Sickbay Clinical Platform

{0}------------------------------------------------ Image /page/0/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 26, 2015 Medical Informatics Corp % David Makanani Consultant OMEDtech, LLC 1725 Signal Ridge Drive, Suite 150 Edmond, Oklahoma 73013 Re: K143304 Trade/Device Name: Sickbay™ Clinical Platform Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: April 13, 2015 Received: April 14, 2015 Dear David Makanani, 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}------------------------------------------------ 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 (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/MedicalDevices/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, forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ # Indication for Use Statement 510(k) Number: K143304 Device Name: Sickbay™ Clinical Platform Indications for Use: The Sickbay Clinical Platform is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Electronic Medical Record (EMR) and Clinical Information Systems. The Sickbay Clinical Platform is a remote monitoring platform that displays physiologic data, waveforms and alarms routed through the Sickbay Clinical Platform for supported devices. The Sickbay Clinical Platform is intended to be used by healthcare professionals in a hospital setting for the following purposes: - To remotely consult, regarding a patient's status . - To remotely review other standard or critical near real-time patient data, . waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner. WARNING: The Sickbay Clinical Platform is intended to supplement and not to re-place any part of the hospital's device monitoring. Do not rely on the Sickbay Clinical Platform product as the sole source of alarms. Note: Sickbay Clinical Platform product includes 3 Apps: Patient Monitoring App; Patient Alarm Data Monitor & Alarm Analytics Dashboard App. Prescription Use: Yes _ AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use: NO (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Division Sign-Off 510(k) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Medical Informatics. The logo consists of a blue square with a stylized "m" inside, followed by the words "Medical" in blue and "Informatics" in gray. The "m" in the square is made up of several smaller squares, some of which are filled in with a lighter shade of blue. # 510(K) SUMMARY | Date | April 10th 2015 | |-------------------|------------------------------------------------------------------------------------------------------| | SUBMITTER | Medical Informatics Corp | | | 6500 Main St. | | | BioScience Research Collaborative Suite 1020G | | | Houston TX 77030 | | CONTACT PERSON | Ralph Krog JD, Chief Compliance Officer | | | Ralph.Krog@MedicalInformaticsCorp.com | | | 713-370-3904 | | DEVICE NAME | Sickbay™ Clinical Platform | | Classification | Device | | Trade Name | Sickbay Clinical Platform | | Common Name | Sickbay | | Classification | Class II | | Product Code | MWI, OUG | | Review Panel | Part 870, | | | Subpart B Cardiovascular Diagnostic Devices, | | | Sec. 870.1425 Programmable diagnostic computer. | | PREDICATE DEVICE: | COVIDIEN VITAL SYNC INFORMATICS MANAGER & VIRTUAL<br>PATIENT MONITORING PLATFORM - 510(k)'s: K132604 | {4}------------------------------------------------ "The Vital Sync™ Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Electronic Medical Record (EMR) and Clinical Information System (CIS). DEVICE DESCRIPTION: Medical Informatics Corp (MIC) has developed a software platform and analytics engine, Sickbay™, which gathers physiological data streams coming from patient monitoring devices and other clinical data sources. Medical Informatics Corp's software platform, Sickbay, captures patient data and enables near real-time display and analytics for clinicians to use in clinical decision support. ENVIRONMENT OF USE: Sickbay Clinical Platform is intended to be used in a hospital environment. ### TECHNOLOGICAL CHARACTERISTIC AND SUBSTANTIAL EQUIVALENCE: The following table provides more detailed information regarding the basis for the determination of substantial equivalence: | Parameter | Vital Sync | Sickbay Platform | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | The Vital Sync Informatics<br>Manager is software that is<br>intended to route and store<br>medical device data and<br>device diagnostic information<br>from supported devices to<br>the Electronic Medical Record<br>(EMR) and Clinical<br>Information System. | The Sickbay Clinical Platform<br>is software that is intended to<br>route and store medical<br>device data and device<br>diagnostic information from<br>supported devices to the<br>Electronic Medical Record<br>(EMR) and Clinical<br>Information Systems. | | | The Vital Sync Virtual Patient<br>Monitoring Platform is a<br>remote monitoring platform<br>that displays physiologic<br>data, waveforms and alarms<br>routed through the Vital Sync<br>Informatics Manager for<br>supported devices. The Vital<br>Sync Virtual Patient | The Sickbay Clinical Platform<br>is a remote monitoring<br>platform that displays<br>physiologic data, waveforms<br>and alarms routed through<br>the Sickbay Clinical Platform<br>for supported devices. The | | Parameter | Vital Sync | Sickbay Platform | | | Monitoring Platform is<br>intended to be used by<br>healthcare professionals for<br>the following purposes:<br>- To remotely consult,<br>regarding a patient's status<br>- To remotely review other<br>standard or critical near real-<br>time patient data, waveforms<br>and alarms in order to utilize<br>this information to aid in<br>clinical decisions and deliver<br>patient care in a timely<br>manner.<br>WARNING: The Vital Sync™<br>Informatics Manager &<br>Virtual Patient Monitoring<br>Platform are intended to<br>supplement and not to<br>replace any part of the<br>hospital's device monitoring.<br>Do not rely on the Vital Sync™<br>Informatics Manager &<br>Virtual Patient Monitoring<br>Platform as the sole source of<br>alarms. | Sickbay Clinical Platform is<br>intended to be used by<br>healthcare professionals in a<br>hospital setting for the<br>following purposes:<br>- To remotely consult,<br>regarding a patient's status<br>- To remotely review other<br>standard or critical near real-<br>time patient data, waveforms<br>and alarms in order to utilize<br>this information to aid in<br>clinical decisions and deliver<br>patient care in a timely<br>manner.<br>WARNING: The Sickbay<br>Clinical Platform is intended<br>to supplement and not to<br>replace any part of the<br>hospital's device monitoring.<br>Do not rely on the Sickbay<br>Clinical Platform as the sole<br>source of alarms.<br>Note: Sickbay Clinical<br>Platform product includes 3<br>Apps: Patient Monitoring<br>App; Patient Alarm Data<br>Monitor & Alarm Analytics<br>Dashboard App. | | Functionality | Display patient monitor data<br>remotely | Display patient monitor data<br>remotely and store it for<br>analysis. | | Device Regulatory<br>Classification | 21 C.F.R.<br>Part 870, Subpart B<br>Cardiovascular Diagnostic | 21 C.F.R.<br>Part 870, Subpart B<br>Cardiovascular Diagnostic | | Parameter | Vital Sync | Sickbay Platform | | | Devices,<br>Sec. 870.1425<br>Programmable diagnostic<br>computer. | Devices,<br>Sec. 870.1425<br>Programmable diagnostic<br>computer. | | Product Code | MWI & OUG | MWI & OUG | | Device Class | II | II | | 510(k) number | K132604 | K143304 | | Technology | Standard computers,<br>network and WIFI technology | Standard computers,<br>network and WIFI technology | | Data Storage | Hour to days of data is<br>buffered and then archived<br>on tape. | All physiological data is<br>stored on disk drives forever,<br>until deleted. | | Wireless | Yes: handheld display devices | Yes: handheld display devices | | Direct Sensor Contact | Covidien sensors supply data<br>but are not part of this<br>device. | Various hospital Monitors<br>and sensors provide data but<br>are not part of our device. | | Optimum Range | Within the Hospital's secure<br>WIFI network. | Within the Hospital's secure<br>WIFI network. | | Wireless vs Wired<br>Function | WIFI from sensor to server,<br>wired and WIFI out to<br>handheld displays. | Both WIFI and wired from<br>sensors to server and both<br>WIFI and wired out. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Medical Informatics. The logo consists of a blue square with a stylized "mi" inside, followed by the words "Medical" in blue and "Informatics" in gray. The logo is simple and modern, and it is likely used to represent a company or organization that specializes in medical informatics. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains a logo for Medical Informatics. The logo consists of a stylized letter "m" inside a rounded square shape on the left, followed by the words "Medical" and "Informatics" on the right. The word "Medical" is in a larger, bolder font than "Informatics". The letter "m" and the word "Medical" are in a teal color, while the word "Informatics" is in a gray color. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Medical Informatics. The logo consists of a blue square with rounded corners, inside of which are the letters "m" and "i" in white and gray. To the right of the square is the word "Medical" in blue, and below that is the word "Informatics" in gray. | Parameter | Vital Sync | Sickbay Platform | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Software Main<br>functionality | Patient information is<br>transmitted wirelessly from<br>bedside devices to the<br>hospital's server<br>The Vital Sync software,<br>which resides on a hospital's<br>server, takes this information<br>and makes it viewable on any<br>web-enabled device on the<br>hospital network<br>The information is formatted<br>into HL7 protocol and<br>written into the hospital EMR | Patient information is<br>transmitted wired or<br>wirelessly from bedside<br>devices to the hospital's<br>network<br>The Sickbay Clinical Platform,<br>which resides on a hospital's<br>servers, takes this<br>information stores it and<br>makes it viewable on any<br>web-enabled device on the<br>hospital network<br>Information from EMR (Lab,<br>Meds and ADT records in<br>HL7 format) is stored in<br>Sickbay and available for<br>redisplay. | | Target population/<br>demographics | ICU and ER patients that have<br>Covidien physiological<br>sensors attached. | ICU and ER patients that have<br>any physiological sensors<br>attached. | ### WHY THE DIFFERENCES ARE NOT CRITICAL TO THE INTENDED USE OF THE DEVICE Covidien has two devices (Vital Sync Informatics Manager & the Vital Sync Virtual Patient Monitoring Platform) performing two functions (route and store medical device data AND re-display physiologic data, waveforms and alarms). MIC has one device (Sickbay Clinical Platform) that performs the same two functions (route and store medical device data AND re-display physiologic data, waveforms and alarms). This difference has no effect on how the devices are used. Indeed both Vital Sync and Sickbay perform the same two general functions. The Vital Sync Informatics Manager routes and stores data from supported devices to the Electronic Medical Record (EMR) and Clinical Information System. The Sickbay Clinical Platform routes and stores data from supported devices and from the Electronic Medical Record (EMR) and Clinical Information Systems. Covidien's Vital Sync is gathering data from Covidien bedside sensors and storing it in the Hospital's EMR. MIC's Sickbay gathers data from all sensors on the bedside from the hospital network (before they get to the EMR) {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Medical Informatics. The logo consists of a blue square with a stylized "m" inside, followed by the words "Medical" in blue and "Informatics" in gray. The font is sans-serif and modern. and stores data in its own Sickbay data base and Sickbay data repository or file set. This difference has no effect on how the devices are used; both devices gather and store medical data from other medical device sensors or monitors and re-display such data on supported devices. The set of medical sensors may differ, but the function and use of the two devices (Vital Sync and Sickbay) are the same. # WHY THE DIFFERENCES DO NOT AFFECT THE SAFETY AND EFFECTIVENESS OF THE DEVICE WHEN USED AS LABELED. Covidien has two products performing two functions and MIC has one product performing the same two functions. This difference in structure or packaging has no effect on safety and effectiveness. The hazards are the same. The difference in data storage (an EMR database versus Sickbay database) do not affect the safety and effectiveness of the product, because the reliability of data storage and retrieval technology is the same for both products. Sickbay's database does not replace or preclude use of an EMR. ### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS: The technological characteristics of the two devices are the same. Both rely on general purpose computers, wired and wireless computer networks, and data storage technology. This technology is several generations old, well established, and its risks and mitigations are well understood. The only technological difference between Vital Sync and Sickbay is one of volume not technology. Sickbay uses more data storage because the data can be analyzed offline as well as redisplayed. ### PERFORMANCE TESTING - (NON-CLINICAL) BENCH Sickbay Clinical Platform has been determined through engineering bench testing to support substantial equivalence with this device and the predicates. | Performance Test | Applicable<br>Standard | Results | |---------------------|--------------------------|----------| | Usability | IEC 62366 | Complies | | Software Life-Cycle | IEC 62304<br>AAMI TIR 45 | Complies | | AAMI/ANSI HE75 | Human Factors | Complies | | Health Informatics | IEEE 11073-10406 | Complies | ### TESTS CONDUCTED: {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Medical Informatics. The logo consists of a blue square with a stylized "m" inside, followed by the words "Medical" in blue and "Informatics" in gray. The "m" in the square is made up of three vertical bars, with the middle bar being a lighter shade of blue. | Performance Test | Applicable<br>Standard | Results | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------| | Risk Management | ISO 14971 | Complies | | Medical Electrical Equipment – Collateral<br>Standard: Gen. Requirements, Tests and<br>Guidance for Alarm systems in Medical<br>Electrical Equipment and Medical Electrical<br>system | IEC 60601-1-8 | Complies | | Medical Electrical Equipment - Particular<br>Requirements for the Basic Safety and Essential<br>Performance of Electrocardiographic<br>Monitoring Equipment | IEC 60601-2-27 | Complies | | | | | MIC referred to the following documents: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm08954 3.htm General Principles of Software Validation; Final Guidance for Industry and FDA Staff http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281. htm Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm07377 8.htm Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design http://www.fda.gov/RegulatoryInformation/Guidances/ucm259748.htm Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidanceDocuments/UCM35619 0.pdf {10}------------------------------------------------ Image /page/10/Picture/0 description: The image is a logo for Medical Informatics. The logo consists of a blue square with a stylized "m" and "i" inside, followed by the words "Medical" in blue and "INFORMATICS" in gray. The logo is simple and modern, and it is likely used to represent a company or organization that provides medical informatics services. Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm07781 2.htm Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm22855 3.htm This testing showed the Sickbay to meet applicable ISO, IEC and FDA safety and performance standards. And guidances. ### PERFORMANCE TESTING - ANIMAL/CLINICAL There has been no animal/clinical testing submitted with this Notification. ### CONCLUSION: Based on the results of non-clinical testing, the Sickbay performs safely, as intended, and the comparative discussion of intended use, principle of operation, and technological characteristics, it is determined by MIC that the Sickbay is substantially equivalent to predicate devices.