Who is the manufacturer of Everion+ System?

Biofourmis Singapore Pte., Ltd. filed the 510(k) submission for Everion+ System (K213863).

What is the FDA product code for Everion+ System?

MSX. It is classified under 21 CFR 870.2300 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Everion+ System?

510(k) clearance (submission type: Traditional).

Does Everion+ System use AI or machine learning?

Yes. Everion+ System (K213863) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for Everion+ System?

Current Health Ltd. (K191272); Vitls Inc. (K191620).

Who can help prepare an FDA 510(k) submission like Everion+ System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Everion+ System get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Everion+ System

K213863 · Biofourmis Singapore Pte., Ltd. · MSX · Feb 23, 2023 · Cardiovascular

Device Facts

Record ID	K213863
Device Name	Everion+ System
Applicant	Biofourmis Singapore Pte., Ltd.
Product Code	MSX · Cardiovascular
Decision Date	Feb 23, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2300
Device Class	Class 2
Attributes	AI/ML

Intended Use

Everion+ provides continuous monitoring of the following vital signs in adults, 18 years of age or older, when at rest: Pulse rate Respiration rate Movement The data from Everion+ is intended to be used in a hospital or home environment in order to support monitoring of wearers under the care of a trained healthcare professional. Everion+ is not in a critical care environment such as an ICU or operating room. The device information should not be the sole basis for clinical decisions.

Device Story

Everion+ is a wireless, battery-operated wearable armband for continuous vital sign monitoring. It uses optical sensors to perform reflective photoplethysmography (PPG) on the upper arm to measure pulse rate, respiration rate, and movement. Data is transmitted via cellular communication to a secure cloud environment when in range of a third-party receiver; otherwise, data is stored locally on the device and transmitted upon reconnection. Clinicians access the data via an API to support patient monitoring. The device is intended for use in hospital or home settings by trained healthcare professionals. It does not provide alarms and is not intended for critical care environments. The output aids clinical decision-making but is not the sole basis for diagnosis or treatment.

Clinical Evidence

Clinical study conducted on 50 subjects (ages 21-80, diverse BMI and skin tones). Accuracy assessed against ECG (PR) and end-tidal CO2 capnography (RR). Results: PR RMSE ≤ 3 bpm; RR RMSE < 3 brpm. Movement detection performance evaluated via confusion matrix; binary classification (Rest vs. Non-Rest) achieved 88.9% accuracy, 98.8% sensitivity, and 66.8% specificity.

Technological Characteristics

Wireless wearable armband with integrated optical sensors for reflective PPG. Battery-operated with wireless transceiver. Materials: stretchy fabric armband with adjustable clip. Connectivity: cellular transmission to cloud, API-based data access. Standards: ISO 15223-1, EN 50419, ISO 10993 (biocompatibility), IEC 62304 (software), ISO 14971 (risk), IEC 60601-1/11 (safety), ISO 80601-2-61 (pulse/respiration).

Indications for Use

Indicated for continuous monitoring of pulse rate, respiration rate, and movement in adults (≥18 years) at rest. Intended for use in hospital or home settings under the care of a trained healthcare professional. Not for use in critical care environments (ICU/OR).

Regulatory Classification

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.

Predicate Devices

Current Health Ltd. (K191272)
Vitls Inc. (K191620)

Related Devices

K233418 — Biofourmis Everion+ (G2) · Biofourmis Singapore Pte., Ltd. · May 9, 2024
K182543 — Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package · Snap40, Ltd. · Nov 14, 2018
K210133 — Current Health Monitoring System Gen 2 (G2) · Current Health · Sep 3, 2021
K220351 — Polso Watch · Chronisense Medical, Ltd. · Nov 18, 2022
K190073 — Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub · Current Health , Ltd. · Mar 27, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 the FDA logo, which 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. February 23, 2023 Biofourmis Singapore Pte. Ltd % Nandini Murthy Regulatory Consultant to Biofourmis Biofourmis 33 Arch Street, Floor# 17 Boston, Massachusetts 02110 Re: K213863 Trade/Device Name: Everion+ System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, MSX, BZQ, DRG Dated: January 20, 2023 Received: January 23, 2023 Dear Nandini Murthy: 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. 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. {1}------------------------------------------------ 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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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, Shruti N. Mistry -S for 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 Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213863 Device Name Everion+ System #### Indications for Use (Describe) Everion+ provides continuous monitoring of the following vital signs in age or older, when at rest: - · Pulse rate - · Respiration rate - · Movement The data from Everion+ is intended to be used in a hospital or home environment in order to support monitoring of wearers under the care of a trained healthcare professional. Everion+ is not in a critical care environment such as an ICU or operating room. The device information should not be the sole basis for clinical decisions. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Traditional 510(k) K213863 Premarket Notification Submission – Everion + System ## 510(k) SUMMARY | Submitter Name: | Biofourmis Singapore Pte. Ltd. 2 Venture Drive Vision Exchange, #23-01 Singapore Singapore 608526 SG | |----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Milan Shah | | Phone Number: | (617) 947-8255 | | Submission Correspondent: | Nandini Murthy | | Phone Number: | (781) 710-5378 | | Date Prepared: | February 22, 2023 | | Device Trade Name: | Everion + System | | Device Common Name: | Multi Parameter Monitor | | Classification regulation: | Primary Product Code: 21 CFR 870.2300, Product Code MWI, MSX Device: Class 2, Classification Panel: Cardiovascular | | | Secondary Product Code: 21 CFR 868.2375, Product Code BZQ Device: Class 2, Classification Panel: Anesthesiology 21CFR 870.2910, Product Code DRG Device: Class 2, Classification Panel: Cardiovascular | | Predicate Devices: | Current Health Ltd., K191272 Vitls Inc., K191620 | | Classification Name: | Cardiovascular | | Classification regulation: | Current Health: 21 CFR 870.2300, Product Code MSX, DQA, BZG 21 CFR 868.2375, Product Code BZG 21CFR 870.2910, Product Code DRG, FLL 21 CFR 858.1840, Product Code BZQ | {4}------------------------------------------------ # Device Description: The Everion+ is a wireless multi-parameter vital-signs monitoring system. The Everion+ was includes an Application Programming Interface (API), which is intended to allow development of user interface applications that enable clinicians and medically-qualified personnel to access recorded vital signs information for active patient monitoring. The system is comprised of the following components: - Wearable device with multiple sensors - Secure cloud environment with an API . - Charger with accessories . - Armband . The Everion+ wearable is battery-operated with integrated sensors and wireless transceiver. The wearable is worn on the upper arm via the adjustable armband that snaps to it. The armband is made of a stretchy material and has an adjustable clip to enable fitting to most adults. The wearable continuously gathers multi-parameter vital signs data from the person being monitored and securely transmits the data to the server component of the system, via cellular communication, when in range of a third-party receiver. # Indications for Use: Everion+ is intended to provide continuous monitoring of the following vital signs in adults, 18 years of age or older, when at rest: - Pulse rate - · Respiration rate - Movement The Everion+ device is intended to be used in a hospital or home environment in order to support monitoring of wearers under the care of a trained healthcare professional. Everion+ is not intended for use in a critical care environment such as an ICU or operating room. The device information should not be the sole basis for clinical decisions. # Rationale for Substantial Equivalence: The table below is a comparison of the Indications for use of the Everion + against the predicate device. {5}------------------------------------------------ # Substantial Equivalence Comparison: # Table 1 Substantial Equivalence Comparison | Characteristics | Subject device Everion + | Primary Predicate K191272 | Predicate 2 K191620 | Comments | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | Everion+ provides continuous monitoring of the following vital signs in adults, 18 years of age or older, when at rest: • Pulse rate • Respiration rate • Movement The Everion+ device is intended to be used in a hospital or home environment in order to support monitoring of wearers under the care of a trained healthcare professional. Everion+ is not intended for use in a critical care environment such as an ICU or operating room. The device information should not be the sole basis for clinical decisions. | The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi- parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained 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 | 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 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 | The intended use and indications for use of the proposed device and the primary predicate are the same for continuous measurement of • Pulse rate • Movement The Everion + device also provides continuous measurement of Respiration Rate but does not provide for alarms and does not include temperature, heart rate, and oxygen saturation like the Current (primary predicate) Wearable device. The secondary predicate, Vitls Platform, does not include alarms, and is cleared under similar | | Characteristics | Subject device Everion + | Primary Predicate K191272 | Predicate 2 K191620 | Comments | | | | 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: | patient monitor, to provide physiological information, on patients who are 2 years of age or older. | product codes of DRG, FLL as the Current Wearable system. Therefore, the differences between the subject Everion + and the primary predicate Current Health wearable system and secondary Vitls Platform are not | | | | • Pulse rate • Oxygen saturation • Temperature • Movement The Current Wearable | | significant, does not raise new questions of safety and effectiveness. | | | | Health Monitoring System is intended for intermittent or spot- check monitoring, in adults, of: • Respiration rate • Non-invasive blood pressure | | | | | | • Lung function & spirometry • Weight The Current Wearable Health Monitoring System is not intended | | | | Characteristics | Subject device Everion + | Primary Predicate K191272 | Predicate 2 K191620 | Comments | | | | for use in high-acuity environments, such as ICU or operating rooms. | | | | | | The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor. | | | | | | The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion. | | | | Regulation | 21 CFR 870.2300 21 CFR 870.2910 21 CFR 868.2375 | 21 CFR 870.2300 21 CFR 870.2910 21 CFR 868.2375 21 CFR 858.1840 | 21 CFR 870.2910 | Equivalent to primary predicate | | Characteristics | Subject device Everion + | Primary Predicate K191272 | Predicate 2 K191620 | Comments | | Product code | MWI, MSX, BZQ | MSX, FLL, DQA, BZQ, DRG, BZG | DRG, FLL | Equivalent to primary predicate for claimed measurement parameters | | Device design | The Everion+ wearable is battery-operated with integrated sensors and wireless transceiver. The wearable is worn on the upper arm via the adjustable armband that snaps to it. | Current Health System consists of a single battery-operated monitoring device worn on the upper arm, along with a software platform (containing an alarming system) | Comprised of a wearable device with multiple sensors (the Tego VSS Sensor - an Adhesive Patch with integrated Sensors) | Equivalent to the primary device predicate system performance with the exception of not containing an alarming system. | | Principle of Operation | An optical sensor allows reflective photoplethysmography (PPG) measurements to be performed on the skin and underlying tissue | Optical based system | Photoplethysmography (PPG) measurements performed using sensors integrated into an adhesive patch | Everion+ is equivalent to the secondary predicate device and similar to the primary predicate. | | Data storage, transmission, display | The wearable continuously gathers multi-parameter vital signs data from the person being monitored and securely transmits the data to the server component of the system, via cellular communication, when in range of a third-party receiver. When not in range, the collected data is stored on the Everion+ wearable and transmitted when connection has been restored. Through APIs of the cloud environment, the data may be accessed from | Current Health includes a user interface to allow presentation of vital signs data both on mobile devices and a central station | 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 | Everion + is equivalent to the secondary predicate. The display of data is via use of APIs, a technological option as opposed to a custom display with the system. This difference between Everion + and the primary predicate is not significant. | | Characteristics | Subject device Everion + | Primary Predicate K191272 | Predicate 2 K191620 | Comments | | | the cloud storage or integrated into a third-party application for monitoring. | | Server Library where they may be stored for future analysis. | | | Use Environment | Healthcare facilities or Home environment in subjects >18y | Healthcare facilities & Home in subjects ≥18y | Healthcare facilities & Home in subjects >2y | Equivalent to primary predicate | | Parameters monitored | • Pulse rate • Respiration rate • Movement | • Pulse rate • Respiration Rate • Oxygen saturation • Temperature • Movement | • Heart rate • Temperature | Similar to primary predicate and does not raise concerns on safety and efficacy. | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ # Performance Data: Preclinical software/algorithm testing, biocompatibility, shipping/packaging and clinical study results validate Everion + System towards its proposed intended use, and supports substantial equivalence to the predicate. The following are the referenced standards during design and development of Everion + system: Table 2 | Standard | Name | Result | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Labeling | The Everion+ System was tested and confirmed to meet all the applicable requirements for medical device symbols and labeling per ISO 15223-1, and EN 50419 | Passed | | Cleaning Method | The Everion+ System was tested and confirmed to meet all the applicable requirements for cleaning reusable medical devices | Passed | | Biocompatibility | The Everion+ System was tested and confirmed to meet all the applicable requirements for Biocompatibility per ISO 10993-1, 10993-5, 10993-10, and 10993-12 | Passed | | Software Life Cycle | The Everion+ System was tested and confirmed to meet all the applicable requirements for software life cycle per IEC 62304 | Passed | | Risk Management | The Everion+ System was tested and confirmed to meet all the applicable requirements for Application of risk management to medical Device per ISO 14971 | Passed | | Product Safety and Environment | The Everion+ System was tested and confirmed to meet all the applicable requirements for product safety per IEC 60601- 1 and IEC 60529, IEC 62133-2, and UL1642 | Passed | | Product Performance | The Everion+ System was tested and confirmed to meet all the applicable requirements for pulse rate and respiration rate per ISO 80601-2-61 | Passed | | EMI/EMC | The Everion+ System was tested and confirmed to meet all the applicable requirements for product emissions and immunity, wireless coexistence per IEC 60601-1-2, ANSI IEEE C63.27, CISPR11, IEC 61000-3, AAMI TIR69 | Passed | | Usability | The Everion+ System was tested and confirmed to meet all the applicable requirements for usability per IEC 60601-1-6 and IEC 62366-1 | Passed | | Home use | The Everion+ System was tested and confirmed to meet all the applicable requirements for electrical systems used in home healthcare environment per IEC 60601-1-11. | Passed | | Shipping | The Everion+ System was tested and confirmed to meet all the applicable requirements for Packaged-Products | Passed | {11}------------------------------------------------ Traditional 510(k) K213863 Premarket Notification Submission – Everion + System In addition to tests to the above referenced standards, the following tests were conducted: Everion+ Hardware Test Everion+ Product Requirement Verification Everion+ Label Verification Everion+ Software Verification Report - Firmware Everion+ Software Verification Report - Cloud Validation of Pulse Rate, Respiratory Rate, And Movement with clinical supporting data Clinical Study Validation Summary: The Everion + device accuracy was assessed in 50 collective subjects (M/F) of ages (46±17, 21-80 vears) and wide ranges of BMI (18.6-49.3). skin tones (range: 1-6 on Fitzpatrick scale) and disease conditions from two clinical studies. The study participants wore two Everion+ devices on both left and right upper arms along with ECG monitor (for PR reference), and end-tidal CO2 capnograph monitor (for RR reference). The device accuracy was assessed by the root-mean-square (RMSE) and mean absolute error (MAE), using the differences between the Everion+ device outputs and the respective ECG monitor's PR or manual RR reference values. Overall. the device met the performance objectives for PR, with an RMSE of ≤ 3 bpm, and for RR, with an RMSE of < 3 brpm.= Movement detection is intended to aid in analysis of raw data, towards display of PR and RR. The multi-class confusion matrix considering all Rest, Low, Moderate and High movement level categories are given in Table 3 with the corresponding epoch count ratio and percentages in parentheses. | Device | Actual | | | | |--------|----------------------|---------------------|----------------------|---------------------| | | Rest_a | Low_a | Mod_a | High_a | | Rest_d | 1026/1535 (66.8%) | 33/1529 (2.2%) | 3/1600 (0.2%) | 5/1411 (0.4%) | | Low_d | 463/1535 (30.2%) | 909/1529 (59.5%) | 114/1600 (7.1%) | 70/1411 (5.0%) | | Mod_d | 46/1535 (3.0%) | 586/1529 (38.3%) | 1482/1600 (92.6%) | 344/1411 (24.4%) | | High_d | 0/1535 (0%) | 1/1529 (0.1%) | 1/1600 (0.1%) | 992/1411 (70.3%) | Table 3. Confusion Matrix with the epoch count ratio and percentages. The multi-class confusion matrix essentially captures positive percent agreement (i.e., sensitivity) on the diagonal elements for all four movement classes. Besides the sensitivity {12}------------------------------------------------ Traditional 510(k) K213863 Premarket Notification Submission – Everion + System metric, the specificity and accuracy performance metrics were also considered to understand the device performance, particularly for movement algorithm's primary purpose of differentiating rest from any movements. Confusion matrices from one-versus-all binary classifiers and with sensitivity alongside the accuracy and specificity is in Table 4 below. | Positive Class | Accuracy (%) | Sensitivity (%) | Specificity (%) | |---------------------------|--------------|-----------------|-----------------| | Level 1 – REST | 88.9 | 66.8 | 98.8 | | Level 2 – LOW | 77.7 | 59.5 | 84.4 | | Level 3 – MODERATE | 80.1 | 92.6 | 75.0 | | Level 4 – HIGH | 91.3 | 70.3 | 99.9 | | Levels 2, 3 & 4 – NONREST | 88.9 | 98.8 | 66.8 | Table 4 Accordingly, the Everion+ device is shown to differentiate the Rest condition from other movement of any type (low, moderate, and high) with an accuracy of 88.9% A detailed listing of all applicable V&V testing is captured in the 510(k) submission. The Everion+ system meets the same applicable performance standards and nonclinical testing as the primary predicate device. Therefore, the Everion+ subject device is substantially equivalent to the primary predicate device. ## Conclusion: Based on the information contained within the 510(k) premarket notification, evaluation of device performance in preclinical and clinical testing where no adverse indications or results were observed, and comparison to the legally marketed predicate devices, the Everion+ is considered substantially equivalent. Therefore, we conclude that the Everion+ is substantially equivalent to the predicate devices.

Everion+ System

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