Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation

K202018 · Hill-Rom, Inc. · BZQ · Mar 4, 2021 · Anesthesiology

Device Facts

• Record ID: K202018
• Device Name: Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation
• Applicant: Hill-Rom, Inc.
• Product Code: BZQ · Anesthesiology
• Decision Date: Mar 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

System provides continuous, contact-free heart and respiration rate monitoring; utilizes piezoelectric sensor placed under mattress on hospital bed frame. Sensor captures mechanical signals; software analyzes and interprets data to derive heart and respiratory rates. Output displayed on bed's graphical caregiver interface (GCI); system transmits data via wired/wireless channels to Hillrom Connectivity Solution. Alerts (audible/visible) triggered when rates exceed predefined thresholds; integrates with existing nurse call systems. Used by clinicians in hospitals/clinical settings to aid evaluation of patient clinical status; adjunctive tool only. Benefits include continuous monitoring without patient contact, facilitating timely clinical intervention.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including software verification and validation, electromagnetic compatibility (IEC 60601-1-2), wireless coexistence (IEEE/ANSI C63.27), and usage life testing.

Technological Characteristics

Contactless piezoelectric sensing unit; ABS and polycarbonate construction. Dimensions 42 x 21 x 1.4 cm; weight 730g. Powered by AC source via bed frame connection. IPX4 water resistance. Connectivity via wired/wireless modules to Hillrom Connectivity Solution and nurse call systems. Software level of concern: Moderate.

Indications for Use

Indicated for continuous, automatic, contact-less measurement of heart rate and respiration rate in children, adolescents, and adults in hospital or clinical settings. Contraindicated for use exceeding the weight, population, or setting limits of the host bed system.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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).

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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <svg height="16" width="16"> <path d="M2 2 L14 14 M2 14 L14 2" stroke="black" stroke-width="2"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

Section 5

### I. SUBMITTER

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

Phone: [phone] Fax: [phone]

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

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.

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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 Rate<br>Monitoring System (Subject) | Vitals Monitoring System<br>(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 Rate<br>Monitoring System (Subject) | Vitals Monitoring System<br>(Predicate K180079) | Comparison |
| | Heart Rate | Heart Rate | Same |
| User Interface and<br>Display | Graphical display and interface unit<br>integrated into a bed | Graphical display and interface unit<br>integrated into a bed | Same |
| Manufacturer of<br>Device | Hill-Rom® | Hill-Rom® | Same |
| Analysis Algorithms<br>Manufacturer | EarlySense® | EarlySense® | Same |
| Indications for Use | The Hillrom™ Heart and Respiration<br>Rate Monitoring System powered by<br>EarlySense is used with compatible<br>bed system models and is intended<br>for continuous measurement of<br>respiration rate (RR) and heart rate<br>(HR) in an automatic, contact-less<br>manner. The system is indicated for<br>use in children, adolescents, and<br>adults in hospitals or clinical<br>settings. It is intended to be used for<br>the same patient populations and<br>the same settings, within these<br>ranges, as the bed with which it is<br>used. The system has been validated<br>to withstand up to 700 lb. (318 kg).<br><br>NOTE: Do not exceed the limit of the<br>bed system for weight, population,<br>or use setting. | The Hill-Rom® Heart and Respiration<br>Rate Monitoring System powered by<br>EarlySense® is used with compatible<br>bed system models and is intended for<br>continuous measurement of<br>respiration rate and heart rate in an<br>automatic, contact-less manner. The<br>system is indicated for use in children,<br>adolescents, and adults in hospitals or<br>clinical settings. It is intended to be<br>used for the same patient populations<br>and the same settings, within these<br>ranges, as the bed with which it is<br>used. The system has been validated<br>to withstand up to 700 lbs. (318 kg).<br><br>NOTE: Do not exceed the limit of the<br>Bed System for weight, population, or<br>use setting. | Same |
| Total System Accuracy<br>(including undetected<br>signals) | 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 Settable<br>Threshold | 35 BPM | 35 BPM | Same |
| Highest Settable<br>Threshold | 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 is<br>greater | ±4% or ±1.5 Br./min whichever is<br>greater | Same |
| Default Threshold Low | 8 Br./min | 8 Br./min | Same |
| Default Threshold High | 32 Br./min | 32 Br./min | Same |
| Lowest Settable<br>Threshold | 8 Br./min | 8 Br./min | Same |
| Highest Settable<br>Threshold | 44 Br./min | 44 Br./min | Same |
| Element | Heart and Respiration Rate<br>Monitoring System (Subject) | Vitals Monitoring System<br>(Predicate K180079) | Comparison |
| Charts | Separate charts for heart rate and<br>respiratory rate | Separate charts for heart rate and<br>respiratory rate | Same |
| Time Periods | Default 8 hours<br>Range 10 minutes to 7 days | Default 8 hours<br>Range 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 sensing<br>unit | Contactless piezoelectric sensing unit | Same |
| Sensor Dimension<br>(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 must<br>be replaced after five years of<br>continuous use to make sure the<br>system operates correctly. A<br>notification will show on the GCI<br>when it is time to replace the<br>sensor. | The EarlySense sensor must be<br>replaced after one year of continuous<br>use to make sure the system operates<br>correctly. A notification will show on<br>the GCI when it is time to replace the<br>sensor. | |
| Water Resistance | IPX4 | IPX4 | Same |
| Manufacturer | EarlySense | EarlySense | Same |
| Sensor Location | Located on bed deck, under<br>mattress – knobs to facilitate<br>placement | Located on bed deck, under mattress<br>– knobs to facilitate placement | Same |
| Hardware “Host”<br>(Non-Sensor) | Bed System | Bed System | Same |
| Software for Analysis | Analyzes and interprets information<br>from sensor and user input | Analyzes and interprets information<br>from sensor and user input | Same |
| Software for Display | Acts as a conduit to send data<br>to/from bed system display | Acts as a conduit to send data to/from<br>bed system display | Same |
| Additional Capabilities | None | None | Same |
| Energy Source | AC power source…