(39 days)
The LifeBed Patient Vigilance System is intended to measure heart rate and respiratory rate in adult patients, in bed, in a general care hospital environment. The system will also monitor bed exit.
The LifeBed Patient Vigilance System consists of two (2) main components: the bedside unit and the Passive Sensor Array™ (PSA™). The bedside unit houses the digital signal processing algorithms that calculate heart and respiratory rates and bed exit status (in-bed sensor) in real time and displays the data as part of the integrated graphical user interface. The bedside unit houses the alarm logic and interfaces to the existing nurse call system found in the hospital. The PSA is comprised of a mattress ticking ("coverlet" that slips over the entire mattress) that houses an array of sensors, which connect to the bedside unit via a cable with an integrated "quick disconnect" safety feature.
The LifeBed Patient Vigilance System's Passive Sensor Array (PSA) technology analyzes basic heart and respiratory physiology without direct patient contact, eliminating the use of electrodes, wires and leads. Hoana's PSA technology integrates proprietary signal processing algorithms with patented data collection devices that produce an electrical signal in response to physiological stimuli. The LifeBed Patient Vigilance System passively extracts patient measurements even through clothing, gowns or sheets.
This 510(k) submission, K082366, is a Special 510(k) for a change to the Graphical User Interface (GUI) of the LifeBed Patient Vigilance System. As such, the submission explicitly states there are "no changes to the original submission" and "no change in the fundamental scientific technology of the device" or "indications for use." Therefore, detailed device performance studies or acceptance criteria comparisons are not included, as the modification is ergonomic, not related to the underlying physiological measurement accuracy.
However, based on the information provided, we can infer some details and state where specific information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a Special 510(k) for a GUI change, detailed performance criteria (e.g., accuracy for heart rate or respiratory rate) and associated reported device performance are not provided in this document. The focus is on the human-computer interaction, not the physiological measurement accuracy.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided as the submission pertains to a GUI change, not a new performance study.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not provided as the submission pertains to a GUI change, not a new performance study requiring expert ground truth for physiological measurements.
4. Adjudication Method
This information is not provided as the submission pertains to a GUI change, not a new performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted or reported in this submission. This type of study would be relevant for evaluating human interpretation of medical images or diagnostic tests, which is not the primary function of a GUI change in a patient vigilance system.
6. Standalone Performance (Algorithm Only)
A standalone performance study was not detailed in this submission. For a GUI change, the accuracy of the underlying algorithms (heart rate, respiratory rate, bed exit) is assumed to have been established in the original 510(k) for the LifeBed system.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used, as it focuses on software ergonomics rather than clinical efficacy.
8. Sample Size for the Training Set
This information is not provided as the submission pertains to a GUI change, not a new algorithm development requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided as the submission pertains to a GUI change, not a new algorithm development requiring a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per this Special 510(k)):
The "study" that proves the device meets the acceptance criteria in this specific Special 510(k) is the design control process itself, as stated in the Conclusion section: "summary information that results from the design control process can serve as the basis for clearing the application."
The acceptance criteria for this Special 510(k) are implicitly:
- The GUI change does not affect the intended use of the device.
- The GUI change does not alter the fundamental scientific technology of the device.
- There are no changes in the indications for use.
- There are no changes to labeling that affects the intended use.
- There are no changes in materials.
- The ergonomics of the patient-user interface (the GUI change) is appropriate.
The basis for meeting these criteria is the absence of changes to the core functionalities, indications, and technology of the device, as asserted by the manufacturer and accepted by the FDA for a Special 510(k) pathway. The "study" per se is the internal design and verification documentation demonstrating that the GUI modification is limited in scope and does not impact safety or efficacy beyond the change in user interface presentation. Electrical, Mechanical, EMC, and Biocompatibility testing (per IEC 60601-1-2 and ISO 10993) were performed on the LifeBed system generally, and likely confirmed no adverse impacts from the GUI integration, but these tests are not specific to the GUI performance itself.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).