(149 days)
No
The document describes a software application for displaying and forwarding physiological data from a monitor. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or decision-making.
No.
The device functions as a remote display and data forwarding app for a physiological monitor, not directly providing therapy.
No
Explanation: The device is described as a software application that displays and forwards data from a physiological monitor and other medical devices. It explicitly states that "The alerts in the subject device are only to be used for historical review and are not intended for time-critical intervention," which suggests it's not for immediate diagnostic use. Its primary function is data display and transfer, not diagnosis. The predicate devices are also monitoring and data display systems.
Yes
The device is described as a "software App" that runs on "Commercial, Off the Shelf (CoTS) hardware" and provides additional controls and features to a separate physiological monitor device (K163255). It also functions as a data display and forwarding platform. The description explicitly states it is a software platform and library, and the testing focuses on data communication and usability, not hardware performance.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device function: The description clearly states that the Caretaker Remote Display App and Software Library are for the remote display and forwarding of securely transmitted wireless data from the Caretaker Physiological Monitor device. It also mentions displaying and storing physiological parameters and waveforms from patient monitoring medical devices.
- No mention of specimens: There is no indication that this device interacts with or analyzes any specimens taken from the human body. Its function is solely related to handling data from a physiological monitor.
Therefore, the device's purpose aligns with displaying and managing patient physiological data, not with performing in vitro diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Caretaker Remote Display App and Caretaker Software Library are indicated for use when remote display and/or forwarding of securely transmitted wireless data from the Caretaker Physiological Monitor device (K163255) is required. The Remote Display App and the Software Library provides bi-directional data transfer capabilities with the Caretaker Physiological Monitor device (K163255). To facilitate communications between the Caretaker Physiological Monitor device and other FDA Cleared patient monitors and Remote Data Displays (RDDS), the Caretaker Software Library provides a well-defined interface for 3rd party data integrations.
In addition to providing data display and forwarding, the Remote Display App can operate as an MDDS for 3rd party wireless medical devices. The alerts in the subject device are only to be used for historical review and are not intended for time-critical intervention.
The Software Library is intended only for use by licensed partners of the company, and the Caretaker Remote Display App is intended for use by clinicians or other properly trained medical personnel. Both the Remote Display App and Software Library are for prescriptive use only.
Product codes
DXN, DRG
Device Description
Caretaker Medical's App ("CareTaker Remote Display App") is a software App that runs on Commercial, Off the Shelf (CoTS) hardware to provide additional controls and features to the CareTaker4 Physiological Monitor, K163255, as well as an interface to other devices.
The App is a software platform that displays and stores physiological parameters and waveforms from patient monitoring medical devices. CareTaker Remote Display App can also forward this data to third party systems, including Electronic Medical Records systems.
The integrated CareTaker Software library provides new control and configuration functions to a connected CareTaker4 Physiological Monitor. This library can also be used by 3rd parties to develop their own Apps that are capable of controlling a CareTaker4 as well. The library does not and cannot control any other medical devices or systems it is connected with.
CareTaker Remote Display App can function without the CareTaker Software Library, in which case it is the same as the RDDS in K163255.
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
The Software Library is intended only for use by licensed partners of the company, and the Caretaker Remote Display App is intended for use by clinicians or other properly trained medical personnel.
Anywhere clinicians consult on patients (local or remote).
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
The safety and effectiveness of the CareTaker Remote Display App have been confirmed through nonclinical testing and conformance to vital signs monitoring, usability, and risk assessment. The App was tested by connecting to a CareTaker4 Physiological Monitor Device using the CareTaker Software Library and to both a SpO2 monitor and a temperature patch using industry standard BLE Protocols to receive data. Data forwarding was tested using both WiFi and USB protocols to an external RDDS.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 3, 2018
Caretaker Medical, LLC Jeff Pompeo President 941 Glenwood Station Ln, Suite 301 Charlottesville, Virginia 22901
Re: K181196
Trade/Device Name: Caretaker Remote Display App and Caretaker Software Library Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DRG Dated: September 5, 2018 Received: September 5, 2018
Dear Jeff Pompeo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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 device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
| Sincerely, | |
|---|---|
| Shawn W. | |
| for Forrest -A | |
| Digitally signed by Shawn W. Forrest -A | |
| DN: c=US, o=U.S. Government, ou=HHS, ou=FDA | |
| ou=People, | |
| 0.9.2342.19200300.100.1.1=1300403341, | |
| cn=Shawn W. Forrest -A | |
| Date: 2018.10.03 22:18:36 -04'00' | |
| Bram D. Zuckerman, M.D. | |
| Director | |
| Division of Cardiovascular Devices | |
| Office of Device Evaluation | |
| Center for Devices and Radiological Health |
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K181196
Device Name
Caretaker Remote Display App and Caretaker Software Library
Indications for Use (Describe)
The Caretaker Remote Display App and Caretaker Software Library are indicated for use when remote display and/or forwarding of securely transmitted wireless data from the Caretaker Physiological Monitor device (K163255) is required. The Remote Display App and the Software Library provides bi-directional data transfer capabilities with the Caretaker Physiological Monitor device (K163255). To facilitate communications between the Caretaker Physiological Monitor device and other FDA Cleared patient monitors and Remote Data Displays (RDDS), the Caretaker Software Library provides a well-defined interface for 3rd party data integrations.
In addition to providing data display and forwarding, the Remote Display App can operate as an MDDS for 3rd party wireless medical devices. The alerts in the subject device are only to be used for historical review and are not intended for time-critical intervention.
The Software Library is intended only for use by licensed partners of the Caretaker Remote Display App is intended for use by clinicians or other properly trained medical personnel. Both the Remote Display App and Software Library are for prescriptive use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary of Safety and Effectiveness
-
- Preparation Date: Aug 31, 2018 2) Submitted by: CareTaker Medical, LLC 941 Glenwood Station Ln, Suite 301 Charlottesville, Virginia 2290 User Fee Organization Number 397095 Owner/Operator #: 10054848 3) Contact Person/Prepared by: Jeff Pompeo President & CEO CareTaker Medical 941 Glenwood Station Ln. Suite 301 Charlottesville. Virginia 22901-1455 Phone: 434-409-1945 Email: Jeff@caretakermedical.net 4) Device Identification: Trade Name: CareTaker Remote Display App and CareTaker Software Library Common Name: CareTaker App Classification: 21 CFR 870.1130, Product Codes: DXN -System, Measurement, Blood-Pressure, Non-Invasive DRG - Transmitters And Receivers, Physiological Signal, Radiofrequency Device Class: II 5) Predicate Devices: VIOS Monitoring System, K150992 Airstrip ONE Web Client, K160862 6)
- Device Description: CareTaker Medical's App ("CareTaker Remote Display App") is a software App that runs on Commercial, Off the Shelf (CoTS) hardware to provide additional controls and features to the CareTaker4 Physiological Monitor, K163255, as well as an interface to other devices.
The App is a software platform that displays and stores physiological parameters and waveforms from patient monitoring medical devices. CareTaker Remote Display App can also forward this data to third party systems, including Electronic Medical Records systems.
The integrated CareTaker Software library provides new control and configuration functions to a connected CareTaker4 Physiological Monitor. This library can also be used by 3rd parties to develop their own Apps that are capable of controlling a CareTaker4 as well. The library does not and cannot control any other medical devices or systems it is connected with.
CareTaker Remote Display App can function without the CareTaker Software Library, in which case it is the same as the RDDS in K163255.
4
K181196
The relationships between the various items as well as between K163255 and K181196 are shown conceptually below.
Image /page/4/Figure/2 description: The image shows a diagram of two systems, K163255 and K181196, with various components and connections. System K163255 includes a CT4 Physiological Monitor connected to an RDDS. System K181196 contains a Library, an App, an RDDS, and Other Devices, all interconnected. Arrows indicate the flow of data or interaction between these components within and between the systems.
7) Intended Use:
The Caretaker Remote Display App and Caretaker Software Library are indicated for use when remote display and/or forwarding of securely transmitted wireless data from the Caretaker Physiological Monitor device (K163255) is required. The Remote Display App and the Software Library provides bi-directional data transfer capabilities with the Caretaker Physiological Monitor device (K163255). To facilitate communications between the Caretaker Physiological Monitor device and other FDA Cleared patient monitors and Remote Data Displays (RDDS), the Caretaker Software Library provides a well-defined interface for 3rd party data integrations.
In addition to providing data display and forwarding, the Remote Display App can operate as an MDDS for 3rd party wireless medical devices. The alerts in the subject device are only to be used for historical review and are not intended for time-critical intervention.
The Software Library is intended only for use by licensed partners of the company, and the Caretaker Remote Display App is intended for use by clinicians or other properly trained medical personnel. Both the Remote Display App and Software Library are for prescriptive use only.
| Feature | VIOS Monitoring System | Airstrip ONE Web Client | CareTaker App |
|---|---|---|---|
| Indications | |||
| for Use | The Vios Monitoring System | ||
| (VMS) is intended for use by | |||
| medically qualified personnel for | |||
| physiological and vital signs | |||
| monitoring of adult (18+) patients | |||
| in healthcare facilities. It is | |||
| indicated for use in monitoring of | |||
| ECG, heart rate, pulse rate, | |||
| functional oxygen saturation of | |||
| arterial hemoglobin, and axillary | Information is generated by other | ||
| medical devices and patient | |||
| information system, and not by | |||
| this device. This device | |||
| captures this information from | |||
| these other systems and displays it | |||
| for clinicians. | |||
| This device is intended to be used | |||
| by clinicians for the following | |||
| purposes: | The Caretaker Remote Display | ||
| App and Caretaker Software | |||
| Library are indicated for use | |||
| when remote display and/or | |||
| forwarding of securely | |||
| transmitted wireless data from | |||
| the Caretaker Physiological | |||
| Monitor device (K163255) is | |||
| required. The Remote Display |
Comparison to Predicate: 8)
5
| K181196 |
|---|
| --------- |
| | temperature. VMS allows for the
input of non-invasive blood
pressure and can display data
from peripheral devices. VMS can
generate alerts when rate-based
cardiac arrhythmias are detected
and when physiological vital signs
fall outside of selected
parameters. | K181196
• To view the near real-time
waveforms remotely
• To remotely review other
standard or critical near real-time
patient data from the monitored
system
• To provide a request for remote
consultation regarding a patient's
waveform or other data
This device software can display
the following physiologic data
captured by other medical
devices:
• ECG Waveform
• Heart Rate Monitored
• Respiratory Rate
• Oxygen Saturation
• Intracranial Pressure
• Central Venous Pressure
• Pulmonary Capillary Wedge
Pressure
• Cardiac Index
• Cardiac Output
• Cerebral Perfusion Pressure
• Systolic Blood Pressure Invasive
• Mean Arterial Pressure Invasive
• Diastolic Blood Pressure
Invasive
• Systolic Blood Pressure Cuff
• Mean Arterial Pressure Cuff
• Diastolic Blood Pressure Cuff
Contraindications
This device is intended for use by
clinicians when they cannot be at
the hospital. This device is
intended for use by clinicians as a
diagnostic aid, and not as a
replacement for direct viewing of
any of the monitoring devices
from which it obtains its data. | App and the Software Library
provides bi-directional data
transfer capabilities with the
Caretaker Physiological Monitor
device (K163255). To facilitate
communications between the
Caretaker Physiological Monitor
device and other FDA Cleared
patient monitors and Remote
Data Displays (RDDS), the
Caretaker Software Library
provides a well-defined interface
for 3rd party data integrations.
In addition to providing data
display and forwarding, the
Remote Display App can operate
as an MDDS for 3rd party
wireless medical devices. The
alerts in the subject device are
only to be used for historical
review and are not intended for
time-critical intervention.
The Software Library is intended
only for use by licensed partners
of the company, and the
Caretaker Remote Display App
is intended for use by clinicians
or other properly trained
medical personnel. Both the
Remote Display App and
Software Library are for
prescriptive use only. |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Regulatory
Classification | - 21 CFR 870.2300; Cardiac
monitor (including
cardiotachometer and rate
alarm)
- 21 CFR 890.2910
Transmitters And Receivers,
Physiological
Signal, Radiofrequency (Class
II, Cardiovascular) - 21 CFR 880.2910 Clinical
Electronic Thermometer (Class | 21 CFR 870.2300; Cardiac
monitor (including
cardiotachometer and rate
alarm) | - 21 CFR 870.1130; System,
Measurement, Blood-
Pressure, Non-Invasive - 21 CFR 890.2910
Transmitters And Receivers,
Physiological
Signal, Radiofrequency (Class
II, Cardiovascular) |
6
| II exempt, General Hospital) | K181196 | ||
|---|---|---|---|
| Product Code | DRT, DRG, FLL | MSX | DXN, DRG |
| Device Class | II | II | II |
| 510(k) | K150992 | K160862 | K181196 |
| Other | |||
| Technologies | |||
| Used | Standard computers, network, | ||
| and WIFI | Standard computers, network, | ||
| and WIFI | Standard computers, tablets, | ||
| cell phones, network, WIFI, | |||
| and Bluetooth | |||
| Where Used | Anywhere clinicians remotely | ||
| consult on patients. | Used by clinicians when they | ||
| cannot be at the hospital. | Anywhere clinicians consult | ||
| on patients (local or remote). | |||
| Wireless | Yes, handheld display devices | Yes, multiple devices and | |
| technologies | Yes, handheld display devices | ||
| Ability to | |||
| view near | |||
| real-time | |||
| data | Yes | Yes | Yes |
| Alerts | Software generated | No | Software generated |
| Synopsis of | |||
| Functionality | Store, route and display patient | ||
| data, generate and display | |||
| alarms | Remotely view near real-time | ||
| waveforms and patient data | Store and display patient data | ||
| and optionally route to EMR, | |||
| provide alarms set by operator |
9) Conclusions:
The safety and effectiveness of the CareTaker Remote Display App have been confirmed through nonclinical testing and conformance to vital signs monitoring, usability, and risk assessment. The App was tested by connecting to a CareTaker4 Physiological Monitor Device using the CareTaker Software Library and to both a SpO2 monitor and a temperature patch using industry standard BLE Protocols to receive data. Data forwarding was tested using both WiFi and USB protocols to an external RDDS.
Storing, Displaying, and Forwarding Patient Data
The Caretaker Remote Display App and CareTaker Software Library are safe to use as they are substantially equivalent to the predicate devices. There are no significant differences in technologies, operating principles, or intended use.
Alarm Functions
The Caretaker Remote Display App and CareTaker Software Library are safe to use as the visual and audio alarms only indicate when a received parameter exceeds a limit set by the operator. No processing of physiological data is done by the App or library. The alarms latch to ensure they are viewed by the operator, but are not intended for time-critical intervention. The alarms are retained for review of historical data.
Controlling the CareTaker4 Physiological Monitor
The Caretaker Remote Display App and CareTaker Software Library are safe to use as the control functions are the same as are available on the previously cleared CareTaker4 Physiological Monitor Device, K163255, and do not alter the safety or efficacy of the CareTaker4 Physiological Monitor itself. The App provides a more convenient method to control the device rather than using the 1-button interface on the device.