The EarlySense (EverOn) 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 (EverOn) 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 EarlySense (EverOn) System consists of the following main components:

A piezoelectric Sensing Unit placed under the mattress or mattress pad.
Bedside Unit with Proprietary recording and data analysis software
OEM Oximetry Module (optional)
The EarlySense (EverOn) System is designed for continuous and contact-less monitoring of respiration rate, heart rate and movement. The under mattress Sensing Unit includes a piezoelectric sensor, which converts mechanical movements into an electric signal. The principles and the mode of operation for the capability of contactless monitoring of the EarlySense (EverOn) is identical to the cleared EverOn 1.0 (K092062). The EarlySense interfaces with a pulse oximeter OEM module (optional feature) and can therefore also monitor oxygen saturation. The oximetry module is connected externally via UART (RS232/TTL) to the Bedside unit. A compatible oximetry sensor is then attached to the patient's finger and the monitor begins to continuously display oximetry data (e.g. SpO2).
The Bedside Unit, processes inputted signals, displays the patient's parameters, and generates alerts (respiration rate, heart rate, movement, and SpO2) as per set thresholds when needed. The continuously accumulated data from the monitored period are displayed on the bedside unit and communicated, via wired or via wireless LAN communication to a dedicated may options of SerilySense Central Display Station (CDS) - cleared under K100376 and K110521). Analysis of the results may be performed either on-line during the monitoring session, or later, off-line. Data for each patient is recorded and can therefore also be retrieved and presented.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the EarlySense (EverOn™) System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses primarily on showing substantial equivalence to predicate devices and adherence to general safety and performance standards. It does not explicitly state specific quantitative acceptance criteria for respiration rate, heart rate, movement, or SpO2, nor does it provide detailed performance values for these metrics. Instead, the summary emphasizes that a "set of software and bench testing was performed to demonstrate the performance and accuracy" and that the device "performs according to its specifications described in the Software Requirements Specifications (SRS)."

However, given the context of a 510(k) for an oximetry module addition and an existing cleared device, we can infer the type of performance that would be required for the added oximetry function based on typical regulatory expectations for pulse oximeters. For the existing functions (respiration rate, heart rate, movement), the claim is that its operation is "identical to the cleared EverOn 1.0 (K092062)."

Acceptance Criteria (Inferred from Regulatory Standards and Device Type)	Reported Device Performance (as stated or implied)
Respiration Rate, Heart Rate, Movement: Performance equivalent to predicate device EverOn 1.0 (K092062).	"The principles and the mode of operation for the capability of contactless monitoring of the EarlySense (EverOn) is identical to the cleared EverOn 1.0 (K092062)."
SpO2 Accuracy: (Typically, within ±2-3% of reference standard for 70-100% SpO2)	"Bench testing including demonstrating the accuracy of the oximetry data display and SpO2 alerting feature." (Specific quantitative accuracy values are not provided in this summary.)
Electrical Safety: Compliance with IEC 60601-1.	"Electrical safety and electromagnetic compatibility testing according to IEC 60601-1 (and amendments)."
Electromagnetic Compatibility: Compliance with EN/IEC 60601-1-2.	"Electrical safety and electromagnetic compatibility testing according to [...] IEC 60601-1-2 (and amendment) standards."
Software Validation: Performance according to Software Requirements Specifications (SRS).	"Software verification and validation testing was conducted to evaluate the performance of the EarlySense System and to verify that it performs according to its specifications described in the Software Requirements Specifications (SRS)."
Absence of New Safety/Effectiveness Issues:	"Testing was performed in order to demonstrate ... that as a result of combining the EarlySense technology and a standard OEM, no new safety and effectiveness issues, in comparison to its predicate devices, are raised."

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

The summary does not provide specific sample sizes for particular performance tests. It mentions "bench testing" and "software verification and validation testing." No information about human subject test sets (sample size, country of origin, retrospective/prospective) is provided beyond the existing claim of equivalence to the predicate device for respiration rate, heart rate, and movement. The indication for use states, "The operation of the EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight <111 Kg) during sleep and resting condition," but it doesn't specify if this refers to the current submission's testing or the predicate's testing. Given the focus on the oximetry module addition, it's possible the bench testing involved simulated data or controlled physiological models.

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

This information is not provided in the summary. For "bench testing" of oximetry, the ground truth would typically come from a reference oximeter or blood gas analysis, not expert interpretation. For the existing functions (respiration rate, heart rate, movement), as it is claimed to be "identical to the cleared EverOn 1.0," the ground truth establishment would refer to the original K092062 submission.

4. Adjudication Method for the Test Set

This information is not provided as the summary focuses on technical compliance and bench testing rather than clinical study data requiring expert adjudication.

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

There is no indication that an MRMC comparative effectiveness study was performed or that AI assistance for human readers is part of this device's functionality. The EarlySense system is a monitoring device that provides objective measurements, not an AI diagnostic aid for human interpretation.

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

Yes, the testing described appears to be standalone performance evaluation of the device's algorithms and hardware. The "bench testing" and "software verification and validation testing" assess the device's ability to accurately measure and display parameters independently. The device's intended use is for continuous, automatic contact-less measurement, implying a standalone function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the oximetry part, the ground truth would typically be established against a clinical reference oximeter or arterial blood gas analysis. For the respiration rate, heart rate, and movement components, given their "identical" nature to the predicate, the ground truth for their original clearance (K092062) would have likely involved reference physiological monitoring equipment (e.g., ECG for heart rate, capnography or specialized respiratory sensors for respiration rate, accelerometers or pressure sensors for movement). The summary indicates "bench testing" which suggests controlled environments where reference measurements are used.

8. The sample size for the training set

This information is not provided. The summary does not disclose details about machine learning or AI model training data. It focuses on the device's functional performance and equivalence.

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

This information is not provided, as details about training sets or the specific algorithms for the core measurements are not disclosed in this summary.

Summary

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510(K) SUMMARY

510(K) Number K_12 Q 465

5.1 Applicant's Name: EarlySense Ltd. 12 Tzvi Street, Ramat Gan, Israel

5.2 Contact Person: Dalia Argaman EarlySense Ltd. 12 Tzvi Street, Ramat Gan, Israel Tel: +972 (3) 752 - 2330 Fax: +972 (3) 752 - 2340 Email: Dalia. Argaman(@)Earlysense.com

April 2012 5.3 Date Prepared:

EarlySense (EverOn™) System 5.4 Trade Name:

5.5 Classification Name: Breathing frequency monitor (868.2375) monitor, cardiac (incl. cardiotachometer & rate alarm) (870.2300) Oximeter (870.2700)

5.6 Product Code:

BZQ, DRT, and DQA

Class II 5.7 Device Class:

5.8 Predicate Devices:

EverOn 1.0 (EarlySense Ltd.), cleared under K092062. .
Avant™ 9600 Pulse Oximeter (Nonin Medical Inc.), cleared under K040589 .
LifeShirt System with VivoLogic Analysis Software (VivoMeterics Inc.), cleared under ● K011903

5.9 Intended Use / Indication for Use:

The EarlySense (EverOn) System is intended for continuous measurement of respiration rate, The Darry other (1) 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 The System 15 marcated 16th children (weight ≥ 10 Kg) and adults (weight <111 Kg) during

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sleep and resting condition, In addition, EarlySense (EverOn) 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 5.10

The EarlySense (EverOn) System consists of the following main components:

A piezoelectric Sensing Unit placed under the mattress or mattress pad. .
Bedside Unit with Proprietary recording and data analysis software .
OEM Oximetry Module (optional) .

The EarlySense (EverOn) System is designed for continuous and contact-less monitoring of respiration rate, heart rate and movement. The under mattress Sensing Unit includes a piezoelectric sensor, which converts mechanical movements into an electric signal. The principles and the mode of operation for the capability of contactless monitoring of the EarlySense (EverOn) is identical to the cleared EverOn 1.0 (K092062). The EarlySense interfaces with a pulse oximeter OEM module (optional feature) and can therefore also monitor oxygen saturation. The oximetry module is connected externally via UART (RS232/TTL) to the Bedside unit. A compatible oximetry sensor is then attached to the patient's finger and the monitor begins to continuously display oximetry data (e.g. SpO2).

The Bedside Unit, processes inputted signals, displays the patient's parameters, and generates alerts (respiration rate, heart rate, movement, and SpO2) as per set thresholds when needed. The antinuously accumulated data from the monitored period are displayed on the bedside unit and communicated, accammunicated, via wired or via wireless LAN communication to a dedicated may options of SerilySense Central Display Station (CDS) - cleared under K100376 and K110521). Analysis of the results may be performed either on-line during the monitoring session, or later, off-line. Data for each patient is recorded and can therefore also be retrieved and presented.

5.11 Performance Standards

The EarlySense System complies with voluntary standards such as:

Medical electrical equipment- general requirements for safety. Part 1: General . Requirements for Safety. IEC 60601-1(1988): +A1(1991) +A2(1995);
Electrical Equipment Part 1: General Requirements for Safety; l Medical Electromagnetic Compatibility -- Requirements and Tests. EN/IEC 60601-1-2 (2007)
Medical device software Software life cycle processes. IEC 62304 (2006) ■
Medical devices Application of risk management to medical devices. ISO 14971 1 (2009)

5.12 Substantial Equivalence

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Intended use and Technological Characteristics

The EarlySense (EverOn), subject to this submission, is similar to the EverOn 1.0 predicate device with the following changes: (1) optional interface with a pulse oximeter OEM module and therefore monitoring of oxygen saturation and (2) operation on a Linux platform. Bv incorporating an oximeter module into the EarlySense System, two cleared scientific technologies are combined into one System. The intended use and indications for use of the EarlySense is similar and encompassed within the intended use and indications for use of its Specifically, with the exclusion of monitoring oxygen saturation, the predicate devices. proposed intended use and indications for use of the EarlySense (EverOn) System is identical to the EverOn 1.0 (K092062) predicate device, while the monitoring of oxygen saturation is encompassed within the intended use and indications for use of the oximeter predicate device Avant 9600 Pulse Oximeter (K040589). Incorporation of an oximeter module into a physiological data monitor, a well understood technology, is shared by other cleared devices.

Testing was performed in order to demonstrate the safety and performance of the EarlySense System and to demonstrate that as a result of combining the EarlySense technology and a standard OEM, no new safety and effectiveness issues, in comparison to its predicate devices, are raised. In summary, the EarlySense System is as safe and effective as its predicate devices for its intended use and is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issues.

Performance Testing

A set of software and bench testing was performed in order to demonstrate the performance and accuracy of the EarlySense System and to verify that it does not raise any new safety and effectiveness issues in comparison to its predicate devices. The testing included the following:

Electrical safety and electromagnetic compatibility testing according to IEC 60601-1 I (and amendments), and IEC 60601-1-2 (and amendment) standards.
Software verification and validation testing was conducted to evaluate the B performance of the EarlySense System and to verify that it performs according to its specifications described in the Software Requirements Specifications (SRS).
Bench testing including demonstrating the accuracy of the oximetry data display and . SpO2 alerting feature.

Summarv

The EarlySense System has the same or similar intended uses and indications, technological The Barrystics, and principles of operation as its predicate devices. Based on the performance testing results, including software verification and validation process and bench testing, the cooning roatio, including and differences, EarlySense Ltd. believes that the EarlySense System andryis of the simmariters o its predicates without raising new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.

Public Health Service

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

Ms. Delia Argaman Vice President Clinical and Regulatory Affairs EarlySense Limited 12 Tzvi Street Ramat Gan Israel 52504

JUN - 8 2012

Re: K120465

Trade/Device Name: EarlySense (EverOn™) System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: BZQ Dated: May 23, 2012 -Received: May 29, 2012

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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): __

Device Name: EarlySense (EverOn™) System

Prescription Use	√
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division Sign-Off) Division Sign-On7
tection Control, Dental Devices

510(k) Number:

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).