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 <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.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 29, 2020

Athena GTX Sean Mahonev VP of Operations and Regulatory Affairs 5900 NW 86th Street. Suite 300 Johnston, Iowa 50131

Re: K191989

Trade/Device Name: Wireless Vital Signs Monitor (WVSM) RWC + miniCap Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DQA, DXN, CCK Dated: December 23, 2019 Received: December 27, 2019

Dear Sean Mahoney:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below

510(k) Number (if known)

K191989

Device Name

Wireless Vital Signs Monitor (WVSM) RWC + miniCap

Indications for Use (Describe)

The monitor is intended to be used by trained healthcare providers.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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510(k) Summary

I. SUBMITTER 807.92(a)(1)]:

Athena GTX 5900 NW 86th Street, Suite 300 Johnston, lowa 50131

Phone: 515.288.3360 515.288.3394 Fax:

Company Contact: Sean Mahoney (VP of Operations and Regulatory Affairs) 515.288.3360 x103 smahoney@athenagtx.com

Date Prepared: January 29, 2020

II. DEVICE [807.92(a)(2)]:

Trade Name:	Wireless Vital Signs Monitor (WVSM) RWC + miniCap
Common Name:	Physiological Patient Monitor
Classification Name:	Cardiac Monitor (21 CFR 870.2300)
	NIBP Measurement System (21 CFR 870.1130)
	Oximeter (21 CFR 870.2700)
	Radiofrequency Physiological Signal Transmitter and Receiver (21 CFR 870.2910)
	Carbon-Dioxide Gas Analyzer (21 CFR 868.1400)

Device Class: Class II Product Code: MWI, DXN, DQA, DRG, CCK Basis for Submission: Device Modification

III. PREDICATE DEVICE [807.92(a)(3)]:

Legally Marketed (Predicate) Device: Athena GTX, Wireless Vital Signs Monitor (WVSM) (K101674)

IV. DEVICE DESCRIPTION [807.92(a)(4)]:

Device Identification

The WVSM Patient Monitor is a device that monitors physiological parameters associated with Electrocardiogram, Non-invasive Blood Pressure, pulse oximetry and carbon dioxide gas.

Device Characteristics

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.

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Environment of Use

WVSM is intended to be used in hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications.

Principle of Operation

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.

Materials

The WVSM Patient Monitor enclosure is primarily plastic and does not contact the patient. The applied parts are OEM accessories that are FDA cleared and meet the biocompatibility requirements for intact skin contact. The Aux Battery enclosure is constructed of the same material as the WVSM and does not contact the patient.

Kev Performance Specification

Key performance specifications are listed in the table in section VI below.

V. INDICATIONS FOR USE [807.92(a)(5)]:

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, FiCO2, 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 Indications for Use statement for the device modification is not identical to the predicate previously cleared device; however, the differences do not alter the general intended use of the WVSM as a multi-parameter monitor nor affect the safety and effectiveness of the device relative to the predicate. The device modification to add an AC power mode does not affect the Indications for use. The modification to add an FDA cleared CO2 gas analyzer as an optional accessory added a capnography indication to the WVSM indications for use.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

This device modification includes the following:

Adding 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.

The WVSM was originally designed to be a multi-parameter monitor and had the AUX port capability built in for future use. Since the capnography accessories are FDA cleared and specifically designed to be connected to a medical backboard (Medical Monitor), this device modification is largely an interface task to connect two cleared devices using a well-established

I-2

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interface protocol. Therefore the addition of the capnography accessory does not alter the fundamental scientific technology of the WVSM device.

An AC power adapter was already used for charging the internal battery of the previously cleared device. The interface and specifications are the previously cleared device. This modification allows for the modified device to be used while the AC power adapter remains plugged into the monitor. An equivalent and updated AC adapter is used for the modified device. The previously cleared device was used only while on battery power. The addition of this AC power mode does not alter the fundamental scientific technology of the WVSM device.

At a high level, the subject and predicate devices are based on the following same technological elements:

The Athena GTX WVSM™ device modification and the previously cleared device have . the same physical characteristics, cleaning, and cannot be used near flammable anesthetics.
The Athena GTX WVSM™ device modification and the previously cleared device have the same electrical characteristics including: protection circuits, battery power, and use of AC power adapters.
. The Athena GTX WVSM™ device modification and the previously cleared device have the same environmental specifications for: Temperature, humidity, altitude, water intrusion, vibration, shock, drop, and EMC.
. The Athena GTX WVSM™ device modification and the previously cleared device use the same ECG monitoring circuitry.
The Athena GTX WVSM™ device modification and the previously cleared device ● integrate the same PureSAT® pulse oximetry technology to compute functional arterial hemoglobin saturation and pulse rate.
. The Athena GTX WVSM™ device modification and the previously cleared device utilize the same SunTech Advantage OEM Non-invasive Blood Pressure (NIBP) module for mean arterial pressure, and systolic and diastolic blood pressure measurements.
. The Athena GTX WVSM™ device modification and the previously cleared device integrate alarms functions in the monitors.
. The Athena GTX WVSM™ device modification and the previously cleared device utilize 802.11 wireless communications to connect with multiple patient vital signs monitoring devices for bi-directional data transfer.
. The Athena GTX WVSM™ device modification and the previously cleared device utilize software, installed on a PC, to allow for data management and display, alert/alarm management, and patient data review.
The Athena GTX WVSM™ device modification and the previously cleared device utilize mobile platforms.

The following technological differences exist between the subject and predicate devices:

. The Athena GTX WVSM™ device modification adds an optional capnography accessory not supported in the previously cleared device.
. A different, but equivalent and improved AC power adapter is used with the modified device.
. The AUX Port was modified to be capable of input and output (Same as the DATA port) to support the connection to the capnography accessory.
Physiological and technical alarms for the capnography parameters (etCO2, FiCO2, RR) and sensor fault respectively were added.

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The following is provided as a summary of how the technological characteristics of the device compare to the predicate device:

Product Name	Athena GTXWVSM RWC + miniCap	Athena GTXWVSM Cleared Device	Comments
Manufacturer	Athena GTX	Athena GTX	Same
Trade/Device Name	WVSM RWC + miniCap	WVSM	Different -DeviceModification
510(k) Number	Pending - Modified Device	K101674
Product Code	MWI, DXN, DQA, DRG, CCK	MWI, DXN, DQA, DRG	DifferentAdded CCK
Regulation Number	870.2300, 870.1130; 870.2700;870.2910, 868.1400	870.2300, 870.1130; 870.2700;870.2910	DifferentAdded868.1400
Prescription Device	YES	YES	Same
PhysiologicalParameters	ECG, heart rate, systolic anddiastolic blood pressure;functional oxygen saturation,pulse rate, etCO2, FICO2,respiration rate	ECG, heart rate, systolic anddiastolic blood pressure;functional oxygen saturation,pulse rate	Different -Added etCO2,FICO2,respiration rate
Displays	Displays ECG, systolic, diastolicBP, SpO2, pulse rate, etCO2,FICO2, respiration rate	Displays ECG, systolic, diastolicBP, SpO2, pulse rate	Different -Added etCO2,FICO2,respiration rate
Patient Population	Adult	Adult	Same
Product Name	Athena GTXWVSM RWC + miniCap	Athena GTXWVSM Cleared Device	Comments
Indications	The Wireless Vital Signs Monitor(WVSM) is intended to be usedas an adult patient monitor. It isindicated as a single or multi-parameter vital signs monitor forECG, noninvasive bloodpressure (NIBP) and SpO2, withan optional accessory forcapnography (ETCO2, FiCO2,RR). It may be used in thefollowing locations: Hospitals,healthcare facilities, emergencymedical applications, duringtransport, and other healthcareapplications. The monitor useswireless communications totransmit vital signs data to ahandheld or PC computer. Themonitor is intended to be usedby trained healthcare providers.	The Wireless Vital Signs Monitor(WVSM) is intended to be usedas an adult patient monitor. It isindicated as a single or multi-parameter vital signs monitor forECG, noninvasive bloodpressure (NIBP) and SpO2. Itmay be used in the followinglocations: Hospitals, healthcarefacilities, emergency medicalapplications, during transport,and other healthcareapplications. The monitor useswireless communications totransmit vital signs data to ahandheld or PC computer Themonitor is intended to be usedby trained healthcare providers.	Different -Added, withan optionalaccessory forcapnography(ETCO2,FiCO2, RR)
Scenario of Use	Continuous or spot monitoring bylicensed healthcareprofessionals	Continuous or spot monitoring bylicensed healthcareprofessionals	Same
Networking/ Telemetry	WVSM may be used standaloneor via wireless network(802.11b/g, 2.4GHz) to ahandheld or PC computer	WVSM may be used standaloneor via wireless network(802.11b/g, 2.4GHz) to ahandheld or PC computer	Same
Environment of Use	Emergency medical services,Transport (including helicopter),emergency departments,hospital, other healthcareapplications	Emergency medical services,Transport (including helicopter),emergency departments,hospital, other healthcareapplications	Same
Physical	No Change		No Changes
Electrical
Power Modes	Operation: Battery or ACMedical Grade Power AdapterCharging: AC Medical GradePower Adapter	Operation: Battery OnlyCharging: AC Medical GradePower Adapter	Different -AddedOperationalAC Powermode
Battery	7.4V, 2800 mAh, Li-Polymer	7.4V, 2800 mAh, Li-Polymer	Same
Power Adapter	Mean Well GSM36B09	SL Power/Ault MW173KB Series	Different -Equivalent,meets latestEMCrequirements
Environmental	No Changes		No Changes
Product Name	Athena GTXWVSM RWC + miniCap	Athena GTXWVSM Cleared Device	Comments
PhysiologicalParameters
ECG	Internal Circuit	Internal Circuit	Same
Pulse-Ox	Nonin OEM Module	Nonin OEM Module	Same
NIBP	Suntech Medical OEM Module	Suntech Medical OEM Module	Same
Capnography	Masimo OEM Gas AnalyzersIRMA (K123043) andISA (K103604)	NA	Different -AddedCapnography
Alarms
Operator PositionPrimary	Patient Environment	Patient Environment	Same
Secondary	Outside Patient Environment(Distributed)	Outside Patient Environment(Distributed)	Same
Verify Alarm Function	1 Second beep at start-up (aftermenu section).To verify activation at limits, usermust simulate alarm condition.	1 Second beep at start-up (aftermenu section).To verify activation at limits, usermust simulate alarm condition.	Same
Silence/Reset	2 min or 30 min Does not affectsame or higher priority audiblealarm functions	2 min. Does not affect same orhigher priority audible alarmfunctions	Different -Includes anadditionalsilence time
Audible Alarms	No Change	No Change	No Change
Alarm Conditions andPriority
Physiological	High and Low Priority based onAlarm Limits set for eachparameter: %SpO2, HR/PR,Systolic BP, Diastolic BP,etCO2, FiCO2, RR	High and Low Priority based onAlarm Limits set for eachparameter: %SpO2, HR/PR,Systolic BP, Diastolic BP	Different -Added etCO2,FiCO2, RR
Technical	Low Priority when a sensor faultis detected: SpO2 andCapnography	Low Priority when a sensor faultis detected: SpO2	Different -AddedCapnographysensor fault
	Medium Priority below 5%Battery Power remaining	Medium Priority below 5%Battery Power remaining
Alarm System Delayat the Monitor
HR/PR	No Change	No Change	No Change
SpO2	No Change	No Change	No Change
NIBP	No Change	No Change	No Change
Product Name	Athena GTXWVSM RWC + miniCap	Athena GTXWVSM Cleared Device	Comments
IRMA Capnography	Alarm Condition delay <1 secAlarm Generation Delay 1 secTotal Alarm System Delay <2sec	NA	Different -AddedCapnography
ISA Capnography	Alarm Condition delay <3 secAlarm Generation Delay 1 secTotal Alarm System Delay <4sec	NA	Different -AddedCapnography
Interfaces
Data Port	Input/Output, RS232Used for Wired Connection toPC	Input/Output, RS232Used for Wired Connection toPC	Same
AUX Port	Input/Output, RS232Used for connecting OptionalCapnography Accessory	Input, RS232For future use	Different -Added Outputcapability
WirelessCommunication	No Change	No Change	No Change
PC and MobileApplication	ADMS	WVSM Management Suite andADMS	Different -WVSMManagementSuite nolongersupported

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K191989 Section 5 – 510(k) Summary

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K191989 Section 5 – 510(k) Summary

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K191989 Section 5 - 510(k) Summary

VII. PERFORMANCE DATA [807.92(b)(1)]:

Biocompatibility

The device modification did not change or alter the biocompatibility of the previously cleared device.

Industry Standards for Safety, EMC and Essential Performance

Where applicable, 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 .

Comparison to the Previously Cleared Predicate

Where applicable, 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.

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Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

Animal Study Data

None.

Clinical Study Data [807.92(b)(2)]: None.

VIII. CONCLUSION [807.92(b)(3)]:

The results for all safety, compliance, and non-clinical performance testing demonstrates that the Athena GTX the WVSM RWC + miniCap Patient Monitor is substantially equivalent to the above listed predicate device.

Regulation Number and Section

§ 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).