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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.

Device Description

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.

AI/ML Overview

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

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