personsto notify healthcare professionals	The VitalConnect Platform is awireless remote monitoring systemintended for use by healthcareprofessionals for continuouscollection of physiological data inhome and healthcare settings. Thisincludes heart rate,electrocardiography (ECG), heartrate variability (R-R interval),respiratory rate, skin temperature,activity (including step count), andposture (body position relative togravity including fall). Data istransmitted wirelessly to a centrallocation where it is stored foranalysis.The VitalConnect Platform can beconfigured by Authorized Personsto notify healthcare professionalswhen physiological data fallsoutside selected parameters.
Feature/Function	Subject device:VV330 Continuous ECGPlatform	Primary Predicate Device:VitalConnect Platform(K132447)	Secondary Predicate Device:VitalConnect Platform(K141167)
The device is not intended to beused on critical care patients andis intended to supplement vitalsigns recording for later viewingby healthcare professionals, notto replace current standards ofcare. The device is anambulatory, continuousrecording system intended foruse on general care patients andon patients who are 18 years ofage or older.	when physiological data fallsoutside selected parameters.The device is not intended to beused on critical care patients andis intended to supplement vitalsigns monitoring by healthcareprofessionals, not to replacecurrent standards of care. Thedevice is intended for use ongeneral care patients and onpatients who are 18 years of ageor older. It is not intended forhome use.	The device is intended for use ongeneral care patients who are 18years of age or older as a generalpatient monitor, to providephysiological information. The datafrom the VitalConnect Platform isintended for use by healthcareprofessionals as an aid to diagnosisand treatment. It is not intended foruse on critical care patients.
Regulations andProduct Code(s)	21 CFR 870.2910, DRG-Transmitters and Receivers,Physiological Signal,Radiofrequency	21 CFR 870.2910, DRG-Transmitters and Receivers,Physiological Signal,Radiofrequency21 CFR 870.1025, DSI- Detectorand alarm, arrhythmia	21 CFR 870.2910, DRG-Transmitters and Receivers,Physiological Signal,Radiofrequency21 CFR 870.1025, DSI- Detectorand alarm, arrhythmia21 CFR 870.1025, MHX- Monitor,physiological, patient (witharrhythmia detection or alarm)
Intended Use	Wireless recording and displayof physiological data	Wireless monitoring, recording,and analysis of physiological data	Wireless monitoring, recording, andanalysis of physiological data
Intended Users	Healthcare Professionals	Healthcare Professionals	Healthcare Professionals
Intended Population	General care patients 18 years ofage or older	General care patients 18 years ofage or older	General care patients 18 years ofage or older
Intended UseEnvironment	For home use and healthcaresetting	For healthcare setting	For home use and healthcare setting
	Hardware
Device Placement onHuman Body	Left upper chest area	Left upper chest area	Left upper chest area
Reuse	ECG Recorder: Re-usableAdhesive Patch: Single use	Sensor Module: Single useAdhesive Patch: Single use	Sensor Module: Single useAdhesive Patch: Single use
Feature/Function	Subject device:VV330 Continuous ECGPlatform	Primary Predicate Device:VitalConnect Platform(K132447)	Secondary Predicate Device:VitalConnect Platform(K141167)
Duration ofContinuous Use	3 days of continuousrecording once fully charged	4 days of continuousmonitoring. Dispose aftersingle usage	4 days of continuous monitoring.Dispose after single usage
Battery	Rechargeable battery	Single use, non-rechargeablebattery	Single use, non-rechargeablebattery
Accelerometer	Tri-axial accelerometer	Tri-axial accelerometer	Tri-axial accelerometer
Size and Weight	Device Size:90mm x 28mm x7.9mmAdhesive Patch Size:110mm x 48mm x 0.9mm(without the release liner)Device Weight: 7.5g	Device Size:~21mm x 12mm x 4mmAdhesive Patch Size:~111mm x 47mm x 6mm(without the release liner)Device Weight: 11g	Device Size:~21mm x 12mm x 4mmAdhesive Patch Size:~111mm x 47mm x 6mm(without the release liner)Device Weight: 11g
Relay Server	No	Yes	Yes
Signal Transmission	Bluetooth Low Energy (BLE)	Bluetooth Low Energy (BLE)	Bluetooth Low Energy (BLE)
OperatingTemperature	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
ElectromagneticCompatibility	Conformed to IEC 60601-1-2	Conformed to IEC 60601-1-2	Conformed to IEC 60601-1-2
		Software
Heart Rate DetectionRange	40-300 Bpm (beats perminute)	30-200 Bpm (beats perminute)	30-200 Bpm (beats per minute)
Heart Rate Accuracy	95% accuracy against trueheart rate value underambulatory conditions	< +/- 5 or 10% Beats perminute, whichever is greater	< +/- 5 or 10% Beats per minute,whichever is greater
R-R Interval Output	Yes	Yes	Yes
Electrocardiogram(ECG) Display	Yes	Yes	Yes
ProgrammableNotification andSetting	No	Yes	Yes
ConfigurableSoftware Library	Yes	Yes	Yes
Performance	Conformed to IEC 60601-2-47	Conformed to IEC 60601-2-47	Conformed to IEC 60601-2-47
		Patient Contact Material
Biocompatibility	Conformed to ISO 10993-1,ISO 10993-5 and ISO 10993-10	Conformed to ISO 10993-1,ISO 10993-5 and ISO 10993-10	Conformed to ISO 10993-1,ISO 10993-5 and ISO 10993-10
Feature/Function	Subject device:VV330 Continuous ECGPlatform	Primary Predicate Device:VitalConnect Platform(K132447)	Secondary Predicate Device:VitalConnect Platform(K141167)
Adhesive Usage	Yes	Yes	Yes

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8. Performance Data

VivaLNK, Inc. ("VivaLNK") completed the appropriate design verification activities to evaluate the safety and performance of the Subject Device in accordance with the device specifications and applicable performance standards through software, hardware, mechanical, biocompatibility, packaging tests, and electromagnetic compatibility testing. These tests were performed in accordance with the following FDA recognized standards:

Standard	Title of Standard
ISO14971:2007/(R)2010 medical devices	Application of Risk Management to Medical Devices
ANSI AAMI ISO 10993-5:2009/(R)2014Biological evaluation of medical devices -Part 5	Tests for in vitro cytotoxicity
ISO 10993-10 Third Edition 2010-08-01Biological evaluation of medical devices -Part 10	Tests for irritation and skin sensitization
AAMI/ANSI EC-12:2000/(R)2012	Disposable ECG electrodes
ANSI AAMI ES60601-1:2005 (ThirdEdition) +CORR. 1:2006 + CORR.2:2007+A1:2012 (or IEC 60601-1:2012reprint) Medical electrical equipment - Part 1	General requirements for basic safety and essential performance
IEC 60601-1-2 Edition 4.0 2014-02Medical electrical equipment - Part 1-2	General requirements for basic safety and essential performance - Collateral Standard:Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11:2015 Part 1-11	General requirements for basic safety and essential performance – Collateral standard:Requirements for medical electrical equipmentand medical electrical systems used in the home healthcare environment
ANSI AAMI IEC 60601-2-47:2012 (SecondEdition) Medical electrical equipment -- Part2-47	Particular requirements for the basic safety and essential performance of ambulatoryelectrocardiographic systems
ANSI IEEE C63.27-2017	American National Standard for Evaluation of Wireless Coexistence

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IEC 62304: 2015	Medical Device- Application of UsabilityEngineering to Medical Devices
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9. Conclusion

The Subject VV330 Continuous ECG Platform device is substantially equivalent to the Primary Predicate VitalConnect Platform (K132447) device and is intended for the same clinical application as the predicate devices. There are minor technological/design differences that do not raise new issues of safety or effectiveness. The primary and secondary predicates share the same intended use, indications for use, intended users, intended population, and device's product code and regulation number. The secondary predicate supports home use. Based on the test results, compliance with FDA recognized industry standards, and the analysis provided in this notice, the Subject device is shown to be substantially equivalent to the Predicate devices.

Regulation Number and Section

§ 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).