(189 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data routing, storage, display, and basic analytics for clinical decision support, without mentioning AI/ML algorithms.
No.
The document states that the Sickbay Clinical Platform is a remote monitoring platform that displays physiologic data, waveforms and alarms, and is intended to aid in clinical decisions and deliver patient care in a timely manner, not to provide therapy itself. It specifically warns that it is intended to supplement and not replace device monitoring or be the sole source of alarms.
No
The Sickbay Clinical Platform is a remote monitoring platform that routes and stores medical device data and device diagnostic information. It displays physiologic data, waveforms, and alarms to aid in clinical decisions and patient care, but it is explicitly stated that it is "intended to supplement and not to replace any part of the hospital's device monitoring" and "Do not rely on the Sickbay Clinical Platform product as the sole source of alarms." Therefore, it acts as a data display and management system for existing device diagnostics, rather than a diagnostic device itself.
Yes
The device description explicitly states it is a "software platform and analytics engine" and gathers data from existing patient monitoring devices, indicating it does not include any hardware components. The performance testing listed is focused on software and usability standards.
Based on the provided information, the Sickbay Clinical Platform is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the platform is for routing, storing, and displaying medical device data (like physiologic data, waveforms, and alarms) from supported devices. It's used by healthcare professionals to remotely monitor patients and aid in clinical decisions based on this data.
- Device Description: The description reinforces that it gathers physiological data streams from patient monitoring devices and other clinical data sources.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Sickbay Clinical Platform does not perform any such analysis on biological specimens. It processes data from medical devices that are monitoring the patient directly.
The Sickbay Clinical Platform falls under the category of a medical device, specifically likely a medical device data system (MDDS) or a clinical decision support (CDS) software that processes and displays data from other medical devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, OUG
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.
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
Not Found
Intended User / Care Setting
Intended to be used by healthcare professionals in a hospital setting.
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)
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. The 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.
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).
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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
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
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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 & VIRTUAL |
| PATIENT 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 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. | 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 Vital Sync Virtual Patient | ||
| Monitoring Platform is a | ||
| remote monitoring platform | ||
| that displays physiologic | ||
| data, waveforms and alarms | ||
| routed through the Vital Sync | ||
| Informatics Manager for | ||
| supported devices. The Vital | ||
| Sync Virtual Patient | 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 | ||
| Parameter | Vital Sync | Sickbay Platform |
| Monitoring Platform is | ||
| intended to be used by | ||
| healthcare professionals 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 Vital Sync™
Informatics Manager &
Virtual Patient Monitoring
Platform are intended to
supplement and not to
replace any part of the
hospital's device monitoring.
Do not rely on the Vital Sync™
Informatics Manager &
Virtual Patient Monitoring
Platform as the sole source of
alarms. | 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
replace any part of the
hospital's device monitoring.
Do not rely on the Sickbay
Clinical Platform 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. |
| Functionality | Display patient monitor data
remotely | Display patient monitor data
remotely and store it for
analysis. |
| Device Regulatory
Classification | 21 C.F.R.
Part 870, Subpart B
Cardiovascular Diagnostic | 21 C.F.R.
Part 870, Subpart B
Cardiovascular Diagnostic |
| Parameter | Vital Sync | Sickbay Platform |
| | Devices,
Sec. 870.1425
Programmable diagnostic
computer. | Devices,
Sec. 870.1425
Programmable diagnostic
computer. |
| 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 is
buffered and then archived
on tape. | All physiological data is
stored on disk drives forever,
until deleted. |
| Wireless | Yes: handheld display devices | Yes: handheld display devices |
| Direct Sensor Contact | Covidien sensors supply data
but are not part of this
device. | Various hospital Monitors
and sensors provide data but
are not part of our device. |
| Optimum Range | Within the Hospital's secure
WIFI network. | Within the Hospital's secure
WIFI network. |
| Wireless vs Wired
Function | WIFI from sensor to server,
wired and WIFI out to
handheld displays. | Both WIFI and wired from
sensors to server and both
WIFI 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 Main | ||
| functionality | Patient information is | |
| transmitted wirelessly from | ||
| bedside devices to the | ||
| hospital's server | ||
| The Vital Sync software, | ||
| which resides on a hospital's | ||
| server, takes this information | ||
| and makes it viewable on any | ||
| web-enabled device on the | ||
| hospital network | ||
| The information is formatted | ||
| into HL7 protocol and | ||
| written into the hospital EMR | Patient information is | |
| transmitted wired or | ||
| wirelessly from bedside | ||
| devices to the hospital's | ||
| network | ||
| The Sickbay Clinical Platform, | ||
| which resides on a hospital's | ||
| servers, takes this | ||
| information stores it and | ||
| makes it viewable on any | ||
| web-enabled device on the | ||
| hospital network | ||
| Information from EMR (Lab, | ||
| Meds and ADT records in | ||
| HL7 format) is stored in | ||
| Sickbay and available for | ||
| redisplay. | ||
| Target population/ | ||
| demographics | ICU and ER patients that have | |
| Covidien physiological | ||
| sensors attached. | ICU and ER patients that have | |
| any physiological sensors | ||
| 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)
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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 | Applicable
Standard | Results |
|---------------------|--------------------------|----------|
| Usability | IEC 62366 | Complies |
| Software Life-Cycle | IEC 62304
AAMI 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 | Applicable
Standard | Results |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------|
| Risk Management | ISO 14971 | Complies |
| Medical Electrical Equipment – Collateral
Standard: Gen. Requirements, Tests and
Guidance for Alarm systems in Medical
Electrical Equipment and Medical Electrical
system | IEC 60601-1-8 | Complies |
| Medical Electrical Equipment - Particular
Requirements for the Basic Safety and Essential
Performance of Electrocardiographic
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
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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.