(98 days)
Not Found
No
The document describes a system for routing existing alarms and events to remote devices. There is no mention of analysis, interpretation, or prediction of data using AI/ML techniques. The focus is on communication and notification, not intelligent processing of information.
No
The device provides supplemental information about alarms and events and is not a source of patient alarms or a replacement for alarming devices. It does not directly treat or diagnose a medical condition.
No
The device is described as providing "supplemental information about patient alarms, technical alarms and system information messages (events)" and "is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices." It routes existing alarm messages and events to remote devices. It does not perform any analysis or interpretation of data to arrive at a diagnosis or aid in diagnosis.
Yes
The device description and intended use clearly state that the "CareEvent solution" and "CareEvent mobile application software" are designed to provide supplemental information by routing messages to external devices. The description focuses on the software's function of receiving and transmitting information, and there is no mention of any hardware components being part of the device itself. The performance studies also focus on system-level and software-related testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides "supplemental information about patient alarms, technical alarms and system information messages (events)". It explicitly states it is "not a source of patient alarms, nor is it a replacement for alarming devices." This indicates it's a communication and information routing system, not a diagnostic tool that analyzes biological samples or provides diagnostic information about a patient's condition.
- Device Description: The description reinforces the intended use, focusing on providing "supplemental information" about various types of alarms and messages.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic or prognostic information about a disease or condition
- Measuring specific analytes or biomarkers
- Using image processing for diagnostic purposes
- Utilizing AI/ML for diagnostic interpretation
The device's function is to relay information from existing alarming devices to healthcare professionals, acting as a communication and notification system rather than a diagnostic one.
N/A
Intended Use / Indications for Use
The intended use of the CareEvent solution is to provide healthcare professionals with supplemental information about patient alarms, technical alarms and system information messages (events). The product can route all of subsets of this information to selective remote devices such as pagers, phones, or marquees. Receipt of alarm messages or events by the external device, is not confirmed and delivery to the end device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This product line is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.
The CareEvent mobile application software provides healthcare professionals with supplemental information about patient alarms, technical alarms and system information messages (events). Receipt of alarm messages or events by the external mobile device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This product line is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.
Product codes
MSX
Device Description
The CareEvent solution is designed to provide healthcare professionals with supplemental information about patient alarms, technical alarms, nurse call alarms and system information messages (events).
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
Not Found
Intended User / Care Setting
healthcare professionals
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
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the device meets all defined reliability requirements and performance claims.
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
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2015
Philips Medical Systems Theresa Poole Regulatory Affairs Specialist 3000 Minuteman Road Andover, Massachusetts 01810
Re: K142935 Trade/Device Name: CareEvent Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX Dated: December 15, 2014 Received: December 16, 2014
Dear Theresa Poole,
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
1
the quality systems (OS) 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,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
CareEvent Device Name:
Indications for Use:
The intended use of the CareEvent solution is to provide healthcare professionals with supplemental information about patient alarms, technical alarms and system information messages (events). The product can route all of subsets of this information to selective remote devices such as pagers, phones, or marquees. Receipt of alarm messages or events by the external device, is not confirmed and delivery to the end device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This product line is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.
The CareEvent mobile application software provides healthcare professionals with supplemental information about patient alarms, technical alarms and system information messages (events). Receipt of alarm messages or events by the external mobile device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This product line is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.
Prescription Use Yes (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use No (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR §807.92.
The submitter of this premarket notification is:
Theresa Poole Regulatory Affairs Specialist Patient Monitoring Philips Medical Systems 3000 Minuteman Road. MS0480 Andover, MA 01810-1099 Tel: 978 659 7621 Fax: 978 685 5624 Email: claire.arakaki@philips.com
This summary was prepared on 15 January 2015.
The name of this device is the CareEvent.
Device Description
The CareEvent solution is designed to provide healthcare professionals with supplemental information about patient alarms, technical alarms, nurse call alarms and system information messages (events).
Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Panel 74 | |||
| Cardiovascular | $870.2300, II | MSX | System, Network and |
| Communication, Physiological | |||
| Monitors |
The CareEvent solution is substantially equivalent to the previously cleared predicate IntelliSphere Event Management (K102974).
Intended Use
The intended use of the CareEvent solution is to provide healthcare professionals with supplemental information about patient alarms, technical alarms, nurse call alarms and system information messages (events). The product can route all of subsets of this information to selective remote devices such as pagers, phones, or marquees. Receipt of alarm messages or events by the external device, is not confirmed and delivery to the end device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This product line is not intended to provide real-time information. nor is it a source of patient alarms, nor is it a replacement for alarming devices.
The CareEvent mobile application software provides healthcare professionals with supplemental information about patient alarms, technical alarms, nurse call alarms and system information messages (events). Receipt of alarm messages or events by the external mobile device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This
4
product line is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.
The device has the same Indications for Use and Intended Use as the legally marketed predicate device.
The technological characteristics are the same as the legally marketed predicate device.
Software changes have been made to accommodate the communication to the CareEvent mobile application accessory.
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the device meets all defined reliability requirements and performance claims.