Search Results
Found 1 results
510(k) Data Aggregation
(188 days)
The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or multi-parameter vital signs monitor for ECG, noninvasive blood pressure (NIBP) and SpO2, with an optional accessory for capnography (ETCO2, RR). It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer.
The monitor is intended to be used by trained healthcare providers.
The WVSM Patient Monitor is a device that monitors physiological parameters associated with Electrocardiogram, Non-invasive Blood Pressure, pulse oximetry and carbon dioxide gas. The WVSM Patient Monitor is a multi-patient use non-sterile device. It utilizes embedded firmware. Patient applied parts are needed for physiological measurement and are provided via FDA cleared OEM accessories to the WVSM monitor. The modification to the WVSM includes: Adding an indication for capnography by interfacing with a FDA cleared accessory. Adding the capability to use the device while connected to the AC power adapter instead of only using the device on battery power.
This document provides information about the Athena GTX Wireless Vital Signs Monitor (WVSM) RWC + miniCap, which is a modified version of a previously cleared device. The primary modifications are the addition of capnography functionality and the ability to operate while connected to an AC power adapter.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding performance results for each parameter. Instead, it states that "Key performance specifications are listed in the table in section VI below," which refers to the comparative table between the modified device and the predicate device. This table primarily highlights differences and similarities in technological characteristics.
However, based on the text, the acceptance criterion for this 510(k) submission appears to be demonstrating that the modifications (capnography and AC power mode) do not adversely affect the safety and effectiveness of the device and that the new functionalities (capnography parameters) meet established standards.
The document implicitly refers to compliance with industry standards for safety, EMC (Electromagnetic Compatibility), and essential performance as the main performance metric for the modified device.
Implicit Acceptance Criteria and Reported Performance (Based on the provided text):
| Parameter / Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Capnography Functionality | Integration of FDA cleared accessories (Masimo IRMA & ISA) without altering fundamental scientific technology. | The WVSM was originally designed with an AUX port for future use. The capnography accessories are FDA cleared and specifically designed for medical monitors. This modification is largely an interface task to connect two cleared devices using a well-established interface protocol. The addition of the capnography accessory does not alter the fundamental scientific technology. |
| AC Power Mode | Operation using AC power adapter without altering fundamental scientific technology. | An AC power adapter was already used for charging. The modification allows operation while plugged in. An equivalent and updated AC adapter is used. The addition of this AC power mode does not alter the fundamental scientific technology. |
| Safety and Essential Performance | Compliance with recognized national standards (e.g., IEC 60601-1). | "Testing of the device modification (WVSM RWC + miniCap) has been completed to verify compliance with recognized national standards for safety and performance for medical devices, and particular requirements applicable to this device have not been affected by this modification including: IEC 60601-1 Basic safety and essential performance, IEC 60601-1-2 EMC." |
| Adverse Effects of Modifications | Modifications do not adversely affect the performance of the previously cleared device. | "Side-by-side comparison testing of the device modification (WVSM RWC + miniCap) and the previously cleared device (WVSM Battery operated) has been completed to verify that the devices modifications did not adversely affect the previously cleared device." |
| Biocompatibility | No adverse change to biocompatibility from previously cleared device. | "The device modification did not change or alter the biocompatibility of the previously cleared device." |
| Software Verification and Validation | Compliance with FDA guidance for software in medical devices. | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance... The software for this device was considered as a 'moderate' level of concern." (Implies successful completion as per guidance, but no specific performance metrics are listed). |
| Alarm System Delay (Capnography) | Meet specified delay limits for IRMA and ISA capnography. | IRMA Capnography: Alarm Condition delay <1 sec, Alarm Generation Delay 1 sec, Total Alarm System Delay <2 sec. ISA Capnography: Alarm Condition delay <3 sec, Alarm Generation Delay 1 sec, Total Alarm System Delay <4 sec. (These are performance specifications, implicitly the acceptance criteria for these new alarm features). |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states "None" under "Animal Study Data" and "Clinical Study Data [807.92(b)(2)]".
For other performance data, it mentions "testing of the device modification" and "side-by-side comparison testing," but it does not specify the sample size for these tests (e.g., number of devices tested, number of hours of testing).
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature for the engineering and bench testing mentioned. However, given that this is a 510(k) summary for a US FDA submission, it's implied that the testing was conducted to US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for any test set. The validation for the modified device relies on:
- Compliance with recognized national standards (e.g., IEC 60601-1 for safety and performance, IEC 60601-1-2 for EMC).
- Side-by-side comparison testing with the predicate device to ensure no adverse effects.
- Integration of previously FDA-cleared capnography accessories (Masimo IRMA and ISA).
- Software verification and validation as per FDA guidance.
Since there are no clinical trials or human read studies described, there is no mention of experts establishing ground truth in that context.
4. Adjudication Method for the Test Set
As no clinical or human-reader studies involving subjective interpretation (like image review) are described, an adjudication method (such as 2+1 or 3+1) is not applicable and therefore not mentioned in the document. The testing described is primarily engineering, bench, and software verification/validation.
5. 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 comparative effectiveness study was done or mentioned. This device is a vital signs monitor, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a hardware vital signs monitor with embedded firmware. While software verification and validation were done (standalone performance of the software module), the device itself is a measurement instrument, not an algorithm in the sense of AI or image analysis that would have "standalone performance" separate from its physical function.
The "standalone" performance in this context refers to the device's ability to accurately measure and display vital signs, and this is generally assessed through compliance with standards and comparison to reference measurement devices, implicitly covered by the "testing of the device modification" and "side-by-side comparison testing" mentioned. No specific "standalone algorithm performance" study as seen in AI/ML device submissions is described.
7. The Type of Ground Truth Used
For the capnography function, the "ground truth" implicitly relies on the fact that the Masimo IRMA and ISA OEM Gas Analyzers are themselves previously FDA-cleared accessories (K123043 and K103604). This means their measurement accuracy and performance characteristics are already established and accepted by the FDA. The WVSM's role is to correctly interface with and display the data from these cleared accessories.
For other parameters (ECG, NIBP, SpO2), the "ground truth" and validation would refer to the performance of the integrated OEM modules (Nonin OEM Module for Pulse-Ox, Suntech Medical OEM Module for NIBP) and internal circuitry for ECG, which were part of the predicate device and were re-verified to ensure performance was not adversely affected. This typically involves comparison to reference standards or highly accurate reference instrumentation in a lab setting.
The document does not explicitly use terms like "expert consensus," "pathology," or "outcomes data" to define ground truth for the device's measurements, as these are more common for diagnostic devices or AI algorithms interpreting complex data.
8. The Sample Size for the Training Set
Not applicable. The Wireless Vital Signs Monitor (WVSM) RWC + miniCap is a traditional medical device (hardware with embedded software logic), not an artificial intelligence (AI) or machine learning (ML) device. Therefore, there is no "training set" in the context of AI/ML model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated in point 8, this is not an AI/ML device, so there is no training set and no ground truth establishment process for such a set.
Ask a specific question about this device
Page 1 of 1