(163 days)
Not Found
No
The summary describes a software application for data management and display, with no mention of AI or ML capabilities for analysis or interpretation.
No
The device is a software application that manages and displays patient data from other monitoring devices; it does not directly treat or diagnose conditions.
No
The device is described as software that "receives, aggregates, processes, distributes and displays physiologic waves, parameters, alarms and events" for patient data from compatible monitoring devices. It is intended to "support the judgement of a medical professional" and is "not intended to be the sole source of information for decision making," which indicates it is an information management system rather than a diagnostic device that directly interprets data for diagnostic purposes.
Yes
The device description explicitly states "The Athena GTX Device Management Suite (ADMS) is a software only device" and "The Athena GTX Device Management Suite (ADMS) consists of software only applications that do not come into physical contact with patients."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ADMS Function: The ADMS software application's intended use and description clearly state that it receives, aggregates, processes, distributes, and displays physiologic waves, parameters, alarms, and events from connected monitoring devices. It does not interact with or analyze specimens taken from the human body.
- Data Source: The data processed by ADMS comes directly from patient monitoring devices, not from laboratory analysis of biological samples.
Therefore, the ADMS software falls under the category of a medical device that manages and displays patient physiological data, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
MSX, DRG, MHX, MWI, DSI, DXN, DQA, MLD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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.
Intended User / Care Setting
ADMS is intended for use by trained healthcare providers in hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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.
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.
| 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.
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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
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3
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
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.
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
4
K173203
Exhibit H - Section 5 - 510(k) Summary of Safety and Effectiveness
Principle of Operation
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.
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.
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.
5
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.
6
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:
| Product
Element | ADMS
(New Device) | PIC iX
(Primary Predicate) | WVSM Management
Suite
(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 |
| Physiological
Parameters | Indicated by labeling of
the Connected Medical
Device | Indicated by labeling of
the Connected Medical
Device | Indicated by WVSM
labeling | Same |
| Patient
Population | Indicated by labeling of
the Connected Medical
Device | Indicated by labeling of
the Connected Medical
Device | Indicated by WVSM
labeling | Same |
| User
Population | Trained healthcare
providers | Trained healthcare
professionals | Trained healthcare
providers | Same |
| Operating
Systems | Windows 7, 8,10
iOS
Android | Windows 10
Windows Server 2012 R2 | Window XP
iOS | Similar
(device
platform
dependent) |
| Network/
Connectivity
Capabilities | 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 Professional
healthcare facilities | Fixed and Field Mobile | Same |
| Real-time
data | Yes | Yes | Yes | Same |
| Historical/
saved record
review | Yes | Yes | No | Same except
for WVSM
Suite |
| Product
Element | ADMS
(New Device) | PIC iX
(Primary Predicate) | WVSM Management
Suite
(Second Predicate) | Comments |
| Bi-directional
Communicati
on with
connected
monitors | Yes (Configuration,
Alarm limits, Start/Stop
BP, Find) | Yes (Configuration,
Alarm limits, Start/Stop
BP, Find) | Yes (Configuration,
Alarm limits, Start/Stop
BP, Find) | Same |
| Display | Platform dependent.
Minimum requirements
specified in the IFU | Minimum requirements
specified in the IFU | Platform dependent.
Minimum requirements
specified in the IFU | Same defined
by minimum
requirement |
| Touch Screen
Compatible | Yes | Yes | Yes | Same |
| Host
Platforms
Supported | Off-the-shelf Windows
PCs, servers and
iOS/Android mobile
devices. Hardware
Requirements Specified
in IFU | Off-the-shelf Windows
PCs and servers.
Hardware Requirements
Specified in IFU | Off-the-shelf Windows
PCs and iOS Mobile
devices. Hardware
Requirements Specified
in IFU | Same defined
by minimum
requirement |
| Patient
Monitors
Supported | Up to 20 devices | Up to 4 devices per
patient. Up to 32
Patient Sectors | Up to 20 devices | Same or a
subset |
| Compatible
Devices/
Monitors | WVSM (K130957)
WiCap (K160582)
WiTemp (Not a medical
device) | Philips approved
medical devices.
Examples Include:
Bedside: IntelliVue MX
and MP Series
Portable: IntelliVue X2
Mobile: IntelliVue MX40 | WVSM (K130957) | Same
System
Compatible/
Approved
Devices |
| Types of Data
Transmitted,
Stored and
Displayed | Waveforms, numerical
values, trends, Alarms | Waveforms, numerical
values, trends, ECG
waveform analysis &
arrhythmia detection,
Alarms | Waveforms, numerical
values, trends, Alarms | Same or
Subset |
| Alarms | Visual | Audio and Visual | Visual | Same or
Subset |
| Remote
Network
Access/
Interface | Yes | Yes (via Web and iPad
Accessory) | No | Same for
PIC iX |
| Product
Element | ADMS
(New Device) | PIC iX
(Primary Predicate) | WVSM Management
Suite
(Second Predicate) | Comments |
| Print
Capability | Yes | Yes | Yes | Same |
| Data Storage | PHI Saved in an
encrypted file, data in a
proprietary binary file
structure | Not Stated. On a Server | Proprietary binary file
structure | Same or
Equivalent |
| Interface to
EMR | Yes (HL7) | Yes (HL7) | No | Same except
for WVSM
Suite |
H - 4
7
Exhibit H – Section 5 – 510(k) Summary of Safety and Effectiveness
8
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.