The EarlySense Chair Sensing Unit is intended to be used for continuous measurement of Respiration Rate, Heart Rate and Movement, in an automatic contact-less manner, at home, hospital or clinic setting. The sensor 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. The Chair Sensing Unit can be used with bedside units that contain appropriate software (graphical interface) that can support reading and displaying EarlySense Chair Sensing Unit readings. In addition, the EarlySense System can continuously monitor oxygen saturation of arterial hemoglobin (Sp02) using pulse oximetry in pediatric (ages 2 years and older), adolescents and adults at home, hospital, or clinical settings.

Device Description

EarlySense is submitting a new accessory for contactless measurement of heart, respiratory rate and motion, the Chair Sensing Unit. The Chair Sensing Unit, similar to its predicate, the EarlySense Bed Sensing Unit cleared as part of previous EarlySense system submissions (K070375, K082465, K092062, K120465), is intended for continuous measurement of Heart Rate, Respiration Rate and motion while the patient is resting.

The EarlySense Chair sensing unit is comprised of the following components:

Sensor: that includes piezoelectric elements incorporated into a plate
A cushion made of foam into which the sensor is inserted into - so not to be touched by the patient.

The Chair sensing unit should be connected to a bedside unit that receives and analyzes the signals from the Chair sensing unit to measure and display heart rate, respiratory rate and motion.

AI/ML Overview

The EarlySense Chair Sensing Unit is an accessory to the EarlySense System for continuous, contactless measurement of Respiration Rate, Heart Rate, and Movement. The 510(k) summary provided does not contain specific, quantitative acceptance criteria or detailed results of a clinical study that proves the device meets such criteria. Instead, it relies on bench testing and comparison to a predicate device to establish substantial equivalence.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria or detailed performance data (e.g., accuracy, precision) for the EarlySense Chair Sensing Unit are explicitly stated in the document. The document primarily focuses on establishing substantial equivalence to the predicate device through bench testing rather than reporting precise performance metrics against pre-defined targets.

The general conclusion from bench testing is that: "the signals as detected by the chair sensing unit are similar to those that are detected by the predicate EarlySense Bed Sensor and thus the performance of the Chair Sensing Unit is equivalent to the performance of the Bed Sensing Unit and the performance of the chair sensor is not affected by the new design that includes insertion of the sensor into a cushion (rather than insertion of the sensor under a bed mattress)."

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

The document mentions "Bench Testing" which involved "Performance tests were performed with signals simulating physiological patient signals". No information is provided regarding the sample size of these simulated signals or their provenance (e.g., country of origin, retrospective/prospective). This was a bench test, not human-subject testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the study described is bench testing using simulated physiological signals, not human data requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable, as there was no human-subject test set requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. The submission focuses on validating the device itself, not on evaluating its impact on human reader performance.

6. Standalone Performance Study (Algorithm Only)

The testing described (bench testing with simulated signals) serves as a standalone performance evaluation of the device's ability to detect and transmit signals, and the system's software to analyze these signals. The document states: "The system's detection algorithms differentiate between large body movements, breathing movements and the cardioballistic effect, and thus compute the continuous heart and respiration rates and the body movement." However, detailed performance metrics (e.g., accuracy against a known true value) are not provided, nor is a specific "standalone study" with quantifiable results reported. The performance is largely inferred as being "equivalent" to the predicate device.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" was likely supplied by the "signals simulating physiological patient signals" themselves, which implies a known input with which the device's output could be compared. The nature or source of these simulated signals is not detailed.

8. Sample Size for the Training Set

No information is provided about a training set since the document describes validation activities for a device accessory, not the development of a new algorithm that would typically require a training set. The underlying algorithms for HR, RR, and movement were likely developed and validated with the predicate device.

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

Not applicable, as no training set is mentioned for the validation of this accessory. The existing algorithms from the predicate device (K120465) are utilized.

Summary

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KI33661

Section 5 510(k) Summary

510(K) SUMMARY

JUN 1 3 2014

EarlySense Ltd.

EarlySense Chair Sensing Unit

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(ext.106) Fax: +972-3-752-2340 e-mail: Dalia.Argaman@EarlySense.com

Date Prepared:

June 12, 2014

Trade Name:

EarlySense Chair Sensing Unit

EarlySense Ltd. 12 Tzvi street, Ramat Gan, 52504, ISRAEL Tel: +972 3 7522330 (ext.106); Fax: +972 3 7522340; E-mail: Dalia.Argaman@Earlysense.com

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Classification Name:

Accessory for Breathing Frequency Monitor

Class: II

Regulation Number:

21 CFR Sec. 868.2375

Product Code:

BZQ, DRT

Predicate Device:

Bed Sensing Unit of EarlySense System (K120465)

Reason for Submission:

A traditional 510{k) is submitted for the addition of the optional accessory (Chair Sensing Unit) to be used with cleared EarlySense bedside units (K120465).

Intended Use/Indications for Use:

EarlySense Ltd. 12 Tzvi street, Ramat Gan, 52504, ISRAEL Tel: +972 3 7522330 (ext.106); Fax: +972 3 7522340; E-mail: Dalia. Argaman@Earlysense.com ·

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of arterial hemoglobin (Sp02) using pulse oximetry in pediatric (ages 2 years and older), adolescents and adults at home, hospital, or clinical settings. .

Device Description

The EarlySense Chair sensing unit is comprised of the following components:

Sensor: that includes piezoelectric elements incorporated into a plate
A cushion made of foam into which the sensor is inserted into - so not to be touched by the patient.

The Chair sensing unit should be connected to a bedside unit that receives and analyzes the signals from the Chair sensing unit to measure and display heart rate, respiratory rate and motion.

Similarities and differences in technological characteristics of Chair Sensing Unit and Bed Sensing Unit (predicate)

Similarities:

Similar piezoelectric sensor is used.

-The sensor performs similar functions as the Bed Sensing Unit does

-The way of receiving, analyzing, sampling and sending signals to the Bedside unit is similar to its predicate, Bed Sensing Unit

EarlySense Ltd. 12 Tzvi street, Ramat Gan, 52504, ISRAEL Tel: +972 3 7522330 (ext.106); Fax: +972 3 7522340; E-mail: Dalia.Argaman@Earlysense.com

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Differences:

-Accelerometer, rod and additional piezoelectric sensor (piezofilm) were added to the Chair Sensor

-Chair Sensor is placed under a specially-designed cushion, in order to avoid the direct contact between the patient and the sensor and to achieve the correct positioning of the sensor on the chair.

Substantial Equivalence

The EarlySense Chair Sensing Unit is similar to its predicate, the EarlySense Bed Sensing Unit. It has similar intended use and indications for use. The fundamental technology and mode of operation of the Chair sensing unit are similar as those of the Earlysense Bed Sensing unit. Similar to the cleared Bed Sensing Unit that is placed under the bed mattress and does not contact the patient, the Chair sensor is inserted into a specific cushion that mimics the bed mattress, so the chair sensor does not touch the patient. The Chair Sensing Unit performs similar functions as the Bed Sensing unit-in a contactless manner it monitors heart, respiration rate and motion. Similar to its predicate, the Earlysense Bed Sensing unit, the mechanical signals that are detected by the piezoelectric element of the sensors (Bed or Chair) are converted into an electric signal, which is then sampled and filtered and transferred to the EarlySense Bedside Unit, in order to be analyzed by the System's software to provide the respiration rate (RR), heart rate (HR), and movement rate. The system's detection algorithms differentiate between large body movements, breathing movements and the cardioballistic effect, and thus compute the continuous heart and respiration rates and the body movement.

The presented additional accessory, Chair Sensing Unit has similar functionality, the similar indications for use, technology, mode of operation and performance specifications as the Bed Sensing Unit.

EarlySense Ltd. 12 Tzvi street, Ramat Gan, 52504, ISRAEL Tel: +972 3 7522330 (ext.106); Fax: +972 3 7522340; E-mail: Dalia.Argaman@Earlysense.com

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Verification and Validation Activities:

The Chair Sensing Unit was subject to the following verification and validation tests to ensure correct performance:

Risk analysis
Bench Testing:

Performance tests were performed with signals simulating physiological patient signals to evaluate the measurement and compare those to the predicate device to show equivalent performance.
Theoretical assessment and bench tests were performed to assess the magnitude and effect of external sources of vibration and their effect on the chair sensing unit's functionality.
Environmental testing including: Random vibration (Non-Operational test), Sinusoidal vibration (Variable Frequency Operational)

Complete software verification and validation testing performed to ensure proper functionality.

In addition, the Chair Sensing Unit as part of the EarlySense System was subject to complete set of testing (electrical safety, EMC and environmental testing) to ensure proper functionality.

The results of the bench tests showed, that the signals as detected by the chair sensing unit are similar to those that are detected by the predicate EarlySense Bed Sensor and thus the performance of the Chair Sensing Unit is equivalent to the performance of the Bed Sensing Unit and the performance of the chair sensor is not affected by the new design that includes insertion of the sensor into a cushion (rather than insertion of the sensor under a bed mattress). Therefore, it was concluded that the Chair Sensing Unit may be considered to be substantially equivalent to the previously cleared EarlySense Bed Sensing Unit (K120465).

EarlySense Ltd. 12 Tzvi street. Ramat Gan. 52504, ISRAEL Tel: +972 3 7522330 (ext.106); Fax: +972 3 7522340; E-mail: Dalia.Argaman@Earlysense.com

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

June 13, 2014

EarlySense Ltd. Ilana Shvorin RA Specialist 12 Tzvi St. Ramat Gan, Israel 52504

Re: K133661

Trade/Device Name: EarlySense Chair Sensing Unit Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing frequency monitor Regulatory Class: II Product Code: BZQ, DRT Dated: May 7, 2014 Received: May 15, 2014

Dear Ms. Shvorin:

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. Shvorin

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/Resourcesfor You/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/ReportalProblem/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.

Tejashri Purohit-Sheth. M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director
DAGRID/ODE/CDRH 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

Sincerely yours.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133661

Device Name EarlySense Chair Sensing Unit

Indications for Use (Describe)

The EarlySense Chair Sensing Unit is intended to be used for continuous measurement of Respiration Rate, Heart Rate and Movement, in an automatic contact-less manner, at home, hospital or clinic setting. The sensor 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 <11 Kg) during sleep and resting condition. The Chair Sensing Unit can be used with bedside units that contain appropriate software (graphical interface) that can support reading and displaying EarlySense Chair Sensing Unit readings. In addition, the EarlySense System can continuously monitor oxygen saturation of arterial hemoglobin (SpO2) using pulse oximerry in pediatric (ages 2 years and older), adolescents and adults at home, hospital, or clinical settings.

Type of Use (Salect one or both, as applicable)

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 FDA USE ONLY

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

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Anva C. Harry -S 2014.06.12 12:17:48 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, galher and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, Including suggestions for reducing this burden, to:

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FORM FDA 3881 (1/14)

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).