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

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).

AI/ML Overview

The provided document is a 510(k) summary for the Philips CareEvent device, which is a software application intended to deliver supplemental medical device data. The key points regarding acceptance criteria and the study are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with numerical targets and reported device performance. Instead, it states that:

"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."

This indicates that the acceptance criteria were implicitly the specifications of the predicate device (CareEvent, K142935) and that the new device met those criteria, thereby demonstrating substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify a numerical sample size for any test set. It broadly refers to "system level tests, performance tests, and safety testing from hazard analysis."
Data Provenance: Not specified. There is no mention of country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The ground truth for this type of software device (a communication system for physiological alarms) is typically established through functional verification and validation against specified requirements, rather than expert judgment on clinical data.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the validation focuses on functional and performance specifications rather than clinical interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No. This type of study is not relevant for the Philips CareEvent device, which is a communication system and not an AI-powered diagnostic or interpretive tool that assists human readers in making clinical decisions on medical images or signals.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The "performance data" described are non-clinical testing results, which are essentially standalone evaluations of the software's functionality, reliability, and safety against its specifications. The document states:

"The Philips CareEvent software Release B.01 was tested in accordance with Philips verification and validation processes."

7. The Type of Ground Truth Used:

The "ground truth" for this device's validation is based on:

Predicate Device Specifications: The "Pass/Fail criteria were based on the specifications cleared for the predicate device."
System Specifications and Requirements: Implicitly, the design and functional requirements of the CareEvent software itself, which incorporate aspects like alarm delivery, notification types, and communication protocols.

8. The Sample Size for the Training Set:

Not applicable. This device is described as a "software application" for a communication system, not a machine learning or AI model that requires a training set of data. Its functionality is based on predefined logic and protocols.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of software device.

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.

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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 (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)

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 Systems3000 Minuteman RoadAndover, MA 01810 USA
Contact Person:	Theresa PooleRegulatory Affairs SpecialistPhilips Medical Systems3000 Minuteman Road, MS0480Andover, MA 01810-1099Tel: 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

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.

Rx Only

KeyCharacteristic	Predicate Device	Subject Device	Comments
	CareEvent (K142935)	CareEvent B.01
IntendedUse/Indicationsfor UseSentence bySentencecomparison	S1: The intended use ofthe CareEvent solution isto provide healthcareprofessionals withsupplemental informationabout patient alarms,technical alarms, nursecall alarms and systeminformation messages(events).	S1: The intended use ofPhilips CareEvent is todeliver supplementalmedical device dataassociated withphysiological alarms,technical alarms, clinicalnotifications, nurse callalarms and informational	S1: Clarification oftiming, what type ofinformation and towhere.
S2: The product can routeall of subsets of thisinformation to selectiveremote devices such aspagers, phones, ormarquees.	messages to a healthcareprofessional's end device.S2: The user may receivevisual or audiblenotifications, and/or othermessage notification typesbased on the communicatorin use.	S2: Changed focus fromproduct function touser experience.Clarified types ofnotifications. Stated itis dependent on enddevice in use(communicator)aligned with IEC 80001terminology.
S3-5: Receipt of alarmmessages or events by theexternal device, is notconfirmed and delivery tothe end device is notguaranteed.The primary alarmnotification is the deviceproducing the alarm orevent.This product line is notintended to provide real-time information, nor is ita source of patient alarms,nor is it a replacement foralarming devices.	S3-5: Philips CareEvent is acomponent of a distributedalarming system.It does not generate thealarm, alter the behavior ofthe alarm-generatingsystem, replace thealarming system thatgenerates the alarms, nor isit intended to provide real-time information, thereforethe device producing thealarm or event remains theprimary notification system.Philips CareEvent providesconfirmed delivery featureswhen it is used with thePhilips CareEvent mobileapplication on Philips-approved devices.	S3-5: Removed entirelyS3 from PredicateIntended use.Replaced withclarification of roleCareEvent plays in aDistributed alarmsystem.Removed termsecondary used inPredicate, it is not astandardized term.S6: Removedredundancy 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 alarmmessages 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 aredifferent 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 PatientPopulation	As determined by thePhilips patient monitors inuse at the facility.	Same
Users	Trained health careprofessionals	Same

DeviceSoftware	Unchanged, as previouslycleared	1. Allow one-way contextsharing from CareEventto MobileCaregiver.	1. When in CareEventMobile Application,allows user to openthe MobileCareGiverApplication, if
		2. Text messagingcapability within theCareEvent system viathe CareEvent mobileapplication.3. Add user button on theCareEvent mobileapplication toAccept/Reject adelegation requestwhen received.	installed on thesame mobiledevice. MobileCareGiver is a viewof data from thePIIC iX centralstation.2. Provides users analternative forteamcommunication.3. Enables additionaluser control, if auser is not able toaccept ownershipof alerts fromanother device,they canintentionally rejectthe request.
TechnologicalCharacteristics	Unchanged, as previouslycleared.	Same
Device Hardwareis specified byPhilips	Off the Shelf PC and otherITE equipment, specificationavailable or can be orderedfrom Philips.	Same.
DeviceAccessories	CareEvent MobileApplication	Same
Care andCleaning	Not applicable, softwaredevice.	Same
Device safetyandenvironmentalspecifications	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.

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).