(29 days)
The ABP 92506 RMS is used to provide data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 48-hour period.
The data is intended to provide preliminary blood pressure data from ambulatory patients for non-time critical applications only.
It is for use in hospitals, clinics or physicians offices by a qualified physician or trained staff member under the supervision of that physician.
Patient diagnosis is not to be performed solely based on the results of this device.
The Spacelabs Medical ABP 92506 Report Management System (RMS) is a PC-based software application that accepts data collected from one of Spacelabs Medical's ABP monitors through an electrically-isolated interface cable.
The ABP 92506 RMS has a graphical user interface (GUI) similar to most Microsoft applications such as Word, Excel, etc. that provides common windowing controls such as menus, icons, mouse support, wizards, etc. These controls allow the operator to communicate with the ABP monitor.
Additionally, the ABP 92506 RMS provides necessary initialization and configuration of operating parameters, as well as acquires the monitor's stored blood pressure reading data. These readings are combined with patient demographic entry data to create an ABP report that can be reviewed, edited, stored, confirmed and printed by a physician.
Furthermore, the ABP 92506 RMS application also performs simple summary trending calculations from the individual blood pressure readings to present global statistical results, such as mean and standard deviations for systolic, diastolic, MAP, heart rate and pulse pressure. These are calculated for intervals such as the entire recording period, day, night or period of time as defined by operator.
Finally, the ABP 92506 RMS application can import reports generated by the ABP 90121 RMS and ABP 90219 RMS, predecessors of the ABP 92506 RMS.
The provided document describes a 510(k) summary for the Spacelabs Medical ABP 92506 Report Management System (RMS). This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
It's crucial to understand that a 510(k) submission primarily focuses on substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a rigorous clinical study in the way a Pre-Market Approval (PMA) application might. Therefore, the information you've requested regarding acceptance criteria, study details, and expert involvement is not explicitly present in this type of document because it's not typically required for a 510(k) for this kind of device.
This device is a software application that manages data from an Ambulatory Blood Pressure (ABP) monitor, not the monitor itself, and its primary function is data acquisition, presentation, and basic statistical calculations. The "validation" mentioned refers to software development and compliance with regulations like 21 CFR §11 (electronic records) and 45 CFR §164 (HIPAA administrative requirements), not clinical performance or diagnostic accuracy.
Here's a breakdown based on the document, highlighting what is and isn't available:
Acceptance Criteria and Device Performance
Since this is a 510(k) for a software management system, and not a diagnostic device with performance metrics like sensitivity/specificity, there are no specific numerical "acceptance criteria" for clinical performance reported in this summary. The "performance" demonstrated is its ability to comply with software regulations and to process and display data in a manner substantially equivalent to its predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: | The ABP 92506 RMS is substantially equivalent to the Spacelabs Medical Ambulatory Blood Pressure Monitor (including 90219 RMS) (K855127) and the Spacelabs Medical Ambulatory Blood Pressure Monitor (including 90121 RMS) (K855127, Letter to File) in design concepts, technologies, materials, and intended uses. |
| Software Functionality: | Functions include: PC-based software application, graphical user interface (GUI) similar to Microsoft applications, initialization and configuration of operating parameters, acquisition of stored blood pressure data, creation/review/editing/storage/confirmation/printing of ABP reports, simple summary trending calculations (mean and standard deviations for systolic, diastolic, MAP, heart rate, pulse pressure for various intervals), and import of reports from predecessors. |
| Compliance with Federal Regulations: | The ABP 92506 RMS was developed following a robust software development process and was fully specified and validated through rigorous testing that supports compliance with 21 CFR §11 (Electronic records; electronic signatures) and 45 CFR §164 (Administrative requirements - likely HIPAA). |
| Safety and Effectiveness: | By demonstrating substantial equivalence to legally marketed predicate devices, the device is considered as safe and effective as those predicates for its stated intended use. |
Study Information (Based on the 510(k) Document)
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Sample size used for the test set and the data provenance:
- The document does not mention a specific "test set" in terms of patient data or clinical images for performance evaluation. The "testing" referred to is against software specifications and regulatory compliance.
- No data provenance (e.g., country of origin, retrospective/prospective) is provided as there's no clinical data test set described for performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. There is no described clinical "ground truth" establishment process by experts for performance evaluation as this is a data management system, not a diagnostic algorithm.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. There is no described test set requiring expert adjudication.
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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:
- No MRMC study was done or is mentioned. This device is a report management system and does not involve AI assistance for interpretation or improving human reader performance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a software tool for managing data from an ABP monitor and is intended for use by qualified medical personnel. It doesn't perform diagnostic interpretations in a "standalone" fashion that would require such testing.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not mentioned. For a software management system, "ground truth" would relate to the accuracy of data import, calculations, and display, which are typically validated through software testing against known inputs and expected outputs, rather than clinical ground truth like pathology.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a "training set" for model development.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant for this type of software.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).