(440 days)
Not Found
No
The document does not mention AI, ML, or DNN, and the performance metrics described (RMSE, MAE, confusion matrices for movement detection) are standard statistical methods and do not inherently indicate the use of AI/ML for vital sign calculation or interpretation. The movement detection uses a multi-class confusion matrix, which can be implemented with various algorithms, not necessarily AI/ML.
No
The device is a vital-signs monitoring system that collects data, but it does not provide any treatment or therapy. It is explicitly stated that "The device information should not be the sole basis for clinical decisions."
Yes
The device provides continuous monitoring of vital signs (pulse rate, respiration rate, movement) to support monitoring of wearers by a trained healthcare professional, which is a diagnostic function. However, it is explicitly stated that the "device information should not be the sole basis for clinical decisions," suggesting it aids in diagnosis rather than providing a sole diagnosis.
No
The device description explicitly lists hardware components including a "Wearable device with multiple sensors", a "Charger with accessories", and an "Armband".
Based on the provided information, the Everion+ device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Everion+ device is a wearable sensor that directly monitors vital signs from the patient's body (on the upper arm). It does not analyze samples like blood, urine, or tissue.
- The intended use describes direct physiological monitoring. The device continuously monitors pulse rate, respiration rate, and movement directly from the wearer.
- The device description focuses on sensors and data transmission from the body. The components listed are a wearable device with sensors, a cloud environment, a charger, and an armband. These are consistent with a device that measures physiological signals externally.
Therefore, the Everion+ falls under the category of a physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, MSX, BZQ, DRG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
worn on the upper arm
Indicated Patient Age Range
adults, 18 years of age or older
Intended User / Care Setting
hospital or home environment in order to support monitoring of wearers under the care of a trained healthcare professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
§ 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).
0
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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.
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)
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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