(84 days)
Not Found
No
The document describes a system for collecting and transmitting physiological data and providing notifications based on pre-selected parameters. There is no mention of AI or ML being used for data analysis, interpretation, or decision-making beyond simple parameter thresholds.
No
The device is a monitoring system intended to aid in diagnosis and treatment by providing physiological information, not directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The data from the VitalConnect Platform is intended for use by healthcare professionals as an aid to diagnosis and treatment." This indicates its role in the diagnostic process.
No
The device description explicitly states that the VitalConnect Platform consists of a "VitalConnect Sensor (includes adhesive Patch and Sensor Module)" in addition to software components. The sensor module is described as performing processing functions and bi-directional communication, indicating it is a hardware component.
Based on the provided information, the VitalConnect Platform is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The VitalConnect Platform collects physiological data directly from the patient's body (heart rate, ECG, respiratory rate, temperature, activity, posture) using sensors applied to the skin. It does not analyze blood, urine, tissue, or other biological samples.
- The intended use is for continuous collection of physiological data and monitoring. While the data is used as an "aid to diagnosis and treatment," the device itself is a patient monitor, not a diagnostic test performed on a specimen.
The device falls under the category of a patient monitoring system or physiological monitor.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DRG, DSI, MHX
Device Description
The VitalConnect Platform is a wireless data collection system that monitors physiological data and consists of the following sub systems:
• VitalConnect Sensor (includes adhesive Patch and Sensor Module)
• Relay Software Library
• Server Software Library
VitalConnect Platform sub-system includes:
• VitalConnect Sensor
a) Adhesive Patch
The Patch is designed as a disposable self-adhesive interface to the body.
b) Sensor Module
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.
• VitalConnect Relay Software Library
The Relay Software Library manages bi-directional communication between the Sensor Module and the Server Software Library and is installed on a relay device.
• VitalConnect Secure Server Software Library
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.
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 with integrated sensors and wireless transceiver module, worn on the torso to record 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Torso
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Healthcare professionals for use in home and healthcare settings.
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)
Non-clinical bench testing was presented as part of the VitalConnect Platform cleared 510(k) submission (K132447). This testing is applicable to the indication submitted here in, including testing of: 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.
An IRB-approved "Long-term Field Study for Home Use" was conducted by Vital Connect with the VitalConnect Platform from September 2013 to March 2014, to assess the long-term use of the VitalConnect Platform in a home setting. The assessment includes the usability of the VitalConnect Platform in a home setting, including interaction with the module, patch, and relay. In addition, the assessment includes the long-term wearability of a series of patches on the same participants. Results indicate successful use of the VitalConnect Platform over a 50-day home use study on 76 participants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K113054, K110809, K121197, K083287
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
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.
900 East Hamilton Avenue
Suite 500
Campbell, CA 95008 |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sam Mostafavi
Vice President of Quality Assurance and Regulatory Affairs
E-mail: smostafavi@vitalconnect.com
Phone: (408) 963-4620
Fax: (408) 963-2828
Vital Connect Inc.
900 East Hamilton Avenue
Suite 500
Campbell, CA 95008 |
| Date Prepared: | June 03, 2014 |
| Trade name: | VitalConnect Platform (consisting of VitalConnect Sensor,
Relay Software Library and Secure Server Software Library) |
| Classification: | Class II |
| Classification: | Classifications presented as part of the VitalConnect
Platform cleared 510(k) submission (K132447):
21 CFR 870.2910, Product Code: DRG
• Transmitters and Receivers, Physiological Signal,
Radiofrequency
21 CFR 870.1025, Product Code: DSI
• Arrhythmia detection and alarm (including ST-segment
measurement and alarm)
New classification for home use indication:
21 CFR 870.1025, Product Code: MHX
• Monitor, physiological, patient (with arrhythmia detection
or alarm) |
| Predicate Device: | Predicate devices presented as part of the VitalConnect
Platform cleared 510(k) submission (K132447):
• CareFusion, Wireless Monitoring System, 510(k) #:
K110809
• Preventice, BodyGuardian System, 510(k) #: K121197
• Corventis, Mobile Patient Management System, 510(k) #:
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:
• VitalConnect Sensor (includes adhesive Patch and Sensor Module)
• Relay Software Library
• Server Software Library
VitalConnect Platform sub-system includes:
• VitalConnect Sensor
a) Adhesive Patch
The Patch is designed as a disposable self-adhesive interface to the body.
b) Sensor Module
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.
• VitalConnect Relay Software Library
The Relay Software Library manages bi-directional communication between the Sensor Module and the Server Software Library and is installed on a relay device.
• VitalConnect Secure Server Software Library
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.
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
with integrated sensors and wireless transceiver module, worn
on the torso to record 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). |
| Physical
Description: | VitalConnect Sensor consisting of Patch and the Sensor
Module dimensions are:
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
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
Technological
Characteristics: | Technological review and comparison to the predicate device,
Hidalgo Ltd, EquivalentTM Vital Signs Physiological Monitor
EQo2, K113054, has been performed through product testing
presented as part of the cleared 510(k) submission K132447.
The VitalConnect Platform and the predicate device (Hidalgo
Ltd, EquivalentTM Vital Signs Physiological Monitor EQo2,
K113054) contain small ambulatory monitoring sensors that
measure ECG, heart rate, respiration rate, activity, body
orientation, body/skin temperature. Both transmit their data to a
remote computer server that allows healthcare professionals to
access and review the data. There are no fundamental
differences between their technological characteristics for
home setting environment. Therefore, we claim that
VitalConnect Platform is substantially equivalent to Hidalgo Ltd,
EquivalentTM Vital Signs Physiological Monitor EQo2
(K113054) in this regard. |
| Non-Clinical
Testing: | Non-clinical bench testing was presented as part of the
VitalConnect Platform cleared 510(k) submission (K132447).
This testing is applicable to the indication submitted here in,
including testing of:
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
conducted by Vital Connect with the VitalConnect Platform from
September 2013 to March 2014, to assess the long-term use of
the VitalConnect Platform in a home setting. The assessment
includes the usability of the VitalConnect Platform in a home
setting, including interaction with the module, patch, and relay. |
| | |
| | In addition, the assessment includes the long-term wearability
of a series of patches on the same participants. Results
indicate successful use of the VitalConnect Platform over a 50-
day home use study on 76 participants. |
| Biocompatibility: | The initial 510k submission, K132447, included biocompatibility
data for the hydrocolloid adhesive. In this submission, a
medical grade silicone adhesive has been added as a separate
option for the patch. The silicone adhesive has been subjected
to the following safety evaluation:
• In Vitro Cytotoxicity
• MEM Elution
• Primary Skin Irritation
• Guinea Pig Sensitization |
| Conclusion: | The performance results for the VitalConnect Platform included
non-clinical and clinical testing already submitted as part of
K132447, and the biocompatibility testing data of silicone
adhesive and clinical study in a home setting are provided in
this 510(k) demonstrate that VitalConnect Platform is safe and
effective for its intended use, including use in the home
environment. |
| | Based on the intended use and product performance results,
VitalConnect Platform has been shown to be substantially
equivalent for home use to the currently marketed predicate
device, Hidalgo Ltd, EquivalentTM Vital Signs Physiological
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
6
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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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
7
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