EARLYSENSE (EVERON) SYSTEM

• K Number: K120465
• Device Name: EARLYSENSE (EVERON) SYSTEM
• Manufacturer: EARLYSENSE LTD.
• Date Cleared: 2012-06-08 ( 114 days)
• Product Code: BZQ AND DRT
• Regulation Number: 868.2375

Intended Use

The EarlySense (EverOn) System is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, at home, hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight <111 Kg) during sleep and resting condition. In addition, EarlySense (EverOn) System can continuously monitor oxygen saturation of arterial hemoglobin (SPO2) using pulse oximetry in pediatric (ages 2 years and older), adolescents, and adults at home, hospital, or clinical settings.

Device Description

The EarlySense (EverOn) System consists of the following main components: - A piezoelectric Sensing Unit placed under the mattress or mattress pad. - Bedside Unit with Proprietary recording and data analysis software - OEM Oximetry Module (optional) The EarlySense (EverOn) System is designed for continuous and contact-less monitoring of respiration rate, heart rate and movement. The under mattress Sensing Unit includes a piezoelectric sensor, which converts mechanical movements into an electric signal. The principles and the mode of operation for the capability of contactless monitoring of the EarlySense (EverOn) is identical to the cleared EverOn 1.0 (K092062). The EarlySense interfaces with a pulse oximeter OEM module (optional feature) and can therefore also monitor oxygen saturation. The oximetry module is connected externally via UART (RS232/TTL) to the Bedside unit. A compatible oximetry sensor is then attached to the patient's finger and the monitor begins to continuously display oximetry data (e.g. SpO2). The Bedside Unit, processes inputted signals, displays the patient's parameters, and generates alerts (respiration rate, heart rate, movement, and SpO2) as per set thresholds when needed. The continuously accumulated data from the monitored period are displayed on the bedside unit and communicated, via wired or via wireless LAN communication to a dedicated may options of SerilySense Central Display Station (CDS) - cleared under K100376 and K110521). Analysis of the results may be performed either on-line during the monitoring session, or later, off-line. Data for each patient is recorded and can therefore also be retrieved and presented.

Predicate Devices

K092062, K040589, K011903

Reference Devices

K100376, K110521

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on signal processing from a piezoelectric sensor and pulse oximetry, with no mention of AI or ML algorithms for data analysis or interpretation. The software is described as "Proprietary recording and data analysis software" which is a general term and doesn't specifically indicate AI/ML.

Therapeutic

No
The device is described as a continuous monitoring system for vital signs like respiration rate, heart rate, movement, and oxygen saturation. It gathers data and provides alerts but does not perform any therapeutic or treatment functions.

Diagnostic

No

Justification: The device is intended for continuous monitoring of physiological parameters (respiration rate, heart rate, movement, and SpO2) and generates alerts based on set thresholds. While it provides data for analysis, its primary function is monitoring, not diagnosing a specific condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components: a piezoelectric Sensing Unit and a Bedside Unit. It also mentions an optional OEM Oximetry Module. While software is a key part of the system, it is not the sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, the EarlySense (EverOn) System is not an In Vitro Diagnostic (IVD) device.

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
• EarlySense (EverOn) System Function: The EarlySense (EverOn) System measures physiological parameters (respiration rate, heart rate, movement, and SpO2) directly from the patient's body using a contact-less sensor and an optional pulse oximeter. It does not analyze samples taken from the body.

Therefore, the EarlySense (EverOn) System falls under the category of a non-invasive patient monitoring device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The EarlySense (EverOn) System is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, at home, hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).

Summary

0

510(K) SUMMARY

510(K) Number K_12 Q 465

5.1 Applicant's Name: EarlySense Ltd. 12 Tzvi Street, Ramat Gan, Israel

5.2 Contact Person: Dalia Argaman EarlySense Ltd. 12 Tzvi Street, Ramat Gan, Israel Tel: [phone] - 2330 Fax: [phone] - 2340 Email: Dalia. Argaman(@)Earlysense.com

April 2012 5.3 Date Prepared:

EarlySense (EverOn™) System 5.4 Trade Name:

5.5 Classification Name: Breathing frequency monitor (868.2375) monitor, cardiac (incl. cardiotachometer & rate alarm) (870.2300) Oximeter (870.2700)

5.6 Product Code:

BZQ, DRT, and DQA

Class II 5.7 Device Class:

5.8 Predicate Devices:

• EverOn 1.0 (EarlySense Ltd.), cleared under K092062. .
• Avant™ 9600 Pulse Oximeter (Nonin Medical Inc.), cleared under K040589 .
• LifeShirt System with VivoLogic Analysis Software (VivoMeterics Inc.), cleared under ● K011903

5.9 Intended Use / Indication for Use:

The EarlySense (EverOn) System is intended for continuous measurement of respiration rate, The Darry other (1) an automatic contact-less manner, at home, hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the The System 15 marcated 16th children (weight ≥ 10 Kg) and adults (weight