(125 days)
Not Found
No
The summary describes a system for collecting and transmitting physiological data and providing notifications based on selected parameters. There is no mention of AI, ML, or any advanced analytical techniques that would typically fall under those categories. The analysis and notification appear to be based on pre-defined thresholds.
No
The device is described as a remote monitoring system for collecting physiological data, intended for use as an aid to diagnosis and treatment, not for direct therapeutic intervention.
Yes
The device description explicitly states, "The data from the Vital Connect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment." This indicates its role in assisting the diagnostic process.
No
The device description explicitly lists a "Vital Connect Sensor" which includes an "Adhesive Patch" and a "Sensor Module". These are physical hardware components used for data acquisition. While the system includes software components (Relay Software Library, Secure Server), it is not solely software.
Based on the provided text, the Vital Connect Platform is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Vital Connect Platform's Function: The Vital Connect Platform is a wireless remote monitoring system that collects physiological data directly from the patient's body (in vivo) through a sensor attached to the skin. It measures things like heart rate, ECG, respiratory rate, temperature, activity, and posture.
- Intended Use: The intended use is for continuous collection of physiological data and providing this information to healthcare professionals as an aid to diagnosis and treatment. This is based on real-time or near real-time measurements from the patient, not on laboratory analysis of samples.
The device's function and intended use clearly fall under the category of patient monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Vital Connect 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 can include 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 are transmitted wirelessly from the Vital Connect Sensor for storage and analysis. The Vital Connect Platform can include the ability to notify healthcare professionals when physiological data fall 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 Vital Connect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.
Product codes
DRG, DSI, MHX
Device Description
The Vital Connect Platform is a wireless data collection system that monitors physiological data and consists of the following sub-systems:
- Vital Connect Sensor (includes Adhesive Patch and Sensor Module) .
- a) Adhesive Patch
The Adhesive Patch is designed as a disposable self-adhesive interface to the body.
-
b) Sensor Module
The Sensor Module performs processing functions related to capture of physiologic data and also performs bi-directional communication with the Relay Software Library. -
Relay Software Library
The Relay Software Library manages communication with the Vital Connect Sensor. The Relay Software Library also manages the communication with the Secure Server when the Secure Server is deployed. The Relay Software Library is installed on a relay device.
The Vital Connect Platform offers an optional sub-system:
- . Secure Server
The Secure Server manages the upload, processing and storage of sensor data, as well as real-time configuration and notification communications with the Relay Software Library.
The Vital Connect 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 can include 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 are transmitted wirelessly from the Vital Connect Sensor for storage and analysis. The Vital Connect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.
The Vital Connect Sensor continuously gathers physiological data from the person being monitored and then transmits encrypted data via bi-directional communication to the relay device when in range of the relay. The encrypted wireless data provided by the Sensor may be downloaded from the relay device for storage, or integrated into a Third-Party Relay Application via the APIs of the Relay Software Library. In addition, the wireless data may be transferred to the Vital Connect Secure Server where they are stored for analysis with the deployment of the server.
During normal operation, data are collected on the Vital Connect Sensor and transmitted to the Relay immediately. A continuous connection is needed between the Sensor and the Relay in order to facilitate continuous data transmission. The continuous wireless transmission of the data occurs with a delay or latency of seconds between continuous data collection and transmission. Data can be stored and downloaded from the Relay. Data can continue to be transferred to the Vital Connect Server with a server connection. If an interruption occurs between the Sensor and the Relay, data will be stored on the Sensor for several hours until the connection is re-established.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
healthcare professionals for continuous collection of physiological data 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)
Verification and validation activities established the safety and performance characteristics of the proposed device with respect to the predicate. The following performance data have been provided in support of the substantial equivalence determination.
6.9.1 Summary of Biocompatibility Testing
Biocompatibility testing, previously conducted, included in-vitro cytotoxicity, irritation and sensitization, according to the recommendations of ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing.
6.9.2 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Vital Connect Sensor. The device complies with the IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 60601-2-25, and IEC 60601-2-47 standards for safety, the IEC 60601-1-2 standard for EMC, IEC/TS 62657-2 and FCC CRF47 Part 15 Subpart C standards for wireless communication.
6.9.3 Software Verification and Validation Testing
Software verification and validation testing was conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software for this device is determined as a "moderate" level of concern because a failure or latent flaw could lead to a minor injury to the patient through incorrect information or through the action of the care provider.
6.9.4 Bench Testing
In vitro bench testing, including shelf life, packaging integrity, operation and storage conditions, water resistance, static load, compression, and drop test were conducted to verify the modified device met all acceptance criteria and performed similarly to the predicate device.
6.9.5 Animal and Clinical Testing
Prior clinical testing was performed to support the clearance of the predicate device and is still relevant to the proposed device. The safety and effectiveness of the device associated with the product changes are demonstrated through performance testing. Thus, animal and clinical studies were not deemed necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 6, 2015
Vital Connect. Inc. Bonnie Wu Sr. Regulatory Manager 900 E. Hamilton Avenue, Suite 500 Campbell, California 95008
Re: K152139
Trade/Device Name: Vital Connect Platform, Healthpatch MD, VitalPatch Regulation Number: 21 CFR Regulation Name: Regulatory Class: Class II Product Code: DRG, DSI, MHX Dated: November 2, 2015 Received: November 4, 2015
Dear Bonnie Wu:
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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 801), 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/ResourcesforYou/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.
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152139
Device Name
Vital Connect Platform
Indications for Use (Describe)
The Vital Connect 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 can include 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 are transmitted wirelessly from the Vital Connect Sensor for storage and analysis. The Vital Connect Platform can include the ability to notify healthcare professionals when physiological data fall 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 Vital Connect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.
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
6.0 510(k) Summary
In accordance with the provisions of the Safe Medical Device Act of 1990, Vital Connect, Inc. is providing a summary of Safety and Effectiveness information regarding the Vital Connect Platform.
6.1 Company Identification
Vital Connect, Inc. 900 E. Hamilton Ave. Suite 500 Campbell, CA 95008 Registration Number: 3010830833
6.2 Contact Person
Bonnie Wu
Sr. Manager, Regulatory Affairs
Telephone: 408-963-4620
Fax: 408-963-2828
Email: bwu@vitalconnect.com
6.3 Preparation Date
July 31, 2015
6.4 ldentification of Product and Classification
Device Trade Name: Vital Connect Platform, HealthPatch® MD, VitalPatch™ Common Name: Wireless Remote Monitoring System Classification Name: Transmitters and Receivers, Physiological Signal, Radiofrequency Classification Panel: Cardiovascular CRF Section: 870.2910, 870.1025 Device Class: II Product Code: DRG, DSI, MHX
6.5 Predicate Device
Manufacturer: Vital Connect, Inc. Model: Vital Connect Platform 510(k) Number: K141167
4
6.6 Device Description
The Vital Connect Platform is a wireless data collection system that monitors physiological data and consists of the following sub-systems:
- Vital Connect Sensor (includes Adhesive Patch and Sensor Module) .
- a) Adhesive Patch
The Adhesive Patch is designed as a disposable self-adhesive interface to the body.
-
b) Sensor Module
The Sensor Module performs processing functions related to capture of physiologic data and also performs bi-directional communication with the Relay Software Library. -
Relay Software Library
The Relay Software Library manages communication with the Vital Connect Sensor. The Relay Software Library also manages the communication with the Secure Server when the Secure Server is deployed. The Relay Software Library is installed on a relay device.
The Vital Connect Platform offers an optional sub-system:
- . Secure Server
The Secure Server manages the upload, processing and storage of sensor data, as well as real-time configuration and notification communications with the Relay Software Library.
The Vital Connect 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 can include 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 are transmitted wirelessly from the Vital Connect Sensor for storage and analysis. The Vital Connect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.
The Vital Connect Sensor continuously gathers physiological data from the person being monitored and then transmits encrypted data via bi-directional communication to the relay device when in range of the relay. The encrypted wireless data provided by the Sensor may be downloaded from the relay device for storage, or integrated into a Third-Party Relay Application via the APIs of the Relay Software Library. In addition, the wireless data may be transferred to the Vital Connect Secure Server where they are stored for analysis with the deployment of the server.
During normal operation, data are collected on the Vital Connect Sensor and transmitted to the Relay immediately. A continuous connection is needed between the Sensor and the Relay in order to facilitate continuous data transmission. The continuous wireless transmission of the data occurs with a delay or latency of seconds between continuous data collection and transmission. Data can be stored and downloaded from the Relay. Data can continue to be transferred to the Vital Connect Server with a server connection. If an interruption occurs
5
between the Sensor and the Relay, data will be stored on the Sensor for several hours until the connection is re-established.
6.7 Indication for Use
The Vital Connect 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 can include 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 are transmitted wirelessly from the Vital Connect Sensor for storage and analysis. The Vital Connect Platform can include the ability to notify healthcare professionals when physiological data fall 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 Vital Connect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.
6.8 Technology Characteristics
The intended use and technological features of the proposed Vital Connect Platform do not substantially differ from the legally marketed predicate device. The Vital Connect Platform and the predicate device have substantially equivalent intended uses and methods of operation.
6.9 Performance Data
Verification and validation activities established the safety and performance characteristics of the proposed device with respect to the predicate. The following performance data have been provided in support of the substantial equivalence determination.
6.9.1 Summary of Biocompatibility Testing
Biocompatibility testing, previously conducted, included in-vitro cytotoxicity, irritation and sensitization, according to the recommendations of ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing.
6.9.2 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Vital Connect Sensor. The device complies with the IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 60601-2-25, and IEC 60601-2-47 standards for safety, the IEC 60601-1-2 standard for EMC, IEC/TS 62657-2 and FCC CRF47 Part 15 Subpart C standards for wireless communication.
6.9.3 Software Verification and Validation Testing
Software verification and validation testing was conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of
6
Premarket Submissions for Software Contained in Medical Devices. The software for this device is determined as a "moderate" level of concern because a failure or latent flaw could lead to a minor injury to the patient through incorrect information or through the action of the care provider.
6.9.4 Bench Testing
In vitro bench testing, including shelf life, packaging integrity, operation and storage conditions, water resistance, static load, compression, and drop test were conducted to verify the modified device met all acceptance criteria and performed similarly to the predicate device.
6.9.5 Animal and Clinical Testing
Prior clinical testing was performed to support the clearance of the predicate device and is still relevant to the proposed device. The safety and effectiveness of the device associated with the product changes are demonstrated through performance testing. Thus, animal and clinical studies were not deemed necessary.
6.10 Conclusion
The proposed Vital Connect Platform is substantially equivalent in design and intended use to the predicate device. Any differences between the proposed Vital Connect Platform and the predicate device have no significant influence on safety or effectiveness as established through performance testing. Therefore, the proposed Vital Connect Platform raises no new issues of safety or effectiveness from the predicate device.