(130 days)
Not Found
No
The summary describes monitoring activity patterns and environmental conditions using advanced motion sensors and providing alerts based on detected conditions or trends. While this involves pattern recognition, the description does not explicitly mention or imply the use of AI or ML algorithms for this analysis. The focus is on sensor data and rule-based alerting rather than learning from data.
No
The device is intended for monitoring environmental conditions and activity patterns, providing information to caregivers, but explicitly states that it "should not be relied on as medical advice or clinical diagnosis" and "does not rely on an assessment of clinical performance data." Its purpose is to assist caregivers with information, not to provide therapy or clinical diagnosis.
No
The document explicitly states, "Data from QuietCare-Networked should not be relied on as medical advice or clinical diagnosis." and also mentions, "The Intel-GE Care Innovations QuietCare-Networked device does not rely on an assessment of clinical performance data", indicating it is not intended or validated for diagnostic purposes.
No
The device description explicitly states that it "uses advanced motion sensors," indicating the presence of hardware components beyond just software.
Based on the provided information, the QuietCare-Networked device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community." It focuses on activity patterns and environmental conditions, not on analyzing biological samples (like blood, urine, tissue) to diagnose or monitor a medical condition.
- Disclaimer: The intended use explicitly states that "Data from QuietCare-Networked should not be relied on as medical advice or clinical diagnosis." This is a strong indicator that the device is not intended for diagnostic purposes.
- Device Description: The description mentions "advanced motion sensors to monitor Activities of Daily Living." This aligns with monitoring physical activity and environmental factors, not with in vitro analysis.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, chemical reactions, or any other processes typically associated with in vitro diagnostics.
In summary, the QuietCare-Networked device is a monitoring system for activity and environmental conditions, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / 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.
Product codes
KMI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
senior residents
Intended User / Care Setting
Home/senior housing community, caregivers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.2400 Bed-patient monitor.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
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: | (916) 847-7794 |
| 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:
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:
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