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:

A Bed Sensing Unit based on piezoelectric sensing
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.

An Optional Oximetry OEM module with communication interface and compatible marketed sensors.

AI/ML Overview

The EarlySense System 2.0 is a modified version of the EarlySense (EverOn™1.0S) System (K120465). The changes include modifications to the Bed Sensing Unit (adding an accelerometer, piezoelectric polymer sensor, and base plate handles) and the Bedside Unit (dimensional changes, replacement of power supply, speaker's buzzer, communication card, fan, additional USB and sensor's connectors, and software update to version 1.0.3).

Acceptance Criteria and Device Performance:

The provided 510(k) summary does not explicitly list numerical acceptance criteria or detail the specific performance metrics achieved by the EarlySense System 2.0. Instead, it states that the device was subject to various verification and validation tests and that the modifications "did not affect its performance, effectiveness or safety." The submission aimed to demonstrate substantial equivalence to the predicate device (K120465).

The performance claims rely on the device maintaining the same functionality and performance as its predicate, which was already cleared. The performance criteria for the predicate device would be relevant here, but are not provided in this document.

Studies and Ground Truth Information:

The document focuses on demonstrating that the modifications did not negatively impact the performance of the device and thus, it remains substantially equivalent to the cleared predicate. It does not present new clinical studies with detailed acceptance criteria and performance results in the same way a de novo submission might.

Here's an analysis of the provided information concerning studies:

#	Feature	Details Provided in K131379
1.	Acceptance Criteria & Reported Performance	Acceptance Criteria: Not explicitly stated as numerical targets for key performance metrics (e.g., accuracy, precision for HR/RR). The implicit acceptance criterion is that the modified device's performance is not worse than the predicate device. Reported Performance: The document states that "The results of the tests showed, that the modifications to the system did not affect its performance, effectiveness or safety." It does not provide specific performance values for respiration rate, heart rate, or movement.
2.	Sample Size & Data Provenance (Test Set)	Not specifically mentioned for a new clinical test set. The document refers to "Performance Bench Testing" (See Section 18 of the current submission), but details are not provided in this extract regarding sample size, country of origin, or retrospective/prospective nature. The intended use indicates studies were done with "children (weight ≥ 10 Kg) and adults (weight <111 Kg) during sleep and resting condition" for respiration rate, heart rate, and movement. For SpO2, it mentions "pediatric (ages 2 years and older), adolescents, and adults." This description refers to the scope of studies for the predicate device or a general statement of intended use, not necessarily a new test set for this 510(k) of a modified device.
3.	Number & Qualifications of Experts (Ground Truth)	Not mentioned in this summary. Ground truth establishment for the predicate device would have involved experts in cardiorespiratory monitoring.
4.	Adjudication Method (Test Set)	Not mentioned in this summary.
5.	MRMC Comparative Effectiveness Study	No. This 510(k) is for modifications to an existing device, focusing on substantial equivalence rather than comparative effectiveness with human readers.
6.	Standalone Performance Study (Algorithm Only)	Not explicitly detailed as a separate standalone study for the modified device. The document mentions "Performance Bench Testing." The EarlySense System is inherently a standalone algorithm reporting vital signs, so its primary clinical performance would be evaluated in a standalone manner against a reference standard. However, specific results from such a study for the modified device are not in this summary.
7.	Type of Ground Truth Used	Not explicitly stated in this summary for the "Performance Bench Testing." For vital sign monitors, ground truth typically comes from established medical devices (e.g., ECG, capnography, pulse oximeters) used as a reference standard.
8.	Sample Size for Training Set	Not mentioned in this summary. The device's algorithms were presumably developed and trained prior to the predicate device's clearance (K120465). This 510(k) is for modifications, and a new training set size is not discussed.
9.	Ground Truth for Training Set Establishment	Not mentioned in this summary. Ground truth for training would have been established using reference medical devices or expert interpretations of raw physiological signals.

Summary of Device Rationale for Substantial Equivalence:

The core of this 510(k) submission is to demonstrate that the modifications made to the EarlySense System 2.0 (hardware and software changes) do not significantly alter its fundamental principles of operation, intended use, indications for use, safety, or effectiveness compared to its previously cleared predicate device (EarlySense EverOn™ 1.0S, K120465). The submission primarily relies on verification and validation activities (risk analysis, software V&V, electrical safety, environmental testing, and performance bench testing) to show that the performance was not negatively affected by the changes. No new clinical study data with specific acceptance criteria and performance tables for the modified device are presented in this summary; rather, the argument is that the performance remains effectively the same as the predicate.

Summary

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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: +972-3-7522330 Fax: +972-3-7522340

Contact Person:

Dalia Argaman, VP Clinical, Regulatory Affairs and QA EarlySense Ltd. 12 Tzvi Street. Ramat Gan 52504, Israel Tel: +972-3-752-2330 Fax: +972-3-752-2340 e-mail: Dalia.Argaman@EarlySense.com

Date Prepared:

June 16, 2013

Trade Name:

EarlySense System (Model 2.0)

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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:

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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:

A Bed Sensing Unit based on piezoelectric sensing
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.

An Optional Oximetry OEM module with communication interface and compatible marketed sensors.

Substantial Equivalence

The EarlySense System Model 2.0, subject of this submission, shares exactly the same intended use and indications for use with its predicate device EarlySense (EverOn™1.0S, K120465). The main technological characteristics and principles of operation are also identical to predicate device: EarlySense Model 2.0 is designed for continuous and contact-less monitoring of respiration rate, heart rate and movement in the same manner as its predicate device. The under mattress Bed Sensing Unit converts mechanical movements into an electrical signal in the same way as its predicate device.

The modifications to the cleared (K120465) EarlySense (EverOn™1.0S) were the following:

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Modifications to the Bed Sensing Unit:

-Addition of the accelerometer component to the Bed Sensing Unit (which helps the user to correctly position the sensor and makes it possible to present the additional directional information also on the GUI)

-Addition of the piezoelectric polymer sensor to the already existing ceramic piezoelectric sensor {in order to increase signal in the bed exit function)

-Addition of Base Plate Handles (integrated handles on the sides of the Bed Sensing Unit to facilitate easy grasping)

Modifications to the Bedside Unit:

The Bedside Unit used in the cleared EarlySense Unit was changed to the thinner and lighter Bedside Unit (dimensional changes), which in its turn leaded to several additional hardware changes: e. g; replacement of power supply, speaker's buzzer, communication card, fan, additional USB and sensor's connectors. The software version was also updated to next version 1.0.3.

The cleared (K120465) EarlySense (EverOn™1.0S) and modified EarlySense System 2.0 are identical in the fundamental system principles and mode of operation and the presented modifications are not expected to affect the functionality of the EarlySense 2.0 System. More specifically, the introduced modifications do not constitute any significant change to the indications for use, performance specifications, or labeling.

Verification and Validation Activities:

The cleared and modified EarlySense Systems share exactly the same intended use and indications for use, the same fundamental functionality and types of components, and the same fundamental principles and mode of operation. The modifications included software and hardware modifications to the Bedside and Bed Sensing Units.

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The EarlySense System 2.0 was subject to the whole range of verification and validation tests:

1. Risk analysis (See Section 21 of the current submission)
1. Software Verification and Validation (See Section 16 of the current submission)
1. Electrical safety and electromagnetic compatibility ( See Section 17 of the current submission)
1. Environmental Conditions Testing (Storage, Operation and Shipping)(See Section 21 of the current submission)
1. Performance Bench Testing (See Section 18 of the current submission)

The results of the tests showed, that the modifications to the system did not affect its performance, effectiveness or safety. Therefore, it may be concluded that the modifications introduced in the EarlySense 2.0 System, individually and collectively, could not significantly affect the EarlySense System safety or effectiveness, and thus it may be considered to be substantially equivalent to the previously cleared (K120465) EarlySense System Model 1.0S.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird or eagle with its wings spread. The image is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 18, 2013

EarlySense Limited Ms. Dalia Argaman Vice President, Regulatory Affairs and Quality Assurance 12 Tzvi Street Ramat Gan ISRAEL 52504

Re: K131379

Trade/Device Name: EarlySense System (Model 2.0) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: BZQ Dated: November 13, 2013 Received: November 18, 2013

Dear Ms. Argaman:

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. 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.

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Page 2 - Ms. Argaman

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tefashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID : FOR

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

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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 < 1 1 Kg) during sleep and resting operation of the Larry Sense 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.

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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FDA USE ONLY . ୍ର

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/7/Picture/12 description: The image shows the name Anya C. Harry in a stylized font. There is a digital signature to the right of the name that reads, "Digitally signed by Anya C. Harry." The signature also includes the date 2013.12.17 21:58:19-05:00.

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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).