(226 days)
The Hillrom™ Heart and Respiration Rate Monitoring System powered by Early Sense is used with compatible bed system models and is intended for continuous measurement of respiration rate (RR) in an automatic, contact-less manner. The system is indicated for use in children, adolescents, and adults in hospitals or clinical settings. It is intended to be used for the same patient populations and the same settings, within these ranges, as the bed with which it is used. The system has been validated to withstand up to 700 lb (318 kg).
The Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense is designed for continuous and contact-free measurement of heart and respiratory rate (also referred to as Bed Sensing Unit). This device is used with a hospital bed system which is exempt from 510(k) premarket submission requirements. The Bed Sensing Unit (sensor) plugs into the bed frame to both receive power and to transmit data. Data from the System is available on the bed's graphical caregiver interface (GCI)/display unit and can be transmitted through wired and wireless communication channels to Hillrom Connectivity Solution (also known as (aka)- Hillrom Digital Health Gateway) for display, use, and storage. Additionally, the System can transmit alerts to an existing hardwired Nurse Call system, speakers, and/or on/off alert lights within a bed system. The healthcare professional can adjust monitoring parameters by interacting with the bed's GCl. These parameters include hospital-defined alert thresholds, display settings, and alert configurations. The system provides alerts when patient heart rate and/or respiratory rate are recorded that are above or below the predefined thresholds.
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
This document describes the Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense, which is intended for continuous, contact-less measurement of respiration rate (RR) and heart rate (HR) in children, adolescents, and adults in hospitals or clinical settings. It is validated to withstand up to 700 lb (318 kg).
- Table of acceptance criteria and reported device performance:
| Metric | Acceptance Criteria | Reported Performance |
|---|---|---|
| Total System Accuracy | 90% (including undetected signals) | 90% |
| Heart Rate Detection | 30 – 170 BPM | 30 – 170 BPM |
| Heart Rate Accuracy | ±4% or ±5 BPM whichever is greater | ±4% or ±5 BPM whichever is greater |
| Respiration Rate Detection Range | 6 - 45 Br./min | 6 - 45 Br./min |
| Respiration Rate Accuracy | ±4% or ±1.5 Br./min whichever is greater | ±4% or ±1.5 Br./min whichever is greater |
| Usage Life of Sensor | 5 years of continuous use | 5 years of continuous use (tested) |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 |
| Software Verification & Validation | As per FDA guidance for "moderate" concern level software | Performed and documented |
| Wireless Coexistence | Meets acceptance criteria for wireless coexistence (IEEE/ANSI C63.27) | Meets acceptance criteria |
-
Sample size used for the test set and data provenance:
The document does not specify a distinct "test set" in terms of patient data for clinical performance evaluation, as clinical testing was not required to demonstrate substantial equivalence. The performance metrics listed above (accuracy, detection range) are identical to the predicate device (K180079), implying that the performance of the core sensing technology and algorithms remains unchanged. The new device's acceptance criteria primarily relate to updated hardware (extended usage life of the sensor) and connectivity features, along with regulatory compliance testing (EMC, software V&V, wireless coexistence).- Usage Life Testing:
- Sample Size: Not specified for "Usage Life Testing."
- Data Provenance: Not specified, but likely refers to lab-based or engineering durability testing, not patient data.
- Usage Life Testing:
-
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
Not applicable, as clinical testing (which would typically involve expert ground truth establishment) was not required for this 510(k) submission. The performance metrics are based on the predicate device's established performance. -
Adjudication method for the test set:
Not applicable, as clinical testing was not required. -
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:
Not applicable. This device is a monitoring system and does not involve "human readers" interpreting AI output for diagnostic purposes in the context of an MRMC study. It provides raw physiological data (HR and RR) and alerts based on configurable thresholds. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the performance characteristics (Heart Rate Accuracy, Respiration Rate Accuracy) represent the standalone performance of the algorithm integrated into the device, measuring these parameters in a contact-less manner. The document states, "The data provided by this system is intended to aid a clinician in the evaluation process of a patient's clinical status and should be interpreted by a healthcare professional only. The Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense has not been studied on any specific patient group, nor has it been studied as a diagnostic tool for any specific disease or medical condition. It is meant as an adjunctive tool only for contact-free measurement of respiration rate and heart rate." This confirms its standalone measurement capability. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the core physiological measurements (HR and RR), the ground truth referenced for the predicate device's performance would have likely been established through comparison with a gold-standard reference monitor (e.g., ECG for HR, capnography or respiratory plethysmography for RR) during its original validation. For the current submission, which establishes substantial equivalence, the performance specifications are stated to be the same as the predicate device, K180079. -
The sample size for the training set:
Not specified. The document states that the software for data analysis, display, and input is identical to that cleared in K180079. Therefore, any training data used for the algorithms would have been part of the development and validation of the predicate device, and details are not provided in this 510(k) summary. -
How the ground truth for the training set was established:
Not specified. Given the software's identity to the predicate device, the ground truth for any training would have been established during the development of the predicate device's algorithms, likely by comparing the device's measurements to gold-standard reference measurements from patients under various conditions.
§ 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).