INTEL-GE CARE INNOVATIONS QUIETCARE

K131585 · Intel-Ge Care Innovations, LLC · KMI · Oct 8, 2013 · General Hospital

Device Facts

• Record ID: K131585
• Device Name: INTEL-GE CARE INNOVATIONS QUIETCARE
• Applicant: Intel-Ge Care Innovations, LLC
• Product Code: KMI · General Hospital
• Decision Date: Oct 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2400
• Device Class: Class 1

Intended Use

QuietCare-Networked is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. QuietCare-Networked recognizes and monitors certain patterns of activity including but not limited to bathroom and bedroom activity, residence entry/exit, and interaction with food and medication storage. Caregivers are provided with information and notification about the occurrence of, and changes in, these monitored activity patterns and environmental conditions. Noteworthy occurrences and changes are communicated to caregivers through direct notification (pager, voice alert, email) as well as a secure Internet website. Data from QuietCare-Networked should not be relied on as medical advice or clinical diagnosis. Caregivers should always rely on licensed medical professionals in making all health decisions and should use the information provided by QuietCare as a resource in that process. Caregivers should not rely solely on the use of QuietCare-Networked for care management of clients/residents. Caregivers should use standard care practices established within their care organization to ensure the safety and wellness of senior clients/residents. QuietCare-Networked is available for over-the-counter use.

Device Story

QuietCare-Networked utilizes motion sensors to monitor activities of daily living for senior residents. System tracks patterns such as room occupancy, entry/exit, and storage interaction; transforms sensor data into activity reports and alerts. Output delivered to caregivers via pager, voice alert, email, or secure website. Used in senior housing communities; operated by caregivers to assist in monitoring resident wellness. Provides situational awareness to support care intervention; does not provide medical diagnosis. Benefits include enhanced monitoring of resident activity patterns to inform care decisions.

Clinical Evidence

Bench testing only; no clinical performance data was required or provided for this submission.

Technological Characteristics

System uses motion sensors for activity monitoring. Connectivity via networked communication protocols to a secure internet website. Data display via pager, voice alert, email, or web interface. Software-based monitoring of activity patterns.

Indications for Use

Indicated for monitoring environmental conditions and motion activity of individuals living in senior housing communities. Monitors patterns including bathroom/bedroom activity, residence entry/exit, and food/medication storage interaction. Intended for over-the-counter use; not for medical diagnosis or sole care management.

Regulatory Classification

Identification

A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.

Predicate Devices

• MobileCareb Monitor™ from AFrame Digital Inc. (K090138)
• Wireless MedCARE LLC VivaTRAK (K101109)

Submission Summary (Full Text)

{0}------------------------------------------------

K131S85

510(k) Notification Submission - Traditional Intel-GE Care Innovations™ QuietCare®-Networked

## 510(k) Summary As required by 21 CFR §807.92(c)

#### Submitter

| 510(k) Owner: | Intel-GE Care Innovations™ |
|-----------------|--------------------------------------------------------|
| Address: | 3721 Douglas Boulevard, Suite 100, Roseville, CA 95661 |
| Telephone: | [phone] |
| Contact Person: | Maureen Glynn |
| Date Prepared: | May 23rd, 2013 |

#### Device Information

| Trade Name: | Intel-GE Care Innovations QuietCare-Networked |
|----------------------|------------------------------------------------------------------|
| Common Name: | Bed-Patient Monitor |
| Classification Name: | Bed-Patient Monitor (21 CFR 880.2400, Product Code KMI, Class I) |

Substantial Equivalence is claimed to the following devices:

- 1. MobileCareb Monitor™ from AFrame Digital Inc., (K090138)
- 2. Wireless MedCARE LLC VivaTRAK (K101109)

#### Device Description

Care Innovations QuietCare-Networked uses advanced motion sensors to monitor Activities of Daily Living for senior residents who require care assistance. It provides alerts and reporting information to care givers when conditions or trends are detected that indicate the senior resident may need care intervention.

#### Indications for Use

QuietCare-Networked is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. QuietCare-Networked recognizes and monitors certain patterns of activity including but not limited to bathroom and bedroom activity, residence entry/exit, and interaction with food and medication storage.

Caregivers are provided with information and notification about the occurrence of, and changes in, these monitored activity patterns and environmental conditions. Noteworthy occurrences and changes are communicated to caregivers through direct notification (pager, voice alert, email) as well as a secure Internet website.

Section 5: 510(k) Summary

{1}------------------------------------------------

#### 510(k) Notification Submission - Traditional Intel-GE Care Innovations™ QuietCare®-Networked

Data from QuietCare-Networked should not be relied on as medical advice or clinical diagnosis. Caregivers should always rely on licensed medical professionals in making all health decisions and should use the information provided by QuietCare as a resource in that process.

Caregivers should not rely solely on the use of QuietCare-Networked for care management of clients/residents. Caregivers should use standard care practices established within their care organization to ensure the safety and wellness of senior clients/residents.

QuietCare-Networked is available for over-the-counter use.

#### Technological Characteristics

QuietCare-Networked is substantially equivalent to the predicate devices in terms of software functionality, method of data collection, sensor types, communication methods, connectivity, communication protocol, and display method.

#### Safety and Efficacy

The Intel-GE Care Innovations QuietCare-Networked device does not rely on an assessment of clinical performance data. The data within this Premarket Notification demonstrates that there are no significant differences between this device and the predicate. The device introduces no new questions concerning the safety or efficacy and is, therefore, substantially equivalent to the predicate device.

#### Conclusion

The information in this Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to the predicate devices already in commercial distribution. Equivalence is demonstrated through intended use, design and testing methods.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

#### October 8, 2013

Intel-GE Care Innovations Ms. Maureen Glynn 3721 Douglas Boulevard, Suite 100 ROSEVILLE CA 95661

Re: K131585

Trade/Device Name: Intel-GE Care Innovations QuietCare-Networked Regulation Number: 21 CFR 880.2400 Regulation Name: Bed-Patient Monitor Regulatory Class: I Product Code: KMI Dated: August 27, 2013 Received: August 30, 2013

Dear Ms. Glynn:

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.

{3}------------------------------------------------

#### Page 2 - Mr. Glynn

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mary S. Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

#### 510(k) Notification Submission - Traditional Intel-GE Care Innovations™ LLC Intel-GE Care Innovations™ QuietCare®-Networked

### Indications for Use:

510(k) Number:

K131582

Device Name:

Intel-GE Care Innovations™ Guide

Indications for Use:

QuietCare-Networked is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. QuietCare-Networked recognizes and monitors certain patterns of activity including but not limited to bathroom and bedroom activity, residence entry/exit, and interaction with food and medication storage.

Caregivers are provided with information and notification about the occurrence of, and changes in, these monitored activity patterns and environmental conditions. Noteworthy occurrences and changes are communicated to caregivers through direct notification (pager, voice alert, email) as well as a secure Internet website.

Data from QuietCare-Networked should not be relied on as medical advice or clinical diagnosis. Caregivers should always rely on licensed medical professionals in making all health decisions and should use the information provided by QuietCare as a resource in that process.

Caregivers should not rely solely on the use of QuietCare-Networked for care management of clients/residents. Caregivers should use standard care practices established within their care organization to ensure the safety and wellness of senior clients/residents.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

> Richard C. Chapman -2013.10.08 11:22:25 -04'00'

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

: ::

Concurrence of CDRH, Office of Device Evaluation (ODE)

Section 4: Indications for Use

Page I of I