(212 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on sensor data collection and transmission, not advanced analytical processing.
No
The device is described as a "multi-parameter vital-signs monitoring system" intended for continuous monitoring of vital signs, not for treating any condition. Its output is for "supporting monitoring of wearers," and the information "should not be the sole basis for clinical decisions."
No
The device is a monitoring device that collects physiological data (vital signs) but explicitly states, "The device information should not be the sole basis for clinical decisions." This indicates it provides data for assessment rather than a diagnosis.
No
The device description explicitly states that the system is comprised of a "Wearable device with multiple sensors," a "Charger with accessories," and an "Armband," in addition to the software components. This indicates the presence of significant hardware components essential to the device's function.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The Biofourmis Everion+ (G2) is a wearable device that monitors vital signs directly from the patient's body (on the upper arm) using optical sensors. It does not examine specimens derived from the human body in vitro.
- Intended Use: The intended use is for continuous monitoring of vital signs in adults, worn on the body, to support monitoring under the care of a healthcare professional. This is a direct physiological measurement, not an in vitro test.
Therefore, the Biofourmis Everion+ (G2) falls under the category of a physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Biofourmis Everion+ (G2) provides continuous monitoring of the following vital signs in adults, 18 years of age or older, when at rest:
- Pulse rate
- Respiration rate
- Movement
- Skin temperature
Biofourmis Everion+ (G2) also provides Blood oxygen saturation (SpO2) as a vital for continuous data collection in adults, 18 years of age or older, when at rest.
Biofourmis Everion+ (G2) is intended for use in a hospital or home environment to support monitoring of wearers under the care of a trained healthcare professional. Biofourmis Everion+ (G2) 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.
Product codes (comma separated list FDA assigned to the subject device)
MSX, BZQ, MWI, DRG, DQA, FLL
Device Description
The Biofourmis Everion+ (G2) 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 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+ G2 wearable is battery-operated with integrated sensors and wireless transceiver. The device is reusable and considered multi-patient use. After a healthcare professional (HCP) prescribes a device to a patient, they can clean the device according to the accompanying documentation for normal expected wear and buildup on the device. When the patient no longer needs the device for remote monitoring, the device can be returned to the HCP and undergo a low-level disinfection process, so it can be prescribed to a new patient.
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 patient contacting components primarily involved in permanent contact are the bottom device housing and the armband. The wearable continuously gathers multiparameter 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+ G2 wearable and transmitted when connection has been restored. Through APIs of the cloud environment, the data may be accessed from the cloud storage or integrated into a thirdparty application for monitoring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical sensors allow reflective photo-plethysmography (PPG) measurements on the skin and underlying tissue.
Anatomical Site
upper arm
Indicated Patient Age Range
adults, 18 years of age or older
Intended User / Care Setting
trained healthcare professional / hospital or home environment
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
A series of clinical trials were conducted to assess the Biofourmis Everion+ G2 accuracy for SpO2. The trials spanned multiple subjects with ages ranging from 19-80 years old, a wide range of BMI (17-53.5), skin tones (1-6 on Fitzpatrick Scale), ethnicities, and physiologic conditions (including COPD, CHF, Asthma, Hypertension, Obesity, and Diabetes) within the five clinical studies. The study participants wore the Biofourmis Everion+ G2 device compared to corresponding FDA cleared reference devices, including ECG for heart rate, etCO2 monitor for respiratory rate, and CO-Oximeter or pulse oximeter for blood oxygen saturation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of clinical trials were conducted to assess the Biofourmis Everion+ G2 accuracy for SpO2.
The device accuracy for SpO2 was assessed over a range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry and was measured using the root-mean-square (RMSE) comparison that could be no greater than a 3.5% difference.
The Everion+ G2 system was validated for oxygen saturation accuracy with supporting clinical data, per ISO 80601-2-61 and FDA Guidance, Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff, March 2013.
The performance results from the clinical validation tests demonstrates that the Everion+ G2 is substantial equivalent to the primary and secondary predicate devices captured in the Table 1: Substantial Equivalence Comparison - Subject device to FDA-cleared predicates of this document.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The device accuracy for SpO2 was assessed over a range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry and was measured using the root-mean-square (RMSE) comparison that could be no greater than a 3.5% difference.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Biofourmis Everion + System, G1, K213863, Current Health Ltd., Current Health Monitoring System Gen 2 (G2)., K210133
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
May 9, 2024
Biofourmis Singapore Pte. Ltd. Seth Kuzdzal VP of QA/RA 2 Venture Drive, Vision Exchange, #23-01 Singapore, SG 608526 Singapore
Re: K233418
Trade/Device Name: Biofourmis Everion+ (G2) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX, BZQ, MWI, DRG, DQA, FLL Dated: March 29, 2024 Received: October 20, 2023
Dear Seth Kuzdzal:
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"
1
(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).
Your device is also subject to, among other requirements, the Quality System (QS) 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 OS 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 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.
Kimberly N. Crowley -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
2
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Biofourmis Everion+ (G2)
Indications for Use (Describe)
Biofourmis Everion+ (G2) provides continuous monitoring of the following vital signs in adults, 18 years of age or older, when at rest:
- · Pulse rate
- · Respiration rate
- · Movement
- · Skin temperature
Biofourmis Everion+ (G2) also provides Blood oxygen saturation (SpO2) as a vital for continuous data collection in adults, 18 years of age or older, when at rest.
Biofourmis Everion+ (G2) is intended for use in a hospital or home environment to support monitoring of wearers under the care of a trained healthcare professional. Biofourmis Everion+ (G2) 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Traditional 510(k) Premarket Notification Submission – Biofourmis Everion+ G2 System
510(k) SUMMARY
| Submitter Name: | Biofourmis Singapore Pte. Ltd. |
|---|---|
| 2 Venture Drive | |
| Vision Exchange, #07-15 | |
| Singapore | |
| Singapore | |
| 608526 | |
| SG | |
| Contact Person: | Seth Kuzdzal |
| Phone Number: | (508) 907 9005 |
| Submission Correspondent: | Seth Kuzdzal |
| Phone Number: | (508) 907 9005 |
| Date Prepared: | April 5, 2024 |
| Device Trade Name: | Biofourmis Everion + G2 System |
| Device Common Name: | Multi Parameter Monitor |
| Classification regulation: | 21 CFR 870.2300, Product Code MWI, MSX |
| Predicate Devices: | Biofourmis Everion + System, |
| G1, K213863 | |
| Predicate Devices: | Current Health Ltd., Current Health Monitoring System |
| Gen 2 (G2)., K210133 | |
| Classification Name: | Cardiovascular |
| Classification regulation: | Everion + System: 21 CFR 870.2300, Product Code MSX, |
| MWI, DRG, BZQ | |
| Current Health: 21 CFR 870.2300, Product Code MSX, | |
| FLL, DQA, BZQ, DRG, BZG |
Device Description:
5
Traditional 510(k) Premarket Notification Submission – Biofourmis Everion+ G2 System
The Biofourmis Everion+ (G2) 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 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+ G2 wearable is battery-operated with integrated sensors and wireless transceiver. The device is reusable and considered multi-patient use. After a healthcare professional (HCP) prescribes a device to a patient, they can clean the device according to the accompanying documentation for normal expected wear and buildup on the device. When the patient no longer needs the device for remote monitoring, the device can be returned to the HCP and undergo a low-level disinfection process, so it can be prescribed to a new patient.
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 patient contacting components primarily involved in permanent contact are the bottom device housing and the armband. The wearable continuously gathers multiparameter 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+ G2 wearable and transmitted when connection has been restored. Through APIs of the cloud environment, the data may be accessed from the cloud storage or integrated into a thirdparty application for monitoring.
Indications for Use:
Biofourmis Everion+ G2 provides continuous monitoring of the following vital signs in adults, 18 years of age or older, when at rest:
- . Pulse rate
- Respiration rate .
- Movement .
- Skin temperature ●
Biofourmis Everion+ G2 also provides Blood oxygen saturation (SpO2) as a vital for continuous data collection in adults. 18 years of age or older, when at rest.
6
Traditional 510(k) Premarket Notification Submission – Biofourmis Everion+ G2 System
The Biofourmis Everion+ G2 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.
7
Traditional 510(k) Premarket Notification Submission – Biofourmis Everion+ G2 System
Substantial Equivalence Comparison:
Table 1 Substantial Equivalence Comparison
| Characteristics | Subject Device
Biofourmis Everion+ G2 | Primary Predicate
Biofourmis Everion+ G1
(K213863) | Secondary Predicate
Current Health (K210133) | Comments |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | Biofourmis Everion+ G2
provides continuous
monitoring of the following
vital signs in adults, 18 years
of age or older, when at rest:
• Pulse rate
• Respiration rate
• Movement
• Skin temperature
Biofourmis Everion+ G2 also
provides Blood oxygen
saturation (SpO2) as a vital
for continuous data
Biofourmis Everion+ G2 is
intended for use in a hospital
or home environment to
support monitoring of wearers
(adults ≥ 18 years) under the
care of a trained healthcare
professional. Biofourmis
Everion+ G2 is not intended
for use in a critical care
environment such as an ICU | Biofourmis Everion+ G1
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 Biofourmis
Everion+ G1 is intended to be
used in a hospital or home
environment in order to
support monitoring of wearers
(adults ≥ 18 years) under the
care of a trained healthcare
professional. Biofourmis
Everion+ G1 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 Health Gen 2
Wearable is intended for
continuous monitoring of the
following parameters in adults:
• Pulse rate
• Movement
• Oxygen saturation
• Temperature
The Current Health Gen 2
Wearable is intended for
intermittent or spot-check
monitoring, in adults, of:
• Respiration rate
• Non-invasive blood pressure
• Lung function & spirometry
• Weight
The Current Health Gen 2
Wearable is not intended for
SpO2 monitoring in conditions
of high motion or low perfusion.
The Current Health Gen 2
Wearable is intended for | Subject is equivalent
to primary predicate,
with the addition of
DQA and FLL for
oximeter and
thermometer
functionality.
Subject is equivalent
to secondary
predicate, except
without BZG for
spirometer
functionality. |
| Characteristics | Subject Device
Biofourmis Everion+ G2 | Primary Predicate
Biofourmis Everion+ G1 | Secondary Predicate
Current Health (K210133) | Comments |
| | | (K213863) | | |
| | or operating room. The device
information should not be the
sole basis for clinical
decisions | | temperature monitoring where
monitoring temperature at the
upper arm is clinically indicated. | |
| | | | The Current Health Gen 2
Wearable is intended to provide
visual and audible physiologic
multi-parameter | |
| Regulation | 21 CFR 870.2300 | 21 CFR 870.2300 | 21 CFR 870.2300 | Subject is equivalent
to predicates. |
| Product code | MWI, (21 CFR 870.2300),
MSX (21 CFR 870.2300),
DRG (21 CFR 870.2910),
BZQ (21 CFR 868.2375),
DQA (21 CFR 870.2700),
FLL (21 CFR 880.2910) | MWI, (21 CFR 870.2300),
MSX (21 CFR 870.2300),
DRG (21 CFR 870.2910),
BZQ (21 CFR 868.2375), | MSX, (21 CFR 870.2300),
DRG (21 CFR 870.2910),
BZQ (21 CFR 868.2375),
DQA (21 CFR 870.2910),
FLL (21 CFR 880.2910),
BZG (21 CFR 886.1840) | Subject is equivalent
to primary predicate,
with the addition of
DQA and FLL for
oximeter and
thermometer
functionality.
Subject is equivalent
to secondary
predicate, except
without BZG for
spirometer
functionality. |
| Device design | The Everion+ wearable is
battery-operated with
integrated sensors and
wireless transceiver. The
wearable is worn on the upper | The Everion+ wearable is
battery-operated with
integrated sensors and
wireless transceiver. The
wearable is worn on the upper | 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) | Subject is equivalent
to primary predicate.
Subject is equivalent
to secondary |
| Characteristics | Subject Device
Biofourmis Everion+ G2 | Primary Predicate
Biofourmis Everion+ G1
(K213863) | Secondary Predicate
Current Health (K210133) | Comments |
| | | | | |
| | arm via the adjustable
armband that snaps to it. | arm via the adjustable
armband that snaps to it. | | predicate, except for
an alarm system. |
| Principle of
Operation | Optical sensors allow
reflective photo-
plethysmography (PPG)
measurements on the skin and
underlying tissue. | Optical sensors allow
reflective photo-
plethysmography (PPG)
measurements on the skin and
underlying tissue. | Optical based system | Subject is equivalent
to predicates. |
| 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 the cloud
storage or integrated into a
third-party application for
monitoring. | 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 the cloud
storage or integrated into a
third-party application for
monitoring. | Current Health includes a user
interface to allow presentation of
vital signs data both on mobile
devices and a central station | Subject is equivalent
to primary predicate. |
| Use
Environment | Healthcare facilities or home
environment in subjects ≥ 18
year | Healthcare facilities or home
environment in subjects ≥ 18
year | Healthcare facilities or home
environment in subjects ≥ 18
year | Subject is equivalent
to predicates. |
| Characteristics | Subject Device
Biofourmis Everion+ G2 | Primary Predicate
Biofourmis Everion+ G1
(K213863) | Secondary Predicate
Current Health (K210133) | Comments |
| Parameters
monitored | Continuous:
• Pulse rate
• Respiration rate
• Movement
• Skin temperature
• Oxygen saturation (SpO2)
as a vital for continuous
data collection | Continuous:
• Pulse rate
• Respiration rate
• Movement | Continuous:
• Pulse rate
• Movement
• Oxygen saturation
• Temperature
Episodic:
• Respiration rate
• Blood pressure
• Lung function & spirometry
• Weight | Subject is equivalent
to primary predicates
for continuous vitals. |
| Sterile | No | No | No | Subject is equivalent
to predicates. |
| Re-usable | Yes | No | Yes | Subject is equivalent
to secondary
predicate. |
| Materials | Plastic case, ISO 10993-
1:2018 compliant | Plastic case, ISO 10993-
1:2018 compliant | Plastic case, ISO 10993-1:2018
compliant | Subject is equivalent
to predicates. |
CONFIDENTIAL
8
Traditional 510(k) Premarket Notification Submission – Biofourmis Everion+ G2 System
9
Traditional 510(k) Premarket Notification Submission – Biofourmis Everion+ G2 System
10
Traditional 510(k) Premarket Notification Submission – Biofourmis Everion+ G2 System
11
Traditional 510(k) Premarket Notification Submission – Biofourmis Everion+ G2 System
Technological Characteristics
Biofourmis Everion+ G2 has an identical intended use, operating principle, performance, and technical specification as the primary predicative device, Biofourmis Everion+ G1 with the addition of oxygen saturation and skin temperature that were added to the indications for use. The optical module in Biofourmis Everion+ G1 is unchanged in Biofourmis Everion+ G2, however the red and infrared LEDs are used to support oxygen saturation measurements. The hardware introduced an internal thermal tab, to support the indication for skin temperature measurements. Pulse rate, respiration rate, and movement are measured using the same technology as the primary predicate device.
Substantial equivalence is based on an assessment of non-clinical performance data and clinical performance data. No animal performance data is included.
Summary of Non-Clinical Tests (Performance Data)
The performance of the Biofourmis Everion+ G2 wearable is identical to Biofourmis Everion+ G1 for pule rate, respiration rate and movement. The following verification and validation activities establish the safety and effectiveness of Biofourmis Everion+ G2, which have all passed:
Electrical. Mechanical, and Thermal Safety: The Biofourmis Everion+ G2 system met the applicable standards for electrical safety per IEC 60601-1.
Electrical, Mechanical, and Thermal Safety: The Biofourmis Everion+ G2 system met the applicable standards for electrical, mechanical, and Thermal safety per IEC 60601-1.
Electromagnetic compatibility: The Biofourmis Everion+ G2 system met the applicable standards for electromagnetic compatibility per IEC 60601-1-2. Wireless Coexistence per ANSI IEEE C63.27 and electromagnetic immunity RFID readers per AIM 7351731
Packaging: The Biofourmis Everion+ G2 system met the applicable standards for packaged product handling and transportation in a parcel delivery system per ISTA 3A.
Oxygen Saturation Accuracy: The Everion+ G2 system validated oxygen saturation accuracy with supporting clinical data, per ISO 80601-2-61 and FDA Guidance, Pulse Oximeters – Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff, March 2013.
Skin Temperature Accuracy: The Biofourmis Everion+ G2 system validated skin temperature accuracy with supporting laboratory test data, per ISO 80601-2-56.
Biocompatibility: The plastic housing material remains unchanged from Biofourmis Everion+ G1, which is compliant to ISO 10993-1: Biological evaluation of medical devices - Guidance.
Cleaning & Disinfection: The Biofourmis Everion+ G2 system validated a low-level disinfection procedure per ISO 17664-2, allowing the product to be re-used between patients. The materials are unchanged, so the cleaning validation demonstrated with Biofourmis Everion+ G1 is still applicable for basic cleaning by a subject during daily use.
CONFIDENTIAL
12
System and Subsystem Verification Performance: The Biofourmis Everion+ G2 system passed product level testing, after subsystems were verified. These subsystems include hardware, firmware, and cloud components.
Summary of Animal & Clinical Studies
A series of clinical trials were conducted to assess the Biofourmis Everion+ G2 accuracy for SpO2. The trials spanned multiple subjects with ages ranging from 19-80 years old, a wide range of BMI (17-53.5), skin tones (1-6 on Fitzpatrick Scale), ethnicities, and physiologic conditions (including COPD, CHF, Asthma, Hypertension, Obesity, and Diabetes) within the five clinical studies. The study participants wore the Biofourmis Everion+ G2 device compared to corresponding FDA cleared reference devices, including ECG for heart rate, etCO2 monitor for respiratory rate, and CO-Oximeter or pulse oximeter for blood oxygen saturation.
The device accuracy for SpO2 was assessed over a range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry and was measured using the root-mean-square (RMSE) comparison that could be no greater than a 3.5% difference. The Everion+ G2 system was validated for oxygen saturation accuracy with supporting clinical data, per ISO 80601-2-61 and FDA Guidance, Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff, March 2013.
The performance results from the clinical validation tests demonstrates that the Everion+ G2 is substantial equivalent to the primary and secondary predicate devices captured in the Table 1: Substantial Equivalence Comparison - Subject device to FDA-cleared predicates of this document.
Conclusion
The Biofourmis Everion+ G2 system is substantially equivalent to the predicate devices.