(349 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on data collection, transmission, and display, without mentioning any analytical or predictive capabilities that would typically involve AI/ML.
No.
The device is described as a "wireless remote monitoring system" and is intended for "continuous collection of physiological data" such as heart rate and body temperature. Its data is explicitly stated to be "an aid to diagnosis and treatment" and "not intended for use on critical care patients nor replace standard monitoring and/or routine care." This indicates it's a diagnostic/monitoring device, not one that directly treats or provides therapy.
No
Explanation: The "Intended Use / Indications for Use" section states, "The data from the Tego VSS Sensor is intended for use by healthcare professionals as an aid to diagnosis and treatment." This indicates that the device provides data to assist in diagnosis, but it is not a diagnostic device itself.
No
The device description explicitly states that the Vitls Platform includes a "Wearable device with multiple sensors (the Tego VSS Sensor – An Adhesive Patch with integrated Sensors)" which is a hardware component.
Based on the provided information, the Vitls Platform is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Vitls Platform Function: The Vitls Platform is a remote monitoring system that collects physiological data (heart rate and body temperature) directly from the patient's body using a wearable sensor. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "continuous collection of physiological data" and "aid to diagnosis and treatment" based on this collected data. This aligns with the function of a patient monitor, not an IVD.
Therefore, the Vitls Platform falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vitls Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in healthcare and home settings. This includes heart rate (HR) and body tomperature.
The data from the Tego VSS Sensor is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients nor replace standard monitoring and/or rouance care,
The device is intended for use as a general patient monitor, to provide physiological information, on patients who are 2 years of age or older.
Product codes (comma separated list FDA assigned to the subject device)
DRG, FLL
Device Description
The Vitls Platform is a wireless multi-parameter vital signs monitoring system. The Vitls Platform was developed to include an Application Programming Interface (API) which is intended to allow development of user interface applications, enabling clinicians and medically qualified personnel to access recorded vital signs information for respective analysis only, not for active patient monitoring. The Vitls Platform consists of:
Wearable device with multiple sensors (the Tego VSS Sensor – An Adhesive Patch with integrated Sensors) The Secure Server Library (Cloud-based, including an API) The Vitls App (accessible on a smartphone, tablet, PC or monitor that displays the data and configures the Tego VSS Sensor)
The Tego VSS Sensor is a battery-operated adhesive patch with integrated sensors and wireless transceiver which is worn on the upper body and records heart rate and body temperature. There are two different sizes, one for adult and one for pediatric patients, they are 140 cm and 80 cm in length of the flexible portion of the sensor, respectively. The Tego VSS Sensor continuously gathers multiparameter vital signs data from the person being monitored and then transmits the encrypted data via bi-directional communication to the third-party connectivity relay, when in range. When not in range, the collected data is stored on the Tego VSS Sensor (for a maximum of 3 hours) and transmitted when a connection with the third-party connectivity relay has been restored. The encrypted wireless data recorded by the Sensor is sent, by the third-party connectivity relay, to the Secure Server. The data may be downloaded from the Secure Server Library or integrated into a Third-Party Application via the APIs of the Secure Server Library. In addition, the wireless data may be transferred to an optional Secure Server Library where they may be stored for future analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest and armpit
Indicated Patient Age Range
2 years of age or older.
Intended User / Care Setting
healthcare professionals / healthcare and home 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)
Performance testing confirmed that the Vitls Platform is substantially equivalent to the predicate devices.
The Vitls Platform was tested to recognized consensus standards to confirm that the device is as safe and effective as the predicate device. Specifically:
- Software V&V demonstrates that the device performs as intended
- Biocompatibility testing per ISO 10993-1, 10993-5 and 10993-10 demonstrate that the two patient contacting materials are biocompatible
- Electrical safety testing per IEC 60601-1 shows that the device meets the relevant requirements for electrical safety
- Electrical safety testing per ISO 60601-1-11 shows the device meets the relevant requirements for devices used in home healthcare environment
- Compliance with ISO 80601-2-56 regarding performance of clinical thermometers for body temperature measurement
- Electromagnetic compatibility testing showed the device met the requirements of IEC 60601-1-2, FCC Part 15, Subpart B, Class B, RF Exposure Evaluation per 47 CFR 2.1091 and 2.1093, wireless coexistence per ASNI C63.27.2017 and RF Testing per FCC Part 15, Subpart C, 15.247
- The heart rate feature of the Vitls Platform was compared to the values acquired by an FDA cleared patient monitor, the GE Medical Systems Information Technologies Dash 5000 Patient Monitor (K073462) providing objective evidence that the design outputs for the design inputs as defined in the test protocol have been met with the required confidence and reliability and that there is no greater bias observed in a particular measurement interval
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.
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
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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 1. 2020
Vitls Inc. % Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, Massachusetts 02180
Re: K191620
Trade/Device Name: Vitls Platform Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, FLL Dated: April 24, 2020 Received: April 28, 2020
Dear Maureen O'Connell:
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.
1
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) 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 (QS) 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.
Jennifer Shih Assistant Director (Acting) 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Vitls Platform
Indications for Use (Describe)
The Vitls Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in in healthcare and home settings. This includes heart rate (HR) and body tomperature.
The data from the Tego VSS Sensor is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients nor replace standard monitoring and/or rouance care,
The device is intended for use as a general patient monitor, to provide physiological information, on patients who are 2 years of age or older.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Vitls Platform
| Submitter: | Vitls Inc.
TMC Innovation Institute, Suite X
2450 Holcombe Avenue
Houston, TX 77021 |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell
O'Connell Regulatory Consultants, Inc.
44 Oak Street
Stoneham, MA 02180
Phone: 978-207-1245 |
| Date Prepared: | May 29, 2020 |
| Trade Name: | Vitls Platform |
| Classification Names: | Radiofrequency physiological signal transmitter |
| Regulation Numbers: | 21 CFR 870.2910 |
| Product Codes: | DRG |
| Predicate Devices: | Isansys Lifecare Ltd. Patient Status Engine cleared in K172329
Vivalnk FeverScout cleared in K162137 |
| Device Description and
Technological
Characteristics: | The Vitls Platform is a wireless multi-parameter vital signs
monitoring system. The Vitls Platform was developed to include an
Application Programming Interface (API) which is intended to
allow development of user interface applications, enabling
clinicians and medically qualified personnel to access recorded vital
signs information for respective analysis only, not for active patient
monitoring. The Vitls Platform consists of:
Wearable device with multiple sensors (the Tego VSS Sensor –
An Adhesive Patch with integrated Sensors) The Secure Server Library (Cloud-based, including an API) The Vitls App (accessible on a smartphone, tablet, PC or |
4
monitor that displays the data and configures the Tego VSS Sensor)
The Tego VSS Sensor is a battery-operated adhesive patch with integrated sensors and wireless transceiver which is worn on the upper body and records heart rate and body temperature. There are two different sizes, one for adult and one for pediatric patients, they are 140 cm and 80 cm in length of the flexible portion of the sensor, respectively. The Tego VSS Sensor continuously gathers multiparameter vital signs data from the person being monitored and then transmits the encrypted data via bi-directional communication to the third-party connectivity relay, when in range. When not in range, the collected data is stored on the Tego VSS Sensor (for a maximum of 3 hours) and transmitted when a connection with the third-party connectivity relay has been restored. The encrypted wireless data recorded by the Sensor is sent, by the third-party connectivity relay, to the Secure Server. The data may be downloaded from the Secure Server Library or integrated into a Third-Party Application via the APIs of the Secure Server Library. In addition, the wireless data may be transferred to an optional Secure Server Library where they may be stored for future analysis.
Indications for Use: The Vitls Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in healthcare and home settings. This includes heart rate and body temperature. The data from the Tego VSS Sensor intended for use by healthcare professionals as an aid in the diagnosis and treatment. It is not intended for use on critical care patients nor replace standard monitoring and/or routine care.
The device is intended for use as a general patient monitor, to provide physiological information, on patients who are 2 years of age or older.
Substantial Equivalence Discussion:
Vitls, Inc. believes that the Vitls Platform described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to a legally marketed predicate device that is a Class II medical device. Table 1 provides a tabular presentation of the Vitls Platform compared with the predicate device which is the Isansys Lifecare Ltd. Patient Status Engine cleared in K172329. Additionally, the thermometer feature of the Vitls Platform is supported by an additional predicate device, the Vivalnk FeverScout cleared in K162137 which is described in Table 2.
5
| Table 1 |
|---|
| Substantial Equivalence |
| Vitls Platform (excluding thermometer) |
.
| Characteristic | Vitls Platform | Patient Status Engine |
|---|---|---|
| Manufacturer | Vitls, Inc. | Isansys Lifecare Ltd. |
| 510(k) Number | K191620 | K172329 |
| Class | II | II |
| Device Classification | ||
| Name | Radiofrequency Physiological Signal | |
| Transmitter and Receiver | Radiofrequency Physiological Signal | |
| Transmitter and Receiver | ||
| Regulation Number | 870.2910 | 870.2910 |
| Product Code | DRG | DRG |
| Use | Prescription | Prescription |
| Use Environment | Home and Healthcare Settings | Home and Healthcare Settings |
| Intended Use | The Vitls Platform is a wireless remote | |
| monitoring system intended for use by | ||
| healthcare professionals for continuous | ||
| collection of physiological data in home | ||
| and healthcare settings. | The Patient Status Engine is | |
| intended for use as a general patient | ||
| monitor, to provide physiological | ||
| information in home and healthcare | ||
| settings. | ||
| Indications for Use | The Vitls Platform is a wireless remote | |
| monitoring system intended for use by | ||
| healthcare professionals for continuous | ||
| collection of physiological data in | ||
| healthcare and home settings. This | ||
| includes heart rate and body temperature. | ||
| The data from the Tego VSS Sensor is | ||
| intended for use by healthcare | ||
| professionals as an aid to diagnosis and | ||
| treatment. It is not intended for use on | ||
| critical care patients nor replace standard | ||
| monitoring and/or routine care. | ||
| The device is intended for use as a | ||
| general patient monitor, to provide | ||
| physiological information, on patients | ||
| who are 2 years of age or older. | The Patient Status Engine is a | |
| wireless remote monitoring system | ||
| intended for use by healthcare | ||
| professionals for continuous | ||
| collection of physiological data in | ||
| home and healthcare settings. | ||
| This includes heart rate, heart rate | ||
| variability (R-R interval), ECG | ||
| derived respiration rate data | ||
| (EDR), skin temperature, | ||
| activity, posture and optional SpO2 | ||
| and noninvasive Blood Pressure | ||
| (BP). | ||
| The device is intended for use on | ||
| general care patients who are 18 | ||
| years of age or older as a general | ||
| Characteristic | Vitls Platform | Patient Status Engine |
| patient monitor, to provide | ||
| physiological information. | ||
| The data from the Patient Status | ||
| Engine is intended for use by | ||
| healthcare professionals as an aid to | ||
| diagnosis and treatment. It is not | ||
| intended for use on critical care | ||
| patients nor replace standard | ||
| monitoring and/or routine care. | ||
| Mechanism of | ||
| Action | Physiological data acquisition (wireless) | |
| and display | Physiological data acquisition | |
| (wireless) and display | ||
| Components | Tego VSS Sensor | |
| The Secure Server Library | ||
| The Vitls App | Patient Gateway (Samsung Tablet) | |
| Patient Gateway Software | ||
| Lifetouch Blue Sensor | ||
| Lifetemp Sensor | ||
| Lifeguard Server Software | ||
| Accessories: | ||
| Pulse Oximeter | ||
| Blood Pressure Monitor | ||
| ECG Electrodes | ||
| Ambu White Sensors | ||
| Physiological | ||
| Parameters | ||
| Monitored: | ||
| Heart Rate | Yes | Yes |
| Heart Rate | ||
| Variability | ||
| (HRV) | No | Yes |
| Respiration Rate | No | Yes |
| SpO2 | No | Optional with FDA cleared SpO2 |
| oximeter | ||
| Temperature | Yes (body) @ axilla/armpit | Yes (skin) |
| Activity | No | Yes (including posture) |
| Blood Pressure | No | Optional with third party accessory |
| Sterile | No | No |
| Characteristic | Vitls Platform | Patient Status Engine |
| Single Use | Yes | Yes |
| Battery Operated | Yes | Yes |
| AC Powered | No | No |
| Central Server | Yes | Yes |
| Biocompatible | Yes | Yes |
6
7
| Characteristic | Vitls Platform | Fever Scout Continuous
Monitoring Thermometer |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Vitls, Inc. | Vivalnk Inc. |
| 510(k) Number | K191620 | K162137 |
| Class | II | II |
| Device Classification
Name | Clinical Electronic Thermometer | Clinical Electronic Thermometer |
| Regulation Number | 880.2910 | 880.2910 |
| Product Code | FLL | FLL |
| Use | Prescription | Over-The-Counter |
| Use Environment | Home and Healthcare Settings | Home and Healthcare Settings |
| Indications for Use | The Vitls Platform is a wireless remote
monitoring system intended for use by
healthcare professionals for continuous
collection of physiological data in
healthcare and home settings. This
includes heart rate and body temperature.
The data from the Tego VSS Sensor is | The wireless Fever Scout Continuous
Monitoring thermometer is a non-
invasive and re-usable electronic
device for home use. This product is
intended for non-urgent ambulatory
continuous armpit body temperature
monitoring from ages 29 days and
older. |
8
| Characteristic | Vitls Platform | Fever Scout Continuous
Monitoring Thermometer |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| | intended for use by healthcare
professionals as an aid to diagnosis and
treatment. It is not intended for use on
critical care patients nor replace standard
monitoring and/or routine care.
The device is intended for use as a
general patient monitor, to provide
physiological information, on patients
who are 2 years of age or older. | |
| Battery | Yes | Yes |
| Measurement Range | 25-45° C | 35-42° C |
| Accuracy | $\pm$ 0.3° C | $\pm$ 0.1° C
From 37-39° C
$\pm$ 0.2° C
From 35-37° C and 39-42° C |
| Anatomical
Application | Chest and armpit | Armpit peel and stick contact
thermometer sensor |
| Biocompatible | Yes | Yes |
Both the Vitls Platform and the Patient Status Engine are wireless physiological monitors. Both systems consist of multiple components including a wireless sensor and data collection system that monitor physiologic parameters. Both systems measure heart rate while the predicate device also measures other physiological parameters sometimes using optional third party accessories. The Vitls platform uses photoplethysmography (PPG) data for all of the monitoring while the predicate uses a combination of ECG and PPG for monitoring. Neither of the systems is provided sterile and both are for single use. Regarding the thermometer functionality, the Vitls Platform's sensor is applied to the chest and armpit while the Fever Scout is applied to the armpit. The measurement range of the Vitls Platform is slightly wider than the Fever Scout.
Performance testing confirmed that the Vitls Platform is substantially equivalent to the predicate devices.
Performance Testing:
The Vitls Platform was tested to recognized consensus standards to confirm that the device is as safe and effective as the predicate device. Specifically:
9
- Software V&V demonstrates that the device performs as intended ●
- . Biocompatibility testing per ISO 10993-1, 10993-5 and 10993-10 demonstrate that the two patient contacting materials are biocompatible
- Electrical safety testing per IEC 60601-1 shows that the device meets the relevant . requirements for electrical safety
- . Electrical safety testing per ISO 60601-1-11 shows the device meets the relevant requirements for devices used in home healthcare environment
- Compliance with ISO 80601-2-56 regarding performance of clinical thermometers for ● body temperature measurement
- Electromagnetic compatibility testing showed the device met the requirements of IEC ● 60601-1-2, FCC Part 15, Subpart B, Class B, RF Exposure Evaluation per 47 CFR 2.1091 and 2.1093, wireless coexistence per ASNI C63.27.2017 and RF Testing per FCC Part 15, Subpart C, 15.247
- The heart rate feature of the Vitls Platform was compared to the values acquired by . an FDA cleared patient monitor, the GE Medical Systems Information Technologies Dash 5000 Patient Monitor (K073462) providing objective evidence that the design outputs for the design inputs as defined in the test protocol have been met with the required confidence and reliability and that there is no greater bias observed in a particular measurement interval
Conclusions:
The Vitls Platform is substantially equivalent to the predicate devices, the Isansys Lifecare Ltd. Patient Status Engine cleared in K172329 and the thermometer feature of the Vitls Platform is supported by an additional predicate device, the Vivalnk FeverScout cleared in K162137. The Vitls Platform has the same intended use and similar technological characteristics as the legally marketed predicate devices and is therefore substantially equivalent to the predicate devices.