(179 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a data acquisition, storage, and transmission system without any mention of algorithmic analysis of physiological data.
No.
The device is described as a "wireless recording system intended for use by healthcare professionals for record and display of physiological data" and "to supplement vital signs recording," not to provide therapy or treatment.
No
The device is described as a "wireless recording system intended for use by healthcare professionals for record and display of physiological data." It is explicitly stated that it is "not intended to replace current standards of care" and "The Subject device, being just a Transmitters and Receivers of Physiological Signal, does not provide any alarms based on physiological data setting." Its purpose is to collect and transmit data, not to interpret or diagnose.
No
The device description explicitly states it is a "single-channel, rechargeable, re-usable, ambulatory medical-grade continuous ECG recorder" and mentions hardware verification and validation activities, indicating it includes physical hardware components beyond just software.
Based on the provided text, the VV330 Continuous ECG Platform is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- VV330 Function: The VV330 Continuous ECG Platform is described as a wireless recording system that records and displays physiological data directly from the patient's body (ECG, accelerometer data, R-R Interval, heart rate). It does not analyze specimens derived from the body.
- Intended Use: The intended use is for recording and displaying physiological data for later viewing by healthcare professionals, supplementing vital signs recording. This is a direct measurement of physiological signals, not an analysis of a biological specimen.
Therefore, the VV330 Continuous ECG Platform falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DRG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Left upper chest area
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Healthcare professionals / healthcare settings or at home.
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)
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: ISO14971:2007/(R)2010, ANSI AAMI ISO 10993-5:2009/(R)2014, ISO 10993-10 Third Edition 2010-08-01, AAMI/ANSI EC-12:2000/(R)2012, ANSI AAMI ES60601-1:2005 (Third Edition) +CORR. 1:2006 + CORR. 2:2007+A1:2012 (or IEC 60601-1:2012 reprint), IEC 60601-1-2 Edition 4.0 2014-02, IEC 60601-1-11:2015 Part 1-11, ANSI AAMI IEC 60601-2-47:2012 (Second Edition), ANSI IEEE C63.27-2017, IEC 62304: 2015.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Heart Rate Accuracy: 95% accuracy against true heart rate value under ambulatory conditions
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).
0
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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
1
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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Section 5. 510(k) Summary
1. General Information
| 510(k) Sponsor | VivaLNK, Inc. |
|---|---|
| Address | 51 East Campbell Ave, Suite#160 |
| Campbell, CA 95008 | |
| Correspondence Person | Quoi Huynh |
| Contact Information | Qh@vivaLNK.com |
| 408 205-4202 | |
| 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, |
| Radiofrequency | |
| Detector and alarm, arrhythmia | |
| Regulation Number | 870.2910 |
| 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, |
| radiofrequency |
4
| 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.
5
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/
| Function | Subject device: | Primary Predicate Device: | Secondary Predicate Device: |
|---|---|---|---|
| VV330 Continuous ECG | |||
| Platform | VitalConnect Platform | ||
| (K132447) | VitalConnect Platform | ||
| (K141167) | |||
| Indications for Use | |||
| 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 VitalConnect Platform is a | ||
| wireless monitoring system | |||
| intended for use by healthcare | |||
| professionals for unattended | |||
| surveillance of physiological data | |||
| within healthcare settings. This | |||
| includes heart rate, | |||
| electrocardiography (ECG), heart | |||
| rate variability, 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 VitalConnect Platform can be
configured by Authorized Persons
to notify healthcare professionals | 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 VitalConnect Platform can be
configured by Authorized Persons
to notify healthcare professionals
when physiological data falls
outside selected parameters. |
| Feature/
Function | Subject device:
VV330 Continuous ECG
Platform | Primary Predicate Device:
VitalConnect Platform
(K132447) | Secondary Predicate Device:
VitalConnect Platform
(K141167) |
| 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. | when physiological data falls
outside selected parameters.
The device is not intended to be
used on critical care patients and
is intended to supplement vital
signs monitoring by healthcare
professionals, not to replace
current standards of care. The
device is intended for use on
general care patients and on
patients who are 18 years of age
or older. It is not intended for
home use. | 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. | |
| Regulations and
Product Code(s) | 21 CFR 870.2910, DRG-
Transmitters and Receivers,
Physiological Signal,
Radiofrequency | 21 CFR 870.2910, DRG-
Transmitters and Receivers,
Physiological Signal,
Radiofrequency
21 CFR 870.1025, DSI- Detector
and alarm, arrhythmia | 21 CFR 870.2910, DRG-
Transmitters and Receivers,
Physiological Signal,
Radiofrequency
21 CFR 870.1025, DSI- Detector
and alarm, arrhythmia
21 CFR 870.1025, MHX- Monitor,
physiological, patient (with
arrhythmia detection or alarm) |
| Intended Use | Wireless recording and display
of physiological data | Wireless monitoring, recording,
and analysis of physiological data | Wireless monitoring, recording, and
analysis of physiological data |
| Intended Users | Healthcare Professionals | Healthcare Professionals | Healthcare Professionals |
| Intended Population | General care patients 18 years of
age or older | General care patients 18 years of
age or older | General care patients 18 years of
age or older |
| Intended Use
Environment | For home use and healthcare
setting | For healthcare setting | For home use and healthcare setting |
| | Hardware | | |
| Device Placement on
Human Body | Left upper chest area | Left upper chest area | Left upper chest area |
| Reuse | ECG Recorder: Re-usable
Adhesive Patch: Single use | Sensor Module: Single use
Adhesive Patch: Single use | Sensor Module: Single use
Adhesive Patch: Single use |
| Feature/
Function | Subject device:
VV330 Continuous ECG
Platform | Primary Predicate Device:
VitalConnect Platform
(K132447) | Secondary Predicate Device:
VitalConnect Platform
(K141167) |
| Duration of
Continuous Use | 3 days of continuous
recording once fully charged | 4 days of continuous
monitoring. Dispose after
single usage | 4 days of continuous monitoring.
Dispose after single usage |
| Battery | Rechargeable battery | Single use, non-rechargeable
battery | Single use, non-rechargeable
battery |
| Accelerometer | Tri-axial accelerometer | Tri-axial accelerometer | Tri-axial accelerometer |
| Size and Weight | Device Size:
90mm x 28mm x7.9mm
Adhesive Patch Size:
110mm x 48mm x 0.9mm
(without the release liner)
Device Weight: 7.5g | Device Size:
~21mm x 12mm x 4mm
Adhesive Patch Size:
~111mm x 47mm x 6mm
(without the release liner)
Device Weight: 11g | Device Size:
~21mm x 12mm x 4mm
Adhesive 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) |
| Operating
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
Compatibility | Conformed to IEC 60601-1-2 | Conformed to IEC 60601-1-2 | Conformed to IEC 60601-1-2 |
| | | Software | |
| Heart Rate Detection
Range | 40-300 Bpm (beats per
minute) | 30-200 Bpm (beats per
minute) | 30-200 Bpm (beats per minute) |
| Heart Rate Accuracy | 95% accuracy against true
heart rate value under
ambulatory conditions |