CareEvent

K142935 · Philips Medical Systems · MSX · Jan 15, 2015 · Cardiovascular

Device Facts

• Record ID: K142935
• Device Name: CareEvent
• Applicant: Philips Medical Systems
• Product Code: MSX · Cardiovascular
• Decision Date: Jan 15, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 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.

Device Story

CareEvent is a notification management system for healthcare environments; it aggregates patient alarms, technical alarms, and nurse call events from monitoring systems. The device routes these events to remote secondary devices, including pagers, phones, marquees, and a mobile application. It functions as a supplemental information tool; it does not provide real-time data and is not a substitute for primary bedside alarm systems. Delivery of notifications to external devices is not guaranteed. Healthcare professionals use the system to receive remote alerts, allowing for awareness of patient status or system issues while away from the primary monitor. The device does not perform clinical analysis or diagnostic functions; it serves as a communication conduit for existing alarm infrastructure.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, performance tests, and safety testing based on hazard analysis. Pass/Fail criteria were established based on predicate device specifications; results demonstrated that the device meets all defined reliability requirements and performance claims.

Technological Characteristics

Networked communication system for physiological monitors. Software-based event routing to remote devices (pagers, phones, marquees) and mobile applications. Operates as a secondary notification layer. No specific hardware materials or energy sources described beyond standard network infrastructure requirements.

Indications for Use

Indicated for healthcare professionals to receive supplemental information regarding patient alarms, technical alarms, nurse call alarms, and system events via remote devices (pagers, phones, marquees) or mobile applications. Not for real-time use; not a replacement for primary alarming devices.

Regulatory Classification

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.

Predicate Devices

• IntelliSphere Event Management (K102974)

Submission Summary (Full Text)

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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

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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 [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" (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 [phone] or [phone] 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

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## 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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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: [phone] Fax: [phone] Email: [e-mail]

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<br>Cardiovascular | \$870.2300, II | MSX | System, Network and<br>Communication, Physiological<br>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

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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.