AWARE

{0}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces right and appears to be in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | | | 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 comblete 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." {3}------------------------------------------------ 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 - 4. 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 - 5. 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. {4}------------------------------------------------ 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. - 6. 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 ● - 7. 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 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 arrhythmia. AWARE provides a visual ICU-based status of events reported from the institutions' source systems to aid in the clinical care decision process. - 8. 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. {5}------------------------------------------------ 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 Basic<br>Safety and Essential Performance – Collateral Standard: General<br>Requirements, Tests and Guidance For Alarm Systems In Medical Electrical<br>Equipment 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. {6}------------------------------------------------ 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. - 10. Clinical Performance: Not applicable. - 11. 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.