The Hillrom™ Heart and Respiration Rate Monitoring System powered by Early Sense is used with compatible bed system models and is intended for continuous measurement of respiration rate (RR) 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 lb (318 kg).

Device Description

The Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense is designed for continuous and contact-free measurement of heart and respiratory rate (also referred to as Bed Sensing Unit). This device is used with a hospital bed system which is exempt from 510(k) premarket submission requirements. The Bed Sensing Unit (sensor) plugs into the bed frame to both receive power and to transmit data. Data from the System is available on the bed's graphical caregiver interface (GCI)/display unit and can be transmitted through wired and wireless communication channels to Hillrom Connectivity Solution (also known as (aka)- Hillrom Digital Health Gateway) for display, use, and storage. Additionally, the System can transmit alerts to an existing hardwired Nurse Call system, speakers, and/or on/off alert lights within a bed system. The healthcare professional can adjust monitoring parameters by interacting with the bed's GCl. These parameters include hospital-defined alert thresholds, display settings, and alert configurations. The system provides alerts when patient heart rate and/or respiratory rate are recorded that are above or below the predefined thresholds.

The Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense consists of:

The Bed Sensing Unit, placed on a 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

AI/ML Overview

This document describes the Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense, which is intended for continuous, contact-less measurement of respiration rate (RR) and heart rate (HR) in children, adolescents, and adults in hospitals or clinical settings. It is validated to withstand up to 700 lb (318 kg).

Table of acceptance criteria and reported device performance:

Metric	Acceptance Criteria	Reported Performance
Total System Accuracy	90% (including undetected signals)	90%
Heart Rate Detection	30 – 170 BPM	30 – 170 BPM
Heart Rate Accuracy	±4% or ±5 BPM whichever is greater	±4% or ±5 BPM whichever is greater
Respiration Rate Detection Range	6 - 45 Br./min	6 - 45 Br./min
Respiration Rate Accuracy	±4% or ±1.5 Br./min whichever is greater	±4% or ±1.5 Br./min whichever is greater
Usage Life of Sensor	5 years of continuous use	5 years of continuous use (tested)
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2	Complies with IEC 60601-1-2
Software Verification & Validation	As per FDA guidance for "moderate" concern level software	Performed and documented
Wireless Coexistence	Meets acceptance criteria for wireless coexistence (IEEE/ANSI C63.27)	Meets acceptance criteria

Sample size used for the test set and data provenance:
The document does not specify a distinct "test set" in terms of patient data for clinical performance evaluation, as clinical testing was not required to demonstrate substantial equivalence. The performance metrics listed above (accuracy, detection range) are identical to the predicate device (K180079), implying that the performance of the core sensing technology and algorithms remains unchanged. The new device's acceptance criteria primarily relate to updated hardware (extended usage life of the sensor) and connectivity features, along with regulatory compliance testing (EMC, software V&V, wireless coexistence).
- Usage Life Testing:
  - Sample Size: Not specified for "Usage Life Testing."
  - Data Provenance: Not specified, but likely refers to lab-based or engineering durability testing, not patient data.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
Not applicable, as clinical testing (which would typically involve expert ground truth establishment) was not required for this 510(k) submission. The performance metrics are based on the predicate device's established performance.
Adjudication method for the test set:
Not applicable, as clinical testing was not required.
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:
Not applicable. This device is a monitoring system and does not involve "human readers" interpreting AI output for diagnostic purposes in the context of an MRMC study. It provides raw physiological data (HR and RR) and alerts based on configurable thresholds.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the performance characteristics (Heart Rate Accuracy, Respiration Rate Accuracy) represent the standalone performance of the algorithm integrated into the device, measuring these parameters in a contact-less manner. The document states, "The data provided by this system is intended to aid a clinician in the evaluation process of a patient's clinical status and should be interpreted by a healthcare professional only. The Hillrom™ 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 contact-free measurement of respiration rate and heart rate." This confirms its standalone measurement capability.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the core physiological measurements (HR and RR), the ground truth referenced for the predicate device's performance would have likely been established through comparison with a gold-standard reference monitor (e.g., ECG for HR, capnography or respiratory plethysmography for RR) during its original validation. For the current submission, which establishes substantial equivalence, the performance specifications are stated to be the same as the predicate device, K180079.
The sample size for the training set:
Not specified. The document states that the software for data analysis, display, and input is identical to that cleared in K180079. Therefore, any training data used for the algorithms would have been part of the development and validation of the predicate device, and details are not provided in this 510(k) summary.
How the ground truth for the training set was established:
Not specified. Given the software's identity to the predicate device, the ground truth for any training would have been established during the development of the predicate device's algorithms, likely by comparing the device's measurements to gold-standard reference measurements from patients under various conditions.

Summary

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March 4, 2021

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

Re: K202018

Trade/Device Name: Hillrom™ 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: February 3, 2021 Received: February 5, 2021

Dear Jigar Shah:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202018

Device Name

Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense

Indications for Use (Describe)

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)
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Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Section 5

I. SUBMITTER

Hill-Rom, Inc. 1069 State Route 46 East Batesville, IN 47006

Phone: 919-743-1170 Fax: 812-934-1675

Contact Person: Jigar Shah Date Prepared: February 1, 2021

II. DEVICE

Name of Device: Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense Common or Usual Name: Heart Rate and Respiration Rate Monitoring System Classification Name: Breathing Frequency Monitor (21 CFR 868.2375) Regulatory Class: II Product Code: BZQ

III. PREDICATE DEVICE

Hill-Rom® Vitals Monitoring System powered by EarlySense® (K180079)

IV. DEVICE DESCRIPTION

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The Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense consists of:

The Bed Sensing Unit, placed on a bed frame under the mattress
- This is functionally identical to the sensor cleared in K180079 O
. Software for data analysis, display, and input

The software for data analysis is identical to that cleared in K180079 о
The software for display and input is identical to the software cleared in K180079 O
. The device hardware, specifically the connection between the sensor and appropriate bed system
- The hardware for the device is identical to that cleared in K180079 O
- The Heart and Respiration Rate Monitoring System also uses certain hardware, such as O the graphical caregiver interface and wireless communication module, of an appropriate bed system

The data provided by this system is intended to aid a clinician in the evaluation process of a patient's clinical status and should be interpreted by a healthcare professional only. The Hillrom™ 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 contact-free measurement of respiration rate and heart rate.

V. INTENDED USE/INDICATIONS FOR USE

The Hillrom™ 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 (RR) and heart rate (HR) 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 lb. (318 kg).

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

The indications for use statement for the subject and predicate devices are identical.

VI. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense is similar to the predicate device, the Hill-Rom® Vitals Monitoring System powered by EarlySense®, with respect to technical characteristics, intended use, function, performance, safety and effectiveness. The differences between the predicate and subject devices do not raise new questions regarding safety or effectiveness.

Element	Heart and Respiration RateMonitoring System (Subject)	Vitals Monitoring System(Predicate K180079)	Comparison
FDA Product Code	BZQ	BZQ	Same
FDA Class	Class II	Class II	Same
Regulation Code	868.2375	868.2375	Same
FDA Common Names	Breathing Frequency Monitor	Breathing Frequency Monitor	Same
Measures and Displays	Respiratory Rate	Respiratory Rate	Same
Element	Heart and Respiration RateMonitoring System (Subject)	Vitals Monitoring System(Predicate K180079)	Comparison
	Heart Rate	Heart Rate	Same
User Interface andDisplay	Graphical display and interface unitintegrated into a bed	Graphical display and interface unitintegrated into a bed	Same
Manufacturer ofDevice	Hill-Rom®	Hill-Rom®	Same
Analysis AlgorithmsManufacturer	EarlySense®	EarlySense®	Same
Indications for Use	The Hillrom™ Heart and RespirationRate Monitoring System powered byEarlySense is used with compatiblebed system models and is intendedfor continuous measurement ofrespiration rate (RR) and heart rate(HR) in an automatic, contact-lessmanner. The system is indicated foruse in children, adolescents, andadults in hospitals or clinicalsettings. It is intended to be used forthe same patient populations andthe same settings, within theseranges, as the bed with which it isused. The system has been validatedto withstand up to 700 lb. (318 kg).NOTE: Do not exceed the limit of thebed system for weight, population,or use setting.	The Hill-Rom® Heart and RespirationRate Monitoring System powered byEarlySense® is used with compatiblebed system models and is intended forcontinuous measurement ofrespiration rate and heart rate in anautomatic, contact-less manner. Thesystem is indicated for use in children,adolescents, and adults in hospitals orclinical settings. It is intended to beused for the same patient populationsand the same settings, within theseranges, as the bed with which it isused. The system has been validatedto withstand up to 700 lbs. (318 kg).NOTE: Do not exceed the limit of theBed System for weight, population, oruse setting.	Same
Total System Accuracy(including undetectedsignals)	90%	90%	Same
Heart Rate	Beats per minute (BPM)	Beats per minute (BPM)	Same
Detection Range	30 – 170 BPM	30 – 170 BPM	Same
Accuracy	±4% or ±5 BPM whichever is greater	±4% or ±5 BPM whichever is greater	Same
Default Threshold Low	40 BPM	40 BPM	Same
Default Threshold High	130 BPM	130 BPM	Same
Lowest SettableThreshold	35 BPM	35 BPM	Same
Highest SettableThreshold	150 BPM	150 BPM	Same
Respiratory Rate	Breaths per minute (Br./min)	Breaths per minute (Br./min)	Same
Detection Range	6 - 45 Br./min	6 - 45 Br./min	Same
Accuracy	±4% or ±1.5 Br./min whichever isgreater	±4% or ±1.5 Br./min whichever isgreater	Same
Default Threshold Low	8 Br./min	8 Br./min	Same
Default Threshold High	32 Br./min	32 Br./min	Same
Lowest SettableThreshold	8 Br./min	8 Br./min	Same
Highest SettableThreshold	44 Br./min	44 Br./min	Same
Element	Heart and Respiration RateMonitoring System (Subject)	Vitals Monitoring System(Predicate K180079)	Comparison
Charts	Separate charts for heart rate andrespiratory rate	Separate charts for heart rate andrespiratory rate	Same
Time Periods	Default 8 hoursRange 10 minutes to 7 days	Default 8 hoursRange 10 minutes to 7 days	Same
Log	Shows a list of Log Alerts	Shows a list of Log Alerts	Same
For Use With	Hospital beds	Hospital beds	Same
Sensor	Contactless piezoelectric sensingunit	Contactless piezoelectric sensing unit	Same
Sensor Dimension(with handle)	42 x 21 x 1.4 cm	42 x 21 x 1.4 cm	Same
Weight	730 g	730 g	Same
Material	ABS & Polycarbonate	ABS & Polycarbonate	Same
Usage Life	5 year of continuous use	1 year of continuous use	Different
NOTE: Usage Life	The HR/RR Monitoring sensor mustbe replaced after five years ofcontinuous use to make sure thesystem operates correctly. Anotification will show on the GCIwhen it is time to replace thesensor.	The EarlySense sensor must bereplaced after one year of continuoususe to make sure the system operatescorrectly. A notification will show onthe GCI when it is time to replace thesensor.
Water Resistance	IPX4	IPX4	Same
Manufacturer	EarlySense	EarlySense	Same
Sensor Location	Located on bed deck, undermattress – knobs to facilitateplacement	Located on bed deck, under mattress– knobs to facilitate placement	Same
Hardware “Host”(Non-Sensor)	Bed System	Bed System	Same
Software for Analysis	Analyzes and interprets informationfrom sensor and user input	Analyzes and interprets informationfrom sensor and user input	Same
Software for Display	Acts as a conduit to send datato/from bed system display	Acts as a conduit to send data to/frombed system display	Same
Additional Capabilities	None	None	Same
Energy Source	AC power source	AC power source	Same
Backup Battery	No	No	Same
Environments	Professional healthcare facilities	Professional healthcare facilities	Same
Alert Indications	Visible and Audible	Visible and Audible	Same
Software Level ofConcern	Moderate	Moderate	Same
Connectivity	Can connect to the user nurse callsystem though hard-wired connection. Can connect tothe Hillrom Connectivitysolution through both wired andwireless connection.	Can connect to customer nurse callsystem through a hard-wiredconnection.	Different

Table 1: Comparison of Subiect to Predicate: Technology and Specifications

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VII. PERFORMANCE DATA

Hill-Rom has verified and validated that the Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense meets its functional, performance, safety, and effectiveness specifications and requirements.

The following performance data were provided in support of the substantial equivalence determination.

Electromagnetic compatibility (EMC)

EMC testing were conducted on the Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense and was tested as an accessory to the bed with which it is currently used. The System is intended for intensive/critical care, acute care, long term care, and outpatient (ambulatory) care environments. The System is not intended for domestic / home care environments. The subject device incorporates wireless functionality. Testing was conducted using standard US power input of 120 volts and 60 hertz frequency, where applicable. The system complies with IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern since a failure or latent flaw in the software could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to minor injury.

Coexistence Testing

Wireless coexistence testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Radio Frequency Wireless Technology in Medical Devices" and the IEEE/ANSI C63.27 American National Standard for Evaluation of Wireless Coexistence. The wireless coexistence testing was performed to verify that the subject device meets the acceptance criteria for wireless coexistence.

Usage Life Testing

Usage Life testing was conducted to demonstrate extended usage life of the bed sensor from 1 year to 5 years.

VIII. CONCLUSIONS

Extensive testing has been conducted on the finished Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense and demonstrate that the System is as safe, as effective, and performs as well as the predicate device. The HR/RR Monitoring System is similar to the predicate device with respect to features, technical characteristics, intended use, and indications for use. The differences do not raise additional or different questions of safety or effectiveness.

Clinical testing was not required to demonstrate substantial equivalence.

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).