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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the CareTaker Remote Display App and CareTaker Software Library (K181196). However, it does not explicitly detail acceptance criteria or a specific study proving the device meets those criteria in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices (VIOS Monitoring System, K150992, and Airstrip ONE Web Client, K160862) and confirming safety and effectiveness through nonclinical testing, usability, and risk assessment.

Based on the available information, I can extrapolate some aspects, but many details regarding specific acceptance criteria, performance metrics, sample sizes, expert qualifications, and study methodologies (like MRMC or standalone performance) are not explicitly stated in this document.

Here's an attempt to answer the questions based on the provided text, highlighting where information is not available:

Acceptance Criteria and Device Performance Study (K181196)

1. A table of acceptance criteria and the reported device performance

The document does not provide a quantitative table of acceptance criteria and reported device performance. Instead, it makes general statements about safety and effectiveness and substantial equivalence to predicate devices. The "performance" described relates to the functionality of displaying, storing, forwarding, and alarming patient data, and controlling a connected physiological monitor.

Feature/Criterion Field	Acceptance Criteria (from document)	Reported Device Performance (from document)
Safety and Effectiveness	Demonstrated through nonclinical testing, conformance to vital signs monitoring, usability, and risk assessment.	"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."
Substantial Equivalence	No significant differences in technologies, operating principles, or intended use compared to predicate devices (VIOS Monitoring System, K150992, and Airstrip ONE Web Client, K160862).	"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."
Storing, Displaying, and Forwarding Patient Data	The device should reliably store, route, and display patient data.	Confirmed to be safe and substantially equivalent for these functions. "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."
Alarm Functions	Visual and audio alarms should indicate when a received parameter exceeds an operator-set limit. No processing of physiological data by the App/Library. Alarms latch and are not intended for time-critical intervention, but for historical review.	"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	Control functions must be the same as available on the previously cleared CareTaker4 Physiological Monitor Device (K163255) and not alter its safety or efficacy.	"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."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The document mentions "nonclinical testing" and testing for interoperability using a CareTaker4 Physiological Monitor, a SpO2 monitor, and a temperature patch.
Data Provenance: Not specified. The nature of the "nonclinical testing" implies it was likely laboratory or simulated data, rather than patient data from a specific country, but this is not explicitly stated. It is described as "nonclinical" which typically refers to bench or simulated tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is an app and software library for displaying and forwarding vital signs data and controlling a monitor. It does not involve interpretation of medical images or complex diagnostic tasks that would require human expert ground truth establishment in the way an AI diagnostic device would. The "ground truth" for its performance would be the accuracy of data transmission, display, and control commands, which are validated through technical and interoperability testing, not expert consensus on medical findings.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as described above. The validation focuses on technical functionality and interoperability, which are typically assessed against technical specifications and communication protocols, not subjective human interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done or mentioned. This is not an AI diagnostic device that assists human interpretation. Its function is to display, store, and forward data from an existing medical device and provide control.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a software application. Its "standalone" performance would refer to its ability to correctly receive, display, store, forward, and transmit control commands. The document indicates that "nonclinical testing" was performed, including testing connections to the CareTaker4 Physiological Monitor, SpO2 monitor, and temperature patch, and testing data forwarding via WiFi and USB. This can be considered the standalone performance evaluation of the software's core functionalities. No human-in-the-loop performance study is described beyond the intended use by clinicians.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be the accurate transmission, display, and storage of physiological parameters, and the correct execution of control commands. This is verified against the known outputs/states of the connected medical devices and standard communication protocols. It is not based on expert medical consensus or pathology.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device in the context of image interpretation or diagnostic prediction that requires a "training set." It's a software application designed for data display, forwarding, and control.

9. How the ground truth for the training set was established

Not applicable (as it's not an AI/ML device requiring a training set).

Summary

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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

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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

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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 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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510(k) Summary of Safety and Effectiveness

1. 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.

CareTaker Remote Display App can function without the CareTaker Software Library, in which case it is the same as the RDDS in K163255.

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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:

Feature	VIOS Monitoring System	Airstrip ONE Web Client	CareTaker App
Indicationsfor Use	The Vios Monitoring System(VMS) is intended for use bymedically qualified personnel forphysiological and vital signsmonitoring of adult (18+) patientsin healthcare facilities. It isindicated for use in monitoring ofECG, heart rate, pulse rate,functional oxygen saturation ofarterial hemoglobin, and axillary	Information is generated by othermedical devices and patientinformation system, and not bythis device. This devicecaptures this information fromthese other systems and displays itfor clinicians.This device is intended to be usedby clinicians for the followingpurposes:	The Caretaker Remote DisplayApp and Caretaker SoftwareLibrary are indicated for usewhen remote display and/orforwarding of securelytransmitted wireless data fromthe Caretaker PhysiologicalMonitor device (K163255) isrequired. The Remote Display

Comparison to Predicate: 8)

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K181196
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	temperature. VMS allows for theinput of non-invasive bloodpressure and can display datafrom peripheral devices. VMS cangenerate alerts when rate-basedcardiac arrhythmias are detectedand when physiological vital signsfall outside of selectedparameters.	K181196• To view the near real-timewaveforms remotely• To remotely review otherstandard or critical near real-timepatient data from the monitoredsystem• To provide a request for remoteconsultation regarding a patient'swaveform or other dataThis device software can displaythe following physiologic datacaptured by other medicaldevices:• ECG Waveform• Heart Rate Monitored• Respiratory Rate• Oxygen Saturation• Intracranial Pressure• Central Venous Pressure• Pulmonary Capillary WedgePressure• Cardiac Index• Cardiac Output• Cerebral Perfusion Pressure• Systolic Blood Pressure Invasive• Mean Arterial Pressure Invasive• Diastolic Blood PressureInvasive• Systolic Blood Pressure Cuff• Mean Arterial Pressure Cuff• Diastolic Blood Pressure CuffContraindicationsThis device is intended for use byclinicians when they cannot be atthe hospital. This device isintended for use by clinicians as adiagnostic aid, and not as areplacement for direct viewing ofany of the monitoring devicesfrom which it obtains its data.	App and the Software Libraryprovides bi-directional datatransfer capabilities with theCaretaker Physiological Monitordevice (K163255). To facilitatecommunications between theCaretaker Physiological Monitordevice and other FDA Clearedpatient monitors and RemoteData Displays (RDDS), theCaretaker Software Libraryprovides a well-defined interfacefor 3rd party data integrations.In addition to providing datadisplay and forwarding, theRemote Display App can operateas an MDDS for 3rd partywireless medical devices. Thealerts in the subject device areonly to be used for historicalreview and are not intended fortime-critical intervention.The Software Library is intendedonly for use by licensed partnersof the company, and theCaretaker Remote Display Appis intended for use by cliniciansor other properly trainedmedical personnel. Both theRemote Display App andSoftware Library are forprescriptive use only.
DeviceRegulatoryClassification	- 21 CFR 870.2300; Cardiacmonitor (includingcardiotachometer and ratealarm)- 21 CFR 890.2910Transmitters And Receivers,PhysiologicalSignal, Radiofrequency (ClassII, Cardiovascular)- 21 CFR 880.2910 ClinicalElectronic Thermometer (Class	21 CFR 870.2300; Cardiacmonitor (includingcardiotachometer and ratealarm)	- 21 CFR 870.1130; System,Measurement, Blood-Pressure, Non-Invasive- 21 CFR 890.2910Transmitters And Receivers,PhysiologicalSignal, Radiofrequency (ClassII, Cardiovascular)

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	II exempt, General Hospital)		K181196
Product Code	DRT, DRG, FLL	MSX	DXN, DRG
Device Class	II	II	II
510(k)	K150992	K160862	K181196
OtherTechnologiesUsed	Standard computers, network,and WIFI	Standard computers, network,and WIFI	Standard computers, tablets,cell phones, network, WIFI,and Bluetooth
Where Used	Anywhere clinicians remotelyconsult on patients.	Used by clinicians when theycannot be at the hospital.	Anywhere clinicians consulton patients (local or remote).
Wireless	Yes, handheld display devices	Yes, multiple devices andtechnologies	Yes, handheld display devices
Ability toview nearreal-timedata	Yes	Yes	Yes
Alerts	Software generated	No	Software generated
Synopsis ofFunctionality	Store, route and display patientdata, generate and displayalarms	Remotely view near real-timewaveforms and patient data	Store and display patient dataand 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.

Regulation Number and Section

§ 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).