(440 days)
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 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 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.
Here's a breakdown of the acceptance criteria and study information for the Everion+ System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Objective) | Reported Device Performance (Result) |
|---|---|---|
| Pulse Rate (PR) | RMSE ≤ 3 bpm | RMSE ≤ 3 bpm (met) |
| Respiration Rate (RR) | RMSE < 3 brpm | RMSE < 3 brpm (met) |
| Movement Detection (Rest vs. Non-Rest) | Accuracy objective implied by general performance claims | Accuracy: 88.9% |
| Movement Detection (Level 1 – REST) | (Not explicitly defined with a numerical objective, but performance reported) | Accuracy: 88.9%, Sensitivity: 66.8%, Specificity: 98.8% |
| Movement Detection (Level 2 – LOW) | (Not explicitly defined with a numerical objective, but performance reported) | Accuracy: 77.7%, Sensitivity: 59.5%, Specificity: 84.4% |
| Movement Detection (Level 3 – MODERATE) | (Not explicitly defined with a numerical objective, but performance reported) | Accuracy: 80.1%, Sensitivity: 92.6%, Specificity: 75.0% |
| Movement Detection (Level 4 – HIGH) | (Not explicitly defined with a numerical objective, but performance reported) | Accuracy: 91.3%, Sensitivity: 70.3%, Specificity: 99.9% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 50 collective subjects (M/F)
- Ages: 46 ± 17 years (range: 21-80 years)
- BMI: 18.6-49.3
- Skin tones: Range 1-6 on Fitzpatrick scale (though not explicitly stated as a characteristic of the 50 subjects, it's mentioned to indicate diversity)
- Disease conditions: Wide ranges (not specified beyond "wide ranges")
- Data Provenance: The text states "two clinical studies," but does not explicitly mention the country of origin. The study appears to be prospective due to the description of subjects wearing devices for assessment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text does not explicitly state the number of experts or their qualifications for establishing ground truth. It mentions:
- "ECG monitor (for PR reference)"
- "end-tidal CO2 capnograph monitor (for RR reference)"
These devices are used as the reference standard, implying that their output is considered the "ground truth" rather than expert interpretation of raw data for these vital signs.
For movement detection, the "actual" categories (Rest_a, Low_a, Mod_a, High_a) in the confusion matrix imply a ground truth for movement, but the method and number/qualifications of experts involved in establishing this ground truth are not detailed.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. For Pulse Rate (PR) and Respiration Rate (RR), direct comparisons were made to instrumental reference standards (ECG and capnograph). For movement, the "Actual" categories define the ground truth, but the process of establishing these categories is not detailed, so no adjudication method is mentioned.
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, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned or performed according to this document. The study focuses on the standalone performance of the Everion+ device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The "Clinical Study Validation Summary" describes the assessment of the Everion+ device's accuracy for Pulse Rate, Respiration Rate, and Movement by comparing its outputs to reference standards. This is a standalone evaluation of the device's algorithms.
7. The Type of Ground Truth Used
- Pulse Rate (PR): ECG monitor
- Respiration Rate (RR): End-tidal CO2 capnograph monitor
- Movement: "Actual" movement categories (Rest, Low, Moderate, High), but the method of establishing these categories (e.g., expert observation, synchronized video analysis, or another objective measure) is not specified. It is likely an objective measure rather than expert consensus on device output.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. The clinical study described appears to be for validation/testing, not training.
9. How the Ground Truth for the Training Set Was Established
Since information on the training set sample size is not provided, the method for establishing its ground truth is also not mentioned.
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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.
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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
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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)
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Traditional 510(k) K213863 Premarket Notification Submission – Everion + System
510(k) SUMMARY
| Submitter Name: | Biofourmis Singapore Pte. Ltd.2 Venture DriveVision Exchange, #23-01SingaporeSingapore608526SG |
|---|---|
| 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, MSXDevice: Class 2, Classification Panel: Cardiovascular |
| Secondary Product Code:21 CFR 868.2375, Product Code BZQDevice: Class 2, Classification Panel: Anesthesiology21CFR 870.2910, Product Code DRGDevice: Class 2, Classification Panel: Cardiovascular | |
| Predicate Devices: | Current Health Ltd., K191272Vitls Inc., K191620 |
| Classification Name: | Cardiovascular |
| Classification regulation: | Current Health: 21 CFR 870.2300, Product Code MSX,DQA, BZG21 CFR 868.2375, Product Code BZG21CFR 870.2910, Product Code DRG, FLL21 CFR 858.1840, Product Code BZQ |
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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.
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Substantial Equivalence Comparison:
Table 1 Substantial Equivalence Comparison
| Characteristics | Subject device Everion + | Primary PredicateK191272 | Predicate 2 K191620 | Comments |
|---|---|---|---|---|
| Indications foruse | Everion+ provides continuousmonitoring of the followingvital signs in adults, 18 years ofage or older, when at rest:• Pulse rate• Respiration rate• MovementThe Everion+ device isintended to be used in ahospital or home environmentin order to support monitoringof wearers under the care of atrained healthcare professional.Everion+ is not intended for usein a critical care environmentsuch as an ICU or operatingroom. The device informationshould not be the sole basis forclinical decisions. | The Current WearableHealth MonitoringSystem is intended forreusable bedside, mobileand central multi-parameter, physiologicpatient monitoring ofadult patients inprofessional healthcarefacilities, such ashospitals or skillednursing facilities, ortheir own home. It isintended for monitoringof patients by trainedhealthcare professionals.The Current WearableHealth MonitoringSystem is intended toprovide visual andaudible physiologicmulti-parameter alarms.The Current WearableHealth MonitoringSystem is intended fortemperature monitoring | The Vitls Platform is awireless remotemonitoring systemintended for use byhealthcare professionalsfor continuouscollection ofphysiological data in inhealthcare and homesettings. This includesheart rate (HR) andbody temperature.The data from the TegoVSS Sensor is intendedfor use by healthcareprofessionals as an aidto diagnosis andtreatment. Itis not intended for useon critical care patientsnor replace standardmonitoring and/orroutine care.The device is intendedfor use as a general | The intended use andindications for use of theproposed device and theprimary predicate arethe same for continuousmeasurement of• Pulse rate• MovementThe Everion + devicealso provides continuousmeasurement ofRespiration Rate butdoes not provide foralarms and does notinclude temperature,heart rate, and oxygensaturation like theCurrent (primarypredicate) Wearabledevice.The secondarypredicate, VitlsPlatform, does notinclude alarms, and iscleared under similar |
| Characteristics | Subject device Everion + | Primary PredicateK191272 | Predicate 2 K191620 | Comments |
| where monitoringtemperature at the upperarm is clinicallyindicated.The Current WearableHealth MonitoringSystem is intended forcontinuous monitoringof the followingparameters in adults: | patient monitor, toprovide physiologicalinformation, on patientswho are 2 years of ageor older. | product codes of DRG,FLL as the CurrentWearable system.Therefore, thedifferences between thesubject Everion + andthe primary predicateCurrent Health wearablesystem and secondaryVitls Platform are not | ||
| • Pulse rate• Oxygen saturation• Temperature• MovementThe Current Wearable | significant, does notraise new questions ofsafety and effectiveness. | |||
| Health MonitoringSystem is intended forintermittent or spot-check monitoring, inadults, of:• Respiration rate• Non-invasive bloodpressure | ||||
| • Lung function &spirometry• WeightThe Current WearableHealth MonitoringSystem is not intended | ||||
| Characteristics | Subject device Everion + | Primary PredicateK191272 | Predicate 2 K191620 | Comments |
| for use in high-acuityenvironments, such asICU or operating rooms. | ||||
| The Current WearableHealth MonitoringSystem is not intendedfor use on acutely illcardiac patients with thepotential to develop lifethreatening arrhythmiase.g. very fast atrialfibrillation. For thesepatients, they should bemonitored using adevice with continuousECG. The CurrentWearable HealthMonitoring System isnot a substitute for anECG monitor. | ||||
| The Current WearableHealth MonitoringSystem is not intendedfor SpO2 monitoring inconditions of highmotion or low perfusion. | ||||
| Regulation | 21 CFR 870.230021 CFR 870.291021 CFR 868.2375 | 21 CFR 870.230021 CFR 870.291021 CFR 868.237521 CFR 858.1840 | 21 CFR 870.2910 | Equivalent to primarypredicate |
| Characteristics | Subject device Everion + | Primary PredicateK191272 | Predicate 2 K191620 | Comments |
| Product code | MWI, MSX, BZQ | MSX, FLL, DQA, BZQ,DRG, BZG | DRG, FLL | Equivalent to primarypredicate for claimedmeasurementparameters |
| Device design | The Everion+ wearable isbattery-operated with integratedsensors and wirelesstransceiver. The wearable isworn on the upper arm via theadjustable armband that snapsto it. | Current Health Systemconsists of a singlebattery-operatedmonitoring device wornon the upper arm, alongwith a software platform(containing an alarmingsystem) | Comprised of awearable device withmultiple sensors (theTego VSS Sensor - anAdhesive Patch withintegrated Sensors) | Equivalent to theprimary device predicatesystem performancewith the exception ofnot containing analarming system. |
| Principle ofOperation | An optical sensor allowsreflectivephotoplethysmography (PPG)measurements to be performedon the skin and underlyingtissue | Optical based system | Photoplethysmography(PPG) measurementsperformed usingsensors integrated intoan adhesive patch | Everion+ is equivalentto the secondarypredicate device andsimilar to the primarypredicate. |
| Data storage,transmission,display | The wearable continuouslygathers multi-parameter vitalsigns data from the personbeing monitored and securelytransmits the data to the servercomponent of the system, viacellular communication, whenin range of a third-partyreceiver. When not in range, thecollected data is stored on theEverion+ wearable andtransmitted when connectionhas been restored. ThroughAPIs of the cloud environment,the data may be accessed from | Current Health includesa user interface to allowpresentation of vitalsigns data both onmobile devices and acentral station | The encrypted wirelessdata recorded by theSensor is sent, by thethird-party connectivityrelay, to the SecureServer. The data may bedownloaded from theSecure Server Libraryor integrated into aThird-Party Applicationvia the APIs of theSecure Server Library.In addition, the wirelessdata may be transferredto an optional Secure | Everion + is equivalentto the secondarypredicate. The display ofdata is via use of APIs, atechnological option asopposed to a customdisplay with the system.This difference betweenEverion + and theprimary predicate is notsignificant. |
| Characteristics | Subject device Everion + | Primary Predicate K191272 | Predicate 2 K191620 | Comments |
| the cloud storage or integratedinto a third-party applicationfor monitoring. | Server Library wherethey may be stored forfuture analysis. | |||
| UseEnvironment | Healthcare facilities or Homeenvironment in subjects >18y | Healthcare facilities &Home in subjects ≥18y | Healthcare facilities &Home in subjects >2y | Equivalent to primarypredicate |
| Parametersmonitored | • Pulse rate• Respiration rate• Movement | • Pulse rate• Respiration Rate• Oxygen saturation• Temperature• Movement | • Heart rate• Temperature | Similar to primarypredicate and does notraise concerns on safetyand efficacy. |
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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 allthe applicable requirements for medical device symbols andlabeling per ISO 15223-1, and EN 50419 | Passed |
| Cleaning Method | The Everion+ System was tested and confirmed to meet allthe applicable requirements for cleaning reusable medicaldevices | Passed |
| Biocompatibility | The Everion+ System was tested and confirmed to meet allthe applicable requirements for Biocompatibility per ISO10993-1, 10993-5, 10993-10, and 10993-12 | Passed |
| Software Life Cycle | The Everion+ System was tested and confirmed to meet allthe applicable requirements for software life cycle per IEC62304 | Passed |
| Risk Management | The Everion+ System was tested and confirmed to meet allthe applicable requirements for Application of riskmanagement to medical Device per ISO 14971 | Passed |
| Product Safety andEnvironment | The Everion+ System was tested and confirmed to meet allthe 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 allthe applicable requirements for pulse rate and respiration rateper ISO 80601-2-61 | Passed |
| EMI/EMC | The Everion+ System was tested and confirmed to meet allthe applicable requirements for product emissions andimmunity, wireless coexistence per IEC 60601-1-2, ANSIIEEE C63.27, CISPR11, IEC 61000-3, AAMI TIR69 | Passed |
| Usability | The Everion+ System was tested and confirmed to meet allthe applicable requirements for usability per IEC 60601-1-6and IEC 62366-1 | Passed |
| Home use | The Everion+ System was tested and confirmed to meet allthe applicable requirements for electrical systems used inhome healthcare environment per IEC 60601-1-11. | Passed |
| Shipping | The Everion+ System was tested and confirmed to meet allthe applicable requirements for Packaged-Products | Passed |
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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
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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.
§ 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).