(59 days)
No reference devices were used in this submission.
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data collection and basic parameter-based notifications, not advanced analytical capabilities.
No
The device is described as a monitoring system that aids in diagnosis and treatment by collecting physiological data. It does not provide therapy or treatment itself.
Yes
The "Intended Use" section states: "The data from the VitalConnect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment."
No
The device description explicitly states "VitalPatch is a wearable biosensor designed to measure a patient's vital signs," indicating a hardware component. The proposed modifications also relate to the wearable biosensor's duration of use, which is a hardware characteristic.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The VitalConnect Platform and VitalPatch are described as a "wireless remote monitoring system" and a "wearable biosensor." They collect physiological data directly from the patient's body (heart rate, ECG, temperature, activity, etc.) through external sensors.
- Lack of Sample Analysis: There is no mention of collecting or analyzing samples from the patient's body in a laboratory setting. The data is collected externally and transmitted wirelessly.
The device is a patient monitoring system that collects physiological data in vivo (from the living body), not in vitro (in glass, referring to laboratory analysis of samples).
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 can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, body temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the VitalConnect Sensor for storage and analysis. The VitalConnect 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 VitalConnect 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
VitalPatch is a wearable biosensor designed to measure a patient's vital signs, including 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).
The following modifications are proposed for the VitalPatch wearable biosensors:
- Increasing the duration for use from 5 days (120 hours) to 7 days (168 hours). This includes a minor software change and minor changes to the IFU.
All other vital signs, including heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, body temperature, skin temperature, activity (including step count), and posture (body position relative to gravity including fall) cleared in K183078 remain the same.
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: Sterilization & Shelf-life Testing, Biocompatibility Testing, Electrical safety and electromagnetic compatibility (EMC) testing, Software Verification and Validation Testing, Benchtop & Simulated Use Testing (Wear Duration Testing, Battery operating life testing, EOL Detection after 168 hours). Animal Study was not required. Clinical testing was not required;
substantial equivalence is based upon benchtop performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
K190196 % Cynthia Merrell Vice-President QA &RA VitalConnect Inc. Contact Address
Re: K190196
Trade/Device Name: VitalPatch® Biosensor Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG Dated: June 7, 2019 Received: April 9, 2019
Dear Cynthia Merrell:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 Matthew Hillebrenner Deputy 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) K190196
Device Name VitalPatch Biosensor
Indications for Use (Describe)
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 can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, body temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the VitalConnect Sensor for storage and analysis. The VitalConnect 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 VitalConnect 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
1. SUBMITTER VitalConnect, Inc. Address 224 Airport Parkway, Suite 300 City, State, Zip USA San Jose, CA, 95110, USA Tel: +1.408.963.4600 Fax: +1.408.963.2828
Contact Person: Cynthia Merrell, VP QA&RA Date Prepared: April 4, 2019
| II. DEVICE | |
|---|---|
| Name of Device: | VitalPatch Biosensor |
| Classification Name: | Cardiovascular Monitoring Devices 2 |
| Regulation: | CFR §870.2910, 21 CFR 870.1025 |
| Regulatory Class: | Class II |
| Product Classification Code: | DRG, DSI, MHX |
PREDICATE DEVICE |||.
| Predicate Manufacturer: | Vital Connect, Inc. |
|---|---|
| Predicate Trade Name: | VitalPatch® VitalConnect Platform |
| Predicate 510(k): | K183078 |
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
VitalPatch is a wearable biosensor designed to measure a patient's vital signs, including 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). VitalPatch was most recently cleared in K183078.
The following modifications are proposed for the VitalPatch wearable biosensors:
- . Increasing the duration for use from 5 days (120 hours) to 7 days (168 hours). This includes a minor software change and minor changes to the IFU.
All other vital signs, including heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, body temperature, skin temperature, activity (including step count), and posture (body position relative to gravity including fall) cleared in K183078 remain the same.
4
INDICATIONS FOR USE V.
VitalConnect, Inc.
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 can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, body temperature, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the VitalConnect Sensor for storage and analysis. The VitalConnect 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 VitalConnect 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE
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.
| Predicate (K183078) | Subject Device |
|---|---|
| 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 can include heart rate, | |
| electrocardiography (ECG), heart rate variability, R-R | |
| interval, respiratory rate, body temperature, skin | |
| temperature, activity (including step count), and posture | |
| (body position relative to gravity including fall). Data are | |
| transmitted wirelessly from the VitalConnect Sensor for | |
| storage and analysis. The VitalConnect 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
VitalConnect 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. | 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 can include heart rate,
electrocardiography (ECG), heart rate variability, R-R
interval, respiratory rate, body temperature, skin
temperature, activity (including step count), and posture
(body position relative to gravity including fall). Data are
transmitted wirelessly from the VitalConnect Sensor for
storage and analysis. The VitalConnect 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
VitalConnect 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. |
Table 1 Comparison of Indications for Use (the indications for use are identical)
5
Table 2 Size Comparison of the adhesive patch
| Dimension | Predicate (K183078) | Subject Device |
|---|---|---|
| Length | 115 mm | 120 mm |
| Width | 35.6 mm | 40.6 mm |
| Height | 7.5 mm | 9.4 mm |
Table 3 Component Comparison of the Predicate and Subject Devices
| Component | Predicate (K183078) | Proposed Device |
|---|---|---|
| ECG electrodes | Allow the recording of a single-lead | |
| bipolar ECG at a sampling rate of 125 | ||
| Hz | Identical | |
| Skin Thermistor | Mounted on the patch. Designed to | |
| monitor skin temperatures when the | ||
| patch is attached to the skin. | Identical | |
| Ambient Thermistor | Designed to monitor ambient | |
| temperature to more accurately calculate | ||
| body temperature using the skin | ||
| temperature input. | Identical | |
| Flexible Assembly | Provides a connection between the ECG | |
| electrodes, thermistors and patch | ||
| electronics. The flexible circuit is sealed | ||
| within the patch. | Identical | |
| Firmware | Version 3.1.0.1 to support functions | |
| listed in Table 4 for Predicate | ||
| (K183078) | Version 3.2.1.0 of firmware fixes a bug | |
| and allows configuration for 120-hour | ||
| patch life timer or 168-hour patch-life | ||
| timer. |
Table 4 – Device Performance Characteristics Comparison
| Performance
| Characteristic | Predicate (K183078) | Proposed Device |
|---|---|---|
| Wireless Transmission | Bluetooth Low Energy (BT4.1) technology | Identical |
| Data encryption | Advanced Encryption Standard-CCM mode | Identical |
| Radio Frequency | 2.4GHz ISM band | |
| FCC Part 15 Complied | Identical | |
| ECG Dynamic Range | The Sensor electrodes make contact with | |
| the skin to measure the differential voltage | ||
| generated from the heart. The resulting | ||
| analog ECG waveform is digitized so that | ||
| the data can be streamed to a display or | ||
| recording device. | ||
| Range: -10mV to +10mV | Identical | |
| Heart Rate (stationary | ||
| and ambulatory) | Heart rate is measured and calculated in | |
| Beats Per Minute (BPM) both for stationary | ||
| and ambulatory use. | ||
| Range: 30 - 200 BPM | Identical | |
| Respiratory Rate | From a combination of ECG and tri-axial | |
| accelerometer sensor signals, the Vital | ||
| Connect Sensor can accurately measure the | ||
| respiratory rate of the person, irrespective of | ||
| whether the person is stationary or | ||
| ambulatory. | ||
| Range: 10-30 breaths per minute | Identical | |
| Skin Temperature | Using a thermistor sensor on the Patch, | |
| which is in close proximity to the skin, the | ||
| Vital Connect Sensor accurately measures | ||
| the temperature of the skin, reporting the | ||
| temperature in degrees Centigrade. A | ||
| known quantity of current generated by the | ||
| sensor is converted to a voltage that is | ||
| accurately matched to skin temperature. | ||
| Range: 15°C - 50 °C (61°F - 113°F) | Identical | |
| Ambient Temperature | Using an additional thermistor sensor on the | |
| Patch, which is away from the skin, the | ||
| VitalConnect Biosensor accurately | ||
| measures patch ambient temperature, | ||
| reporting the temperature in degrees | ||
| Centigrade. A known quantity of current | ||
| generated by the sensor is converted to a | ||
| voltage that is accurately matched to the | ||
| ambient temperature. | ||
| Range: 15°C - 50 °C (61°F - 113°F) | Identical | |
| Body Temperature | A calculated value as a function of the skin | |
| and ambient temperatures. | ||
| Range: 32°C - 42°C | Identical | |
| Fall Detection | Using a tri-axial accelerometer and digital | |
| signal processing techniques, the Vital | ||
| Connect Sensor detects falls while | ||
| minimizing false notifications. | ||
| Range: Fall or No Fall | Identical | |
| Step Count | The Vital Connect Sensor also uses the tri- | |
| axial accelerometer to compute step count. | ||
| As the person walks, the Vital Connect | ||
| Sensor is capable of distinguishing steps | ||
| from other movements. The detected steps | ||
| are accumulated to provide an accurate step | ||
| count. | ||
| Range: 0 - 65535 steps | Identical | |
| Posture Detection | Using the built-in tri-axial accelerometer, | |
| the Vital Connect Sensor can determine the | ||
| posture of the person and provide wireless | ||
| real-time updates to a central server. | ||
| Postures detected include lying down, | ||
| upright, walking, running and leaning. | Identical | |
| R-R Interval | The R-R interval is the measurement of the | |
| interval from the R wave peak of one QRS | ||
| complex to the next R-wave peak on the | ||
| electrocardiogram. The device has enhanced | ||
| QRS performance during motion. | Identical | |
| Heart Rate Variability | HRV quantifies the variation in the beat-to- | |
| beat interval time series obtained from the | ||
| ECG waveform. Using advanced signal | ||
| processing algorithms, the Sensor detects | ||
| each QRS peak with high temporal | ||
| accuracy. Measurement of the R wave to R | ||
| wave (RR) interval allows short and long- | ||
| term variability analysis to determine | ||
| analytics such as mean, median, standard | ||
| deviation, frequency content, etc. | Identical | |
| Low Power Mode | When patch is off the body, to conserve | |
| battery power, the processor goes into a low | ||
| power mode, resulting in reduced current | ||
| draw | Identical |
6
7
VII. 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:
Sterilization & Shelf-life Testing
The Vital Connect Platform is provided non-sterile, and therefore sterilization data is not provided. Accelerated aging data was provided to support a shelf-life of 9 months as previously cleared.
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.
8
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the VitalPatch. The device complies with the IEC 60601-1, IEC 60601-1-11. IEC 60601-2-25, and the IEC 60601-2-47 standards for safety. The device also complies with the IEC 60601-1-2 standard for EMC, IEC/TS 62657-2 and FCC CRF47 Part 15 Subpart C standards for wireless communication.
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.
Benchtop & Simulated Use Testing
The following testing was provided to demonstrate the safe and effective performance of the subject device for 168 hours:
- Wear Duration Testing .
- . Battery operating life testing
- . EOL Detection after 168 hours
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the VitalPatch. Instead, substantial equivalence is based upon benchtop performance testing.
VIII. CONCLUSIONS
The subject device is substantially equivalent in design and intended use to the predicate device. Any differences between the subject device and the predicate device have no significant influence on safety or effectiveness as established through performance testing. The subject device raises no new issues of safety or effectiveness from the predicate device.