(349 days)
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.
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.
The provided text describes the Vitls Platform, a wireless remote monitoring system that continuously collects physiological data, specifically heart rate and body temperature. The document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical effectiveness through extensive clinical trials for new AI/ML devices. Therefore, the information regarding acceptance criteria and performance studies is primarily focused on engineering and functional validation against established standards and predicate device performance for the cleared device.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, or accuracy metrics typical for AI/ML diagnostic devices) for the entire Vitls Platform beyond the temperature accuracy specification. Instead, it focuses on demonstrating compliance with recognized consensus standards and performance in comparison to predicate devices, particularly for heart rate and temperature measurements.
| Parameter | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Heart Rate | - Implied: Performance comparable to predicate device (Isansys Patient Status Engine) & FDA cleared patient monitor (GE Dash 5000). | - "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." |
| Body Temperature | - Accuracy: ± 0.3° C (from table) | - Reported as: "± 0.3° C" (Explicitly stated in the table comparing to Fever Scout). |
| Biocompatibility | - Compliance with ISO 10993-1, 10993-5, and 10993-10. | - "Biocompatibility testing per ISO 10993-1, 10993-5 and 10993-10 demonstrate that the two patient contacting materials are biocompatible." |
| Electrical Safety | - Compliance with IEC 60601-1 and IEC 60601-1-11. | - "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." |
| Software V&V | - Demonstrated performance as intended. | - "Software V&V demonstrates that the device performs as intended." |
| EMC | - Compliance with 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. | - "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." |
| Clinical Thermometer Performance | - Compliance with ISO 80601-2-56. | - "Compliance with ISO 80601-2-56 regarding performance of clinical thermometers for body temperature measurement." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size (number of subjects/patients) for the heart rate and temperature comparison studies, nor does it specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions a comparison against an FDA cleared patient monitor for heart rate and compliance with a standard for temperature. This level of detail is typically not required for 510(k) substantial equivalence claims for monitoring devices unless there are novel clinical claims or significant technological differences.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable in the context of this device and study. The ground truth for physiological measurements like heart rate and temperature is typically established directly by reference devices (e.g., FDA-cleared patient monitors or calibrated thermometers) or established clinical methods, not by expert human readers/reviewers in the same way it would be for image-based diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Physiological measurements are directly compared to reference devices, not subject to human adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. This type of study is more common for diagnostic AI/ML algorithms that assist human interpretation of complex data (e.g., medical images). The Vitls Platform is a physiological monitoring device, not a diagnostic AI intended to assist human readers in interpreting readings.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a form of "standalone" performance was effectively assessed for the core physiological measurements. The device's heart rate and temperature measurements were compared directly against established reference methods/devices (GE Dash 5000 for HR, and compliance with ISO 80601-2-56 for temperature), without an explicit human-in-the-loop component being evaluated. The device itself is intended for continuous collection of physiological data for healthcare professionals to use as an aid, meaning the algorithm is providing the base measurements that healthcare professionals use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for heart rate and temperature measurements was established by comparison to established, FDA-cleared reference devices/methods (e.g., GE Medical Systems Information Technologies Dash 5000 Patient Monitor for heart rate, and compliance with ISO 80601-2-56 for body temperature measurements, which would imply a validated reference thermometer).
8. The sample size for the training set
The document pertains to a 510(k) submission for a physiological monitoring device, not a machine learning or AI-driven diagnostic device in the modern sense that typically involves extensive training datasets. While the "Vitls Platform" might have some algorithmic processing for its physiological signal acquisition (e.g., PPG signal processing for heart rate), the document does not discuss a discernible "training set" in the context of machine learning. The validation described is more akin to traditional medical device testing for accuracy, reliability, and safety against known standards and predicate devices.
9. How the ground truth for the training set was established
Not applicable, as a distinct "training set" and associated ground truth establishment process for machine learning are not detailed or implied by the provided 510(k) summary for this device.
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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.
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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
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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 X2450 Holcombe AvenueHouston, TX 77021 |
|---|---|
| Contact Person: | Maureen O'ConnellO'Connell Regulatory Consultants, Inc.44 Oak StreetStoneham, MA 02180Phone: 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 K172329Vivalnk FeverScout cleared in K162137 |
| Device Description andTechnologicalCharacteristics: | The Vitls Platform is a wireless multi-parameter vital signsmonitoring system. The Vitls Platform was developed to include anApplication Programming Interface (API) which is intended toallow development of user interface applications, enablingclinicians and medically qualified personnel to access recorded vitalsigns information for respective analysis only, not for active patientmonitoring. 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 |
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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.
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| 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 ClassificationName | Radiofrequency Physiological SignalTransmitter and Receiver | Radiofrequency Physiological SignalTransmitter 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 remotemonitoring system intended for use byhealthcare professionals for continuouscollection of physiological data in homeand healthcare settings. | The Patient Status Engine isintended for use as a general patientmonitor, to provide physiologicalinformation in home and healthcaresettings. |
| Indications for Use | The Vitls Platform is a wireless remotemonitoring system intended for use byhealthcare professionals for continuouscollection of physiological data inhealthcare and home settings. Thisincludes heart rate and body temperature.The data from the Tego VSS Sensor isintended for use by healthcareprofessionals as an aid to diagnosis andtreatment. It is not intended for use oncritical care patients nor replace standardmonitoring and/or routine care.The device is intended for use as ageneral patient monitor, to providephysiological information, on patientswho are 2 years of age or older. | The Patient Status Engine is awireless remote monitoring systemintended for use by healthcareprofessionals for continuouscollection of physiological data inhome and healthcare settings.This includes heart rate, heart ratevariability (R-R interval), ECGderived respiration rate data(EDR), skin temperature,activity, posture and optional SpO2and noninvasive Blood Pressure(BP).The device is intended for use ongeneral care patients who are 18years of age or older as a general |
| Characteristic | Vitls Platform | Patient Status Engine |
| patient monitor, to providephysiological information.The data from the Patient StatusEngine is intended for use byhealthcare professionals as an aid todiagnosis and treatment. It is notintended for use on critical carepatients nor replace standardmonitoring and/or routine care. | ||
| Mechanism ofAction | Physiological data acquisition (wireless)and display | Physiological data acquisition(wireless) and display |
| Components | Tego VSS SensorThe Secure Server LibraryThe Vitls App | Patient Gateway (Samsung Tablet)Patient Gateway SoftwareLifetouch Blue SensorLifetemp SensorLifeguard Server SoftwareAccessories:Pulse OximeterBlood Pressure MonitorECG ElectrodesAmbu White Sensors |
| PhysiologicalParametersMonitored: | ||
| Heart Rate | Yes | Yes |
| Heart RateVariability(HRV) | No | Yes |
| Respiration Rate | No | Yes |
| SpO2 | No | Optional with FDA cleared SpO2oximeter |
| 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 |
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| Characteristic | Vitls Platform | Fever Scout ContinuousMonitoring Thermometer |
|---|---|---|
| Manufacturer | Vitls, Inc. | Vivalnk Inc. |
| 510(k) Number | K191620 | K162137 |
| Class | II | II |
| Device ClassificationName | 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 remotemonitoring system intended for use byhealthcare professionals for continuouscollection of physiological data inhealthcare and home settings. Thisincludes heart rate and body temperature.The data from the Tego VSS Sensor is | The wireless Fever Scout ContinuousMonitoring thermometer is a non-invasive and re-usable electronicdevice for home use. This product isintended for non-urgent ambulatorycontinuous armpit body temperaturemonitoring from ages 29 days andolder. |
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| Characteristic | Vitls Platform | Fever Scout ContinuousMonitoring Thermometer |
|---|---|---|
| intended for use by healthcareprofessionals as an aid to diagnosis andtreatment. It is not intended for use oncritical care patients nor replace standardmonitoring and/or routine care.The device is intended for use as ageneral patient monitor, to providephysiological information, on patientswho 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° CFrom 37-39° C$\pm$ 0.2° CFrom 35-37° C and 39-42° C |
| AnatomicalApplication | Chest and armpit | Armpit peel and stick contactthermometer 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:
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- 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.
§ 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).