Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense

K223246 · Baxter Healthcare Corproration · BZQ · Nov 18, 2022 · Anesthesiology

Device Facts

• Record ID: K223246
• Device Name: Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
• Applicant: Baxter Healthcare Corproration
• Product Code: BZQ · Anesthesiology
• Decision Date: Nov 18, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

System provides continuous, contactless heart rate (HR) and respiration rate (RR) monitoring; utilizes piezoelectric sensor placed under mattress on hospital bed frame. Sensor connects to bed system for power and data transmission; data displayed on bed's graphical caregiver interface (GCI). System transmits alerts via Bluetooth to nurse call systems, speakers, or lights; also connects to Hillrom Connectivity Solution for storage/display. Healthcare professionals configure thresholds and monitoring parameters via GCI. Alerts trigger when HR/RR exceed predefined limits. Benefits include automated, non-invasive patient monitoring, reducing manual checks and enabling timely clinical intervention. Device intended for professional healthcare facilities; operated by clinical staff.

Clinical Evidence

Bench testing only. Performance verified through software verification/validation, EMC testing (IEC 60601-1-2), cybersecurity assessment, and wireless coexistence testing (IEEE/ANSI C63.27). No clinical data presented.

Technological Characteristics

Piezoelectric sensor (42x21x1.4 cm, 730g) made of ABS/Polycarbonate; IPX4 water resistance. Operates via AC power from host bed. Connectivity: wired/wireless to Hillrom Connectivity Solution; Bluetooth/hard-wired to nurse call. Software level of concern: Moderate. 5-year usage life.

Indications for Use

Indicated for continuous, contactless heart and respiration rate monitoring in children, adolescents, and adults within 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

• Heart Rate and Respiration Rate Monitoring System (K202018)

Submission Summary (Full Text)

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November 18, 2022

Baxter Healthcare Corproration Jigar Shah Senior Manager, Regulatory Affairs 1069 State Route 46 East Batesville, Indiana 47006

Re: K223246

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: October 20, 2022 Received: October 20, 2022

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 -S

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

Enclosure

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### Indications for Use

510(k) Number (if known) K223246

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 EarlySense is used with compatible bed system models and is intended for continuous measurement of respiration rate (RR) in an automatic, contactless 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> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### 510(k) Summary

November 18, 2022

#### OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

#### CONTACT PERSON:

Jigar Shah Senior Manager, Regulatory Affairs 1069 State Route 46 East Batesville, Indiana 47006, USA Jigar [e-mail] Telephone: [phone] Fax: [phone]

#### IDENTIFICATION OF THE DEVICE:

Common Name: Heart Rate and Respiration Rate Monitoring System Trade/Device Name: Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense Classification Panel: Anesthesiology Regulation Number: (21 CFR 868.2375) Regulation Name: Monitor, Breathing Frequency Regulatory Class: Class II Product Code: BZQ

#### PREDICATE DEVICE:

Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense

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| Device | Company | Predicate 510(k) | Clearance Date |
|------------------------------------------------------|----------------|------------------|----------------|
| Heart Rate and Respiration<br>Rate Monitoring System | Hill-Rom, Inc. | K202018 | March 4, 2021 |

#### Table 1. Predicate Device(s)

#### DESCRIPTION OF THE DEVICE:

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 via Bloetooth 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 GCI. 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
- This is functionally identical to the sensor cleared in K202018 -
- Software for data analysis, display, and input ●
- The software for data analysis is identical to that cleared in K202018 -
- The software for display and input is identical to the software cleared in -K202018

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- The device hardware, specifically the connection between the sensor and • appropriate bed system
- The hardware for the device is identical to that cleared in K202018 -
- The Heart and Respiration Rate Monitoring System also uses certain hardware, such as the graphical caregiver interface and wireless communication module, of an appropriate bed system
- Hillrom Connectivity Solution (aka Hillrom Digital Health Gateway) .
- The Hillrom Digital Health Gateway consists of gateways that make information about the bed and patient available to 3rd party applications. This is functionally identical to that cleared in K202018.

### 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.

### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

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.

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| Features | Heart and Respiration Rate<br>Monitoring System<br>SUBJECT | Heart and Respiration Rate<br>Monitoring System<br>PREDICATE Cleared under<br>K202018 | Assessment of<br>Differences |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| FDA Product<br>Code | BZQ | BZQ | Same |
| FDA Class | Class II | Class II | Same |
| Regulation Code | 868.2375 | 868.2375 | Same |
| FDA Common<br>Names | Breathing Frequency Monitor | Breathing Frequency Monitor | Same |
| Measures and<br>Displays | Respiratory Rate<br>Heart Rate | Respiratory Rate<br>Heart Rate | Same |
| User Interface and<br>Display | Graphical display and<br>interface unit integrated into a<br>bed | Graphical display and interface<br>unit integrated into a bed | Same |
| Manufacturer of<br>Device | Hill-Rom® | Hill-Rom® | Same |
| Analysis<br>Algorithms<br>Manufacturer | EarlySense® | EarlySense® | Same |
| Indications for<br>Use | The Hillrom Heart and<br>Respiration Rate Monitoring<br>System powered by<br>EarlySense is used with<br>compatible bed system<br>models and is intended for<br>continuous measurement of<br>respiration rate (RR) and heart<br>rate (HR) in an automatic,<br>contact-less manner. The<br>system is indicated for use in<br>children, adolescents, and<br>adults in hospitals or clinical<br>settings. It is intended to be<br>used for the same patient<br>populations and the same<br>settings, within these ranges,<br>as the bed with which it is<br>used. The system has been<br>validated to withstand up to<br>700 lb (318 kg).<br>NOTE: Do not exceed the<br>limit of the bed system for | The Hill-Rom Heart and<br>Respiration Rate Monitoring<br>System powered by<br>EarlySense® is used with<br>compatible bed system models<br>and is intended for continuous<br>measurement of respiration rate<br>and heart rate in an automatic,<br>contact-less manner. The<br>system is indicated for use in<br>children, adolescents, and<br>adults in hospitals or clinical<br>settings. It is intended to be<br>used for the same patient<br>populations and the same<br>settings, within these ranges, as<br>the bed with which it is used.<br>The system has been validated<br>to withstand up to 700 lbs (318<br>kg).<br>NOTE: Do not exceed the limit<br>of the Bed System for weight, | Same |
| Features | Heart and Respiration Rate<br>Monitoring System<br>SUBJECT<br>weight, population, or use<br>setting. | Heart and Respiration Rate<br>Monitoring System<br>PREDICATE Cleared under<br>K202018 | Assessment of<br>Differences |
| Total System<br>Accuracy<br>(including<br>undetected<br>signals) | 90%<br>(measured as ±10% of<br>predicate) | 90%<br>(measured as ±10% of<br>predicate) | 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<br>greater | ±4% or ±5 BPM whichever is<br>greater | Same |
| Default Threshold<br>Low | 40 BPM | 40 BPM | Same |
| Default Threshold<br>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<br>whichever is greater | ±4% or ±1.5 Br./min whichever<br>is greater | Same |
| Default Threshold<br>Low | 8 Br./min | 8 Br./min | Same |
| Default Threshold<br>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 |
| Charts | Separate charts for heart rate<br>and respiratory rate | Separate charts for heart rate<br>and 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 |
| Features | Heart and Respiration Rate<br>Monitoring System<br>SUBJECT | Heart and Respiration Rate<br>Monitoring System<br>PREDICATE Cleared under<br>K202018 | Assessment of<br>Differences |
| For Use With | Hospital beds | Hospital beds | Same |
| Sensor | Contactless piezoelectric<br>sensing unit | Contactless piezoelectric<br>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 years of continuous use | 5 years of continuous use | Same |
| NOTE: Usage<br>Life | The HR/RR Monitoring<br>sensor must be replaced after<br>five years of continuous use to<br>make sure the system operates<br>correctly. A notification will<br>show on the GCI when it is<br>time to replace the sensor. | The HR/RR Monitoring sensor<br>must be replaced after five<br>years of continuous use to make<br>sure the system operates<br>correctly. A notification will<br>show on the GCI when it is<br>time to replace the 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<br>mattress - knobs to facilitate<br>placement | Same |
| Hardware "Host"<br>(Non-Sensor) | Bed System | Bed System | Same |
| Software for<br>Analysis | Analyzes and interprets<br>information from sensor and<br>user input | Analyzes and interprets<br>information from sensor and<br>user input | Same |
| Software for<br>Display | Acts as a conduit to send data<br>to/from bed system display | Acts as a conduit to send data<br>to/from bed system display | Same |
| Additional<br>Capabilities | None…