AWARE™ is intended for use in the data collection, management and storage of patient information, and is used in conjunction with independent patient bedside devices and Hospital Information Systems connected via a network. This device is indicated for use by health care providing patient care in an ICU and Emergency Department healthcare setting.

AWARE is indicated for use in the clinical care of hospitalized adult and pediatric patient (newborn, infant, child, and adolescent) with or at risk of critical illness.

AWARE is not an Electronic Medical Record (EMR) application and AWARE use is not intended to replace electronic data management systems utilized by healthcare institutions such as an EMR, LIMS (Laboratory Information Management System), PACS (Picture Archive Communication), patient medical device monitoring and alarm systems.

AWARE is not a medical Alarm System and AWARE use is not intended to replace medical Alarm Systems (including monitors) within a healthcare institution. AWARE provides no auditory alerts nor does it provide monitoring and alerting of life threatening situations such as a ventilator disconnection, asystolia, or arthythmia. AWARE provides a visual ICUbased status of events reported from the institutions' source systems to aid in the clinical care decision process.

Device Description

AWARE ™ is a stand-alone software product used by professional care providers in ICU and Emergency Department healthcare settings for the presentation, collection, management and storage of patient information. The AWARE application was created based on healthcare provider requirements to provide patient data through the use of an interface with built-in tools, practice surveillance, and decision support. The philosophy behind the system is the following:

Identify and present relevant information from an institution's currently deployed patient . information systems
Bundle related data into discrete systemic organ based packages to facilitate efficient informed ● decision making in a healthcare setting.
Automatically collect and display critical patient data ●

AI/ML Overview

This document is a 510(k) premarket notification for the AWARE™ device, a clinical decision support software.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific quantitative acceptance criteria or a dedicated performance table comparing AWARE™ to such criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and usability studies.

The "Non-clinical Performance" section describes the following activities:

System level tests
Performance tests
Safety testing based on hazard analysis
Cybersecurity issues addressed
Verification and validation testing activities

The standards utilized are:

ISO 14971: Medical Devices – Applications Of Risk Management To Medical Devices
IEC 62304: Medical Device Software - Software Life Cycle Processes
IEC 60601-1-8: Medical Electrical Equipment - Part 1-8: General Requirements For Basic Safety and Essential Performance – Collateral Standard: General Requirements, Tests and Guidance For Alarm Systems In Medical Electrical Equipment And Medical Electrical Systems

Reported Device Performance:
The "Conclusions from Non-clinical Performance Testing" states: "The AWARE™ 510(k) package and results on non-clinical testing demonstrate AWARE™ is substantially equivalent to the predicate devices, the iMDsoft MetaVision Graphical Patient Information System and the Philips Intellivue Clinical Information Portfolio."

The usability studies cited discuss "reducing information overload," "effect of two different electronic health record user interfaces on intensive care provider task load, errors of cognition, and performance," "representation of organ system domains," "interpretation of graphical icons," and "comparing accuracy, efficiency, and user satisfaction of two EMR [interfaces]." While these studies indicate performance related to usability, they do not provide specific quantitative metrics that directly map to "acceptance criteria" for the device's core functionality in collecting, managing, and storing patient information.

2. Sample Size Used for the Test Set and the Data Provenance:

Test Set Sample Size: Not explicitly stated for any of the non-clinical or usability tests. The usability studies describe methodologies but do not detail the number of "cases" or "patients" used for evaluation.
Data Provenance: Not specified for the non-clinical or usability tests. Given the nature of usability studies for a clinical interface, it is likely that simulated or retrospective data would be used, but this is not stated. The device itself is designed to interface with "an institution's currently deployed patient information systems," implying it processes real-world clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

The document does not describe the establishment of a "ground truth" in the traditional sense of diagnostic accuracy for the test set, as AWARE™ is a data management and presentation system, not a diagnostic tool.

The usability studies referenced involve clinical professionals, but their role is generally as participants providing feedback on the interface's effectiveness and usability, rather than establishing a "ground truth" for a medical condition. For example, the studies involved "intensive care providers" and "clinicians." Specific numbers or detailed qualifications (e.g., years of experience) are not provided in this summary.

4. Adjudication Method for the Test Set:

Not applicable as there is no mention of a ground truth establishment process that would require adjudication. The usability studies would likely involve qualitative and quantitative analysis of user interactions and feedback, but not a consensus-based adjudication of medical findings.

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 reported. The device is described as "clinical decision support software," but its primary function is data collection, management, and storage, with visual presentation to aid decision-making. It does not appear to provide "AI assistance" in the sense of interpreting data or making automated recommendations that would be evaluated for improvement in human reader performance. Its value lies in organizing existing data efficiently.

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

Yes, in spirit, the primary evaluation is standalone performance for the software's intended function. The regulatory submission focuses on non-clinical performance (system level, performance, safety, cybersecurity, and V&V testing of the software itself) and usability. The "Clinical Performance" section is explicitly marked "Not applicable." This indicates that the device's functionality, as a data aggregation and display system, was evaluated independently of human diagnostic performance.

7. The Type of Ground Truth Used:

Not applicable in the typical sense of a diagnostic device. For AWARE™'s function (data collection, management, storage, and presentation), the "ground truth" would relate to the accuracy and integrity of the data displayed against the source systems, and the usability and effectiveness of the interface in presenting that information. The document focuses on demonstrating that the software correctly processes and displays data from source systems, adhering to standards for risk management, software lifecycle, and alarm systems (even though AWARE™ is not an alarm system, it adheres to relevant safety standards). The usability studies investigate how clinicians interact with and interpret the presented data.

8. The Sample Size for the Training Set:

Not applicable. This device is not described as utilizing a machine learning algorithm that requires a "training set" in the context of AI model development. It is a rules-based and data integration software.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no explicit training set for a machine learning model.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 2, 2015

Ambient Clinical Analytics % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

K143372 Re: Trade/Device Name: Aware Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: January 19, 2015 Received: January 20, 2015

Dear Mark Job,

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

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Page 2 - Mark Job

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/McdicalDcvices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143372

Device Name AWARETM

Indications for Use (Describe)

A WARE™ is intended for use in the data collection, management and storage of patient information, and is used in conjunction with independent patient bedside devices and Hospital Information Systems connected via a network. This device is indicated for use by health care providing patient care in an ICU and Emergency Department healthcare setting.

A WARE is indicated for use in the clinical care of hospitalized adult and pediatric patient (newborn, infant, child, and adolescent) with or at risk of critical illness.

A WARE is not an Electronic Medical Record (EMR) application and AWARE use is not intended to replace electronic data management systems utilized by healthcare institutions such as an EMR, LIMS (Laboratory Information Management System), PACS (Picture Archive Communication), patient medical device monitoring and alarm systems.

A WARE is not a medical Alarm System and AWARE use is not intended to replace medical Alarm Systems (including monitors) within a healthcare institution. AWARE provides no auditory alerts nor does it provide monitoring and alerting of life threatening situations such as a ventilator disconnection, asystolia, or arthythmia. AWARE provides a visual ICUbased status of events reported from the institutions' source systems to aid in the clinical care decision process.

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)
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Image /page/3/Picture/0 description: The image shows a logo for a company called "Ambient Clinical Analytics". The logo features a large letter "A" with a circle around it, followed by the word "AMBIENT" in bold, uppercase letters. Below the word "AMBIENT", the words "CLINICAL ANALYTICS" are written in smaller, uppercase letters.

K143372

510(k) Summary AWARE™ 1.0

1. Date Prepared: 2015-03-24

2. Owner:

Allen Berning Ambient Clinical Analytics 221 1st Avenue SW Rochester, MN 55902 United States Phone: 952-240-6775 Email: info@ambientclinical.com

3. Contact person:

Amy Fowler DuVal & Associates, P.A. 825 Nicollet Mall, Suite 1820 Minneapolis, MN 55402 United States Phone: 612-338-7170, ext. 4 Email: fowler@duvalfdalaw.com

1. Trade name: AWARETM Version 1.0
  Common/Usual Name is: Clinical Decision Support Software

Classification Name: Cardiac monitor (including cardiotachometer and rate alarm) Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)

Product code: MWI

1. Predicate devices:
  a. MetaVision Graphical Patient Information System, iMDsoft, Ltd. Cleared for marketing as K012349 on January 29th, 2002, Product Code MWI.

b. Intellivue Clinical Information Portfolio (ICIP), Philips Medical Systems. Cleared for marketing as K100272 on April 14th, 2010, Product Codes DXJ, NSX.

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Image /page/4/Picture/0 description: The image shows the logo for Ambient Clinical Analytics. The logo features a large letter A with a circle around it, followed by the word "AMBIENT" in bold, uppercase letters. Below "AMBIENT" are the words "CLINICAL ANALYTICS" in a smaller font size.

1. Device Description:
  AWARE ™ is a stand-alone software product used by professional care providers in ICU and Emergency Department healthcare settings for the presentation, collection, management and storage of patient information. The AWARE application was created based on healthcare provider requirements to provide patient data through the use of an interface with built-in tools, practice surveillance, and decision support. The philosophy behind the system is the following:
Identify and present relevant information from an institution's currently deployed patient . information systems
Bundle related data into discrete systemic organ based packages to facilitate efficient informed ● decision making in a healthcare setting.
Automatically collect and display critical patient data ●
1. Intended Use/Indications for Use:

AWARE™ is intended for use in the data collection, presentation, management and storage of patient information, and is used in conjunction with independent patient bedside devices and Hospital Information Systems connected via a network. This device is indicated for use by health care providers when providing patient care in an ICU and Emergency Department healthcare setting.

AWARE is indicated for use in the clinical care of hospitalized adult and pediatric patient (newborn, infant, child, and adolescent) with or at risk of critical illness.

AWARE is not a medical Alarm System and AWARE use is not intended to replace medical Alarm Systems (including monitors) within a healthcare institution. AWARE provides no auditory alerts nor does it provide monitoring and alerting of life threatening situations such as a ventilator disconnection, asystolia, or arrhythmia. AWARE provides a visual ICU-based status of events reported from the institutions' source systems to aid in the clinical care decision process.

1. Summary of Technological Characteristics of AWARE™ compared to predicate devices:
  The technological characteristics of AWARE™ and the predicate devices are the same. All devices use Microsoft SQL, existing IT infrastructure, and rules engine technology. All employ software and computers to interact with a healthcare institution's source electronic data systems via a network to collect, display, manage and store patient data. The way the system is used for generating patient records, computation of drug and fluid dosage and research tasks is determined by the health care providers, in terms of their environment and requirements.

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Image /page/5/Picture/0 description: The image shows the logo for Ambient Ecological Analytics. The logo features a large letter 'A' with a partial circle around it, followed by the word 'AMBIENT' in bold, uppercase letters. Below 'AMBIENT' is the phrase 'ECOLOGICAL ANALYTICS' in a smaller, less bold font.

The predicate application is resident on a workstation that provides for data input and patient data display to health care professionals. Typically, the predicate system comprises several workstations connected via a network system to one or more servers. Data is stored and managed by servers. The predicate system network can communicate with a number of remotely located patient care units.

The predicate applications "look and feel" is similar to Electronic Medical Records presentation of data, AWARE™ has a user interface designed from clinician requirements and that provide physiological systemic organ based views. The predications perform patient admit and discharge functions and associated data input screens for billing, AWARE™ doesn't perform patient admit and discharge functions. The iMD system provides Research analytics and reporting, A WARE™ does not support Research analytics and reporting. The predicate Graphical Patient Information Systems supports 15 languages, AWARETM supports English.

9. Non-clinical Performance:

Testing involved system level tests, performance tests and safety testing based on hazard analysis. Cybersecurity issues have been addressed. In addition to the verification and validation testing activities executed by Ambient Clinical Analytics to establish the performance and functionality of A WARE™ and the predicate devices, several standards were utilized:

14971	Medical Devices – Applications Of Risk Management To Medical Devices
62304	Medical Device Software - Software Life Cycle Processes
60601-1-8	Medical Electrical Equipment - Part 1-8: General Requirements For BasicSafety and Essential Performance – Collateral Standard: GeneralRequirements, Tests and Guidance For Alarm Systems In Medical ElectricalEquipment And Medical Electrical Systems

Usability testing was independently conducted and published:

Pickering BW, Herasevich V, Ahmed A, Gajic O. Novel Representation of Clinical Information in the ICU: Developing User Interfaces which Reduce Information Overload. Appl Clin Inform. 2010:1(2):116-31.doi:10.4338/ACI-2009-12-CR-0027. PMID: 23616831

Ahmed A, Chandra S, Herasevich V, Gajic O, Pickering BW. The effect of two different electronic health record user interfaces on intensive care provider task load, errors of cognition, and performance. Crit Care Med. 2011;39(7):1626-34. doi:10.1097/CCM.0b013e31821858a0. PMID: 21478739

JM Litell, TW Suther, CJ Ridgeway, IC Tiong, BW Pickering, V. Herasevich Representation of Organ System Domains in a Novel Critical Care EMR Interface: Implications for Effective Partnership Between Clinicians and Design Professionals. AMIA 2012 proceedings.

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Image /page/6/Picture/0 description: The image shows the logo for Ambient Clinical Analytics. The logo features a stylized letter "A" with a partial circle around it, followed by the words "AMBIENT" in bold, uppercase letters. Below "AMBIENT" is the phrase "CLINICAL ANALYTICS" in smaller, uppercase letters.

Marc D, Pickering B, Harder K, Herasevich V. Interpretation of graphical icons in a critical care EMR interface. AMIA 2013 proceedings.

Marc D, Thongprayoon C, et al. Two interfaces cognitive load efficiency user sat Comparing Accuracy, Efficiency, and User satisfaction of Two EMR. AMIA 2014 proceedings.

1. Clinical Performance:
  Not applicable.
1. Conclusions from Non-clinical Performance Testing:
  The AWARE™ 510(k) package and results on non-clinical testing demonstrate AWARE™ is substantially equivalent to the predicate devices, the iMDsoft MetaVision Graphical Patient Information System and the Philips Intellivue Clinical Information Portfolio.

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).