CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM

K120941 · Constant Care, LLC · DRG · Jul 3, 2012 · Cardiovascular

Device Facts

• Record ID: K120941
• Device Name: CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM
• Applicant: Constant Care, LLC
• Product Code: DRG · Cardiovascular
• Decision Date: Jul 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 connectally available wireless and wired glucose meters, weight scales, blood pressure monitors, medication reminders, 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 utilizing 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 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 Story

System consists of patient-side software (installed on touchscreen PC or tablet) and caregiver-side software (Caretaker Portal server). Inputs: data from wireless/wired medical devices (glucose meters, scales, BP monitors, pulse oximeters). Operation: system guides patient in sensor use, provides medication reminders, and facilitates text/video communication with caregivers. Output: patient data displayed on screen and transmitted to secure portal for remote review. Used in home or clinical settings by patients and healthcare professionals. Caregivers set thresholds for non-emergency alerts. Benefits: supports chronic disease maintenance via remote connectivity and compliance reminders; not for real-time or emergency care.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Software-based remote monitoring system. Patient-side hardware: Asus EeeTop PC ET1611PUT or Acer ICONIA Tab W500-C52G03iss. Connectivity: Wi-Fi, cellular, internet, Ethernet. Data transmission to secure host server. Threshold-based alert system.

Indications for Use

Indicated for patients with chronic disease requiring non-emergency, delayed remote monitoring. Contraindicated for patients requiring direct medical or emergency intervention. Intended for patients willing and capable of managing system use.

Regulatory Classification

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.

Predicate Devices

• Honeywell HomMed Genesis Touch Personal Health Device (K112858)

Submission Summary (Full Text)

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K120941

## 510(k) Summary

JUL 3 2012

| Submitted by | Constant Care, LLC |
|-----------------|------------------------------------|
| Address: | 4333 Shreveport Highway |
| | Pineville, LA 71360 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact Name: | Jodi Funderburk, VP of Development |
| Date Submitted: | March 27, 2012 |

| Trade Name: | Constant Care LILAH Home Health Monitoring System |
|--------------|---------------------------------------------------|
| Common Name: | Remote patient monitoring system |

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<br>Measurement System | II |
| 21 C.F.R. 880.2700 | FRI | Stand-on Patient Scale | I |
| 21 C.F.R. 870.2700 | DQA | Oximeter | II |
| 21 C.F.R. 862.1345 | NBW | Glucose Test System | II |
| 21 C.F.R. 890.5050 | NXQ | Daily Activity Assist Device | I |

The Constant Care LILAH Home Health Monitoring System consists of two Descrintion: components: patient-side software to be installed on either 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 remote 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 Constant Care LILAH Home Health Monitoring System is a remote patient monitoring device available by prescription designed to be used in the home or healthcare setting of a patient undergoing 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 real-time video conferencing technology.

Intended Use: The Constant Care LILAH Home Health Monitoring System is intended for use in the home or healthcare setting to provide non-emergency, delayed, remote monitoring of a patient for maintenance of chronic disease; connecting to

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commercially available wireless and wired medical devices such as glucose meters, weight scales, blood pressure monitors, medication reminders, 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 is similar in intended use and technological characteristics to other Remote Patient Monitoring Devices, including the Honeywell HomMed Genesis Touch™ Personal Health Device (K112858).

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

> JUL 3 2012

Constant Care, LLC C/O Seth A. Mailhot Sheppard Mullin Richter & Hampton LLP 1300 I ST NW, 11th Floor East Washington, DC 20005

Re: K120941

Trade/Device Name: Constant Care LILAH Home Health Monitoring System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Codes: DRG, DXN, FRI, DQA, FLL, NBW, NXQ Dated: May 29, 2012 Received: May 30, 2012

Dear Mr. 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.

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#### Page 2 - Mr. Mailhot

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

#### 510(k) Number (if known):

Device Name: Constant Care LILAH Home Health Monitoring System

#### 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 connectally available wireless and wired glucose meters, weight scales, blood pressure monitors, medication reminders, 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 utilizing 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 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)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices

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120941 510(k) Number

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