(29 days)
Not Found
No
The summary describes a system for continuous, contactless measurement of heart and respiration rate using a sensor and software for data analysis and display. It does not mention any AI or ML algorithms being used for this analysis or any other function. The software is described as identical to that cleared in a previous 510(k), which also does not indicate the presence of AI/ML.
No.
The device is strictly for monitoring heart and respiration rates and provides alerts when these rates exceed predefined thresholds; it does not provide any therapy or treatment.
No
Justification: The device is described as a "monitoring system" that measures heart and respiration rates and provides alerts when these rates are outside predefined thresholds. While it provides data that can inform medical care, the document explicitly states that a software failure could lead to "erroneous diagnosis or a delay in delivery of appropriate medical care," implying that it itself is not making a diagnosis. Its function is to provide continuous measurement and alerts, not to diagnose.
No
The device description explicitly states that the system consists of a "Bed Sensing Unit" (sensor) which is a hardware component placed under the mattress, and also mentions "device hardware, specifically the connection between the sensor and appropriate bed system". While it includes software, it is not solely software.
Based on the provided information, the Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Hillrom system measures physiological parameters (heart rate and respiration rate) directly from the patient's body in a contactless manner. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use is for continuous measurement of respiration rate and heart rate in a clinical setting for monitoring purposes. This is a direct physiological measurement, not an in vitro test.
Therefore, the Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense falls under the category of a non-IVD medical device.
N/A
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) 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.
Product codes
BZQ
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
- Software for data analysis, display, and input
- The device hardware, specifically the connection between the sensor and appropriate bed system
- Hillrom Connectivity Solution (aka Hillrom Digital Health Gateway)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
children, adolescents, and adults
Intended User / Care Setting
hospitals or clinical settings. Professional healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
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) | |
|---|---|
| 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 Respiration | |||
| 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 ●
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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
Monitoring System
SUBJECT | Heart and Respiration Rate
Monitoring System
PREDICATE Cleared under
K202018 | Assessment of
Differences |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| 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
Heart Rate | Respiratory Rate
Heart Rate | Same |
| User Interface and
Display | Graphical display and
interface unit integrated into a
bed | Graphical display and interface
unit integrated into a bed | Same |
| Manufacturer of
Device | Hill-Rom® | Hill-Rom® | Same |
| Analysis
Algorithms
Manufacturer | EarlySense® | EarlySense® | Same |
| 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 | The Hill-Rom Heart and
Respiration Rate Monitoring
System powered by
EarlySense® is used with
compatible bed system models
and is intended for continuous
measurement of respiration rate
and heart rate in an automatic,
contact-less manner. The
system is indicated for use in
children, adolescents, and
adults in hospitals or clinical
settings. It is intended to be
used for the same patient
populations and the same
settings, within these ranges, as
the bed with which it is used.
The system has been validated
to withstand up to 700 lbs (318
kg).
NOTE: Do not exceed the limit
of the Bed System for weight, | Same |
| Features | Heart and Respiration Rate
Monitoring System
SUBJECT
weight, population, or use
setting. | Heart and Respiration Rate
Monitoring System
PREDICATE Cleared under
K202018 | Assessment of
Differences |
| Total System
Accuracy
(including
undetected
signals) | 90%
(measured as ±10% of
predicate) | 90%
(measured as ±10% of
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
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
Threshold | 35 BPM | 35 BPM | Same |
| Highest Settable
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 greater | ±4% or ±1.5 Br./min whichever
is greater | Same |
| Default Threshold
Low | 8 Br./min | 8 Br./min | Same |
| Default Threshold
High | 32 Br./min | 32 Br./min | Same |
| Lowest Settable
Threshold | 8 Br./min | 8 Br./min | Same |
| Highest Settable
Threshold | 44 Br./min | 44 Br./min | Same |
| Charts | Separate charts for heart rate
and respiratory rate | Separate charts for heart rate
and respiratory rate | Same |
| Time Periods | Default 8 hours
Range 10 minutes to 7 days | Default 8 hours
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
Monitoring System
SUBJECT | Heart and Respiration Rate
Monitoring System
PREDICATE Cleared under
K202018 | Assessment of
Differences |
| For Use With | Hospital beds | Hospital beds | Same |
| Sensor | Contactless piezoelectric
sensing unit | 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 years of continuous use | 5 years of continuous use | Same |
| NOTE: Usage
Life | The HR/RR Monitoring
sensor must be replaced after
five years of continuous use to
make sure the system operates
correctly. A notification will
show on the GCI when it is
time to replace the sensor. | The HR/RR Monitoring sensor
must be replaced after five
years of continuous use to make
sure the system operates
correctly. A notification will
show on the GCI when it is
time to replace the sensor. | |
| Water Resistance | IPX4 | IPX4 | Same |
| Manufacturer | EarlySense | EarlySense | Same |
| Sensor Location | Located on bed deck, under
mattress – knobs to facilitate
placement | 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
information from sensor and
user input | Analyzes and interprets
information from sensor and
user input | Same |
| Software for
Display | Acts as a conduit to send data
to/from bed system display | Acts as a conduit to send data
to/from bed 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 of
Concern | Moderate | Moderate | Same |
| Features | Heart and Respiration Rate
Monitoring System
SUBJECT | Heart and Respiration Rate
Monitoring System
PREDICATE Cleared
under K202018 | Assessment of
Differences |
| Connectivity | Can connect to the user nurse
call system though Bluetooth,
and hard-wired connection.
Can connect to the Hillrom
Connectivity solution through
both wired and wireless
connection. | Can connect to the user nurse
call system though hard-wired
connection. Can connect to the
Hillrom Connectivity solution
through both wired and
wireless connection. | Different;
Bluetooth
communication
has been added
for the subject
device. |
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.