(251 days)
The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review.
The device is intended for continuous data collection supporting intermittent retrospective review of the following physiological parameters:
• Pulse Rate,
- · Blood Oxygen Saturation under no-motion conditions,
- · Respiratory Rate under no motion conditions,
- · Peripheral Skin Temperature,
- · Electrodermal Activity,
- · Activity associated with movement during sleep
The Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion.
The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring, where monitoring temperature at the wrist is clinically indicated.
The Empatica Health Monitoring Platform is not intended for Respiratory Rate monitoring in motion conditions. This device does not detect apnea and should not be used for detecting or monitoring cessation of breathing.
The Empatica Health Monitoring Platform is not intended for Pulse Rate monitoring in patients with chronic cardiac arrhythmias, including atrial fibrillation and atrial/ventricular bigeminy and trigeminy. and is not intended to diagnose or analyze cardiac arrhythmias. The Empatica Health Monitoring Platform is not a substitute for an ECG monitor, and should not be used as the sole basis for clinical decision-making.
The Empatica Health Monitoring Platform is a wearable device and software platform composed by:
- A wearable medical device called EmbracePlus,
- A mobile application running on smartphones called "Care App", ●
- A cloud-based software platform named "Care Portal". ●
The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors. These data are wirelessly transmitted via Bluetooth Low Energy to a paired mobile device where the Care App is up and running. The data received are analyzed by one of the Care App software modules, EmpaDSP, which computes the user physiological parameters. Based on the version of the Care App installed, the user can visualize a subset of these physiological parameters. The Care App is also responsible for transmitting, over cellular or Wi-Fi connection sensors' raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, further analyzed, and accessible by healthcare providers or researchers via a specific cloud-based software called Care Portal.
The Empatica Health Monitoring Platform is intended for retrospective remote monitoring of physiological parameters in ambulatory adults in home-healthcare environments. It is designed to continuously collect data to support intermittent monitoring of the following physiological parameters and digital biomarkers by trained healthcare professionals or researchers: Pulse Rate (PR), Respiratory Rate (RR), blood oxygen saturation (SpO-), peripheral skin temperature (TEMP), and electrodermal activity (EDA). Activity sensors are used to detect sleep periods and to monitor the activity associated with movement during sleep.
Here's a summary of the acceptance criteria and the study details for the Empatica Health Monitoring Platform, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Subject Device) | Reported Device Performance | Comments |
|---|---|---|---|
| Pulse Rate (PR) | |||
| PR Range | 24 – 240 bpm | 24 – 240 bpm | Matches range |
| PR Resolution | 1 bpm | 1 bpm | Matches resolution |
| PR Accuracy (no-motion) | ≤ 3 bpm Arms | ≤ 3 bpm Arms | Meets criteria, tested against ECG |
| PR Accuracy (motion) | ≤ 5 bpm Arms | ≤ 5 bpm Arms | Meets criteria, tested against ECG |
| Respiratory Rate (RR) | |||
| RR Range | 6 - 40 brpm | 6 - 40 brpm | Matches range |
| RR Resolution | 1 brpm | 1 brpm | Matches resolution |
| RR Accuracy (no-motion) | ≤ 3 brpm Arms | ≤ 3 brpm Arms | Meets criteria, tested against capnography. Not intended for motion conditions. |
| Blood Oxygen Saturation (SpO2) | |||
| SpO2 Range | 70-100% | 70-100% | Matches range. Not intended for motion or low perfusion conditions. |
| SpO2 Resolution | 1% | 1% | Matches resolution |
| SpO2 Accuracy | 3% Arms | 3% Arms | Meets criteria (implies compliance with ISO 80601-2-61 and FDA Guidance for Pulse Oximeters). No additional clinical data provided for this submission, relying on prior clearance K221282. |
| Peripheral Skin Temperature (TEMP) | |||
| Temperature Range | 0°C to 50°C | 0°C to 50°C | Matches range |
| Temperature Resolution | 0.1°C | 0.1°C | Matches resolution |
| Temperature Accuracy | ± 0.1ºC within 30.0ºC - 45.0ºC range | ± 0.1ºC within 30.0ºC - 45.0ºC range | Meets criteria. No additional bench tests provided for this submission, relying on prior clearance K221282. |
| Electrodermal Activity (EDA) | |||
| EDA Range | 0.01 μS – 100 μS | 0.01 μS – 100 μS | Matches range. No additional data or documentation provided for this submission, relying on prior clearance K221282. |
| EDA Resolution | 1 digit ~ 55 pS | 1 digit ~ 55 pS | Matches resolution |
| Activity/Sleep | Bench testing confirmed equivalence for activity counts and sleep detection with the predicate device. No additional bench testing provided for this submission, relying on prior clearance K221282. |
2. Sample Size Used for the Test Set and Data Provenance
- Pulse Rate:
- Study 1: 12 healthy adult subjects.
- Study 2: 85 healthy adult subjects.
- Study 3: 49 adult subjects (healthy, PVCs, other comorbidities).
- Total N = 146 adult subjects.
- Data Provenance: Not explicitly stated, but clinical studies are generally prospective in nature for regulatory submissions. Country of origin not specified.
- Respiratory Rate:
- Study 1: 14 healthy adult subjects.
- Study 2: 46 healthy adult subjects.
- Study 3: 17 adult subjects with various health conditions.
- Study 4: 40 adult subjects with various health conditions.
- Total N = 117 adult subjects.
- Data Provenance: Not explicitly stated, but clinical studies are generally prospective in nature for regulatory submissions. Country of origin not specified.
- SpO2, Temperature, EDA, Activity/Sleep: For these parameters, the submission relies on previous clearance (K221282), indicating no new clinical test data was provided for this specific submission. The reported performance for these parameters is thus based on the studies supporting K221282. Sample sizes and provenance for those underlying studies are not detailed in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The document does not mention the use of human experts to establish ground truth for the test sets.
- Instead, for Pulse Rate, the ground truth was established using a reference electrocardiogram (ECG).
- For Respiratory Rate, the ground truth was established using a capnography reference device.
4. Adjudication Method for the Test Set
- Not applicable as the ground truth was established against reference medical devices (ECG, capnography) rather than human expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The studies described are focused on the standalone performance of the device against reference standards.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, standalone studies were performed. The clinical data presented for Pulse Rate and Respiratory Rate directly evaluate the accuracy of the device's computed values against reference standards, without human intervention in the measurement process. The device itself is described as a "platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring," implying that the data collection and parameter computation are algorithmic, and review is done by humans.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)
- Pulse Rate: Reference Electrocardiogram (ECG).
- Respiratory Rate: Reference Capnography device.
- SpO2: Based on the technology description, it would typically be a co-oximeter or a clinically validated pulse oximeter meeting ISO standards. The document notes that no new clinical data for SpO2 was provided, relying on K221282, which would have established ground truth similarly.
8. The Sample Size for the Training Set
- The document does not provide details about the sample size for the training set used for the device's algorithms. It focuses entirely on the clinical validation (test set) data.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide details on how the ground truth for the training set was established. This information is typically not included in a 510(k) summary, which focuses on the validation of the final product.
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October 30, 2023
Empatica S.r.1. Alberto Poli, Regulatory Affairs & Quality Manager Via Stendhal, 36 Milan, 20144, Italy
Re: K230457
Trade/Device Name: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, BZQ, DQA, DRG, FLL, GZO, LEL Dated: April 3, 2023 Received: September 29, 2023
Dear Alberto Poli:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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 W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
Indications for Use (Describe)
The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review.
The device is intended for continuous data collection supporting intermittent review of the following physiological parameters:
· Pulse Rate,
- · Blood Oxygen Saturation under no-motion conditions,
- · Respiratory Rate under no motion conditions,
- · Peripheral Skin Temperature,
- · Electrodermal Activity,
- · Activity associated with movement during sleep
The Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion.
The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring, where monitoring temperature at the wrist is clinically indicated.
The Empatica Health Monitoring Platform is not intended for Respiratory Rate monitoring in motion conditions. This device does not detect apnea and should not be used for detecting or monitoring cessation of breathing.
The Empatica Health Monitoring Platform is not intended for Pulse Rate monitoring in patients with chronic cardiac arrhythmias, including atrial fibrillation and atrial/ventricular bigeminy and trigeminy. and is not intended to diagnose or analyze cardiac arrhythmias. The Empatica Health Monitoring Platform is not a substitute for an ECG monitor, and should not be used as the sole basis for clinical decision-making.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
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Empatica Health Monitoring Platform
510(k) Summary
l. SUBMITTER
| Company Name | Empatica Srl |
|---|---|
| Establishment Registration Number | 3012933969 |
| Contact Person | Alberto Poli, Director, Quality & Regulatory Compliance |
| Contact Person email | apo@empatica.com |
| Address | Via Stendhal, 36 - 20144, Milan, Italy |
| Telephone Number | +39 02 36165068 |
| Date prepared | September 27, 2023 |
II. DEVICE
Trade/Proprietary Name: Common/Usual Name:
Empatica Health Monitoring Platform Remote Patient Monitoring System
Primary Product Code:
| Classification Regulation | Classification Name | Device Class | Product Code | Classification Panel |
|---|---|---|---|---|
| 870.2300 | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class II | MWI | Cardiovascular |
Secondary Product Codes:
| Classification Regulation | Classification Name | DeviceClass | Product Code | ClassificationPanel |
|---|---|---|---|---|
| 870.2700 | Oximeter | Class II | DQA | Cardiovascular |
| 868.2375 | Monitor, Breathing Frequency | Class II | BZQ | Anesthesiology |
| 870.2910 | Transmitters and Receivers, PhysiologicalSignal, Radiofrequency | Class II | DRG | Cardiovascular |
| 882.5050 | Device, Sleep Assessment | Class II | LEL | Neurology |
| 882.1540 | Galvanic skin response measurementdevice | Class II | GZO | Neurology |
| 880.2910 | Thermometer, Electronic, Clinical | Class II | FLL | GeneralHospital |
PREDICATE DEVICES lll.
| PredicateDevice | Name | Submitter | Product Code(s) | 510(k) Number |
|---|---|---|---|---|
| Primary | Current Health MonitoringSystem Gen 2 | Spry Health,Inc. | MSXDQADRGBZQBZGFLL | K210133 |
| Secondary | Empatica Health MonitoringPlatform | Empatica S.r.l. | DQADRGLELFLLGZO | K221282 |
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Empatica Health Monitoring Platform
| PredicateDevice | Name | Submitter | Product Code(s) | 510(k) Number |
|---|---|---|---|---|
| Secondary | Loop System | Spry Health,Inc. | DQABZQ | K181352 |
None of these predicates have been subject to a design-related recall.
REFERENCE DEVICE IV.
| Name | Submitter | Product Code(s) | 510(k) Number |
|---|---|---|---|
| Everion+ System | Biofourmis Singapore Pte. Ltd | MWI, MSX, BZQ | K213863 |
DEVICE DESCRIPTION V.
The Empatica Health Monitoring Platform is a wearable device and software platform composed by:
- A wearable medical device called EmbracePlus,
- A mobile application running on smartphones called "Care App", ●
- A cloud-based software platform named "Care Portal". ●
The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors. These data are wirelessly transmitted via Bluetooth Low Energy to a paired mobile device where the Care App is up and running. The data received are analyzed by one of the Care App software modules, EmpaDSP, which computes the user physiological parameters. Based on the version of the Care App installed, the user can visualize a subset of these physiological parameters. The Care App is also responsible for transmitting, over cellular or Wi-Fi connection sensors' raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, further analyzed, and accessible by healthcare providers or researchers via a specific cloud-based software called Care Portal.
The Empatica Health Monitoring Platform is intended for retrospective remote monitoring of physiological parameters in ambulatory adults in home-healthcare environments. It is designed to continuously collect data to support intermittent monitoring of the following physiological parameters and digital biomarkers by trained healthcare professionals or researchers: Pulse Rate (PR), Respiratory Rate (RR), blood oxygen saturation (SpO-), peripheral skin temperature (TEMP), and electrodermal activity (EDA). Activity sensors are used to detect sleep periods and to monitor the activity associated with movement during sleep.
INDICATION FOR USE vi.
The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review.
The device is intended for continuous data collection supporting intermittent retrospective review of the following physiological parameters:
• Pulse Rate,
- · Blood Oxygen Saturation under no-motion conditions,
- · Respiratory Rate under no motion conditions,
- · Peripheral Skin Temperature,
- · Electrodermal Activity,
- · Activity associated with movement during sleep
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Empatica Health Monitoring Platform
The Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion.
The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring, where monitoring temperature at the wrist is clinically indicated.
The Empatica Health Monitoring Platform is not intended for Respiratory Rate monitoring in motion conditions. This device does not detect apnea and should not be used for detecting or monitoring cessation of breathing.
The Empatica Health Monitoring Platform is not intended for Pulse Rate monitoring in patients with chronic cardiac arrhythmias, including atrial fibrillation and atrial/ventricular bigeminy, and is not intended to diagnose or analyze cardiac arrhythmias. The Empatica Health Monitoring Platform is not a substitute for an ECG monitor, and should not be used as the sole basis for clinical decision-making.
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Empatica Health Monitoring Platform
I. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The application Enpatica Health Monitoring Platform is substantially equivate devices. The devices have similar Indications for Use, features, technology, and accuracy.
| Features | Empatica HealthMonitoring Platform(Subject Device) | Current Health MonitoringSystem Gen 2 (K210133) | Empatica Health MonitoringPlatform (K221282) | Loop System (K181352) | Analysis of differences |
|---|---|---|---|---|---|
| Common Name | Monitor, Physiological,Patient (WithoutArrhythmia Detection OrAlarms) | System, Network andCommunication,PhysiologicalMonitors | Oximeter | Oximeter | N/A |
| DeviceManufacturer | Empatica S.r.l. | Current Health Ltd. | Empatica S.r.l. | Spry Health Ltd. | N/A |
| DeviceClassification | II | ll | ll | ll | N/A |
| 510(k) number | N/A | K210133 | K221282 | K181352 | N/A |
| PrimaryProduct Code | MWI | MSX | DQA | DQA | N/A |
| SecondaryProduct Code | DQA, BZQ, DRG, GZO, LEL,FLL | FLL, DQA, BZQ, DRG,BZG | DRG, GZO, LEL, FLL | BZQ | N/A |
| IntendedUse/Indicationsfor Use | The Empatica HealthMonitoring Platform is awearable device andpaired mobile andcloud-based softwareplatform intended to beused by trainedhealthcare professionalsor researchers forretrospective remotemonitoring of physiologicparameters in ambulatory | The Current WearableHealth Monitoring System isintended for reusablebedside, mobile and centralmulti-parameter, physiologicpatient monitoring of adultpatients in professionalhealthcare facilities, such ashospitals or skilled nursingfacilities, or their own home.It is intended for monitoringof patients by trained | The Empatica HealthMonitoring Platform is awearable device and pairedmobile and cloud-basedsoftware platform intendedto be used by trainedhealthcare professionals orresearchers to remotelymonitor physiologicparameters in ambulatoryindividuals 18 years of ageand older in | The Loop System isintended for adultpatients in the homeenvironment forpassive, noninvasive,intermittent datacollection ofphysiologicalparameters that willlater be transmitted to aweb server for remotereview by a clinician. | The subject deviceindication for useincludes the monitoringof a subset of thephysiological parametersmonitored by the primarypredicate and additionalparameters comparedwith the secondarypredicates. |
| Features | Empatica HealthMonitoring Platform(Subject Device) | Current Health MonitoringSystem Gen 2 (K210133) | Empatica Health MonitoringPlatform (K221282) | Loop System (K181352) | Analysis of differences |
| individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review.The device is intended for continuous data collection supporting intermittent retrospective review of the following physiological parameters:• Pulse Rate,• Blood Oxygen Saturation under no-motion conditions,• Respiratory Rate under no motion conditions, | healthcare professionals.The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated. The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:• Pulse rate• Oxygen saturation• Temperature• MovementThe Current Wearable Health Monitoring System is intended for intermittent or spot-check monitoring, in adults, of:• Respiration rate | home-healthcare environments.The device supports the continuous monitoring of the following:• Peripheral skin temperature,• Electrodermal activity• Blood Oxygen Saturation under no motion conditions• Activity associated with movement during sleepThe Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion.The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring, | The Loop System measures and records:• arterial oxygen saturation (SpO2) • heart rate (HR) • respiration rate (RR) All of these measurements are made when no motion is detected by the System. The Loop System device does not provide physiological alarms. | ||
| Features | Empatica HealthMonitoring Platform(Subject Device) | Current Health MonitoringSystem Gen 2 (K210133) | Empatica Health MonitoringPlatform (K221282) | Loop System (K181352) | Analysis of differences |
| Peripheral SkinTemperature, Electrodermal Activity, Activity associated withmovement during sleep The Empatica HealthMonitoring Platform canbe used to analyzecircadian rhythms andassess activity in anyinstance wherequantifiable analysis ofphysical motion isdesirable.The Empatica HealthMonitoring Platform isnot intended for SpO2monitoring in conditionsof motion or lowperfusion.The Empatica HealthMonitoring Platform isintended for peripheralskin temperaturemonitoring, wheremonitoring temperature | Non-invasive bloodpressure Lung function &spirometry Weight The Current WearableHealth Monitoring System isnot intended for use inhigh-acuity environments,such as ICU or operatingrooms.The Current WearableHealth Monitoring System isnot intended for use onacutely ill cardiac patientswith the potential todevelop life threateningarrhythmias e.g. very fastatrial fibrillation. For thesepatients, they should bemonitored using a devicewith continuous ECG. TheCurrent Wearable HealthMonitoring System is not asubstitute for an ECGmonitor.The Current WearableHealth Monitoring System is | where monitoringtemperature at the wrist isclinically indicated. | |||
| Features | Empatica HealthMonitoring Platform(Subject Device) | Current Health MonitoringSystem Gen 2 (K210133) | Empatica Health MonitoringPlatform (K221282) | Loop System (K181352) | Analysis of differences |
| at the wrist is clinicallyindicated. | not intended for SpO2monitoring in conditions ofhigh motion orlow perfusion | ||||
| The Empatica HealthMonitoring Platform isnot intended forRespiratory Ratemonitoring in motionconditions. This devicedoes not detect apneaand should not be usedfor detecting ormonitoring cessation ofbreathing. | |||||
| The Empatica HealthMonitoring Platform isnot intended for PulseRate monitoring inpatients with chroniccardiac arrhythmias,including atrial fibrillationand atrial/ventricularbigeminy and trigeminy,and is not intended todiagnose or analyzecardiac arrhythmias. TheEmpatica HealthMonitoring Platform is | |||||
| Features | Empatica HealthMonitoring Platform(Subject Device) | Current Health MonitoringSystem Gen 2 (K210133) | Empatica Health MonitoringPlatform (K221282) | Loop System (K181352) | Analysis of differences |
| not a substitute for anECG monitor, and shouldnot be used as the solebasisforclinicaldecision-making. | |||||
| TargetPopulation | Adult | Adult | Adult | Adult | The subject device andthe predicates areidentical |
| Anatomical Site | Wrist | Upper Arm | Wrist | Wrist | Clinical testingdemonstrated theequivalence between thesubject device and thepredicates. Thedifference in wearinglocationon the bodydoes not raise newquestions ofsafety or efficacy. |
| Over theCounter or Rx | Rx | Rx | Rx | Rx | The subject device andthe predicates areidentical |
| Environment | Home | Professional HealthcareFacilities & Home | Home | Home | The subject deviceincludes a subgroup ofthe predicates, hence thisdoes not raise newquestions of safety orefficacy. |
| Features | Empatica HealthMonitoring Platform(Subject Device) | Current Health MonitoringSystem Gen 2 (K210133) | Empatica Health MonitoringPlatform (K221282) | Loop System (K181352) | Analysis of differences |
| Alarms | No | Yes | No | No | This difference does notraise new questions ofsafety or efficacy sincethe Empatica HealthMonitoring Platform isnot intended, by design,to include alarms for usein situations where thepresence of alarms is arequirement forappropriate patient care. |
| User Interface | Device screen, Mobiledevice application, andcloud software platform | Mobile devices and a centralstation | Device screen, Mobile deviceapplication, and cloudsoftware platform | Central station | The differences betweenthe subject device andthe predicates do notraise new questions ofsafety or efficacy |
| Energy Source | Battery | Battery | Battery | Battery | The subject device andthe predicates areidentical |
| Battery Type | Rechargeable Lithium-Ion | Rechargeable Lithium-Ion | Rechargeable Lithium-Ion | RechargeableLithium-Ion | The subject device andthe predicates areidentical |
| WirelessCommunicationInterface | Bluetooth® Low Energy(device to mobile device)IEEE 802.11 WiFi/cellularto Empatica cloud | IEEE 802.11 WiFi | Bluetooth® Low Energy(device to mobile device)IEEE 802.11 WiFi/cellular toEmpatica cloud | Wireless (cellularconnection) viacharging station to SpryServer. | All the devices aredesigned totransmit their data toalternatedevices or sites. Thedifferent technologiesused do not raise new |
| Features | Empatica HealthMonitoring Platform(Subject Device) | Current Health MonitoringSystem Gen 2 (K210133) | Empatica Health MonitoringPlatform (K221282) | Loop System (K181352) | Analysis of differences |
| questions of safety orefficacy | |||||
| Patientcontactingmaterials | Compliant to ISO 10993-1 | Compliant to ISO 10993-1 | Compliant to ISO 10993-1 | Compliant to ISO10993-1 | The subject device andthe predicates areidentical |
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| Technical and Performance Information for Pulse Rate | |||||
|---|---|---|---|---|---|
| Features | Empatica HealthMonitoring Platform(Subject Device) | Current Health MonitoringSystem Gen 2 (K210133) | Empatica Health MonitoringPlatform (K221282) | Loop System (K181352) | Analysis of differences |
| Technology | PR measured by analyzingcyclic variations inthe reflectance of certainLEDfrequencies in aphotoplethysmogramdesign.The diodes are mounted inthe device such that theyin contact with the skin. | PR measured by analyzingcyclic variations inthe reflectance of certainLEDfrequencies in aphotoplethysmogramdesign.The diodes are mounted inthe device such that they arein contact with the skin. | N/A | HR measured byanalyzing cyclicvariations in reflectanceof certain LEDfrequencies in aphotoplethysmogramdesign. The diodes aremounted in the devicesuch that they are incontact with the skin. | The subject device andthe predicates areidentical in that they alluse thephotoplethysmogramtechnology |
| PR Range | 24 – 240 beats per minute(bpm) | 30 – 240 beats per minute(bpm) | N/A | 25 – 250 beats perminute (bpm) | Clinically equivalent. Thesubject device and thepredicatescomply with ISO80601-2-61 |
| PR Resolution | 1 bpm | 1 bpm | N/A | 1 bpm | The subject device andthe predicates areidentical |
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| Features | Empatica HealthMonitoring Platform(Subject Device) | Current Health MonitoringSystem Gen 2 (K210133) | Empatica Health MonitoringPlatform (K221282) | Loop System (K181352) | Analysis of differences |
|---|---|---|---|---|---|
| PR Accuracy | (no-motion) 3 bpm Arms(motion) 5 bpm Arms | (generic) ±3bpm | N/A | (no-motion) 3 bpm Arms | The subject device andthe predicates all meetaccuracy acceptancecriteria thresholdsrecommended by FDA.The difference inaccuracy does not impactthe clinical safety of theproduct. |
| Technical and Performance Information for Respiratory Rate | ||||||
|---|---|---|---|---|---|---|
| Features | Empatica HealthMonitoring Platform(Subject Device) | Current HealthMonitoring SystemGen 2 (K210133) | Empatica HealthMonitoring Platform(K221282) | Loop System(K181352) | Everion+ System(K213863) | Analysis ofdifferences |
| Technology | Respiration rate (RR)data is continuouslycollected by analyzingcyclic variations in thephotoplethysmogram.The diodes are mountedin the device such thatthey are in contact withthe skin | Not used forsubstantialequivalence | N/A | Respiration rate (RR)is intermittentlycollected by analyzingcyclic variations in thephotoplethysmogram.The diodes aremounted in thedevice such that theyare in contact withthe skin. | An optical sensorallows reflectivephotoplethysmography(PPG) measurementsto be performed on theskin and underlyingtissue | The core technologyofphotoplethysmography is identicalbetween the subjectdevice and thepredicate. Technicaldifferences arelimited to differencesin data collectionfrequency, whichdoes not raise newquestions of safety oreffectiveness when |
| Technical and Performance Information for Respiratory Rate | ||||||
| Features | Empatica HealthMonitoring Platform(Subject Device) | Current HealthMonitoring SystemGen 2 (K210133) | Empatica HealthMonitoring Platform(K221282) | Loop System(K181352) | Everion+ System(K213863) | Analysis ofdifferences |
| consideringperformance of thedevice. Adequacy ofperformance using acontinuous datasampling technologyis supported by thereference devicelegally marketed forthe same indicationfor use under theproduct code MWI,BZQ. | ||||||
| RR Range | 6 - 40 breaths perminute (brpm) | N/A | 4 - 40 respirations perminute (RPM) | 6 – 30 breaths perminute (brpm) | The subject devicehas a different lowerlimit. The differencedoes not impact theclinical safety of theproduct. | |
| RRResolution | 1 brpm | N/A | 1 RPM | The subject deviceand the predicatesare identical | ||
| RRAccuracy | 3 brpm Arms | N/A | 3 RPM Arms | 3 brpm Arms | The subject deviceand the predicatesare identical | |
| Technical and Performance Information for Blood Oxygen Saturation | ||||||
| Features | Empatica Health MonitoringPlatform (Subject Device) | Current HealthMonitoring System Gen2 (K210133) | Empatica HealthMonitoring Platform(K221282) | Loop System (K181352) | Analysis of differences | |
| Technology | SpO2 relies on the principlethat hemoglobin at differentoxygenation states absorbslight differently based uponthe wavelength of light. | SpO2 is measured byanalyzing thereflectance of certainLED frequencies in aphotoplethysmogramdesign. The diodes aremounted in the devicesuch that they are incontact with the skin. | SpO2 relies on theprinciple thathemoglobin at differentoxygenation statesabsorbs light differentlybased upon thewavelength of light. | SpO2 measured byanalyzing reflectance ofcertain LED frequenciesin aphotoplethysmogramdesign. The diodes aremounted in the devicesuch that they are incontact with the skin | The subject device andthe predicates areidentical in that they alluse thephotoplethysmogramtechnology | |
| SpO2 Range | 70-100% | 70-100% | 70-100% | 70-100% | The subject device andthe predicates areidentical | |
| SpO2 Resolution | 1% | 1% | 1% | 1% | The subject device andthe predicates areidentical | |
| SpO2 Accuracy | 3% Arms | ± 2 Digits | 3% Arms | 3% Arms | The subject device andthe predicates complywith ISO 80601-2-61 as well as with FDAGuidance for PulseOximeters(2012) |
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No changes to the computation of Blood Oxygen Saturation (SpO-) have been introduced in the Empatica Health Monitoring Platform presented in this 510(k) submission compared with the recently cleared K221282. No additional clinical data or documentation has been attached to this 510(k) submission.
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| Technical and Performance Information for Temperature | |||||
|---|---|---|---|---|---|
| Features | Empatica Health MonitoringPlatform (Subject Device) | Current Health MonitoringSystem Gen 2 (K210133) | Empatica HealthMonitoring Platform(K221282) | Loop System (K181352 | Analysis of differences |
| Technology | high-precision temperaturesensor | In-Built Thermistor | high-precisiontemperature sensor | N/A | The subject device andthe predicates areidentical |
| Temperature Range | 0°C to 50°C | 0°C to 50°C | 0°C to 50°C | N/A | The subject device andthe predicates areidentical |
| TemperatureResolution | 0.1°C | 0.1°C | 0.1°C | N/A | The subject device andthe predicates areidentical |
| TemperatureAccuracy | ± 0.1ºC within 30.0ºC - 45.0ºCrange | ±0.1°C | ± 0.1ºC within 30.0ºC- 45.0ºC range | N/A | The subject device andthe predicates areidentical |
No changes to the computation of Peripheral Skin Temperature (TEMP) have been introduced in the Empatica Heath Monitoring Platform presented in this 510(k) submission compared with the recently cleared K221282. No additional bench test or documentation have been attached to this 510(k) submission.
| Technical and Performance Information for Electrodermal Activity | |||||
|---|---|---|---|---|---|
| Features | Empatica Health MonitoringPlatform (Subject Device) | Current HealthMonitoring System Gen2 (K210133) | Empatica Health MonitoringPlatform (K221282) | Loop System (K181352) | Analysis of differences |
| Technology | EDA is measured by analyzingdetected changes in theconductivity of the superficiallayers of the skin. | N/A | EDA is measured by analyzingdetected changes in theconductivity of the superficiallayers of the skin. | N/A | The subject device andthe predicates areidentical |
| EDA Range | 0.01 μS – 100 μS | N/A | 0.01 μS – 100 μS | N/A | The subject device andthe predicates areidentical |
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| Technical and Performance Information for Electrodermal Activity | |||||
|---|---|---|---|---|---|
| Features | Empatica Health MonitoringPlatform (Subject Device) | Current HealthMonitoring System Gen2 (K210133) | Empatica Health MonitoringPlatform (K221282) | Loop System (K181352) | Analysis of differences |
| EDA Resolution | 1 digit ~ 55 pS | N/A | 1 digit ~ 55 pS | N/A | The subject device andthe predicates areidentical |
No changes to the computation of EDA (EDA) have been in the version of the Empatica Health Monitoring Platform presented in this 510(k) submission compared with the recently cleared K221282. No addition data or documentation have been attached to this 510(k) submission.
| Technical and Performance Information for Activity and Sleep | |||||
|---|---|---|---|---|---|
| Features | Empatica HealthMonitoring Platform(Subject Device) | Current HealthMonitoring SystemGen 2 (K210133) | Empatica Health MonitoringPlatform (K221282) | Loop System(K181352) | Analysis of differences |
| Technology | Accelerometer | N/A | Accelerometer | N/A | The subject device and thepredicate are identical |
| Accelerometer Type | Microelectromechanicalsystem(MEMS)-based integratedcircuit | N/A | Microelectromechanical system(MEMS)-based integratedcircuit | N/A | The subject device and thepredicate are identical |
| AccelerometerSampling Rate | Digital method, 26 Hz -208 Hz | N/A | Digital method, 26 Hz – 208 Hz | N/A | The subject device and thepredicate are identical |
| AccelerometerDynamic Range | ± 16 g | N/A | ± 16 g | N/A | The subject device and thepredicate are identical |
| AccelerometerSensitivity | 0.488 milli-g per LeastSignificant Bit | N/A | 0.488 milli-g per LeastSignificant Bit | N/A | The subject device and thepredicate are identical |
No changes to the computation of Activity during sleep (ACT and SLEEP) have been introduced in the version of the Empatica Health Monitoring Platform presented in this 510(k) submission compared with the recently cleared K221282. No additional bench test and validation data or documentation have been attached to this 510(k) submission
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ll. PERFORMANCE DATA
Non-Clinical testing (Bench testing)
The following non-clinical (bench) testing was conducted to support a determination of substantial equivalence to the predicates and to demonstrate performance. The non-clinical bench tests included:
| Test Name | Test Description | Results |
|---|---|---|
| Biocompatibility testing | The wearable device component of the Empatica Health Monitoring Platform, called EmbracePlus, was tested in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" September 4, 2020, and International Standard ISO 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:• Cytotoxicity• Sensitization• IrritationThe EmbracePlus wearable device is considered surface contacting for a prolonged duration (>24 hours < 30 days) | Passed |
| Electrical safety testing | The wearable device component of the Empatica Health Monitoring Platform, called EmbracePlus, was tested in accordance with International Standard IEC 60601-1 for electrical safety | Passed |
| Electromagnetic compatibility (EMC) testing | The wearable device component of the Empatica Health Monitoring Platform, called EmbracePlus, was tested in accordance with International Standard IEC 60601-1-2 for EMC | Passed |
| Wireless Radio Communication | Empatica Health Monitoring Platform was tested to ensure it can communicate via wireless radio in its intended environment in compliance with FDA Radio Frequency Wireless Technology in Medical Devices Guidance, issued August 2013 | Passed |
| Usability testing | The Empatica Health Monitoring Platform was assessed with regards to usability for compliance with IEC 62366-1. The EmbracePlus was also tested in accordance with International Standard IEC 60601-1-6 for Usability of medical devices. | Passed |
| Home-Use testing | The wearable device component of the Empatica Health Monitoring Platform, called EmbracePlus, was tested in accordance with International Standard IEC 60601-1-11 for medical devices used in home healthcare environments. | Passed |
| Cleaning validation | The wearable device component of the Empatica Health Monitoring Platform, called EmbracePlus, was tested in accordance with International Standard ISO 17664 and AAMI TIR 30 to assess device cleaning procedure | Passed |
| Manual disinfection | The wearable device component of the Empatica Health Monitoring Platform, called EmbracePlus, was tested in accordance with ASTM E1837:2014 and AAMI TIR 12 to assess device low-level disinfection procedure | Passed |
| Test Name | Test Description | Results |
| Temperaturemeasurementaccuracy | The Empatica Health Monitoring Platform was tested to confirm theSkin temperature measurement accuracy and transient timecomplies with ISO 80601-2-56 Medical electrical equipment - Part2-56: Particular requirements for basic safety and essentialperformance of clinical thermometers for body temperaturemeasurement. [Including: Amendment 1 (2018)] to assess itsaccuracy. | Passed |
| Electrodermalactivitymeasurement | The Empatica Health Monitoring Platform computed electrodermalactivity (EDA) was tested to determine its equivalence to thepredicate device Empatica E4. | Passed |
| ActivityCounts/Sleep | Bench testing has been performed to demonstrate the equivalenceof the Empatica Health Monitoring Platform activity counts andsleep detection with the predicate device. | Passed |
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Software Verification and Validation Testing
Software verification and validation testing were conducted. Documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." All the Empatica Health Monitoring Platform software components were considered a "moderate" level of concern since a failure or latent flaw in the software could result in minor injury to the patient or operator.
Cybersecurity
Cybersecurity activities were conducted. Documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff, " Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." All the Empatica Health Monitoring Platform software components underwent appropriate cybersecurity assessment and testing.
Animal study
No animal studies were conducted as part of the submission to prove substantial equivalence.
Clinical data - Pulse Rate
The accuracy of the pulse rate values computed by the Empatica Health Monitoring Platform in motion and no-motion conditions, was investigated through the execution of three clinical studies on a total of 146 adult subjects. The Empatica Health Monitoring Platform was compared to a reference electrocardiogram.
The first study investigated the accuracy of the computed pulse rate values during no-motion conditions in 12 healthy adult subjects (Male=7, Female=5; Fitzpatrick I-IV=11, This testing demonstrated an accuracy of ≤3 bpm Am in no-motion conditions across a range of 24-240 beats per minute.
A second study investigated the accuracy of the computed pulse rate values in motion and no-motion conditions in 85 healthy adult subjects (Male=40, Female=45; Fitzpatrick I-IV=63, V-VI=22). This testing demonstrated an accuracy of ≤3 bpm Ame in no-motion conditions, and ≤5 bpm Am in motion conditions across the range of 24-240 beats per minute.
The third study investigated the accuracy of the computed pulse rate values in motion and no-motion conditions in 49 adult subjects across a range of clinical conditions (Male=22; Fitzpatrick I-IV=38, V-VI=11; Healthy=10, Subjects with PVCs=19, Subjects with other
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comorbidities=20). This testing demonstrated an accuracy of ≤3 bpm Am in no-motion conditions, and <5 bpm Am in motion conditions across the range of 24-240 beats per minute.
Subgroup analyses on data pooled across the three studies were performed for sex, skin tone, and clinical condition, and confirmed adequate performance for the intended use in the target population.
Clinical data - Respiratory Rate
The accuracy of the respiratory rate values computed by the Empatica Health Monitoring Platform in no-motion conditions was investigated through the execution of four clinical studies on a total of 117 adult subjects. The Empatica Health Monitoring Platform was compared to a capnography reference device.
The first study investigated the accuracy of the computed respiratory rate values during no-motion conditions in 14 healthy adult subjects (Male=7, Fitzpatrick I-IV=11, V-VI=3). This testing demonstrated an accuracy of ≤3 brpm Ams across a range of 6-40 breaths per minute.
The second study investigated the accuracy of the computed respiratory rate values during no-motion conditions in 46 healthy adult subjects (Male=23, Fitzpatrick I-IV=33, V-VI=13). This testing demonstrated an accuracy of _3 brpm Am across a range of 6-40 breaths per minute.
The third and fourth studies, considered confirmatory studies, investigated the accuracy of the computed respiratory rate values during no-motion conditions in subjects with various health conditions that might impact the accuracy of the computed values. In particular, the third study investigated a total of 17 adult subjects (Male=6, Female=11; Fitzpatrick I-IV=15, V-VI=2), and the fourth study investigated a total of 40 subjects (Male=18, Fitzpatrick I-IV=31, V-VI=9). This testing confirmed an accuracy of ≤3 brpm Arms across a range of 6-40 breaths per minute.
Subgroup analyses on data pooled across the four studies were performed for sex and skin tone and confirmed adequate performance for the intended use in the target population.
No adverse events related to the device were encountered during the execution of both studies. The results of the clinical investigations demonstrate an effectiveness profile similar to the predicate devices.
III. CONCLUSION
Based on the information presented in this 510(k) premarket notification, device performance and safety profile evaluated in clinical testing, and comparison with legally marketed predicate devices, it is our determination that the Empatica Health Monitoring Platform has a safety and effectiveness profile that is substantially equivalent to the predicate devices.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).