EARLYSENSE

• K Number: K131379
• Device Name: EARLYSENSE
• Manufacturer: EARLYSENSE LTD.
• Date Cleared: 2013-12-18 ( 218 days)
• Product Code: BZQ DQA DRT
• Regulation Number: 868.2375

Intended Use

The EarlySense 2.0 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 2.0 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 modified EarlySense System 2.0 is similar to cleared (EverOn™1.0S) System (K120465) except for the hardware and software changes that are described below. The cleared (K120465) EarlySense (EverOn™1.0S) System is comprised of the following components: 1. A Bed Sensing Unit based on piezoelectric sensing 2. A Bedside Unit incorporating a medical grade power supply and the following modules: A Signal Sampling Module consisting of amplifiers, filters and analog to a. digital converter as well as a microprocessor designated to transfer the sampled data to the Signal Processing Module, and b. A Signal Processing and Display Module. 3. An Optional Oximetry OEM module with communication interface and compatible marketed sensors.

Predicate Devices

K120465

Reference Devices

K120465

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on traditional signal processing and hardware components, with no mention of AI, ML, or related concepts.

Therapeutic

No.
The device's intended use is for continuous measurement and monitoring of physiological parameters (respiration rate, heart rate, movement, and oxygen saturation), rather than providing therapy or treatment.

Diagnostic

No

The device is intended for continuous measurement of physiological parameters (respiration rate, heart rate, movement, and SpO2), which are monitoring functions rather than diagnostic functions. It provides data but does not interpret the data to make a diagnosis of a disease or condition.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as a Bed Sensing Unit, a Bedside Unit with modules, and an optional Oximetry OEM module, indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• EarlySense 2.0 System function: The EarlySense 2.0 System measures physiological parameters (respiration rate, heart rate, movement, and SpO2) directly from the patient in a contact-less manner (except for the optional pulse oximetry which is still a direct measurement on the body). It does not analyze samples taken from the body.

Therefore, the EarlySense 2.0 System falls under the category of a non-invasive patient monitoring device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The EarlySense 2.0 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

K1313791.

DEC 510(k) Summ

510(K) SUMMARY

EarlySense Ltd. EarlySense System 2.0

Applicant's Name:

EarlySense Ltd. 12 Tzvi St. Ramat Gan 52504, Israel Tel: [phone] Fax: [phone]

Contact Person:

Dalia Argaman, VP Clinical, Regulatory Affairs and QA EarlySense Ltd. 12 Tzvi Street. Ramat Gan 52504, Israel Tel: [phone] Fax: [phone] e-mail: [e-mail]

Date Prepared:

June 16, 2013

Trade Name:

EarlySense System (Model 2.0)

1

Classification Name:

Breathing frequency monitor, Cardiac monitor (including cardiotachometer and rate alarm), Oximeter

Class: II

Regulation Number:

21 CFR Sec. 868.2375 21 CFR Sec. 870.2300 21 CFR Sec. 870.2700

Product Code:

BZQ, DRT, DQA

Predicate Device:

EarlySense (EverOn™1.0S) System (K120465)

Reason for Submission:

A traditional 510(k) is submitted for the hardware and software modifications made to the cleared EarlySense (EverOn™1.0S) System (K120465).

Intended Use/Indications for Use:

The EarlySense 2.0 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 Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

7

Indications for Use

510(k) Number (if known) K131379

Device Name EarlySense System 2.0

Indications for Use (Describe)

The EarlySense 2.0 System is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic I he Early of System is included to commodal . 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