The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® is used with compatible bed system models and is intended for continuous measurement of respiration rate and heart rate in an automatic, contact-less manner. The system is indicated for use in children, adolescents, and adults in hospitals or clinical settings. It is intended to be used for the same patient populations and the same settings, within these ranges, as the bed with which it is used. The system has been validated to withstand up to 700 lbs (318 kg).

Device Description

The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® is designed for continuous and contact-free measurement of heart and respiratory rate. This device is used with a hospital bed system which is exempt from premarket submission requirements. The Bed Sensing Unit (sensor) attaches to the bed frame and plugs into the bed to both receive power and to transmit data to the bed's graphical user interface/display unit. Additionally, the System can send alarms to an existing hardwired Nurse Call system, speakers, and/or on/off alarm lights within a bed system. The healthcare professional is able to adjust monitoring parameters by interacting with the bed's graphical user interface/display. These parameters include alarm thresholds, display settings, and alarm configurations. The system provides alarm when patient heart rate and/or respiratory rate excurse above or below the predefined thresholds.

The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® consists of:

. The Bed Sensing Unit, placed on the bed frame under the mattress
. Software for data analysis, display, and input
. The device hardware, specifically the connection between the sensor and appropriate bed system

The System also uses the graphical user interface of an appropriate bed system.

The data provided by this system is intended to provide trending information on monitored parameters which should be interpreted by a healthcare professional only. The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® has not been studied on any specific patient group, nor has it been studied as a diagnostic tool for any specific disease or medical condition. It is meant as an adjunctive tool only for measuring respiration rate and heart rate. The system helps healthcare professionals detect unanticipated patient deterioration quickly by providing heart and respiratory rate continuously rather than through standard periodic caregiver rounding.

AI/ML Overview

The provided text describes the Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® and its substantial equivalence to a predicate device (EarlySense® Insight System, K152911). It highlights several performance tests, but explicitly states "No clinical testing was performed." and instead focuses on demonstrating equivalence to the predicate device. Therefore, the information needed to fully answer some of the questions, particularly those related to human-in-the-loop performance and expert-established ground truth from a clinical study, is not present in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not provide a specific table of defined acceptance criteria (e.g., target accuracy percentages for respiration rate) and corresponding reported performance metrics. Instead, it states that "Hill-Rom has verified and validated that the Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® meets its functional, and performance specifications and requirements." and that "Accuracy Testing" was conducted to determine the accuracy of the system compared to the predicate.

The table below summarizes the measurable performance characteristics mentioned and implies that the device is deemed acceptable if it performs comparably or within the ranges of the predicate device.

Performance Characteristic	Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance
Respiration Rate Range	6 - 45 Breaths/minute	6 - 45 Breaths/minute
Heart Rate Range	30 – 170 beats per minute	30 – 170 beats per minute
Durability (Weight)	Withstand up to 440 lbs (200 kg) (predicate's limit)	Withstand up to 700 lbs (318 kg)
Accuracy Testing	Comparable to predicate device	Conducted and deemed equivalent to predicate
Compliance with Standards	Adherence to specified IEC, ISO, AAMI/ANSI standards	Adherence to specified IEC, ISO, AAMI/ANSI standards

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

The document does not specify the sample size used for the "Accuracy Testing" or "Durability Testing." It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for these tests, as the focus is on technical equivalence rather than clinical study data.

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

This information is not provided. The testing described focuses on comparing the device's measurements to those of the predicate device or established technical standards, rather than using expert-established ground truth in a clinical context.

4. Adjudication method for the test set

This information is not provided.

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 performed. The document explicitly states: "No clinical testing was performed." The device is intended as an "adjunctive tool" and "has not been studied on any specific patient group, nor has it been studied as a diagnostic tool for any specific disease or medical condition." Therefore, no effect size for human reader improvement with or without AI assistance is reported.

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

Yes, standalone performance testing was conducted. The "Accuracy Testing" and "Durability Testing" mentioned evaluate the device's (and its algorithms') performance characteristics (e.g., heart rate and respiration rate measurement accuracy, weight bearing capacity) without human intervention in the loop for interpretation or decision-making.

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

The document does not explicitly state the "ground truth" methodology. Instead, the accuracy testing was conducted "to determine the accuracy of the system compared to the predicate." This implies the predicate device's measurements served as a reference for comparison, or the comparison was against a known, controlled input in a laboratory setting for technical accuracy. It is not an expert consensus, pathology, or outcomes data ground truth in a clinical sense.

8. The sample size for the training set

The document does not provide information on the training set sample size. Since the device utilizes proprietary algorithms developed by EarlySense® (the predicate device manufacturer), and the "Software for data analysis is identical to that cleared in K152911," it's highly probable that any algorithm training occurred prior to the development of this specific Hill-Rom product, and details of that training are not included in this submission.

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

This information is not provided. As mentioned above, details about the training of EarlySense's proprietary algorithms are not part of this 510(k) summary.

Summary

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May 7, 2018

Hill-Rom Inc. Sarah Fitzgerald Regulatory Affairs Manager 1069 State Route 46 East Batesville, Indiana 47006

Re: K180079

Trade/Device Name: Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: BZQ Dated: April 4, 2018 Received: April 5, 2018

Dear Sarah Fitzgerald:

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.

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 (QS) regulation (21 CFR Part 820);

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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,

Geeta K. Pamidimukkala -S

for 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) K180079

Device Name

Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense®

Indications for Use (Describe)

The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® is used with compatible bed system models and is intended for continuous measurement of respiration rate in an automatic, contact-less manner. The system is indicated for use in children, adolescents, and adults in hospitals or clinical settings. It is intended to be used for the same patient populations and the same settings, within these ranges, as the bed with which it is used. The system has been validated to withstand up to 700 lbs (318 kg).

NOTE: Do not exceed the limit of the Bed System for weight, population, or use setting.

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)

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510(k) Summary: Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense®

Date Prepared:	May 7, 2018
Company	Hill-Rom, Inc.
	1069 State Route 46 East
	Batesville, IN 47006
Contact	Sarah Marie Fitzgerald
	Regulatory Affairs Manager
	812-931-2924 (telephone)
Device Trade Name	Hill-Rom® Heart and Respiration Rate Monitoring System powered by
	EarlySense®
Device Common Names	Breathing Frequency Monitor
Device Regulation	21 CFR 868.2375
Classification	Product Code: BZQ; Panel Code 73; Regulatory Class II
Predicate Device	EarlySense Ltd. EarlySense® Insight System; Product Code BZQ; K152911

Purpose:

The purpose of this submission is to request clearance for the Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense®.

Device Description:

The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® consists of:

. The Bed Sensing Unit, placed on the bed frame under the mattress
- O This is functionally identical to the sensor cleared in K152911
. Software for data analysis, display, and input
- The software for data analysis is identical to that cleared in K152911
. The device hardware, specifically the connection between the sensor and appropriate bed system
- O The System also uses the graphical user interface of an appropriate bed system.

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professionals detect unanticipated patient deterioration quickly by providing heart and respiratory rate continuously rather than through standard periodic caregiver rounding.

Indications for Use:

NOTE: Do not exceed the limit of the Bed System for weight, population, or use setting.

Performance Data:

Hill-Rom has verified and validated that the Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® meets its functional, and performance specifications and requirements. Software and hardware testing of components as well as the final device have been conducted. The device has been tested for compliance to International Standards including the following:

. IEC/AAMI/ANSI/ES 60601-1 : Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance : Edition 3.1
. IEC 60601-1-2 : Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests : Edition 4.0
IEC 60601-1-6 : Medical Electrical Equipment – Part 1-6: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability : Edition 3.1
IEC 60601-2-49 : Particular Requirements for the Basic Safety and Essential Performance of Multifunction Patient Monitoring Equipment : Edition 2.0
ISO 14971 : Medical Devices – Application of Risk Management to Medical Devices : 2012 (covers ANSI/AAMI/ISO 14971:2007/(R)2010)
AAMI/ANSI HE75 : Human Factors Engineering – Design of Medical Devices : 2009
AAMI/ANSI/IEC 62366-1 : Medical Devices – Part 1: Application of Usability Engineering to Medical Devices : 2015
. AAMI/ANSI/IEC 62304 : Medical Device Software – Software Life Cycle Processes : 2006
. Human Factors evaluation was conducted per FDA guidance document "Applying Human Factors and Usability Engineering to Medical Devices"

Durability testing was conducted to demonstrate the sensor can withstand weight up to 700 lbs. Additionally, heart rate and respiration rate verification was conducted to determine the accuracy of the system compared to the predicate.

The extensive performance testing that has been conducted demonstrate that the System is equivalent to the predicate device. No clinical testing was performed.

Technological Characteristics:

The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® has the substantially equivalent technological characteristics as the predicate device, as summarized on the table below.

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Technological	Subject Device	Predicate / Reference Device	Comparison
Characteristic		(K152911 unless noted)
Indications forUse	The Hill-Rom® Heart andRespiration Rate MonitoringSystem powered byEarlySense® is used withcompatible bed system modelsand is intended for continuousmeasurement of respirationrate and heart rate in anautomatic, contact-lessmanner. The system isindicated for use in children,adolescents, and adults inhospitals or clinical settings. Itis intended to be used for thesame patient populations andthe same settings, within theseranges, as the bed with which itis used.	The EarlySense® 2.0 System isintended for continuousmeasurement of respirationrate, heart rate and movementin an automatic, contact-lessmanner at a home, hospital orclinical setting. The system isindicated for use in children,adolescents, and adults. Theoperation of the EarlySense®2.0 System has been studied inchildren (weight ≥ 22 lbs [10kg]) and adults (weight < 245lbs [111 kg]) during sleep andresting conditions.	Equivalent:Additionalwording relevantto use with a bedsystem.
	The system has been validatedto withstand up to 700 lbs (318kg).	[Elsewhere in Manual: Do notuse the EarlySense® 2.0 Systemfor patients who weigh morethan 200 kg (440 lbs)]	Different:Testing provided
	NOTE: Do not exceed the limit ofthe Bed System for weight,population, or use setting.	In addition, the EarlySense® 2.0System can continuouslymonitor oxygen saturation ofArterial Hemoglobin (SpO2)using Pulse Oximetry inpediatric (ages 2 years andolder), adolescents and adultsat a home, hospital, or clinicalsetting.	Different: Withinthe scope of thepredicatecapabilities.
For Use With	Hospital Beds	Hospital Beds and Chairs	Similar
Sensing Unit	Contactless, piezoelectricsensing unit	Contactless, piezoelectricsensing unit	Same
Bedside Display	Utilizes bed system display	K152911: No bedside displayK131379: Stand-alone bedsidedisplay	Equivalent
Sensing andAnalysisAlgorithms	Proprietary, developed byEarlySense®	Proprietary, developed byEarlySense®	Same
RespiratoryRate Range	6 - 45 Breaths/minute	6 - 45 Breaths/minute	Same
Heart RateRange	30 – 170 beats per minute	30 – 170 beats per minute	Same
PerformanceTesting	IEC/AAMI/ANSI/ES 60601-1IEC 60601-1-2IEC 60601-1-6	IEC/AAMI/ANSI/ES 60601-1IEC 60601-1-2IEC 60601-1-6	Same
Technological	Subject Device	Predicate / Reference Device(K152911 unless noted)	Comparison
Characteristic
	IEC 60601-2-49	IEC 60601-2-49
	ISO 14971	ISO 14971
	AAMI/ANSI HE75	AAMI/ANSI HE75
	AAMI/ANSI/IEC 62366-1	AAMI/ANSI/IEC 62366-1
	AAMI/ANSI/IEC 62304	AAMI/ANSI/IEC 62304
	Durability Testing (Sensor)	Durability Testing (Sensor)
	Accuracy Testing	Accuracy Testing

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Basis of Substantial Equivalence / Conclusion:

The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® is similar and substantially equivalent to the predicate device with respect to technological characteristics, intended use, function, and performance. The information provided within this premarket notification supports substantial equivalence 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).