The EarlySense InSight System is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in 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.

Device Description

A traditional 510(k) is submitted to clear the new EarlySense InSight System. The EarlySense Insight System developed by EarlySense Ltd. is designed for continuous and contact-free measurement of Heart and Respiratory Rate. In addition, the System tracks body motion; monitors patient movement and can notify users when the patient exits the bed or the chair. The device does not have a display and is controlled from a remote control and display station by the user. The measured data on Heart Rate, Respiratory Rate, Movement and alerts are communicated to a remote station that can communicate with the EarlySense device according to predefined protocol, to be displayed to users. The Remote Control and Display Device (RCD) can be computer or central monitoring device that can communicate with the InSight Unit through predefined standard protocol through LAN or Wi-Fi and is capable to remotely access the InSight Unit and display the information received from InSight Unit. All the settings and changing of configurations is performed by the user, via a Remote Control and Display Device (RCD device). The EarlySense Insight monitoring device can notify the Remote Control and Display device, when monitored parameters excurse above or below predefined limits. The user (Healthcare practitioner) receives the information and should actively acknowledge the alert notifications and adjust monitoring parameters as required.

The EarlySense InSight device incorporates the following components:

-EarlySense InSight Unit – placed at bedside (subject of this submission)
EarlySense Bed Sensing Unit (K131379) placed under the mattress -
Chair Sensing Unit (optional)(K133661)

AI/ML Overview

Acceptance Criteria and Study for EarlySense InSight System

This response is based solely on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in a quantitative or pass/fail format. However, it describes that the device's performance was compared to a reference device and found to be "similar."

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Heart Rate	Similar to reference device	Found to be similar
Respiration Rate	Similar to reference device	Found to be similar
Motion Measures	Similar to reference device	Found to be similar
Communication	As good as predicate device	Found to be as good as EarlySense 2.0

2. Sample Size Used for the Test Set and Data Provenance

The document states that signals were tested from "children, adolescents and adults' populations," suggesting a diverse age range. However, it does not specify the exact sample size (number of individuals or data points) for the test set.

Data Provenance: The document does not explicitly state the country of origin. It describes "Non Clinical Testing" and refers to "signals from children, adolescents and adults' populations were tested." Given that the submitter is EarlySense Ltd. from Israel, it's possible the data originated there, but this is not confirmed. The study appears to be prospective benchmark testing given its description of "side by side performance testing" against a reference device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used or their qualifications to establish ground truth.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The ground truth was established by a "reference device" rather than human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study described focuses on the standalone performance of the EarlySense InSight device against a reference device and its predicate, rather than comparing human reader performance with and without AI assistance.

6. If a Standalone Study Was Done

Yes, a standalone study was done. The "Non Clinical Testing" section explicitly describes "side by side performance testing of the InSight device vs. its predicate EarlySense 2.0. Signals from children, adolescents and adults' populations were tested. The accuracy of the InSight and EarlySense 2.0 in analyzing the signals and generating heart rate, respiration rate and motion measures were compared to results of reference device (Embla Sleep lab. System Medcare K024322)." This directly assesses the algorithm's performance without human intervention.

7. The Type of Ground Truth Used

The ground truth used was based on a reference device: "Embla Sleep lab. System Medcare K024322." This is a medical device indicated for sleep laboratory use, implying a high standard for physiological measurements.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set. It only mentions that the system's detection algorithms are "the same as those used in the predicate EarlySense 2.0 device" and that the predicate device likely used data for its development.

9. How the Ground Truth for the Training Set Was Established

The document does not explicitly describe how the ground truth for the training set was established. It states that the algorithms are the same as those from the predicate EarlySense 2.0 device, which implies that the training was done for the predicate device, but the details of that process (e.g., specific ground truth methods or datasets) are not provided in this submission.

Summary

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

May 6, 2016

EarlySense Ltd. Ms. Dalia Argaman VP Clinical, Regulatory Affairs and QA 12 Tzvi Street Ramat Gan, 5250429 Israel

Re: K152911

Trade/Device Name: EarlySense Insight System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: BZO Dated: April 4, 2016 Received: April 5, 2015

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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours,

Tina Kiang -

for Erin I. Keith, M.S. 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) K152911

Device Name EarlySense InSight System

Indications for Use (Describe)

The EarlySense InSight System is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in hospital or clinic setting. The system is indicated for use in children, add escents 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.

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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510(K) SUMMARY

EarlySense InSight System

I. SUBMITTER

EarlySense Ltd. 12 Tzvi St. Ramat Gan 5250429, Israel Phone: +972-3-7522330 (ext.106); Fax: +972-3-7522340 Contact Person: Dalia Argaman E-mail: Dalia.Argaman@EarlySense.com Date Updated: May 5, 2016

II. DEVICE

Trade Name: EarlySense InSight System Classification Name: Breathing frequency monitor (21 CFR Sec. 868.2375) Regulatory Class: II Product Code: BZQ, There were no prior submissions for the subject device.

DEVICES III.

Primary Predicate:

EarlySense 2.0 System (K131379) manufactured by EarlySense Ltd, which can be used both with under the mattress bed sensing unit and with Chair Sensing Unit (K133661)

Secondary Predicate:

Wireless 2000 PAM™3000 (K082626) manufactured by Wireless 2000 These predicates have not been subjects to a design-related recall. Reference:

Chair Sensing Unit (K133661) can also be used with Insight Device as optional sensing unit.

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DEVICE DESCRIPTION IV.

The EarlySense InSight device incorporates the following components:

-EarlySense InSight Unit – placed at bedside (subject of this submission)
EarlySense Bed Sensing Unit (K131379) placed under the mattress -
Chair Sensing Unit (optional)(K133661)

V. INTENDED USE/INDICATIONS FOR USE

The EarlySense InSight Device is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense System has been

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studied in children (weight ≥ 10 Kg) and adults (weight <111 Kg) during sleep and resting condition.

The intended use of EarlySense InSight System is similar to its' primary predicate, EarlySense 2.0 System in all aspects, including clinical environment of usage and patient population.

EarlySense InSight has similar intended use as the cleared intended use for EarlySense System 2.0 (K131379) device that has already been cleared for usage in hospital and clinic environment for children, adolescents and adults. The intended use is also similar to the second predicate device, PAM™3000, the only difference is that in terms of patient population - the usage of the EarlySense Insight device is wider than PAM™3000 and includes children over the 2 years old, similar to the intended use of EarlySense 2.0 device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The EarlySense InSight System shares the similar fundamental technology and functionality, similar types of components, similar intended use and indications for use with the predicate devices. The following table in details describes the similarities and differences between the submitted device and its predicate devices.

Table 5-1: Substantial Equivalence between the EarlySense InSight System and its' predicate devices

	EarlySense InSightSystem	EarlySense 2.0System	PAM™3000		EarlySense InSightSystem	EarlySense 2.0System	PAM™3000
K number	K152911	K131379	K082626				breathing frequencymonitor
Product Code	BZQ	BZQ	DRT/BZQ	Manufacturer	EarlySense Ltd.	EarlySense Ltd.	Wireless 2000
RegulationNumber	868.2375	868.2375	870.2300/868.2375	Intended Useand Indicationsfor Use	The EarlySense InSightDevice is intended forcontinuousmeasurement ofrespiration rate, heartrate and movement, inan automatic contact-less manner, inhospital or clinicsetting. The system isindicated for use inchildren, adolescentsand adults. Theoperation of theEarlySense has beenstudied in children(weight $≥$ 10 Kg) andadults (weight $<$ 111Kg) during sleep andresting condition.	The EarlySense 2.0System is intendedfor continuousmeasurement ofrespiration rate, heartrate and movement,in an automaticcontact-less manner,at home, hospital orclinic setting. Thesystem is indicatedfor use in children,adolescents andadults. The operationof the EarlySense hasbeen studied inchildren (weight $≥$ 10Kg) and adults(weight $<$ 111 Kg)during sleep andresting condition. Inaddition, EarlySense2.0 System cancontinuously monitoroxygen saturation ofarterial hemoglobin(SpO2) using pulseoximetry in pediatric(ages 2 years andolder), adolescents,and adults at home,hospital or clinicsettings.	The PAM™3000 systemis intended to measureheart rate andrespiration rate in adultpatients, in a generalcare hospitalenvironment includingnursing homes. Thesystem monitorspresence or absence ifa patient in bed (bedexit). The system alsotimes the length ofcontinuous patientmotion or absence ofpatient motion.
ClassificationName	Breathing FrequencyMonitor	Breathing FrequencyMonitor	Monitor, Cardiac ( incl.cardiotachometer&rate alarm) monitor,	Sensing Unit	The SameContactless sensingunit (Piezoelectric)placed under themattress / on the chair	Contactless sensingunit (Piezoelectric)placed under themattress / on thechair	Ultra Wide Bandmotion sensor - Bedsensor Panel (BSP),placed under the bedmattress

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	EarlySense InSightSystem	EarlySense 2.0System	PAM™3000
	(Bed Sensing Unitsubmitted as part ofEarlySense 2.0 System(K131379) and ChairSensing Unit,submitted separatelyK133661)	(Bed Sensing Unitsubmitted as part ofEarlySense 2.0 System(K131379) and ChairSensing Unit,submitted separatelyK133661)
Chair SensingUnit Cover,Material	The Same100% Polyester	100% Polyester
SpO2 module	Not supported byInSight device	Is supported byEarlysense 2.0 - asoptional module	Not used with thesystem
Bedside Unit	Yes (processing unit).No display andgraphical userinterface	YesIncludes processingunit, and graphicalUser interfaceDisplay.	No
Energy source	AC power source	AC power source	AC power source
Battery exist	No	Yes	No
Clinicalenvironment ofUse	Hospital, or clinicenvironment	Home, Hospitals, orclinic environment.	Hospital or hospitaltype and clinicenvironment
PatientPopulation	SameChildren, adolescentsand adults	Children, adolescentsand adults	Adults
Visual andAudio Indicationat bedside	YesLEDS and Buzzer	Yes.LEDS, buzzer anddisplay	No
SoftwareApplication andAlgorithms	Proprietary Softwaredeveloped byEarlysense (Same)	Proprietary Softwaredeveloped byEarlysense.	Proprietary GraphicUser Interface Softwareon Central ComputerStation
	EarlySense InSightSystem	EarlySense 2.0System	PAM™3000
User InterfaceDisplay atbedside	No	Yes	No
NetworkCommunication	SameLAN and Wi-Fi	YesLAN and WI-FI	YesWI-FI
Communicationwith CentralStation	Communication withCentral control anddisplay Stations (LANor Wi-Fi) according tostandard predefinedprotocols	Communication withEarlySense CentralDisplay Station (LANand/ or Wi-Fi)	Communication withCentral ComputerStation (that controlsoperation and displaysmonitoring information
Patientmonitoring	Same.Monitoringphysiologicalparameters:- Heart Rate- Respiration Rate- Movement- Occupancy and- Exit (Bed /Chair)Does not supportconnection to OxygenSaturation monitoringoption and display.	Monitoringphysiologicalparameters:- Heart Rate- Respiration Rate- Movement- Occupancy and- Exit (Bed /Chair)- Oxygen- Saturation(optionalexternal moduleis supported),	Monitoringphysiologicalparameters:- Heart Rate,- Respiration Rate- Motion- bed occupancydata, patientmotion
Alerts	Same(for parameterscrossing predefinedthresholds)- Heart Rate- Respiratory Rate- Motion- Bed / Chair- Occupancy	(for parameterscrossing predefinedthresholds)- Heart Rate- Respiratory Rate- Motion- Bed / Chair- Occupancy- Oxygen- Saturation	- Heart Rate- Respiratory RateAlert- Bed Occupancy- Motion
Displayedinformation	No Display Screen atBedside.Monitoring data iscommunicated toremote control and	Parameters aredisplayed at bedsidescreen , and arecommunicated to	The informationgathered by the system(physiologicalparameters and alerts)are displayed on a PC
EarlySense InSightSystem	EarlySense 2.0System	PAM™3000
display station thatallows the user tocontrol bedside unitoperation and displaysmonitoring data.	Earlysense CentralStation	monitor using Wireless2000's proprietaryGraphic User Interface(GUI) software. TheCentral ComputerStation (CCS) is typicallyplaced at the nursingstation.

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The following similarities are found between the EarlySense InSight System and its predicate devices:

The EarlySense Insight System share the same technological principle with its predicate devices and at the high level, the subject and predicate devices are based on the same technological features:

EarlySense InSight System's performance is based on contactless . monitoring of Heart Rate, Respiration Rate and movement using piezoelectric sensors which were used and cleared in its predicate EarlySense 2.0 System- Bed Sensing Unit (K131379) and Chair Sensing Unit (K133661). The sensing units are used in exactly the same as cleared by FDA, no changes were performed.
. The Bed or Chair Sensing Unit of the EarlySense System detects motion signals (mechanical movements) in a continuous contact-less manner. These signals are converted into an electric signal, which is transferred to the InSight Unit. In the InSight Unit the electric signal is sampled, filtered and analyzed by the System software to provide the respiration rate (RR), heart rate (HR), and movement level. The system's detection algorithms ( the same as those used in the predicate EarlySense 2.0 device) differentiate between large body movements, breathing movements and the cardioballistic effect, and thus compute the continuous heart and respiration rates and the body movement rate.

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. The data is then transferred for display to a remote control and display device via LAN or Wi-Fi, similar to the predicate the EarlySense 2.0 System.

The following differences exist between the EarlySense InSight System and its predicate devices:

The EarlySense InSight Unit has no display (opposite to the EarlySense . 2.0 System) – the monitoring parameters and alerts can be viewed from the remote control and display system that can be placed on the nurse station. However, in this aspect, the Insight is similar to its second predicate, PAM™3000, which also has no display and no bedside unit.
. EarlySense InSight Unit does not support monitoring and display of Sp02 measurement by external module, and in this aspect it is similar to PAM™3000, but different from EarlySense 2.0 device.
. EarlySense InSight device does not have secondary power source – a battery, similar to PAM™3000, but different from EarlySense 2.0 device.

VII. PERFORMANCE AND NON CLINICAL TESTING

The EarlySense InSight System was subject to the verification and validation tests:

1. Risk analysis
1. Software Verification and Validation
1. EMC and Safety testing
1. Full load bench testing

Non Clinical Testing: EarlySense Insight Performance Verification Non-clinical tests included side by side performance testing of the InSight device vs. its predicate EarlySense 2.0. Signals from children, adolescents and adults' populations were tested. The accuracy of the InSight and EarlySense 2.0 in analyzing the signals and generating heart rate, respiration rate and motion measures were compared to results of reference device (Embla Sleep

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lab. System Medcare K024322). The devices' performance was found to be similar in respect to heart rate, respiratory rate and motion measurements.

Full load bench testing was also performed to examine the communication behavior aspects of EarlySense Insight units vs. EarlySense 2.0 predicate. The results of the bench tests showed that the InSight system performance is as good as the EarlySense 2.0, and thus concluded that it is substantially equivalent to the predicate device.

Specification

	Bed Sensing Unit	Chair SensingUnit	InSight Unit
Dimensions	Sensor: 300 X 210 X 6.45mm	300x210x6.45mm	145.6 x 62 x 65.07mm
	With handles:420.7X210X13.8 mm
Weight	730 g	482gr	235 ± 10 gr
Materials	ABS + Poly carbonate	ABS+ PolycarbonateInserted intocushion:Cushion : Viscoelastic(dimension-400 x 450 x 60mm).Cushion Cover:100% Polyester	ABS + Polycarbonate

Physical Characteristics

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Electrical

VoltageInput Range	100-240 V AC, 50-60 Hz, 0.9A max
------------------------	----------------------------------

Monitoring Range

Respiratory Rate	Heart Rate	Movement
6 – 45 Br./min	30 - 170 BPM	0, L, M, H, EH

Conclusions:

The conclusions drawn from the non-clinical tests demonstrate that the device can be considered substantially equivalent to its predicate devices: EarlySense 2.0 System (K131379) and Wireless 2000 PAM™3000 (K082626).

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).