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K Number
K233418
Device Name
Biofourmis Everion+ (G2)
Manufacturer
Biofourmis Singapore Pte. Ltd.
Date Cleared
2024-05-09

(212 days)

Product Code
MSX,BZQ,DQA,DRG,MWI
Regulation Number
870.2300
Type
Traditional
Panel
CV
Reference & Predicate Devices
K213863,K210133
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

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 third-party application for monitoring.

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) submission does not contain the detailed information necessary to fully answer your request regarding the acceptance criteria and the study that proves the device meets them.

Specifically, the document lists:

  • Indications for Use for the Biofourmis Everion+ (G2) for continuous monitoring of pulse rate, respiration rate, movement, skin temperature, and blood oxygen saturation (SpO2) in adults (18+) at rest in hospital or home environments.
  • A Summary of Non-Clinical Tests indicating that the device met applicable standards for electrical, mechanical, thermal safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2, ANSI IEEE C63.27, AIM 7351731), packaging (ISTA 3A), biocompatibility (ISO 10993-1), and cleaning/disinfection (ISO 17664-2).
  • A Summary of Animal & Clinical Studies mentions that SpO2 accuracy was assessed by comparing the device to arterial blood samples analyzed by CO-Oximetry, aiming for a root-mean-square (RMSE) comparison of no greater than 3.5% difference over a range of 70-100% SaO2, in accordance with ISO 80601-2-61 and FDA Guidance. It also mentions validation of skin temperature accuracy with laboratory test data per ISO 80601-2-56.

However, the document does not provide:

  1. A table of specific acceptance criteria and the reported device performance for each vital sign, outside of the SpO2 RMSE target.
  2. Sample sizes used for the test set (clinical studies) for SpO2, and other parameters like pulse rate, respiration rate, movement, or skin temperature. It only broadly mentions "multiple subjects."
  3. Data provenance (country of origin, retrospective/prospective).
  4. Number of experts and their qualifications for establishing ground truth.
  5. Adjudication method.
  6. Whether an MRMC comparative effectiveness study was done, or any effect size of human readers improving with AI assistance.
  7. Whether a standalone (algorithm only) performance was done.
  8. Type of ground truth for all parameters (beyond CO-Oximetry for SpO2, and "corresponding FDA cleared reference devices" generally).
  9. Sample size for the training set.
  10. How the ground truth for the training set was established.

The provided text focuses on demonstrating substantial equivalence to predicate devices and general compliance with regulatory standards, rather than a detailed breakdown of specific performance study results against defined acceptance criteria for each monitored parameter.

§ 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).