(117 days)
No
The document does not mention AI, ML, or any related technologies in the device description or performance studies. The system relies on a sensor and software for data analysis and display, but there is no indication of advanced algorithms or learning capabilities.
No.
The device is described as a monitoring system that provides trending information on heart and respiration rates and helps detect patient deterioration, but it does not claim to treat or cure any disease or condition. It explicitly states it has "not been studied as a diagnostic tool for any specific disease or medical condition" and is meant as an "adjunctive tool only for measuring respiration rate and heart rate."
No
Explanation: The device description explicitly states: "The Hill-Rom® 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 measuring respiration rate and heart rate."
No
The device description explicitly states that the system consists of a "Bed Sensing Unit" (hardware) and "device hardware, specifically the connection between the sensor and appropriate bed system," in addition to software. This indicates it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® measures heart and respiration rate contact-free and externally from the patient's body, using a sensor placed under the mattress. It does not analyze samples taken from the body.
- Intended Use: The intended use is for continuous monitoring of vital signs to provide trending information and help healthcare professionals detect patient deterioration. It is explicitly stated that it has not been studied as a diagnostic tool for any specific disease or medical condition.
Therefore, the device falls under the category of a patient monitoring system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 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, population, or use setting.
Product codes
BZQ
Device Description
The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® is designed for continuous and contact-free measurement of heart and respiratory rate. This device is used with a hospital bed system which is exempt from premarket submission requirements. The Bed Sensing Unit (sensor) attaches to the bed frame and plugs into the bed to both receive power and to transmit data to the bed's graphical user interface/display unit. Additionally, the System can send alarms to an existing hardwired Nurse Call system, speakers, and/or on/off alarm lights within a bed system. The healthcare professional is able to adjust monitoring parameters by interacting with the bed's graphical user interface/display. These parameters include alarm thresholds, display settings, and alarm configurations. The system provides alarm when patient heart rate and/or respiratory rate excurse above or below the predefined thresholds.
The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® consists of:
- . The Bed Sensing Unit, placed on the bed frame under the mattress
- O This is functionally identical to the sensor cleared in K152911
- . Software for data analysis, display, and input
- The software for data analysis is identical to that cleared in K152911
- . The device hardware, specifically the connection between the sensor and appropriate bed system
- O The System also uses the graphical user interface of an appropriate bed system.
The data provided by this system is intended to provide trending information on monitored parameters which should be interpreted by a healthcare professional only. The Hill-Rom® 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 measuring respiration rate and heart rate. The system helps healthcare professionals detect unanticipated patient deterioration quickly by providing heart and respiratory rate continuously rather than through standard periodic caregiver rounding.
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
Used with compatible bed system models. Indicated for use in children, adolescents, and adults in hospitals or clinical settings. Intended to be used for the same patient populations and the same settings, within these ranges, as the bed with which it is used.
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
Study Type: Verification and validation testing.
Sample Size: Not specified.
AUC: Not specified.
MRMC: Not specified.
Standalone Performance: Not specified.
Key results: Hill-Rom has verified and validated that the Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® meets its functional, and performance specifications and requirements. Software and hardware testing of components as well as the final device have been conducted. The device has been tested for compliance to International Standards including the following: IEC/AAMI/ANSI/ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-49, ISO 14971, AAMI/ANSI HE75, AAMI/ANSI/IEC 62366-1, AAMI/ANSI/IEC 62304. Human Factors evaluation was conducted per FDA guidance document "Applying Human Factors and Usability Engineering to Medical Devices". Durability testing was conducted to demonstrate the sensor can withstand weight up to 700 lbs. Additionally, heart rate and respiration rate verification was conducted to determine the accuracy of the system compared to the predicate. The extensive performance testing that has been conducted demonstrate that the System is equivalent to the predicate device. No clinical testing was performed.
Key Metrics
Accuracy of the system compared to the predicate was determined (details not reported).
Predicate Device(s)
EarlySense Ltd. EarlySense® Insight System; Product Code BZQ; K152911
Reference Device(s)
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).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
May 7, 2018
Hill-Rom Inc. Sarah Fitzgerald Regulatory Affairs Manager 1069 State Route 46 East Batesville, Indiana 47006
Re: K180079
Trade/Device Name: Hill-Rom® 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: April 4, 2018 Received: April 5, 2018
Dear Sarah Fitzgerald:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180079
Device Name
Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense®
Indications for Use (Describe)
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 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, population, or use setting.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary: Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense®
| Date Prepared: | May 7, 2018 |
|---|---|
| Company | Hill-Rom, Inc. |
| 1069 State Route 46 East | |
| Batesville, IN 47006 | |
| Contact | Sarah Marie Fitzgerald |
| Regulatory Affairs Manager | |
| 812-931-2924 (telephone) | |
| Device Trade Name | Hill-Rom® Heart and Respiration Rate Monitoring System powered by |
| EarlySense® | |
| Device Common Names | Breathing Frequency Monitor |
| Device Regulation | 21 CFR 868.2375 |
| Classification | Product Code: BZQ; Panel Code 73; Regulatory Class II |
| Predicate Device | EarlySense Ltd. EarlySense® Insight System; Product Code BZQ; K152911 |
Purpose:
The purpose of this submission is to request clearance for the Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense®.
Device Description:
The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® is designed for continuous and contact-free measurement of heart and respiratory rate. This device is used with a hospital bed system which is exempt from premarket submission requirements. The Bed Sensing Unit (sensor) attaches to the bed frame and plugs into the bed to both receive power and to transmit data to the bed's graphical user interface/display unit. Additionally, the System can send alarms to an existing hardwired Nurse Call system, speakers, and/or on/off alarm lights within a bed system. The healthcare professional is able to adjust monitoring parameters by interacting with the bed's graphical user interface/display. These parameters include alarm thresholds, display settings, and alarm configurations. The system provides alarm when patient heart rate and/or respiratory rate excurse above or below the predefined thresholds.
The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® consists of:
- . The Bed Sensing Unit, placed on the bed frame under the mattress
- O This is functionally identical to the sensor cleared in K152911
- . Software for data analysis, display, and input
- The software for data analysis is identical to that cleared in K152911
- . The device hardware, specifically the connection between the sensor and appropriate bed system
- O The System also uses the graphical user interface of an appropriate bed system.
The data provided by this system is intended to provide trending information on monitored parameters which should be interpreted by a healthcare professional only. The Hill-Rom® 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 measuring respiration rate and heart rate. The system helps healthcare
4
professionals detect unanticipated patient deterioration quickly by providing heart and respiratory rate continuously rather than through standard periodic caregiver rounding.
Indications for Use:
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, population, or use setting.
Performance Data:
Hill-Rom has verified and validated that the Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® meets its functional, and performance specifications and requirements. Software and hardware testing of components as well as the final device have been conducted. The device has been tested for compliance to International Standards including the following:
- . IEC/AAMI/ANSI/ES 60601-1 : Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance : Edition 3.1
- . IEC 60601-1-2 : Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests : Edition 4.0
- IEC 60601-1-6 : Medical Electrical Equipment – Part 1-6: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability : Edition 3.1
- IEC 60601-2-49 : Particular Requirements for the Basic Safety and Essential Performance of Multifunction Patient Monitoring Equipment : Edition 2.0
- ISO 14971 : Medical Devices – Application of Risk Management to Medical Devices : 2012 (covers ANSI/AAMI/ISO 14971:2007/(R)2010)
- AAMI/ANSI HE75 : Human Factors Engineering – Design of Medical Devices : 2009
- AAMI/ANSI/IEC 62366-1 : Medical Devices – Part 1: Application of Usability Engineering to Medical Devices : 2015
- . AAMI/ANSI/IEC 62304 : Medical Device Software – Software Life Cycle Processes : 2006
- . Human Factors evaluation was conducted per FDA guidance document "Applying Human Factors and Usability Engineering to Medical Devices"
Durability testing was conducted to demonstrate the sensor can withstand weight up to 700 lbs. Additionally, heart rate and respiration rate verification was conducted to determine the accuracy of the system compared to the predicate.
The extensive performance testing that has been conducted demonstrate that the System is equivalent to the predicate device. No clinical testing was performed.
Technological Characteristics:
The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® has the substantially equivalent technological characteristics as the predicate device, as summarized on the table below.
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| Technological | Subject Device | Predicate / Reference Device | Comparison |
|---|---|---|---|
| Characteristic | (K152911 unless noted) | ||
| Indications for | |||
| Use | 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 EarlySense® 2.0 System is | ||
| intended for continuous | |||
| measurement of respiration | |||
| rate, heart rate and movement | |||
| in an automatic, contact-less | |||
| manner at a home, hospital or | |||
| clinical setting. The system is | |||
| indicated for use in children, | |||
| adolescents, and adults. The | |||
| operation of the EarlySense® | |||
| 2.0 System has been studied in | |||
| children (weight ≥ 22 lbs [10 | |||
| kg]) and adults (weight |