CareEvent inclusive of the CareEvent Mobile Application accessory

K161164 · Philips Medical Systems · MSX · Jun 24, 2016 · Cardiovascular

Device Facts

• Record ID: K161164
• Device Name: CareEvent inclusive of the CareEvent Mobile Application accessory
• Applicant: Philips Medical Systems
• Product Code: MSX · Cardiovascular
• Decision Date: Jun 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The intended use of Philips CareEvent is to deliver supplemental medical device data associated with physiological alarms, technical alarms, clinical notifications, nurse call alarms and informational messages to a healthcare professional's end device. The user may receive visual or audible notifications, and/or other message notification types based on the communicator in use. Philips CareEvent is a component of a distributed alarming system. It does not generate the alarm, alter the behavior of the alarm-generating system, replace the alarming system that generates the alarms, nor is it intended to provide real-time information, therefore the device producing the alarm or event remains the primary notification system. Philips CareEvent provides confirmed delivery features when it is used with the Philips CareEvent mobile application on Philips-approved devices. The Philips CareEvent mobile application either communicates alarm information that is sent from the Philips CareEvent server, or the user is notified that communication is not possible. Receipt of alarm messages or events by all other external devices is not confirmed and delivery to the end device is not guaranteed.

Device Story

CareEvent is a software-based distributed alarming system component; it routes supplemental alarm data (physiological, technical, nurse call) from primary alarm-generating systems to healthcare professionals' mobile devices. It does not generate alarms, replace primary monitoring systems, or provide real-time clinical data. The system operates via a server that pushes notifications to the CareEvent mobile application on approved devices; it supports confirmed delivery features. Users receive visual/audible alerts and can perform team communication, accept/reject delegation requests, or launch the MobileCaregiver application for patient data viewing. The device benefits patients by facilitating timely notification of clinical events to caregivers, though it is not a primary life-safety alarm source.

Clinical Evidence

No clinical testing was performed. Substantial equivalence was supported by non-clinical performance testing, including risk analysis, product specifications, design reviews, and system-level verification and validation.

Technological Characteristics

Software-only device; operates on off-the-shelf PC and ITE hardware. Functions as a distributed alarm system component. Connectivity via network to primary alarm-generating systems and mobile end-devices. No specific materials or sterilization required as it is a software application.

Indications for Use

Indicated for delivery of supplemental medical device data (physiological/technical alarms, clinical notifications, nurse call alarms) to healthcare professionals. Patient population determined by the Philips patient monitors in use at the facility. Rx only.

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

• CareEvent (K142935)

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

June 24, 2016

Philips Medical Systems Theresa Poole Regulatory Specialist 3000 Minuteman Road Andover, Massachusetts 01810

Re: K161164

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, OUG Dated: April 14, 2016 Received: April 25, 2016

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 of medical devicerelated 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.

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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,

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) K161164

Page 1 of 1

Device Name CareEvent

#### Indications for Use (Describe)

The intended use of Philips CareEvent is to deliver supplemental medical device data associated with physiological alarms, technical alarms, clinical notifications, nurse call alarms and informational messages to a healthcare professional's end device. The user may receive visual or audible notifications, and/or other message notification types based on the communicator in use.

Philips CareEvent is a component of a distributed alarming system. It does not generate the alarm, alter the behavior of the alarm-generating system, replace the alarming system that generates the alarms, nor is it intended to provide real-time information, therefore the device producing the alarm or event remains the primary notification system. Philips CareEvent provides confirmed delivery features when it is used with the Philips CareEvent mobile application on Philips-approved devices. The Philips CareEvent mobile application either communicates alarm information that is sent from the Philips CareEvent server, or the user is notified that communication is not possible. Receipt of alarm messages or events by all other external devices is not confirmed and delivery to the end device is not guaranteed.

Rx Only

Type of Use (Select one or both, as applicable)

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/1 description: The image shows the Philips logo in blue, followed by the words "CareEvent" and "Traditional 510(k)" in black. The Philips logo is a stylized version of the company's name. The text below the logo appears to be related to a product or service offered by Philips, possibly referencing a regulatory pathway for medical devices.

# 510(k) Summary Philips CareEvent release B.01

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92(c).

Date Prepared: 23 June 2016

#### l. Submitter's name and address

| Manufacturer: | Philips Medical Systems<br>3000 Minuteman Road<br>Andover, MA 01810 USA |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Theresa Poole<br>Regulatory Affairs Specialist<br>Philips Medical Systems<br>3000 Minuteman Road, MS0480<br>Andover, MA 01810-1099<br>Tel: [phone] |

Fax: [phone]

### II. Device information

Device Name: CareEvent Common Name: Communication System Classification panel: 74 - Cardiovascular

Classification names are as follows:

| Classification | ProCode | Description |
|----------------|---------|--------------------------------------------------------------|
| 870.2300, II | MSX | System, Network and Communication,<br>Physiological Monitors |
| 880.6310, I | OUG | Medical Device Data System |

Email: [e-mail]

#### III. Predicate device information

| Trade name: | CareEvent |
|----------------------------|-------------------------------------------------------------|
| Manufacturer: | Philips Medical Systems |
| 510(k) clearance: | K142935 |
| Classification name | Cardiac Monitor (Including Cardiotachometer And Rate Alarm) |
| Device class: | Class II |
| Classification regulation: | 21 CFR 892.2300 |
| Classification panel: | Cardiovascular |
| Product code: | MSX |

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Image /page/4/Picture/0 description: The image shows the Philips logo in blue, followed by the text "CareEvent" and "Traditional 510(k)" in black. The Philips logo is a stylized wordmark with bold, sans-serif letters. The text "CareEvent" is smaller than the Philips logo and is positioned below and to the right of it. The text "Traditional 510(k)" is below the "CareEvent" text.

### IV.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).

### V. Intended use/ Indications for Use

The Philips CareEvent software application change in the intended use wording was initiated to clarify the previous predicate intended use statement. The Philips CareEvent software application release B.01 has the intended use statement listed below.

The intended use of Philips CareEvent is to deliver supplemental medical device data associated with physiological alarms, technical alarms, clinical notifications, nurse call alarms and informational messages to a healthcare professional's end device. The user may receive visual or audible notifications, and/or other message notification types based on the communicator in use.

Philips CareEvent is a component of a distributed alarming system. It does not generate the alarm, alter the behavior of the alarm-generating system, replace the alarming system that generates the alarms, nor is it intended to provide real-time information, therefore the device producing the alarm or event remains the primary notification system. Philips CareEvent provides confirmed delivery features when it is used with the Philips CareEvent mobile application on Philips-approved devices. The Philips CareEvent mobile application either communicates alarm information that is sent from the Philips CareEvent server, or the user is notified that communication is not possible. Receipt of alarm messages or events by all other external devices is not confirmed and delivery to the end device is not guaranteed.

Rx Only

| Key<br>Characteristic | Predicate Device | Subject Device | Comments |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | CareEvent (K142935) | CareEvent B.01 | |
| Intended<br>Use/Indications<br>for Use<br>Sentence by<br>Sentence<br>comparison | S1: The intended use of<br>the CareEvent solution is<br>to provide healthcare<br>professionals with<br>supplemental information<br>about patient alarms,<br>technical alarms, nurse<br>call alarms and system<br>information messages<br>(events). | S1: The intended use of<br>Philips CareEvent is to<br>deliver supplemental<br>medical device data<br>associated with<br>physiological alarms,<br>technical alarms, clinical<br>notifications, nurse call<br>alarms and informational | S1: Clarification of<br>timing, what type of<br>information and to<br>where. |
| S2: The product can route<br>all of subsets of this<br>information to selective<br>remote devices such as<br>pagers, phones, or<br>marquees. | messages to a healthcare<br>professional's end device.<br>S2: The user may receive<br>visual or audible<br>notifications, and/or other<br>message notification types<br>based on the communicator<br>in use. | S2: Changed focus from<br>product function to<br>user experience.<br>Clarified types of<br>notifications. Stated it<br>is dependent on end<br>device in use<br>(communicator)<br>aligned with IEC 80001<br>terminology. | |
| S3-5: Receipt of alarm<br>messages or events by the<br>external device, is not<br>confirmed and delivery to<br>the end device is not<br>guaranteed.<br>The primary alarm<br>notification is the device<br>producing the alarm or<br>event.<br>This product line is not<br>intended to provide real-<br>time information, nor is it<br>a source of patient alarms,<br>nor is it a replacement for<br>alarming devices. | S3-5: Philips CareEvent is a<br>component of a distributed<br>alarming system.<br>It does not generate the<br>alarm, alter the behavior of<br>the alarm-generating<br>system, replace the<br>alarming system that<br>generates the alarms, nor is<br>it intended to provide real-<br>time information, therefore<br>the device producing the<br>alarm or event remains the<br>primary notification system.<br>Philips CareEvent provides<br>confirmed delivery features<br>when it is used with the<br>Philips CareEvent mobile<br>application on Philips-<br>approved devices. | S3-5: Removed entirely<br>S3 from Predicate<br>Intended use.<br>Replaced with<br>clarification of role<br>CareEvent plays in a<br>Distributed alarm<br>system.<br>Removed term<br>secondary used in<br>Predicate, it is not a<br>standardized term.<br>S6: Removed<br>redundancy of the | |
| | S6: The CareEvent mobile | S6: The Philips CareEvent | predicate intended use |
| | application software | mobile application either | for the CareEvent |
| | provides healthcare | communicates alarm | mobile application. |
| | professionals with | information that is sent | |
| | supplemental information | from the Philips CareEvent | |
| | about patient alarms, | server, or the user is | Replaced it with clear |
| | technical alarms, nurse | notified that communication | definition of the role |
| | call alarms and system | is not possible. | the mobile application |
| | information messages | | plays in the distributed |
| | (events). Receipt of alarm | | alarm system and |
| | messages or events by the | | confirmed delivery. |
| | external mobile device is | | |
| | not guaranteed. The | | |
| | primary alarm notification | | |
| | is the device producing | | |
| | the alarm or event. This | | S7: Added from |
| | product line is not | S7: Receipt of alarm<br>messages or events by all | predicate device to |
| | intended to provide real- | other external devices is not | clarify that only Philips |
| | time information, nor is it | confirmed and delivery to | approved devices are<br>different from the |
| | a source of patient alarms, | the end device is not | predicate. |
| | nor is it a replacement for | guaranteed. | |
| | alarming devices. | | |
| | | | |
| | | | Same |
| | Rx Only | Rx Only | |
| | | | |
| Target Patient<br>Population | As determined by the<br>Philips patient monitors in<br>use at the facility. | Same | |
| Users | Trained health care<br>professionals | Same | |
| | | | |
| Device<br>Software | Unchanged, as previously<br>cleared | 1. Allow one-way context<br>sharing from CareEvent<br>to MobileCaregiver. | 1. When in CareEvent<br>Mobile Application,<br>allows user to open<br>the Mobile<br>CareGiver<br>Application, if |
| | | 2. Text messaging<br>capability within the<br>CareEvent system via<br>the CareEvent mobile<br>application.<br>3. Add user button on the<br>CareEvent mobile<br>application to<br>Accept/Reject a<br>delegation request<br>when received. | installed on the<br>same mobile<br>device. Mobile<br>CareGiver is a view<br>of data from the<br>PIIC iX central<br>station.<br>2. Provides users an<br>alternative for<br>team<br>communication.<br>3. Enables additional<br>user control, if a<br>user is not able to<br>accept ownership<br>of alerts from<br>another device,<br>they can<br>intentionally reject<br>the request. |
| Technological<br>Characteristics | Unchanged, as previously<br>cleared. | Same | |
| Device Hardware<br>is specified by<br>Philips | Off the Shelf PC and other<br>ITE equipment, specification<br>available or can be ordered<br>from Philips. | Same. | |
| Device<br>Accessories | CareEvent Mobile<br>Application | Same | |
| Care and<br>Cleaning | Not applicable, software<br>device. | Same | |
| Device safety<br>and<br>environmental<br>specifications | Not applicable, software | Same |…