(122 days)
No reference devices were used in this submission.
No
The summary describes a device that collects and transmits physiological data and can notify healthcare professionals based on selected parameters. There is no mention of AI or ML being used for analysis, interpretation, or decision-making beyond simple parameter thresholds. The modifications described are related to adding an ambient temperature sensor and updating the IFU.
No.
The device is a monitoring system intended to collect physiological data as an aid to diagnosis and treatment, not to provide therapy.
No
The text states, "The data from the VitalConnect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment," indicating that the device itself is not making the diagnosis but rather providing data to assist in the diagnostic process.
No
The device description explicitly states "VitalPatch is a wearable biosensor designed to measure a patient's vital signs," indicating a hardware component. The modifications also describe adding an "ambient temperature sensor" to the biosensor.
Based on the provided information, 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.
- Device Function: The VitalConnect Platform and VitalPatch Biosensor are described as a wireless remote monitoring system that collects physiological data directly from the patient's body (heart rate, ECG, temperature, activity, etc.).
- 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 involves monitoring the patient's vital signs in real-time or near real-time.
- No Sample Analysis: There is no mention of analyzing samples taken from the body. The device measures parameters on the body.
Therefore, the device falls under the category of a patient monitoring system, not an in vitro diagnostic device.
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 Biosensor 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 (comma separated list FDA assigned to the subject device)
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). VitalPatch was most recently cleared in K163453.
The following modifications are proposed for the VitalPatch wearable biosensors:
- An ambient temperature sensor is added to the original VitalPatch, which was most recently cleared in K163453, to measure ambient temperature. The measured ambient temperature along with the measured skin temperature cleared in K163453 are used to calculate the body temperature.
- An updated IFU for VitalPatch has been created to reflect the temperature sensor changes.
All other 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) cleared in K163453 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 / 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: 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, 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.
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: Shipping validation and transit testing and was performed to demonstrate that changes to VitalPatch did not negatively affect the safety and efficacy when compared to the predicate device. Paired readings, using VitalPatch and hand-held oral thermometers simultaneously, were analyzed to verify accuracy when compared to the hand-held oral thermometers.
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.
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.
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.
No reference devices were used in this submission.
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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March 7, 2019
VitalConnect, Inc. % Robert Packard President Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05738
Re: K183078
Trade/Device Name: VitalConnect Platform, VitalPatch Biosensor Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, DSI, MHX Dated: November 5, 2018 Received: November 5, 2018
Dear Robert Packard:
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 mav, 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 avare 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 and Part 809; 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, vou may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Arielle Drummond -S
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) K183078
Device Name
VitalConnect Platform, 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 Biosensor 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)
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
- 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: March 6, 2019
| II. DEVICE | |
|---|---|
| Name of Device: | VitalConnect Platform, VitalPatch Biosensor |
| Classification Name: | Cardiovascular Monitoring Devices |
| Regulation: | 21 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: | VitalConnect Platform, VitalPatch Biosensor |
| Predicate 510(k): | K163453 |
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 K163453.
The following modifications are proposed for the VitalPatch wearable biosensors:
- . An ambient temperature sensor is added to the original VitalPatch, which was most recently cleared in K163453, to measure ambient temperature. The measured ambient temperature along with the measured skin temperature cleared in K163453 are used to calculate the body temperature.
- . An updated IFU for VitalPatch has been created to reflect the temperature sensor changes.
All other 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) cleared in K163453 remain the same.
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V. 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, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the VitalConnect Biosensor 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 (K163453) | Subject Device |
|---|---|
| The VitalConnect Platform is a wireless remote monitoring | The VitalConnect Platform is a wireless remote monitoring |
| system intended for use by healthcare professionals for | system intended for use by healthcare professionals for |
| continuous collection of physiological data in home and | continuous collection of physiological data in home and |
| healthcare settings. This can include heart rate, | healthcare settings. This can include heart rate, |
| electrocardiography (ECG), heart rate variability, R-R | electrocardiography (ECG), heart rate variability, R-R |
| interval, respiratory rate, body temperature, skin | interval, respiratory rate, body temperature, skin |
| temperature, activity (including step count), and posture | temperature, activity (including step count), and posture |
| (body position relative to gravity including fall). Data are | (body position relative to gravity including fall). Data are |
| transmitted wirelessly from the VitalConnect Sensor for | transmitted wirelessly from the VitalConnect Sensor for |
| storage and analysis. The VitalConnect Platform can | storage and analysis. The VitalConnect Platform can |
| include the ability to notify healthcare professionals when | include the ability to notify healthcare professionals when |
| physiological data fall outside selected parameters. | physiological data fall outside selected parameters. |
| The device is intended for use on general care patients who | The device is intended for use on general care patients who |
| are 18 years of age or older as a general patient monitor, to | are 18 years of age or older as a general patient monitor, to |
| provide physiological information. The data from the | provide physiological information. The data from the |
| VitalConnect Platform are intended for use by healthcare | VitalConnect Platform are intended for use by healthcare |
| professionals as an aid to diagnosis and treatment. The | professionals as an aid to diagnosis and treatment. The |
| device is not intended for use on critical care patients. | device is not intended for use on critical care patients. |
Table 1 Comparison of Indications for Use (change is identified in bold font)
Table 2 Size Comparison of the adhesive patch
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| Dimension | Predicate (K163453) | 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 Proposed Devices
| Component | Predicate (K163453) | 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 | N/A - only in subject device | Designed to monitor ambient temperature |
| to more accurately calculate body | ||
| temperature using the skin temperature | ||
| input. | ||
| Flexible Assembly | Provides a connection between the ECG | |
| electrodes, thermistors and patch | ||
| electronics. The flexible circuit is sealed | ||
| within the patch. | Equivalent except the addition of the | |
| ambient thermistor | ||
| Firmware | Rev. 1.0.1.13 to support functions listed | |
| in Table 4 for Predicate (K163453) | Version 3.1.0.1 of firmware adds: | |
| • Support for VitalPatch 3 | ||
| hardware | ||
| • Sense ambient temperature | ||
| • Body temperature derivation | ||
| • Ability to blink the LED | ||
| • 30° bed-angle posture calibration | ||
| • 120-hour patch-life timer (based | ||
| on K163453 clearance) | ||
| • Maintenance improvements |
Table 4 – Device Performance Characteristics Comparison
| Performance
| Characteristic | Predicate (K163453) | 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 | Identical |
| FCC Part 15 Complied | ||
| 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 |
| 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 | N/A - Subject Device Only | 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) |
| Body Temperature | N/A - Subject Device Only | A calculated value as a function of the
skin and ambient temperatures.
Range: 32°C - 42°C |
| 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
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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.
8
Biocompatibility Testing
Biocompatibility testing, previously conducted, 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.
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
Shipping validation and transit testing and was performed to demonstrate that changes to VitalPatch did not negatively affect the safety and efficacy when compared to the predicate device. Paired readings, using VitalPatch and hand-held oral thermometers simultaneously, were analyzed to verify accuracy when compared to the hand-held oral thermometers.
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.