The EarlySense Bed Sensing Unit is an accessory that is compatible with bedside units of EarlySense Systems (Models 2.0 and InSight) intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner. Environment of use for the accessory is defined as per compatible cleared bedside units labeling: EarlySense 2.0 - at home, in hospital or clinic setting and InSight - in hospital or clinic setting. The device is indicated for use in children, adolescents and adults. The operation of the EarlySense system has been studied in children (weight ≥10 Kg) and adults (weight <111 Kg) during sleep and resting condition.

Device Description

EarlySense is submitting a new model for its Bed Sensing Unit to be used with cleared EarlySense bedside unit models (EarlySense 2.0 -K131379 and EarlySense InSight -K152911) which are intended for contactless measurement of heart rate (HR), respiratory rate (RR) and motion. Similar to the cleared Bed Sensing units, the subject device is placed under the bed mattress and connected to supporting bedside unit, to allow contactless measurements of HR, RR and motion and detection of bed exit. The modification of the cleared sensing unit includes addition of two load cells elements intended to be used in the Bed Exit feature of the system. The cleared and subject device share exactly the same intended use, the same fundamental functionality and similar types of components, and the same fundamental principles and mode of operation. As also described above, the modification that includes addition of load cells is not considered to affect the system performance. The subject device is also compatible with the existing optional accessories of the cleared sensor, i.e., extension cable and solid metal plate. Utilization of extension cable is to allow placing the sensing unit under the mattress farther than 3 meters from compatible bedside units. The solid metal plate can be used for beds that have un-flat surface (such as grid like).

AI/ML Overview

The provided text describes the EarlySense Bed Sensing Unit and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or detailed results from a study proving the device meets those criteria in a format that would allow filling out all the requested fields.

The document states that the modification to the cleared sensing unit (addition of two load cell elements) did not affect the system performance. The performance data presented focuses on verifying that the outputs of the modified device are similar to the predicate device and within system algorithms' specifications, rather than explicitly stating and demonstrating achievement of specific, quantitative performance acceptance criteria for heart rate or respiration rate accuracy.

Therefore, I cannot provide a complete answer to all parts of your request. However, I can extract what is available regarding performance and testing.

Here's an analysis of what information is available and what is missing:

Information Available:

Device Performance (Comparative): "Bench testing results showed that in all relating parameters the signals from the sensing unit were similar to the predicate sensor and all parameters were within system's algorithms specification. In addition, tests were performed to compare performance of the sensing unit to predicate sensor in providing 'time to alert' for bed exit notification. Controlled experiments showed that the time to alert for bed exit notifications are similar for both sensors, thus addition of the load cells does not affect system's performance and the sensing unit is substantially equivalent to the cleared sensor."

Information NOT Available (and thus cannot be filled in):

Specific Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria (e.g., "Accuracy of respiration rate shall be within X bpm of reference"). It only states that the modified device's signals were "similar" to the predicate and "within system's algorithms specification."
Reported Device Performance (against specific criteria): Since specific criteria aren't provided, performance against them cannot be reported.
Sample Size for Test Set: Not specified. The document mentions "controlled experiments" for bed exit, but no numbers.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
Number of Experts for Ground Truth: Not specified.
Qualifications of Experts: Not specified.
Adjudication Method: Not specified.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned, and likely not applicable for a bed sensing unit measuring vital signs.
Effect size of human readers with AI vs. without AI assistance: Not applicable.
Standalone (algorithm only) performance: The performance data focuses on the new component (load cells) and its similarity to the predicate. The overall system (EarlySense System Models 2.0 and InSight) with the Bed Sensing Unit measures HR, RR, and movement, and its performance was likely established in prior 510(k)s (K131379 and K152911). This document asserts that the new bed sensing unit does not negatively impact that performance.
Type of Ground Truth: Not explicitly stated, though for vital signs, it would typically be a reference device or manual measurement.
Sample Size for Training Set: Not applicable for this submission, as the focus is on a hardware modification and its impact on signal characteristics and similarity to a predicate. It's not a new algorithm being trained.
How Ground Truth for Training Set was Established: Not applicable.

Summary of Available Information:

1. A table of acceptance criteria and the reported device performance

Performance Metric (Implicit)	Acceptance Criteria (Implicit)	Reported Device Performance
Signal characteristics (HR, RR, motion)	Signals (amplitudes, signal-to-noise ratios, time domain, frequency domain, spectral intensities) from the subject device should be "similar" to the predicate sensor and "within system's algorithms specification."	Bench testing results showed that in all relating parameters, the signals from the sensing unit were similar to the predicate sensor and all parameters were within system's algorithms specification.
"Time to alert" for bed exit	"Time to alert" for bed exit notifications should be "similar" for the subject device to the predicate sensor.	Controlled experiments showed that the time to alert for bed exit notifications are similar for both sensors, thus addition of the load cells does not affect system's performance and the sensing unit is substantially equivalent to the cleared sensor.

2. Sample sized used for the test set and the data provenance

Sample Size: Not specified. The document mentions "controlled experiments" and "bench tests" but provides no participant or case numbers.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified.

4. Adjudication method for the test set

Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was reported. This type of study is not applicable given the nature of the device (a vital signs bed sensing unit).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The performance data provided is related to the hardware component (Bed Sensing Unit) itself, assessing its signal characteristics compared to an earlier version. The system's algorithms process these signals, and the focus of this 510(k) is that the new hardware does not negatively impact the algorithmic performance already established. The document states, "Bench tests were performed to verify that the heart beat and respiration signals obtained from the subject device are similar to its predicate device, and to validate that the addition of load cells do not affect signal parameters as required by the EarlySense system's algorithms, to maintain specifications."

7. The type of ground truth used

For heart rate and respiration rate signal similarity, the ground truth was effectively the predicate device's signals and the system's algorithms specifications. For bed exit "time to alert," the ground truth was implied to be direct observation in "controlled experiments."

8. The sample size for the training set

Not applicable. This submission is for a hardware modification to an existing device, not a new algorithm training.

9. How the ground truth for the training set was established

Not applicable.

Summary

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January 4, 2018

EarlySense Ltd. Dalia Argaman VP Clinical, Regulatory Affairs and QA 7 Derech Zeev Jabotinsky Ramat Gan, 525007 ISRAEL

Re: K171836

Trade/Device Name: EarlySense Bed Sensing Unit Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: BZQ Dated: November 30, 2017 Received: December 5, 2017

Dear Dalia 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 of medical device-related 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tina Kiang -
s

Tina Kiang, Ph.D. 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) K171836

Device Name EarlySense Bed Sensing Unit

Indications for Use (Describe)

The EarlySense Bed Sensing Unit is an accessory that is compatible with of EarlySense Systems (Models 2.0 and InSight) intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner. Environment of use for the accessory is defined as per compatible cleared bedside units labeling: EarlySense 2.0 - at home, in hospital or clinic setting and InSight - in hospital or clinic setting. The device is indicated for use in children, adolescents and adults. The operation of the EarlySense system 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 Ltd.

EarlySense Bed Sensing Unit (K171836)

I. SUBMITTER:

EarlySense Ltd. 7 Derech Zeev Jabotinsky Ramat Gan, 5252007, Israel Tel: +972-3-7522330 (106) Fax: +972-3-7522340

Contact Person:

Dalia Argaman, VP Clinical, Regulatory Affairs and QA EarlySense Ltd. Dalia.Argaman@earlysense.com Date Prepared: November 30th, 2017

II. DEVICE:

Name of device: EarlySense Bed Sensing Unit Classification Name: 21 CFR Sec. 868.2375 - breathing frequency monitor Regulatory Class: II Product Code: BZQ

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III.Predicate Devices:

EarlySense Bed Sensing unit cleared as component to EarlySense 2.0 System (K131379) and

EarlySense Bed Sensing unit cleared as component to EarlySense InSight System (K152911).

A Traditional 510(k) is submitted for the modifications made to the cleared EarlySense Bed Sensing Unit.

IV. Device Description:

V. Intended Use

The subject device is intended to be used as an accessory with EarlySense System (Models 2.0 -K131379 and InSight - K152911).

VI. Indications for Use

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Comparison of technological characteristics with VII. the predicate device

The cleared (AME-00200-K131379) and subject device share exactly the same intended use and indications for use. Piezoelectric sensor is the basic technological principle for both subject device and predicate Bed Sensing unit in order to monitor Heart Rate, Respiration Rate and motion in a contactless manner. The same piezoelectric sensor (located inside the both Bed Sensing units) is used to detect respiration related mechanical movement signals, heart beat-related mechanical movements and converts them into an electric signal that are sampled, filtered and transferred to the compatible EarlySense Bedside Unit where they are analyzed by algorithms to provide the respiration rate (RR), heart rate (HR), and motion measurements. The subject device consists of the following technological elements, which are identical to the cleared Bed Sensing Unit:

. Piezoelectric ceramic sensing element: detects gross body motion, heart and breathing rate motion related signals
. Sensor Plate: housing the piezoelectric sensing element
. Cable and connector: to allow connection to compatible bedside unit
Base plate with handles: to allow placing the sensor under the mattress

The following technological differences exist between the subject device and predicate Bed Sensing Unit:

• Two load cell elements and supporting electronic circuit board added

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to the base plate of the sensor. The function of the modification is to

be used in the detection of the Bed Exit function.

The following table contains the summary of the substantial equivalence comparison.

	PredicateDevice 1:Cleared BedSensing Unit(accessory toEarlySense 2.0 -K131379)	Predicate Device2:Cleared BedSensing Unit(accessory toEarlySenseInSight-K152911)	Subject Device
K_number	K131379	K152911	K171836
ProductCode	• BZQ	The Same	The Same
Regulation	Accessory for:• 21 CFR Sec.868.2375Breathingfrequencymonitor	The Same	The Same
Environmentof use/care	At home, inhospital or clinicsetting	In hospital orclinic setting	Environment ofuse is defined asper compatiblecleared bedsideunits labeling:EarlySense 2.0 - athome, in hospitalor clinic settingand InSight - inhospital or clinicsetting.
SensorTechnology	Piezoelectricceramic sensingelement is usedto detect motionsignals(mechanicalmovements) in acontinuouscontact-lessmanner. Thesesignals areconverted into	Identical	Identical
	Predicate Device 1:Cleared Bed Sensing Unit(accessory to EarlySense 2.0 -K131379)	Predicate Device 2:Cleared Bed Sensing Unit(accessory to EarlySenseInSight-K152911)	Subject Device
	an electric signal,sampled, filteredand transferredto the BedsideUnit where theyare analyzed bythe Bedsideunit's software(algorithms) toprovide therespiration rate(RR), heart rate(HR), andmotion. Bed exitsignal is alsodetected andavailable.
Bed ExitFunction	Is performed bypiezoelectricceramic sensingelement	Is performed bypiezoelectricceramic sensingelement	Is performed bypiezoelectricceramic elementas in the predicateand by addition oftwo load cells andsupporting circuitboard
Sensor"housing" /material	ABS/Polycarbonate plate	Identical	Identical
SignalsDetected	Pulse rateRespiration RateMovementBed occupancy/exit	Identical	IdenticalPulse rateRespiration RateMovementBed occupancy/exit
Technology	Detection ofrespirationmechanicalsignal and heartbeat-relatedmechanicalmovements	Identical	Identical
	PredicateDevice 1:Cleared BedSensing Unit(accessory toEarlySense 2.0 -K131379)	Predicate Device2:Cleared BedSensing Unit(accessory toEarlySenseInSight-K152911)	Subject Device
	(based onrespiratorymotion andcardioballisticeffect motion)
PatientPopulation	Adults,adolescents andchildren	Identical	Identical
Mode ofOperation	Connection toEarlySenseBedside unit	Identical	Identical
Analysis(Signalsprocessingand Displayofparametersto user)	Connection toEarlysensebedside unit.Processing ofsignals byEarlySenseproprietaryalgorithms whichprocess thesignals and GUIprovided bybedside unit.	Identical	Identical
SpO2monitoring	Allows SpO2monitoring byutilizing an off-the-shelf module(manufacturedby Nonin MedicalInc.)	The design of thedevice (InSight)does not allowconnection to off-the-shelf SpO2module.	Identical to thepredicate devices- the SpO2monitoring isperformed byseparate off-the-shelf modulewhile usingEarlySense 2.0model and is notperformed, whileconnected toInSight device.SpO2 monitoring isnot a function ofthe subject device
PowerSource	5 Volt - receivedfrom EarlySense	Identical	Identical
	Predicate Device 1:Cleared BedSensing Unit(accessory toEarlySense 2.0 -K131379)	Predicate Device2:Cleared BedSensing Unit(accessory toEarlySenseInSight-K152911)	Subject Device
	bedside unit
Way ofconnection /Communication to theBedside Unit	Communicationprotocol (RS-232) and specificconnector	Identical	Identical
SensorDimensions	420 X 210 X 14mm	Identical	Identical
SensorWeight	730 gr.	730gr.	760 gr
Additionalsensingelement	No additionalsensing elementin the clearedbed sensing unit	No additionalsensing element inthe cleared bedsensing unit	Two load cellelements wereadded to thesensor's baseplate (housed inspecially designedniches) to be usedin bed exit feature,supported byadditional circuitboard
Method ofConnectionto patient	The Bed SensingUnit is placedunder the bedmattress - nottouching thepatient	Identical	Identical
Optionalaccessories	Extension cableand metal plate	The same	The same

Substantial Equivalence Comparison subject device to its predicate devices

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VIII. Performance data

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The subject device (as component to EarlySense System (Models 2.0 -K131379 and InSight - K152911) was subject to the verification, validation activities and bench testing, namely:

Risk analysis
· Electrical safety and electromagnetic compatibility
· Environmental Conditions Testing (Storage, Operation and Shipping,)
Performance Bench Testing

Risk analvsis

Risk analysis was performed as for the potential hazards that are relevant to the addition of load cells to the subject device, and required testing performed as mitigations.

Electrical safety and electromagnetic compatibility

Electrical safety and EMC testing, according to the IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 62366, IEC 62304 and IEC 60601-1-2 standards. Subject device was found to comply with the requirements of the standards, when connected to compatible bedside units.

Environmental Conditions Testing

The sensing unit was subject to storage, operation and shipping testing according to standards IEC 60721-4-2:2001+A1:03 (Class 2K4) and IEC 60721-4-3:2001+A1:03 (Class 3K3). In addition, Sinusoidal vibration, Bump, Free fall test were performed according to EC TR 6071-4-2:2001+A1:03(Class 2M2). Shock test (according to IEC 60068-2-27:2008), Broad-band random vibration test (according to IEC 60068-2-64:2008), Free fall test (according to IEC 60068-2-31:2008) were performed. Subject device successfully passed all the testing. Water and solid object ingress tests were performed and sensing unit was found to be IP24 protected.

Performance Bench Testing

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Bench tests were performed to verify that the heart beat and respiration signals obtained from the subject device are similar to its predicate device, and to validate that the addition of load cells do not affect signal parameters as required by the EarlySense system's algorithms, to maintain specifications. The bench testing included comparison of parameters such as: signal's amplitudes, signal to noise ratios, time domain and frequency domain comparisons, signal spectral intensities. Bench testing results showed that in all relating parameters the signals from the sensing unit were similar to the predicate sensor and all parameters were within system's algorithms specification. In addition, tests were performed to compare performance of the sensing unit to predicate sensor in providing "time to alert" for bed exit notification. Controlled experiments showed that the time to alert for bed exit notifications are similar for both sensors, thus addition of the load cells does not affect system's performance and the sensing unit is substantially equivalent to the cleared sensor.

IX. Conclusions

The non-clinical tests demonstrate that subject device is substantially equivalent to the predicate device.

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).