(189 days)
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.
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.
The Medical Informatics Corp's Sickbay™ Clinical Platform is a software device intended to route, store, and display medical device data, waveforms, and alarms from supported devices to an Electronic Medical Record (EMR) and Clinical Information Systems. It also acts as a remote monitoring platform for healthcare professionals in a hospital setting for patient status consultation and review of real-time patient data to aid in clinical decisions.
Here's an analysis of its acceptance criteria and the supporting study, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Applicable Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Usability | IEC 62366 | Compliance with standard | Complies |
| Software Life-Cycle | IEC 62304, AAMI TIR 45 | Compliance with standards | Complies |
| Human Factors | AAMI/ANSI HE75 | Compliance with standard | Complies |
| Health Informatics | IEEE 11073-10406 | Compliance with standard | Complies |
| Risk Management | ISO 14971 | Compliance with standard | Complies |
| Alarm systems in Medical Electrical Equipment and Medical Electrical system | IEC 60601-1-8 | Compliance with standard | Complies |
| Basic Safety and Essential Performance of Electrocardiographic Monitoring Equipment | IEC 60601-2-27 | Compliance with standard | Complies |
The document states that "This testing showed the Sickbay to meet applicable ISO, IEC and FDA safety and performance standards. And guidances." This indicates that the reported device performance met the specified acceptance criteria for each test.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify any specific sample size for a test set or the data provenance (e.g., country of origin, retrospective/prospective) for these performance tests. The listed tests are primarily "non-clinical bench testing" and relate to software development, usability, risk management, and compliance with general medical device standards, rather than direct performance evaluation on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a "ground truth" for any specific test set. The tests performed are compliance-based (e.g., software development, usability guidelines, risk management standards), which do not typically require expert-established ground truth in the same way clinical performance studies do.
4. Adjudication Method for the Test Set
As no specific test set requiring ground truth or adjudication is described, there is no mention of an adjudication method (e.g., 2+1, 3+1, none) in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The document states: "PERFORMANCE TESTING - ANIMAL/CLINICAL: There has been no animal/clinical testing submitted with this Notification." The device is intended to display data for human review, but its performance was not evaluated through a study comparing human readers with and without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
The document primarily describes a software platform that processes, stores, and displays data. While it includes "Alarm Analytics Dashboard App," the core functionality is data management and display. The listed performance tests are primarily related to general software, usability, and safety standards for medical devices. There is no mention of a standalone performance study specifically evaluating the algorithm's diagnostic or analytical performance without human intervention in a clinical context (e.g., for detecting specific conditions). The device's function is to aid in clinical decisions, not to make them independently.
7. Type of Ground Truth Used
Given the "non-clinical bench testing" nature of the studies, the "ground truth" used is adherence to established technical standards, regulations, and specifications (e.g., IEC, ISO, IEEE for software, safety, usability, and health informatics). There is no use of expert consensus, pathology, or outcomes data as ground truth for these specific compliance tests.
8. Sample Size for the Training Set
The document does not provide any information on a training set or its sample size. This is consistent with the nature of the device being a data management and display platform, rather than a diagnostic AI that requires supervised learning with labeled training data.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for the performance evaluation, there is no information on how its ground truth would have been established.
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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
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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
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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)
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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 & VIRTUALPATIENT MONITORING PLATFORM - 510(k)'s: K132604 |
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"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 InformaticsManager is software that isintended to route and storemedical device data anddevice diagnostic informationfrom supported devices tothe Electronic Medical Record(EMR) and ClinicalInformation System. | The Sickbay Clinical Platformis software that is intended toroute and store medicaldevice data and devicediagnostic information fromsupported devices to theElectronic Medical Record(EMR) and ClinicalInformation Systems. |
| The Vital Sync Virtual PatientMonitoring Platform is aremote monitoring platformthat displays physiologicdata, waveforms and alarmsrouted through the Vital SyncInformatics Manager forsupported devices. The VitalSync Virtual Patient | The Sickbay Clinical Platformis a remote monitoringplatform that displaysphysiologic data, waveformsand alarms routed throughthe Sickbay Clinical Platformfor supported devices. The | |
| Parameter | Vital Sync | Sickbay Platform |
| Monitoring Platform isintended to be used byhealthcare professionals forthe following purposes:- To remotely consult,regarding a patient's status- To remotely review otherstandard or critical near real-time patient data, waveformsand alarms in order to utilizethis information to aid inclinical decisions and deliverpatient care in a timelymanner.WARNING: The Vital Sync™Informatics Manager &Virtual Patient MonitoringPlatform are intended tosupplement and not toreplace any part of thehospital's device monitoring.Do not rely on the Vital Sync™Informatics Manager &Virtual Patient MonitoringPlatform as the sole source ofalarms. | Sickbay Clinical Platform isintended to be used byhealthcare professionals in ahospital setting for thefollowing purposes:- To remotely consult,regarding a patient's status- To remotely review otherstandard or critical near real-time patient data, waveformsand alarms in order to utilizethis information to aid inclinical decisions and deliverpatient care in a timelymanner.WARNING: The SickbayClinical Platform is intendedto supplement and not toreplace any part of thehospital's device monitoring.Do not rely on the SickbayClinical Platform as the solesource of alarms.Note: Sickbay ClinicalPlatform product includes 3Apps: Patient MonitoringApp; Patient Alarm DataMonitor & Alarm AnalyticsDashboard App. | |
| Functionality | Display patient monitor dataremotely | Display patient monitor dataremotely and store it foranalysis. |
| Device RegulatoryClassification | 21 C.F.R.Part 870, Subpart BCardiovascular Diagnostic | 21 C.F.R.Part 870, Subpart BCardiovascular Diagnostic |
| Parameter | Vital Sync | Sickbay Platform |
| Devices,Sec. 870.1425Programmable diagnosticcomputer. | Devices,Sec. 870.1425Programmable diagnosticcomputer. | |
| Product Code | MWI & OUG | MWI & OUG |
| Device Class | II | II |
| 510(k) number | K132604 | K143304 |
| Technology | Standard computers,network and WIFI technology | Standard computers,network and WIFI technology |
| Data Storage | Hour to days of data isbuffered and then archivedon tape. | All physiological data isstored on disk drives forever,until deleted. |
| Wireless | Yes: handheld display devices | Yes: handheld display devices |
| Direct Sensor Contact | Covidien sensors supply databut are not part of thisdevice. | Various hospital Monitorsand sensors provide data butare not part of our device. |
| Optimum Range | Within the Hospital's secureWIFI network. | Within the Hospital's secureWIFI network. |
| Wireless vs WiredFunction | WIFI from sensor to server,wired and WIFI out tohandheld displays. | Both WIFI and wired fromsensors to server and bothWIFI and wired out. |
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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.
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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.
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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 Mainfunctionality | Patient information istransmitted wirelessly frombedside devices to thehospital's serverThe Vital Sync software,which resides on a hospital'sserver, takes this informationand makes it viewable on anyweb-enabled device on thehospital networkThe information is formattedinto HL7 protocol andwritten into the hospital EMR | Patient information istransmitted wired orwirelessly from bedsidedevices to the hospital'snetworkThe Sickbay Clinical Platform,which resides on a hospital'sservers, takes thisinformation stores it andmakes it viewable on anyweb-enabled device on thehospital networkInformation from EMR (Lab,Meds and ADT records inHL7 format) is stored inSickbay and available forredisplay. |
| Target population/demographics | ICU and ER patients that haveCovidien physiologicalsensors attached. | ICU and ER patients that haveany physiological sensorsattached. |
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)
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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 | ApplicableStandard | Results |
|---|---|---|
| Usability | IEC 62366 | Complies |
| Software Life-Cycle | IEC 62304AAMI TIR 45 | Complies |
| AAMI/ANSI HE75 | Human Factors | Complies |
| Health Informatics | IEEE 11073-10406 | Complies |
TESTS CONDUCTED:
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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 | ApplicableStandard | Results |
|---|---|---|
| Risk Management | ISO 14971 | Complies |
| Medical Electrical Equipment – CollateralStandard: Gen. Requirements, Tests andGuidance for Alarm systems in MedicalElectrical Equipment and Medical Electricalsystem | IEC 60601-1-8 | Complies |
| Medical Electrical Equipment - ParticularRequirements for the Basic Safety and EssentialPerformance of ElectrocardiographicMonitoring 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
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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.
§ 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).