CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION

{0}------------------------------------------------ # 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 {1}------------------------------------------------ #### K130360 pg. 1 of 2 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. 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. {2}------------------------------------------------ #### 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 {3}------------------------------------------------ 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 {4}------------------------------------------------ # Indications for Use ### 510(k) Number (if known): _K130360 ` ## Device Name: Constant Care LILAH Home Health Monitoring System - Multi-User Version ### Intended Use: 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. 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