Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on delivering existing alarm data, not analyzing or generating new insights.

Therapeutic

No
The device is described as a component of a distributed alarming system that delivers supplemental medical device data. It does not generate alarms or alter the behavior of existing alarm-generating systems, nor does it provide real-time information. Its purpose is notification and communication to healthcare professionals, not direct treatment or diagnosis.

Diagnostic

No

The device delivers supplemental medical device data associated with alarms and messages but does not generate the alarms or alter the behavior of the alarm-generating system, nor does it provide real-time information for diagnosis.

SaMD (Software as a Medical Device)

Yes

The device description and performance studies focus solely on software verification and validation, with no mention of hardware components or their testing. The device is described as a "solution" and "software application" that delivers information to existing end devices.

IVD (In Vitro Diagnostic)

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 delivers supplemental medical device data related to physiological and technical alarms, clinical notifications, and messages to healthcare professionals. It is a component of a distributed alarming system and does not perform any tests on biological samples.
Device Description: The description reinforces that the device provides supplemental information about alarms and events.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
Focus on Communication: The core function described is the communication and delivery of existing alarm and event data.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Rx Only

Product codes

MSX, OUG

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

Trained health care 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

Not Found

Summary of Performance Studies

Verification, validation, and testing activities, where required to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed. 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 Philips CareEvent software application Release B.01 meets all defined reliability requirements and performance claims.

Key Metrics

Not Found

Predicate Device(s)

K142935

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

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.

1

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,

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)

Prescription Use (Part 21 CFR 801 Subpart D)
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
3000 Minuteman Road
Andover, MA 01810 USA |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Theresa Poole
Regulatory Affairs Specialist
Philips Medical Systems
3000 Minuteman Road, MS0480
Andover, MA 01810-1099
Tel: 978 659 7621 |

Fax: 978 685 5624

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,
Physiological Monitors
880.6310, I	OUG	Medical Device Data System

Email: theresa.poole@philips.com

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

Characteristic	Predicate Device	Subject Device	Comments
	CareEvent (K142935)	CareEvent B.01
Intended
Use/Indications
for Use
Sentence by
Sentence
comparison	S1: 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).	S1: 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	S1: Clarification of
timing, what type of
information and to
where.
S2: The product can route
all of subsets of this
information to selective
remote devices such as
pagers, phones, or
marquees.	messages to a healthcare
professional's end device.
S2: The user may receive
visual or audible
notifications, and/or other
message notification types
based on the communicator
in use.	S2: Changed focus from
product function to
user experience.
Clarified types of
notifications. Stated it
is dependent on end
device in use
(communicator)
aligned with IEC 80001
terminology.
S3-5: 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.	S3-5: 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.	S3-5: Removed entirely
S3 from Predicate
Intended use.
Replaced with
clarification of role
CareEvent plays in a
Distributed alarm
system.
Removed term
secondary used in
Predicate, it is not a
standardized term.
S6: Removed
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
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
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
Population	As determined by the
Philips patient monitors in
use at the facility.	Same
Users	Trained health care
professionals	Same

Device
Software	Unchanged, as previously
cleared	1. Allow one-way context
sharing from CareEvent
to MobileCaregiver.	1. When in CareEvent
Mobile Application,
allows user to open
the Mobile
CareGiver
Application, if
		2. Text messaging
capability within the
CareEvent system via
the CareEvent mobile
application.

Add user button on the
CareEvent mobile
application to
Accept/Reject a
delegation request
when received. | installed on the
same mobile
device. Mobile
CareGiver is a view
of data from the
PIIC iX central
station.
Provides users an
alternative for
team
communication.
Enables additional
user control, if a
user is not able to
accept ownership
of alerts from
another device,
they can
intentionally reject
the request. |
| Technological
Characteristics | Unchanged, as previously
cleared. | Same | |
| Device Hardware
is specified by
Philips | Off the Shelf PC and other
ITE equipment, specification
available or can be ordered
from Philips. | Same. | |
| Device
Accessories | CareEvent Mobile
Application | Same | |
| Care and
Cleaning | Not applicable, software
device. | Same | |
| Device safety
and
environmental
specifications | Not applicable, software | Same | |

VI.Comparison of Technological Characteristics with the Predicate Device

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Image /page/5/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 version of the company's name. The text "CareEvent" is likely a product or service name offered by Philips. The text "Traditional 510(k)" refers to a type of premarket submission to the FDA for medical devices.

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Image /page/6/Picture/0 description: The image contains the word "PHILIPS" in large, bold, blue letters. Below that, the word "CareEvent" is written in a smaller, black font. Underneath "CareEvent", the phrase "Traditional 510(k)" is written in the same font and color.

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Image /page/7/Picture/1 description: The image contains the word "PHILIPS" in large, bold, blue letters. Below the word "PHILIPS" is the word "CareEvent" in a smaller, black font. The word "CareEvent" is positioned slightly to the right of the word "PHILIPS". The image appears to be a logo or branding element.

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Image /page/8/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 version of the company's name. The text "CareEvent" and "Traditional 510(k)" are likely related to a specific product or service offered by Philips. The image is likely used for marketing or informational purposes.

VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination:

Summary of Non-clinical testing

No performance standards have been issued under the authority of Section 514. The Philips CareEvent software Release B.01 was tested in accordance with Philips verification and validation processes. Quality Assurance measures were applied to the system design and development, including:

Risk Analysis ●
Product Specifications ●
Design Reviews ●
. Verification & Validations

Summary of Clinical Testing

Clinical Performance testing for Philips CareEvent software application Release B.01 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence.

Conclusions drawn from the Non-clinical and Clinical testing

Verification, validation, and testing activities, where required to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed. 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 Philips CareEvent software application Release B.01 meets all defined reliability requirements and performance claims.

VIII. Conclusion

Philips CareEvent software application Release B.01 is substantially equivalent to the predicate device Philips CareEvent software application (K142935) in terms of design features, fundamental scientific technology, safety and effectiveness. The change in the intended use was initiated to clarify the previous predicate intended use statement. Additionally, substantial equivalence was demonstrated with nonclinical performance testing, which complied with the requirements specified in the international and FDA-recognized consensus standards. The non-clinical performance tests provided in this 510(k) premarket notification demonstrate that the subject device is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.