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).

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 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
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.

AI/ML Overview

The provided text focuses on the substantial equivalence of the Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense to a predicate device, K202018. It does not contain a dedicated study section detailing acceptance criteria for the device itself or a study proving those criteria are met.

However, the "Comparison of Subject to Predicate: Technology and Specifications" table (Table 2) lists certain performance characteristics identified as "Accuracy" for Heart Rate and Respiratory Rate, which can be interpreted as acceptance criteria based on the predicate device's established performance.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the comparison table (Table 2), the "Accuracy" values for the subject device are stated to be the same as the predicate device. Therefore, we can infer the acceptance criteria for these specific metrics by looking at the predicate's reported performance.

Metric	Acceptance Criteria (Inferred from Predicate)	Reported Device Performance (Subject Device)
Total System Accuracy (including undetected signals)	90% (measured as ±10% of predicate)	90% (measured as ±10% of predicate)
Heart Rate Accuracy	±4% or ±5 BPM whichever is greater	±4% or ±5 BPM whichever is greater
Respiratory Rate Accuracy	±4% or ±1.5 Br./min whichever is greater	±4% or ±1.5 Br./min whichever is greater

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

The document does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the accuracy testing of the subject device. It states, "Extensive testing has been conducted on the finished Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense and demonstrates that the System is as safe and as effective as the predicate device." However, no specifics about these "extensive tests" are provided beyond non-clinical tests like EMC, Software V&V, Cybersecurity, and Coexistence testing.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the performance metrics listed. It does not describe how the ground truth for the accuracy measurements (Heart Rate and Respiratory Rate) was established.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not describe any adjudication method used for establishing ground truth or evaluating the test set performance.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a monitoring system and does not typically involve human "readers" or an AI component that assists in interpreting medical images or complex data in a way that would be assessed by MRMC.

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

The entire description of the device focuses on its standalone performance in continuously measuring heart and respiration rates. The accuracy values provided are for the system itself. Therefore, it can be inferred that standalone performance testing was done for the algorithm. However, no specific study details are provided, only that the reported accuracy performance (same as predicate) was met.

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

The document does not explicitly state the type of ground truth used for measuring the Heart Rate and Respiratory Rate accuracy. Given the nature of vital sign monitoring, the ground truth would typically be established by simultaneously recorded, highly accurate reference devices (e.g., ECG for heart rate, capnography or direct spirometry for respiration rate) in a controlled environment, rather than expert consensus, pathology, or outcomes data in the usual sense.

8. The sample size for the training set

The document describes the device as being "powered by EarlySense" and states that "The software for data analysis is identical to that cleared in K202018." This suggests the core algorithms and models were developed and potentially trained earlier as part of the predicate device's development. However, the document does not provide information on the sample size used for the training set.

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

Similar to point 8, the document states the software and analysis algorithms developed by EarlySense are identical to the predicate device. There is no information provided within this document about how the ground truth for any potential training set for these algorithms was established.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

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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 Shah1@baxter.com Telephone: 984-270-9799 Fax: 812-934-1675

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 RespirationRate 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 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 RateMonitoring SystemSUBJECT	Heart and Respiration RateMonitoring SystemPREDICATE Cleared underK202018	Assessment ofDifferences
FDA ProductCode	BZQ	BZQ	Same
FDA Class	Class II	Class II	Same
Regulation Code	868.2375	868.2375	Same
FDA CommonNames	Breathing Frequency Monitor	Breathing Frequency Monitor	Same
Measures andDisplays	Respiratory RateHeart Rate	Respiratory RateHeart Rate	Same
User Interface andDisplay	Graphical display andinterface unit integrated into abed	Graphical display and interfaceunit integrated into a bed	Same
Manufacturer ofDevice	Hill-Rom®	Hill-Rom®	Same
AnalysisAlgorithmsManufacturer	EarlySense®	EarlySense®	Same
Indications forUse	The Hillrom Heart andRespiration Rate MonitoringSystem powered byEarlySense is used withcompatible bed systemmodels and is intended forcontinuous measurement ofrespiration rate (RR) and heartrate (HR) in an automatic,contact-less manner. Thesystem is indicated for use inchildren, adolescents, andadults in hospitals or clinicalsettings. It is intended to beused for the same patientpopulations and the samesettings, within these ranges,as the bed with which it isused. The system has beenvalidated to withstand up to700 lb (318 kg).NOTE: Do not exceed thelimit of the bed system for	The Hill-Rom Heart andRespiration Rate MonitoringSystem powered byEarlySense® is used withcompatible bed system modelsand is intended for continuousmeasurement of respiration rateand heart rate in an automatic,contact-less manner. Thesystem is indicated for use inchildren, adolescents, andadults in hospitals or clinicalsettings. It is intended to beused for the same patientpopulations and the samesettings, within these ranges, asthe bed with which it is used.The system has been validatedto withstand up to 700 lbs (318kg).NOTE: Do not exceed the limitof the Bed System for weight,	Same
Features	Heart and Respiration RateMonitoring SystemSUBJECTweight, population, or usesetting.	Heart and Respiration RateMonitoring SystemPREDICATE Cleared underK202018	Assessment ofDifferences
Total SystemAccuracy(includingundetectedsignals)	90%(measured as ±10% ofpredicate)	90%(measured as ±10% ofpredicate)	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 isgreater	±4% or ±5 BPM whichever isgreater	Same
Default ThresholdLow	40 BPM	40 BPM	Same
Default ThresholdHigh	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./minwhichever is greater	±4% or ±1.5 Br./min whicheveris greater	Same
Default ThresholdLow	8 Br./min	8 Br./min	Same
Default ThresholdHigh	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
Charts	Separate charts for heart rateand respiratory rate	Separate charts for heart rateand respiratory 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
Features	Heart and Respiration RateMonitoring SystemSUBJECT	Heart and Respiration RateMonitoring SystemPREDICATE Cleared underK202018	Assessment ofDifferences
For Use With	Hospital beds	Hospital beds	Same
Sensor	Contactless piezoelectricsensing unit	Contactless piezoelectricsensing 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 years of continuous use	5 years of continuous use	Same
NOTE: UsageLife	The HR/RR Monitoringsensor must be replaced afterfive years of continuous use tomake sure the system operatescorrectly. A notification willshow on the GCI when it istime to replace the sensor.	The HR/RR Monitoring sensormust be replaced after fiveyears of continuous use to makesure the system operatescorrectly. A notification willshow on the GCI when it istime to replace the sensor.
Water Resistance	IPX4	IPX4	Same
Manufacturer	EarlySense	EarlySense	Same
Sensor Location	Located on bed deck, undermattress – knobs to facilitateplacement	Located on bed deck, undermattress - knobs to facilitateplacement	Same
Hardware "Host"(Non-Sensor)	Bed System	Bed System	Same
Software forAnalysis	Analyzes and interpretsinformation from sensor anduser input	Analyzes and interpretsinformation from sensor anduser input	Same
Software forDisplay	Acts as a conduit to send datato/from bed system display	Acts as a conduit to send datato/from bed system display	Same
AdditionalCapabilities	None	None	Same
Energy Source	AC power source	AC power source	Same
Backup Battery	No	No	Same
Environments	Professional healthcarefacilities	Professional healthcarefacilities	Same
Alert Indications	Visible and Audible	Visible and Audible	Same
Software Level ofConcern	Moderate	Moderate	Same
Features	Heart and Respiration RateMonitoring SystemSUBJECT	Heart and Respiration RateMonitoring SystemPREDICATE Clearedunder K202018	Assessment ofDifferences
Connectivity	Can connect to the user nursecall system though Bluetooth,and hard-wired connection.Can connect to the HillromConnectivity solution throughboth wired and wirelessconnection.	Can connect to the user nursecall system though hard-wiredconnection. Can connect to theHillrom Connectivity solutionthrough both wired andwireless connection.	Different;Bluetoothcommunicationhas been addedfor the subjectdevice.

Table 2. Comparison of Subject to Predicate: Technology and Specifications

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Table 2. Comparison of Subject to Predicate: Technology and Specifications

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Table 2. Comparison of Subject to Predicate: Technology and Specifications

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Table 2. Comparison of Subject to Predicate: Technology and Specifications

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DISCUSSION OF NONCLINICAL TESTS:

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 testing were conducted for the modification 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 delav in delivery of appropriate medical care that would likely lead to minor injury.
. Cybersecurity Testing - Cybersecurity concerns for monitoring system were addressed in accordance with FDA's "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff' document issued October 2, 2014.
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.

CONCLUSION:

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. Extensive testing has been conducted on the finished Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense and demonstrates that the System is as safe and as effective as 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).