(182 days)
CareAware Event Management™ is a software application intended to provide healthcare professionals with supplemental information about events and alarms originating from medical devices, or other event or alarm producing systems within a clinical setting. This device can route notifications including all or a subset of the event or alarm information along with related contextual information to selected end points such as but not limited to mobile phones, or other computing or communications end points.
Receipt of notifications by the end point is not confirmed, and delivery to the end point is not guaranteed. The primary alarm notification is the device or system producing the alarm or event. This device is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.
CareAware Event Management™ is not intended to directly monitor, diagnose or treat patients or to be used in the prevention of a disease or condition, nor does CareAware Event Management™ come into direct contact with patients.
CareAware Event Management™ is a software application intended to provide healthcare professionals with supplemental information about events and alarms originating from medical devices, or other event or alarm producing systems within a clinical setting. This device can route notifications including all or a subset of the event or alarm information along with related contextual information to selected end points such as but not limited to mobile phones, or other computing or communications end points.
This document is an FDA 510(k) clearance letter for the Cerner CareAware Event Management™ device. It does not contain information about a study proving the device meets acceptance criteria.
The letter explicitly states:
- "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... to legally marketed predicate devices..."
- "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."
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring a detailed study proving performance against specific acceptance criteria for the new device as would be seen in a clinical trial.
Therefore, I cannot provide the requested information because the provided document does not contain a description of a study with acceptance criteria and reported device performance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2015
Cerner Corporation Shelley Looby Director, Regulatory Affairs/Ouality Assurance 2800 Rockcreek Pkwy. Kansas City, Missouri 64117
Re: K151672
Trade/Device Name: Cerner CareAware Event Management Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX Dated: November 3, 2015 Received: November 9, 2015
Dear Shelley Looby:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Mitchell Stein
forBram D. Zuckerman, M.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) K151672
Page 1 of 1
Device Name
Cerner CareAware Event Management™
Indications for Use (Describe)
CareAware Event Management™ is a software application intended to provide healthcare professionals with supplemental information about events and alarms originating from medical devices, or other event or alarm producing systems within a clinical setting. This device can route notifications including all or a subset of the event or alarm information along with related contextual information to selected end points such as but not limited to mobile phones, or other computing or communications end points.
Receipt of notifications by the end point is not confirmed, and delivery to the end point is not guaranteed. The primary alarm notification is the device or system producing the alarm or event. This device is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.
CareAware Event Management™ is not intended to directly monitor, diagnose or treat patients or to be used in the prevention of a disease or condition, nor does CareAware Event Management™ come into direct contact with patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).