The Constant Care LILAH Home Health Monitoring System is a non-emergency, delayed, remote patient monitoring device available by prescription. The Constant Care LILAH Home Health Monitoring System is designed to be used in the home of a patient or healthcare setting to provide remote monitoring for maintenance of chronic disease. The Constant Care LILAH Home Health Monitoring System provides guidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and realtime video conferencing technology.

The Constant Care LILAH Home Health Monitoring System connects to commercially available wireless and wired medical devices such as glucose meters, weight scales, blood pressure monitors, electronic thermometers, peak-flow meters and pulse oximeters. The Constant Care LILAH Home Health Monitoring System stores and displays the information on a computer screen and transmits the information to the Caretaker Portal secure host server using connectivity including, but not limited to, FCC approved Wi-Fi, Cellular Wireless, Internet, or Ethernet.

Healthcare professionals and remote caregivers can review the transmitted information unilizing the Caretaker Portal and set thresholds to trigger non-emergency alerts based on specific thresholds being exceeded.

The Constant Care LILAH Home Health Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when timecritical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The system is intended for patients who are willing and capable of managing its use, Judgment and experience by a caregiver or by a family member are required to check and interpret the information delivered.

Device Description

The Constant Care LILAH Home Health Monitoring System - Multi-User Version is a software device consisting of two components: patient-side software to be installed on hardware compatible with an Asus EeeTop PC ET1611PUT 15.6 inch TouchScreen Atom D425 All-in-One PC, or an Acer ICONIA Tab W500-C52G03iss 10.1' LED Tablet PC for use in performing patient monitoring, and sending data to the Caretaker Portal secure host server; and caregiver-side software for receiving patient-side data and transmitting that data to healthcare professionals and remote caregivers through the Caretaker Portal secure host server.

The patient-side software component is offered in two different versions. The single-user version, designated as "LILAH Version 1.1," is designed to be used by one individual, and is streamlined for simplicity of use. The multi-user version, designated as "LILAH Multi-User," allows for multiple individuals to be monitored through a single application. Changes covered by this clearance are applicable to both the LILAH Multi-User and LILAH Version 1.1 versions of the patient-side software component.

The Constant Care LILAH Home Health Monitoring System - Multi-User Version is a remote patient monitoring device available with or without prescription designed to be used in the home or healthcare setting of patients undergoing remote monitoring for maintenance of chronic disease. The Constant Care LILAH Home Health Monitoring System - Multi-User Version can be used to monitor and track a single patient or multiple patients. The Constant Care LILAH Home Health Monitoring System - Multi-User Version provides guidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and real-time video conferencing technology.

AI/ML Overview

Here's an analysis of the provided text regarding the Constant Care LILAH Home Health Monitoring System:

This 510(k) summary does not contain the information requested about acceptance criteria and a study proving the device meets them.

The document is a 510(k) submission, which is a premarket notification for medical devices. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to provide detailed performance study results against specific acceptance criteria.

The key statement regarding performance is: "Results of software validation and verification activities establish the device as safe and effective for its intended use, which is comparable to other predicate devices." This is a general statement and does not provide specifics about the studies or acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document. Here's a breakdown of what can be inferred or is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in this document. The document states that "software validation and verification activities establish the device as safe and effective," but it does not specify acceptance criteria or report specific performance metrics from those activities.

2. Sample size used for the test set and the data provenance

Not available in this document. No details about a specific test set, its size, or data provenance (e.g., country of origin, retrospective/prospective) are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not available in this document. Since no specific test set or ground truth establishment is described, this information is not present.

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

Not available in this document. No information on adjudication methods for a test set is provided.

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

Not applicable/Not available in this document. The Constant Care LILAH system is a remote patient monitoring system that provides data, reminders, and communication tools. It is not an AI-driven diagnostic or interpretative tool that would typically involve human "readers" improving performance with AI assistance in the way a MRMC study would measure for imaging or pathology. The document does not describe any such study.

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

Not available in this document. The device is described as a system integrating patient data, providing guidance, and connecting to healthcare professionals. Its function isn't primarily a standalone algorithmic interpretation in the way, for example, an AI-powered diagnostic algorithm would be evaluated. The "software validation and verification activities" likely focused on the software's functionality, data integrity, and compliance with its intended use, rather than a standalone performance metric against a ground truth.

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

Not available in this document. No specific ground truth type is mentioned as no detailed performance study is described. The "validation and verification activities" would typically involve testing the system's functions (e.g., data transmission, alarm triggering, user interface functionality) against design specifications and user requirements.

8. The sample size for the training set

Not applicable/Not available in this document. This device is a software system for monitoring, not a machine learning or AI model that requires a "training set" in the conventional sense of supervised learning. Its "training" would be its software development and testing phases.

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

Not applicable/Not available in this document. As with point 8, the concept of a "training set ground truth" is not relevant for this type of device based on the information provided.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and broadly states that "software validation and verification activities establish the device as safe and effective." It does not delve into the detailed performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert evaluations that would be expected for a device with an AI/ML component performing diagnostic or interpretative tasks.

Summary

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510(k) Summary

JUL 1 5 2013 Submitted by Constant Care, LLC 4333 Shreveport Highway Address: Pineville, LA 71360 (318) 229-6670 Telephone: Facsimile: (866) 551-6030 Contact Name: Jodi Funderburk, VP of Development Date Submitted: April 3, 2013 Trade Name: Constant Care LILAH Home Health Monitoring System - Multi-User Version Common Name: Remote patient monitoring system 510(k) No .: K130360 Product Code / Regulation: DRG (21 C.F.R. 870.2910)

The Constant Care LILAH Home Health Monitoring System also supports the following medical device product codes by means of separate medical devices:

Classification Regulation	Product Code	Classification Name	Device Class
21 C.F.R. 870.1130	DXN	Noninvasive Blood Pressure	II
		Measurement System
21 C.F.R. 880.2700	FRI	Stand-on Patient Scale
21 C.F.R. 890.3940	INF	Wheelchair Platform Scale
21 C.F.R. 870:2700	DOA	Oximeter	ll
21 C.F.R. 880.2910	FLL	Electronic Clinical Thermometer	D
21 C.F.R. 862.1345	NBW	Glucose Test System	II
21 C.F.R. 890.5050	NXQ	Daily Activity Assist Device
21 C.F.R. 868.1860	BZH	Peak-Flow Meter for Spirometry	II

Description: The Constant Care LILAH Home Health Monitoring System - Multi-User Version is a software device consisting of two components: patient-side software to be installed on hardware compatible with an Asus EeeTop PC ET1611PUT 15.6 inch TouchScreen Atom D425 All-in-One PC, or an Acer ICONIA Tab W500-C52G03iss 10.1' LED Tablet PC for use in performing patient monitoring, and sending data to the Caretaker Portal secure host server; and caregiver-side software for receiving patient-side data and transmitting that data to healthcare professionals and remote caregivers through the Caretaker Portal secure host server.

The patient-side software component is offered in two different versions. The single-user version, designated as "LILAH Version 1.1," is designed to be used by one individual, and is streamlined for simplicity of use. The multi-user version, designated as "LILAH Multi-User," allows for multiple individuals to be monitored through a single application. Changes covered by this clearance are applicable to both the LILAH Multi-User and LILAH Version 1.1 versions of the

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K130360 pg. 1 of 2

patient-side software component.

Intended Use: The Constant Care LILAH Home Health Monitoring System - Multi-User Version is intended for use in the home or healthcare setting to provide nonemergency, delayed, remote monitoring of patients for maintenance of chronic disease; connecting to commercially available wireless and wired medical devices such as glucose meters, weight scales, blood pressure monitors, medication reminders, electronic thermometers, peak-flow meters and pulse oximeters; and providing guidance in operating medical sensor devices, reminders for medication compliance, and connectivity to healthcare professionals and remote caregivers through text messaging and real-time video conferencing technology.

Substantial Equivalence: The Constant Care LILAH Home Health Monitoring System -Multi-User Version is identical in intended use and technological characteristics to the Constant Care LILAH Home Health Monitoring System (K120941), which is legally marketed by Constant Care.

Results of software validation and verification activities establish the device as safe and effective for its intended use, which is comparable to other predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

July 15, 2013

Constant Care, Lic C/O Seth Mailhot 1300 1 St, Nw, 11th Floor East Washington, DC 20005-3314 US

Re: K130360

Trade/Device Name: Constant care lilah home health monitoring system - multi-user version Regulation Number: 21 CFR 870.2910 Regulation Name: Remote Patient Monitoring System, Radiofrequency Physiological Signal Transmitters And Receivers Regulatory Class: Class II Product Code: DRG, DXN, FRJ, INF, DQA, FLL, NBW, NXQ, BZH Dated: May 23, 2013 Received: May 24, 2013

Dear Seth Mailhot:

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 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); 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.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

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Page 2 - Seth Mailhot

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/Medica]Devices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/6 description: The image contains the text "Owen Dearis -S". The text is written in a simple, bold font. The letters are black against a white background. The word "Owen" is followed by "Dearis" and then "-S".

for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _K130360 `

Device Name: Constant Care LILAH Home Health Monitoring System - Multi-User Version

Intended Use:

A list of devices that are compatible with the Constant Care LILAH Home Health Monitoring System will be available in the user's manual and the Constant Care website,

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Owen P.
Faris
Date: 2013.07.15 11:42:57
-04'00'

Page 1 of 1

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).