(328 days)
Not Found
No
The summary describes a remote monitoring system that collects and transmits physiological data and can provide notifications based on selected parameters. There is no mention of AI, ML, or any algorithms that would suggest the use of these technologies for analysis or interpretation beyond simple parameter thresholds. The modification is solely focused on extending the wear duration of the sensor.
No
The device is described as a "remote monitoring system" and a "general patient monitor" intended to "provide physiological information" and for use as "an aid to diagnosis and treatment." It does not explicitly state that it provides a therapeutic function or delivers therapy.
Yes
The "Intended Use / Indications for Use" section states: "The data from the VitalConnect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment." This explicitly indicates its role in aiding diagnosis.
No
The device description explicitly states that the VitalPatch is a "wearable biosensor" and a "disposable, battery-powered, adhesive patch containing sensors," indicating it is a hardware component. The 510(k) modification also relates to the wear duration of this hardware component.
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 are described as a wireless remote monitoring system that collects physiological data directly from the patient's body (heart rate, ECG, respiratory rate, skin temperature, activity, posture).
- Lack of Sample Analysis: There is no mention of analyzing samples taken from the body. The data is collected from the body itself.
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, 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.
Product codes (comma separated list FDA assigned to the subject device)
DRG, DSI, MHX
Device Description
VitalPatch is a wearable biosensor which may be used as part of the VitalConnect Platform. The device is a disposable, battery-powered, adhesive patch containing sensors used to gather patients' physiological data, which are transmitted wirelessly. The modification proposed in this 510(k) increases the wear duration for the VitalPatch wearable biosensor from 96 hours to 120 hours.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Adhesive patches affixed to user's torso
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)
The following device performance tests were performed on the VitalPatch wearable biosensor during the early design and development phase:
Electrical Safety Testing (IEC 60601-1, 3.1 Ed.)
Electromagnetic Compatibility Testing (IEC 60601-1-2, 4th Ed.)
Battery Performance Testing (N/A – internal performance testing)
Skin Adherence/Wear Duration (N/A – internal performance testing)
Wear Performance (Sensor Functionality) (N/A – internal performance testing)
Wireless Coexistence (FDA Radio Frequency Wireless Technology in Medical Devices)
The following device performance tests were performed on the VitalPatch wearable biosensor during the commercialization phase, in support of this 510(k) submission for the extension of wear duration from 96 to 120 hours:
Firmware Verification and Validation (FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
0
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November 2, 2017
Vital Connect, Inc. Kevin Potgieter Senior Manager, Regulatory Affairs 900 E. Hamilton Avenue Suite 500 Campbell, California 95008
Re: K163453
Trade/Device Name: VitalPatch® VitalConnect Platform Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, DSI, MHX Dated: October 12, 2017 Received: October 13, 2017
Dear Kevin Potgieter:
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 of medical device-related 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,
M.A. Willehemen
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163453
Device Name VitalPatch® VitalConnect Platform
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, 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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 - Modification to VitalPatch®
510(k) Owner's Name, Address, and Telephone Number
VitalConnect, Inc. 224 Airport Parkway. Suite 300 San Jose, CA 95110 (408) 963-4600
Contact Person
Kevin Potgieter, MS, RAC Senior Manager, Regulatory Affairs Direct: (408) 963-4603 (408) 963-2828 Fax: Email: kpotgieter@vitalconnect.com
510(k) Number: K163453
Date Prepared: 30 October 2017
Trade Name of Device: VitalPatch® VitalConnect Platform
Common or Usual Name: Wearable Biosensor
Classification Name:
21 CFR 870.2910 - Transmitters and Receivers, Physiological Signal, Radiofrequency
Product Code: DRG
Predicate Device(s) VitalConnect Platform by VitalConnect, Inc. (K152139)
Intended 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.
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, 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.
4
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.
Device Description
VitalPatch is a wearable biosensor which may be used as part of the VitalConnect Platform. The device is a disposable, battery-powered, adhesive patch containing sensors used to gather patients' physiological data, which are transmitted wirelessly. The modification proposed in this 510(k) increases the wear duration for the VitalPatch wearable biosensor from 96 hours to 120 hours.
Technological Characteristics
This 510(k) does not involve any changes to the technological characteristics of the VitalPatch wearable biosensor.
Performance Data
The following device performance tests were performed on the VitalPatch wearable biosensor during the early design and development phase:
| Test Description | Standard/Guidance Referenced |
|---|---|
| Electrical Safety Testing | IEC 60601-1, 3.1 Ed. |
| Electromagnetic Compatibility Testing | IEC 60601-1-2, 4th Ed. |
| Battery Performance Testing | N/A – internal performance testing |
| Skin Adherence/Wear Duration | N/A – internal performance testing |
| Wear Performance (Sensor Functionality) | N/A – internal performance testing |
| Wireless Coexistence | FDA Radio Frequency Wireless |
| Technology in Medical Devices |
The following device performance tests were performed on the VitalPatch wearable biosensor during the commercialization phase, in support of this 510(k) submission for the extension of wear duration from 96 to 120 hours:
| Test Description | Standard/Guidance Referenced |
|---|---|
| Firmware Verification and Validation | FDA Guidance for the Content of |
| Premarket Submissions for Software | |
| Contained in Medical Devices |
5
Substantial Equivalence
VitalPatch with the 120-hour wear duration has the same intended use, indications for use, and technological characteristics as the predicate device. Thus, VitalPatch is substantially equivalent to the predicate device.
Conclusions
VitalPatch is substantially equivalent to the predicate device. The modifications described in this 510(k) do not raise different questions of safety and effectiveness.
| Summary of Substantial Equivalence Table | ||
|---|---|---|
| Topic | Predicate Device | |
| K152139 | Modified Device | |
| K163453 | ||
| Classification | Class II | |
| 21 CFR 870.2910 | Class II | |
| 21 CFR 870.2910 | ||
| Classification | ||
| Name | Transmitters and Receivers, | |
| Physiological Signal, Radiofrequency | Transmitters and Receivers, | |
| Physiological Signal, Radiofrequency | ||
| Product Code | DRG | DRG |
| Trade Name | VitalPatch® | VitalPatch® |
| Patch | ||
| Configuration | Disposable adhesive patch containing | |
| integrated disposable sensor module | Disposable adhesive patch containing | |
| integrated disposable sensor module | ||
| Shelf Life | 9 months | 9 months |
| Vital Signs | ||
| Monitored | 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) | 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) | ||
| Wear | ||
| Duration | 96 hours | 120 hours |
| Principles of | ||
| Operation | Adhesive patches affixed to user's | |
| torso allowing for continuous | ||
| monitoring of wearer's physiological | ||
| data. Wireless transmission and | ||
| storage of data via Relay devices and | ||
| optional Secure Server. | Adhesive patches affixed to user's | |
| torso allowing for continuous | ||
| monitoring of wearer's physiological | ||
| data. Wireless transmission and | ||
| storage of data via Relay devices and | ||
| optional Secure Server. |
Summary of Substantial Equivalence Table