(269 days)
The PRESSUREALERT® Pressure Monitoring System monitors the activity of patients who are susceptible to pressure ulcers by measuring pressure at various points of the body. It allows healthcare providers to medividualized turn management plan for each patient by continuously monitoring pressure on various points of the body of each patient. The PRESSUREALERT® Pressure Monitoring System provides alerts when patient activity deviates from the pressure prevention parameters set for by the healthcare providers. The device is in medical, nursing, and longterm care facilities including independent living, assisted living, and rehabilitation facilities.
The PRESSUREALERT® Pressure Monitoring System is composed of a wireless pressure sensing dressing assembly as part of a system supported by the PRESSUREALERT® Management Software for providing a warning to the healthcare provider that soft tissue pressure has exceeded a predetermined level that, over a period of time, would necessitate that the patient should be moved to prevent or at least reduce the risk of soft tissue damage.
The PRESSUREALERT® Pressure Monitoring System functions as a pressure monitoring system with the primary function to monitor a patient that is laying down on their back or otherwise in a position that may result in the patient's weight applying pressure to an area of the patient's body that is susceptible to pressure ulcers/injuries, such as soft tissue overlying a bony prominence.
The dressing assembly, with the enclosed pressure sensor, is applied on the patient's body that is susceptible to damage from soft tissue pressure. The identified areas are referred to as "at-risk" in the instructional documentation and intended use and include up to eleven (11) sites defined as the upper spine, head-skull, hip (right or left), Ischia (right or left), heels and elbows (right or left), and sacrum.
The material components of the PRESSUREALERT® Pressure Monitoring System, and described in detail in the Device Description section, includes:
- i. PRESSUREALERT® Segmented Oval Dressing
- ii. PRESSUREALERT® Round Dressing
- iii. PRESSUREALERT® Sacral Dressing
- iv. PRESSUREALERT® Oval Sensor
- v. PRESSUREALERT® Round Sensor
The Walgreen Health Solutions, LLC's PRESSUREALERT® Pressure Monitoring System did not perform any clinical studies. All acceptance criteria were met through non-clinical testing.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Device Performance |
|---|---|
| Ingress Protection (IP4X 1mm Sphere Test) | Pass |
| Ingress Protection (IPX7 Temporary Water Immersion Test) | Pass |
| Drop Test (Functionality & Visual Damage) | Pass |
| Battery Life (Maximum Storage) | Pass (1 year) |
| Battery Life (Activated Operating) | Pass (25 days) |
| Pressure Sensor Performance (Activation Pressure Threshold) | Attained 32 mmHg (equivalent to 43.5 g/cm²) |
2. Sample Size Used for the Test Set and Data Provenance
Since only non-clinical bench tests were performed, there was no "test set" in the context of patient data. The tests were likely performed on a sample of the manufactured devices. The document does not specify the exact number of devices or components used for each bench test.
- Data Provenance: Not applicable as no human-subject data was used. All testing was non-clinical and conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth for non-clinical bench testing is established by engineering specifications, regulatory standards, and objective measurements, not by expert consensus on patient data.
4. Adjudication Method for the Test Set
Not applicable. As no clinical studies were performed, there was no need for adjudication of patient data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. No clinical studies, including MRMC studies, were conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a hardware and software system that provides alerts to healthcare providers. While the sensors and software operate autonomously to detect pressure and generate alerts, the overall system is designed to be human-in-the-loop as it aids healthcare providers in executing turn management plans. There wasn't a separate "algorithm only" performance evaluation presented in the context of clinical outcomes. The non-clinical tests evaluate the physical and electronic performance of the components.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" was based on:
- Engineering specifications: For physical attributes like ingress protection and drop resistance.
- Performance standards: For battery life and pressure threshold (32 mmHg is a physiological threshold related to capillary pressure).
- Objective measurements: Performed during the bench testing.
8. The Sample Size for the Training Set
Not applicable. The document does not describe any machine learning or AI components that would require a "training set" in the typical sense for image analysis or diagnostic algorithms. The software appears to be rule-based for pressure detection and alerting.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was explicitly mentioned or used in this submission.
§ 880.2400 Bed-patient monitor.
(a)
Identification. A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.