Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than at the patient, for multiple patients.

Display visual alarm conditions as generated by a connected monitor.

Display of patient information can be real-time or historical record review.

Provide review and trend application data, designed to the screening of patient condition. All information or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making.

Provide connection to other systems not associated with active patient monitoring, such as information systems. The software performs the action to transfer, store, convert from one format to another according to preset specifications, or to display medical device data.

ADMS is intended for use in professional healthcare facilities, emergency medical applications, during transport, and other healthcare environments by trained healthcare professionals. ADMS Software is not intended for home use.

Indicated for use for specific patient populations (adult, pediatric, infant/neonate) depends on the indicated labeling of medical device(s) connected to ADMS providing the data.

Device Description

The Athena GTX Device Management Suite (ADMS) is a software only device that manages patient data from compatible monitoring devices.

The Athena GTX Device Management Suite (ADMS) receives, distributes and displays physiologic waves, parameters and visual alarms at locations other than at the patient, for multiple patients. Data is generate by compatible connected devices and can be real-time or historical review.

The Athena GTX Device Management Suite provides a method of controlling ADMS compatible devices and viewing the device's data on Android devices (smartphones and tablets), iOS devices (smartphones and tablets) and on PCs running Windows OS.

The ADMS software receives data using Wi-Fi (802.11) from any Athena device within range. Whenever a device comes within range of ADMS, it will start receiving data from the device automatically. Commands to devices is transmitted via Wi-Fi (802.11) to the device. Each platform running ADMS can support viewing up to twenty (20) devices at one time.

The Athena GTX Device Management Suite (ADMS) consists of software only applications that do not come into physical contact with patients.

AI/ML Overview

The Athena GTX Device Management Suite (ADMS) is a software-only device. The provided text, an FDA 510(k) summary, details the device's characteristics, comparison to predicate devices, and software verification and validation activities rather than a clinical study evaluating specific performance metrics against acceptance criteria. Therefore, several of the requested sections (sample size, data provenance, expert adjudication, MRMC study, ground truth, training set information) are not directly applicable or available in the provided document.

Here's an overview based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and successful software verification and validation. The "reported device performance" is described qualitatively as meeting the intended use and being safe and effective due to these comparisons and testing.

Acceptance Criteria (Inferred from Substantial Equivalence and V&V)	Reported Device Performance
Functional Equivalence to Predicates:
Receive, aggregate, process, distribute, and display physiologic waves, parameters, alarms, and events.	ADMS performs these functions.
Display visual alarm conditions generated by connected monitors.	ADMS displays visual alarms.
Display real-time or historical patient information.	ADMS displays both.
Provide review and trend application data.	ADMS provides this.
Connect to other systems (e.g., information systems) for data transfer, storage, conversion, or display.	ADMS performs these actions, including HL7 interface to EMR.
Bi-directional communication with connected monitors (configuration, alarm limits, start/stop BP, find command).	ADMS supports this.
Safety and Effectiveness:
Complies with FDA's Guidance for "moderate" level of concern software.	Software verification and validation testing were conducted and documentation provided as recommended.
Device functions as intended without unreasonable risks.	Results of safety, compliance, and non-clinical performance testing demonstrate substantial equivalence.
Not raising different questions of safety and effectiveness compared to predicates.	Differences from predicates (e.g., lack of ECG waveform analysis, visual-only alarms, PHI encryption) are presented as not raising new safety/effectiveness concerns or enhancing security.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "Software verification and validation testing," which typically involves various forms of testing (unit, integration, system, regression) but does not specify a "test set" in the context of clinical or performance data with associated sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. The study described is not a clinical or performance study that would typically involve a ground truth established by medical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. As there is no clinical test set described requiring expert ground truth, adjudication methods are irrelevant here.

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, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Study Data [807.92(b)(2)]: None."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes the "Athena GTX Device Management Suite (ADMS)" as a "software only device" that "receives, aggregates, processes, distributes and displays physiologic waves, parameters, alarms and events." It also states, "All information or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making." This indicates that ADMS is designed to operate as a standalone algorithm in terms of data processing and display, but its output is intended for human-in-the-loop evaluation. However, the "standalone performance" in the context of diagnostic accuracy (which is not the primary function of this device) was not explicitly tested or reported in the context of classifying patient conditions. The core function is data management and display.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given that no clinical validation study is described, no ground truth from "expert consensus, pathology, outcomes data" was used. The ground truth for the software verification and validation would be based on expected system behavior and output specifications.

8. The sample size for the training set

This information is not provided in the document. This device is a data management and display software, not an AI/ML algorithm that typically requires a 'training set' in the traditional sense for diagnostic or predictive tasks. The software is developed based on specifications and programming logic.

9. How the ground truth for the training set was established

This information is not provided in the document. As mentioned, the concept of a 'training set' for this type of software is not applicable in the context of AI/ML model training described here. The "ground truth" for software development and testing would be defined by the design specifications and functional requirements.

Summary

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March 14, 2018

Athena GTX Sean Mahoney V.P. Regulatory Affairs 5900 NW 86th Street. Suite 300 Johnston, Iowa 50131

Re: K173203

Trade/Device Name: Athena GTX Device Management Suite (ADMS) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX, DRG, MHX, MWI, DSI, DXN, DQA, MLD Dated: November 3, 2017 Received: November 6, 2017

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M.A. Hillemann

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation 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)

K173203

Device Name

Athena GTX Device Management Suite (ADMS)

Indications for Use (Describe)

The intended use of the ADMS software application is to:

Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than at the patient, for multiple patients.

Display visual alarm conditions as generated by a connected monitor.

Display of patient information can be real-time or historical record review.

Indicated for use for specific patient populations (adult, pediatric, infant/neonate) depends on the indicated labeling of medical device(s) connected to ADMS providing the data.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K173203

Exhibit H - Section 5 - 510(k) Summary of Safety and Effectiveness

510(k) Summary of Safety and Effectiveness

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

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

Phone: 515.288.3360 Fax: 515.288.3394

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

Date Prepared: January 12, 2018

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

Trade Name: Athena GTX Device Management Suite (ADMS) Common Name: Physiological Monitors Network and Communication System Classification Name: Cardiac monitor (incl. cardio tachometer and rate alarm) (21 CFR 870.2300) Radiofrequency physiological signal transmitter and receiver (21 CFR 870.2910)

Device Class: Class II Product Code: MSX. DRG Other Product Codes: MHX, MWI, DSI, DXN, DQA, MLD Basis for Submission: New Device

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

Legally Marketed (Primary Predicate) Device: M3290B Patient Information Center iX (PIC iX) (K163584) (Second Predicate) Device: WVSM Management Suite (K130957)

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

Device Identification

The Athena GTX Device Management Suite (ADMS) is a software only device that manages patient data from compatible monitoring devices.

Device Characteristics

Environment of Use

ADMS is intended for use by trained healthcare providers in hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare environments.

H - 1 Page 1 of 6

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K173203

Exhibit H - Section 5 - 510(k) Summary of Safety and Effectiveness

Principle of Operation

Materials

The Athena GTX Device Management Suite (ADMS) consists of software only applications that do not come into physical contact with patients.

Key Performance Specification

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

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

The intended use of the ADMS software application is to:

Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than at the patient, for multiple patients.

Display visual alarm conditions as generated by a connected monitor.

Display of patient information can be real-time or historical record review.

Indicated for use for specific patient populations (adult, pediatric, infant/neonate) depends on the indicated labeling of medical device(s) connected to ADMS providing the data.

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Exhibit H - Section 5 - 510(k) Summary of Safety and Effectiveness

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The new device (ADMS), the primary predicate and second predicate devices have similar technological characteristics: Software running on off-the-self personal computer and/or mobile platforms that establish a wired or wireless network with connected medical monitors. The second predicate more clearly demonstrates the specific use of a Bi-Directional communication technological characteristic (including adjusting monitor configuration, alarm limits, start/stop taking a blood pressure and initiating a "find" command) between the Software device and the connected medical monitor(s).

Summary points from the specification comparison show that the ADMS and the predicates:

Use off the shelf operating systems. ●
Use both wired and wireless network connections. .
. Use off the shelf computers and handheld hardware.
Provide the same function - central station and remote system patient monitoring.
. Include use in fixed professional healthcare facilities as well as in the field, mobile applications and patient transport locations.
Provide for real-time/active patient monitoring as well as historical patient record review.
. Include bi-directional communication and control of some monitor functions and configuration settings.
. Provide minimum requirements for hardware and operating system compatibility are specified by the manufacturer - typically in the Instructions for Use (IFU).
. List system compatible monitors tvpically in the device labeling or in the 510(k) summary.
Are able to receive, transmit, store, print and display patient information including: waveforms, numerical values, show trends and alarms.
. Are able to interface to Electronic Medical Records data bases via the HL7 protocol.
. Are touch screen compatible.
ADMS and the secondary predicate have only visual alarms.

The following differences between the predicates and the ADMS software are as follows:

. The primary predicate includes additional ECG waveform analysis and/or display capabilities that are not included in the ADMS.
. The primary predicate has the ability to determine alarm conditions and generate alarm signals for Philips approved medical devices that send physiological data and do not have the ability to determine the alarm condition. This capability is not included in ADMS.
. The primary predicate has both audio and visual alarms. ADMS has only visual alarms. The Secondary predicate has only visual alarms and is the same as ADMS.
. The second predicate does not readily interface with EMRs and does not have an HL7 interface.
The second predicate does not include Protected Health Information (PHI) data. PHI is . included and encrypted in ADMS.

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Exhibit H – Section 5 – 510(k) Summary of Safety and Effectiveness

These differences do not raise different questions of safety and effectiveness because they are additional features that are not part of the ADMS functionality or have been included in ADMS for HIPPA and security purposes.

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

ProductElement	ADMS(New Device)	PIC iX(Primary Predicate)	WVSM ManagementSuite(Second Predicate)	Comments
Manufacturer	Athena GTX	Philips Medical Systems.	Athena GTX	- - -
510(k)Number	Pending - new device	K163584	K130957	- - -
Rx Only	Yes	Yes	Yes	Same
PhysiologicalParameters	Indicated by labeling ofthe Connected MedicalDevice	Indicated by labeling ofthe Connected MedicalDevice	Indicated by WVSMlabeling	Same
PatientPopulation	Indicated by labeling ofthe Connected MedicalDevice	Indicated by labeling ofthe Connected MedicalDevice	Indicated by WVSMlabeling	Same
UserPopulation	Trained healthcareproviders	Trained healthcareprofessionals	Trained healthcareproviders	Same
OperatingSystems	Windows 7, 8,10iOSAndroid	Windows 10Windows Server 2012 R2	Window XPiOS	Similar(deviceplatformdependent)
Network/ConnectivityCapabilities	Wired (USB, LAN)WiFi (802.11b/g/n)Cell Network	Wired (LAN)WiFi (802.11)	WiFi (802.11b/g)	Same
Location	Fixed and Field Mobile	Fixed Professionalhealthcare facilities	Fixed and Field Mobile	Same
Real-timedata	Yes	Yes	Yes	Same
Historical/saved recordreview	Yes	Yes	No	Same exceptfor WVSMSuite
ProductElement	ADMS(New Device)	PIC iX(Primary Predicate)	WVSM ManagementSuite(Second Predicate)	Comments
Bi-directionalCommunication withconnectedmonitors	Yes (Configuration,Alarm limits, Start/StopBP, Find)	Yes (Configuration,Alarm limits, Start/StopBP, Find)	Yes (Configuration,Alarm limits, Start/StopBP, Find)	Same
Display	Platform dependent.Minimum requirementsspecified in the IFU	Minimum requirementsspecified in the IFU	Platform dependent.Minimum requirementsspecified in the IFU	Same definedby minimumrequirement
Touch ScreenCompatible	Yes	Yes	Yes	Same
HostPlatformsSupported	Off-the-shelf WindowsPCs, servers andiOS/Android mobiledevices. HardwareRequirements Specifiedin IFU	Off-the-shelf WindowsPCs and servers.Hardware RequirementsSpecified in IFU	Off-the-shelf WindowsPCs and iOS Mobiledevices. HardwareRequirements Specifiedin IFU	Same definedby minimumrequirement
PatientMonitorsSupported	Up to 20 devices	Up to 4 devices perpatient. Up to 32Patient Sectors	Up to 20 devices	Same or asubset
CompatibleDevices/Monitors	WVSM (K130957)WiCap (K160582)WiTemp (Not a medicaldevice)	Philips approvedmedical devices.Examples Include:Bedside: IntelliVue MXand MP SeriesPortable: IntelliVue X2Mobile: IntelliVue MX40	WVSM (K130957)	SameSystemCompatible/ApprovedDevices
Types of DataTransmitted,Stored andDisplayed	Waveforms, numericalvalues, trends, Alarms	Waveforms, numericalvalues, trends, ECGwaveform analysis &arrhythmia detection,Alarms	Waveforms, numericalvalues, trends, Alarms	Same orSubset
Alarms	Visual	Audio and Visual	Visual	Same orSubset
RemoteNetworkAccess/Interface	Yes	Yes (via Web and iPadAccessory)	No	Same forPIC iX
ProductElement	ADMS(New Device)	PIC iX(Primary Predicate)	WVSM ManagementSuite(Second Predicate)	Comments
PrintCapability	Yes	Yes	Yes	Same
Data Storage	PHI Saved in anencrypted file, data in aproprietary binary filestructure	Not Stated. On a Server	Proprietary binary filestructure	Same orEquivalent
Interface toEMR	Yes (HL7)	Yes (HL7)	No	Same exceptfor WVSMSuite

H - 4

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Exhibit H – Section 5 – 510(k) Summary of Safety and Effectiveness

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Exhibit H - Section 5 - 510(k) Summary of Safety and Effectiveness

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

Biocompatibility

ADMS is a software only device, does not come in contact with the patient and was not tested for biocompatibility.

Industry Standards for Safety, EMC and Essential Performance

Athena GTX Device Management Suite (ADMS) software is a software only device and therefore all testing was completed under software verification and validation. This submission does not rely on FDA recognized performance standards or device-specific guidance for design or testing.

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 Athena GTX Device Management Suite (ADMS) software has the same performance characteristics and is substantially equivalent to the above listed predicate devices.

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).