Philips Xperius Ultrasound system is intended for diagnostic Ultrasound imaging in B (2D), Color Doppler, M-Mode, and Color Power Angio (CPA) modes. It is indicated for diagnostic ultrasound imaging, and fluid flow analysis in the following applications: Abdominal Peripheral Vessel MSK Small Organ Pediatric

Device Description

The modified/proposed Xperius Ultrasound System is a general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation.

AI/ML Overview

The provided text is a 510(k) summary for the Philips Xperius Ultrasound System (K182529). It details the device's indications for use and compares its technological characteristics to predicate devices. However, it explicitly states that no clinical studies were required or performed to determine substantial equivalence. Therefore, it is not possible to provide information about acceptance criteria, device performance from a test set, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance, as these items are typically derived from clinical or performance studies.

The document indicates that substantial equivalence was demonstrated through non-clinical performance data and attributes such as design features, indications for use, and fundamental scientific technology.

Here's a breakdown of the requested information based only on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided document. The submission explicitly states "The proposed Xperius Ultrasound System did not require clinical studies since substantial equivalence to the currently marketed predicate devices... was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing; and Safety and effectiveness." As such, there are no reported device performance metrics against specific acceptance criteria from a clinical or performance study.

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

This information is not available in the provided document. No clinical or performance test set was used according to the submission.

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

This information is not available in the provided document. No clinical or performance test set was used, and therefore no experts were involved in establishing ground truth for such a test set.

4. Adjudication Method for the Test Set

This information is not available in the provided document. No clinical or performance test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not available in the provided document. No clinical studies, including MRMC studies, were performed.

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

This information is not available in the provided document. The device is an ultrasound system with various modes, not an AI algorithm. No standalone performance study of an algorithm was mentioned.

7. The Type of Ground Truth Used

This information is not applicable as there were no clinical or performance studies generating results that would require ground truth for comparison. Substantial equivalence was based on non-clinical performance data and comparison to predicate devices, not on a new clinical evaluation requiring ground truth.

8. The Sample Size for the Training Set

This information is not available in the provided document. The document describes an ultrasound system, not a device that underwent machine learning training with a specific training set.

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

This information is not applicable as there is no mention of a training set for a machine learning model.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue.

October 23, 2018

Philips Ultrasound, Inc % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO, MN 55313

Re: K182529

Trade/Device Name: Xperius Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 15, 2018 Received: October 16, 2018

Dear Mark Job:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Image /page/1/Picture/5 description: The image shows the name "Michael D. O'hara -S" in large font. To the right of the name is a digital signature, which includes the name "Michael D. O'hara -S" again, as well as the date "2018.10.23 17:30:49-04'00'". The signature also includes information about the signer's identity, such as their country, organization, and organizational units.

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182529

Device Name Xperius Ultrasound System

Indications for Use (Describe)

The clinical environments where the Xperius Ultrasound system can be used for are: hospitals, surgery centers, clinics, and physician offices

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number: TBD Device name: Xperius Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal /Obstetric
	Abdominal	P	N			P		P(3,4,6,8,9)N(5)
	Intra-operative (Vascular)
	Intra-operative (Neuro)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N			N		N(5)
	Small Organ (breast,thyroid, testicle)	N	N			N		N(5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel.(Conventional)	N	N			N		N(5)
	Musculo-skel. (Superficial)	N	N			N		N(5)
	Intra-luminal
	Other (Urology)
	Other (Gynecology)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel	P	N			P		P(3,4,6,8,9)N(5)
	Cerebral Vascular
N= new indication; P= previously cleared by FDA K163020; E= added under Appendix E
Other Modes1. Harmonic (Tissue or Contrast)2. Tissue Doppler Imaging3. iScan4. X-Res	5. Angio Imaging (CPA)6. SonoCT7. Biopsy Guidance8. Needle Visualization Regional anesthesia, Nerve9., Vascular access
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

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Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal /Obstetric
	Abdominal	P	N			P		P(3,4,6,8,9)N(5)
	Intra-operative (Vascular)
	Intra-operative (Neuro)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N			N		N(5)
	Small Organ (breast,thyroid, testicle)	N	N			N		N(5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel.(Conventional)	N	N			N		N(5)
	Musculo-skel. (Superficial)	N	N			N		N(5)
	Intra-luminal
	Other (Urology)
	Other (Gynecology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel	P	N			P		P(3,6,4 8,9)N(5)
	Cerebral Vascular
	N= new indication; P= previously cleared by FDA K163020; E= added under Appendix E
Other Modes			5. Angio Imaging (CPA)
1. Harmonic (Tissue or Contrast)			6. SonoCT
2. Tissue Doppler Imaging			7. Biopsy Guidance
3. iScan			8. Needle Visualization, Regional Anesthesia, Nerve
4. X-Res		9. Vascular Access

510(k) Number: TBD

System: Xperius Ultrasound system

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

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510(k) No:	TBD
	System: Xperius Ultrasound System
Transducer:	C5-2
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal /Obstetric
	Abdominal	P	N			P		P (3,4,6,8)N(5)
	Intra-operative (Vascular)
	Intra-operative (Neuro)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N			N		N(5)
	Small Organ (breast,thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel.(Conventional)	N	N			N		N(5)
	Musculo-skel. (Superficial)	N	N			N		N(5)
	Intra-luminal
	Other (Urology)
	Other (Gynecology)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)

PeripheralVessel	Peripheral vessel	P				P		P (3,4,6,8)N(5)
	Cerebral Vascular

N= new indication; P= previously cleared by FDA 163020; E=added under Appendix E

Other Modes	5. Angio Imaging (CPA)
1. Harmonic (Tissue or Contrast)	6. SonoCT
2. Tissue Doppler Imaging	7. Biopsy Guidance
3. iScan	8. Regional Anesthesia, Nerve
4. X-Res	9. Vascular Access

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

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Philips Ultrasound, Inc.	Quality, Regulatory and SustainabilityXperius Traditional 510(k)	Doc. ID:Revision:Doc. date:Page 1 of 95	254784COct 19, 2018
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510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21CFR. Part 807, Subpart E, Section 807.92

1. Submitter's name, address, telephone number, contact person
  Saraswathi Deora Program Manager- Q&R-Regulatory Affairs Saraswathi.Deora@philips.com

On Behalf Of: Philips Ultrasound 22100 Bothell Everett Highway Bothell, WA 98021-8431

Date Prepared: October 19, 2018

Name of the device, including the trade or proprietary name if applicable, the common or usual 2) name, and the classification name, if known:

Common/Usual Name:	Diagnostic Ultrasound system and transducers
Proprietary Name:	Xperius Ultrasound System
Classification:	Class II
21 CFR Section	Classification Name	Product Code
892.1550	System, Imaging, Pulsed Doppler, Ultrasonic	90 IYN
892.1560	System, Imaging, Pulsed Echo, Ultrasonic	90 IYO
892.1570	Transducer, Ultrasonic, diagnostic	90 ITX
Substantially Equivalent Devices
Primary Predicate Device
Philips Xperius Ultrasound System		K163020	11/16/2016
Reference Devices
Philips ClearVue 850 Diagnostic Ultrasound System		K153480	12/16/2015

Philips CX50 and Sparq Diagnostic Ultrasound Systems K162329 09/14/2016 Philips Lumify Ultrasound System K162549 10/05/2016

Device Description 4)

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Philips Ultrasound, Inc.	Quality, Regulatory and SustainabilityXperius Traditional 510(k)	Doc. ID:Revision:Doc. date:Page 2 of 95	254784COct 19, 2018
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The modified Xperius Ultrasound System is substantially equivalent to the currently marketed and predicate Philips Xperius Ultrasound System (K163020), Philips ClearVue 850 Diagnostic Ultrasound System (K153480) in terms of design and fundamental scientific technology. The modified Xperius Ultrasound System is provided with additional indications.

ર) Intended Use

Philips Xperius Ultrasound system is intended for diagnostic Ultrasound imaging in B (2D), Color Doppler, M- Mode, and Color Power Angio (CPA) modes. It is indicated for diagnostic ultrasound imaging, and fluid flow analysis in the following applications: Abdominal Peripheral Vessel MSK Small Organ Pediatric

The clinical environments where the Xperius Ultrasound system can be used for are: hospitals, surgery centers, clinics, and physician offices

Comparison of the Design and Technological characteristics ರ್(

A comparison of the design and technological characteristics of the proposed Xperius System to the currently marketed and predicate Xperius is provided in Table 1 below:

Feature	Proposed Xperius System	Predicate Xperius System(K163020)	Reference ClearVue850(K153480)
Intended Use	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody as follows	Diagnostic ultrasoundimaging or fluid flowanalysis of the human bodyas follows	Diagnostic ultrasoundimaging or fluid flowanalysis of the human bodyas follows
	-	-	Fetal/Obstetric
	Abdominal	Abdominal	Abdominal
	Small Organ (thyroid,scrotum, prostate, breast)	-	Small Organ (breast,thyroid, testicle)
	-	-	Adult Cephalic
	-	-	Trans-rectal
	-	-	Trans-vaginal
Indication for Use	Musculo-skel(conventional)	-	Musculo-skel(conventional)
	Musculo-skel (superficial)	-	Musculo-skel (superficial)
	-	-	Other (Gynecological)
	-	-	Cardiac Adult
	-	-	Trans-esoph. (Cardiac)
	Peripheral vessel	Peripheral vessel	Peripheral vessel
	Pediatric	-	Pediatric Neonatal CephalicCardiac Pediatric Other(Fetal) Other (Carotid)
Philips Ultrasound, Inc.	Quality, Regulatory and Sustainability	Doc. ID:	254784
	Xperius Traditional 510(k)	Revision:Doc. date:Page 3 of 95	COct 19, 2018
Feature	Proposed Xperius System	Predicate Xperius System(K163020)	Reference ClearVue850(K153480)
			Cerebral Vascular
Transducer Types	C5-2 Curved ArrayL12-4 Broadband SectorLinear Array	C5-2 Curved ArrayL12-4 Broadband SectorLinear Array	S4-1 Sector ArrayC5-2 Curved ArrayC9-4v Curved ArrayL12-4Broadband Sector LinearArray3D9-3VV6-2L12-5D2CWc
TransducerFrequency	1-6 Mhz	1-6Mhz	1-12Mhz
Modes of Operation	B (or 2-D) Color Doppler,M-mode and Color PowerAngio (CPA) modes modesinclude RegionalAnesthesia, Vascularaccess, NeedleVisualization, X-Res,SonoCT, iSCAN)	B (or 2-D) Color Doppler,modes include RegionalAnesthesia, Vascularaccess, NeedleVisualization, X-Res,SonoCT, iSCAN)	B (or 2-D), M-mode (includingAnatomical M- mode),Pulse Wave Doppler,Continuous Wave Doppler,Color Doppler, TissueHarmonics, iSCAN, X-Res,Color Power Angio, 3D(freehand), 4D and SonoCT,Combined modes includesFloVue, Elastography(strain).
PWDoppler	-	Not Available	Available
CWDoppler	-	Not Available	Available
Patient contactmaterials	-	Acrylonitrile butadienestyreneSilicone RubberPVC - Flexible	Acrylonitrile butadienestyrene Silicone RubberPVC - Flexible
510(k)Track	-	Track 3	Track 3
Philips Ultrasound, Inc.	Quality, Regulatory and Sustainability	Doc. ID:	254784
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Feature	Proposed Xperius System	Predicate Xperius System(K163020)	Reference ClearVue850(K153480)
Regulatory Class	-	Class II	Class II

Technological Characteristics

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Quality, Regulatory and Sustainability	Doc. ID:	254784
Xperius Traditional 510(k)	Revision:	C
	Doc. date:	Oct 19, 2018
	Page 5 of 95

Modified and proposed Xperius System that employs the same fundamental scientific technology as that cleared with currently marketed and predicate Philips Xperius Ultrasound System (K163020). The primary difference with an add additional Modes of Operation.

Features	Proposed XperiusUltrasound System	PredicateXperius Ultrasound System (K163020)	ReferenceClearVue 850Ultrasound System(K153480)	ReferenceCX50 UltrasoundSystem(K162329)	ReferenceLumify UltrasoundSystem(K162549)
Software Revision	1.5	1	N/A	N/A	N/A
Analysis	Same	Non-Qlab quantification is explored, basicmeasurements,calculations, their configuration and use. Depthand distance measurement	Same	Same	Same
Annotation	Same	Users describe the imaging situation andfindings, both during the imaging session and inreview, by adding words, phrases and bodymarker graphics to the images.	Same	Same	Same
Capture	Same	Single frame and multi frame images (loops) aresaved in a persistent manner for later review.The workflow and techniques surroundingprospective and retrospective capture of theseimages is considered, along with the systemimpact of offering different post- processingcapabilities on the saved data, as well as thesize and timing constraints of the platform.	Same	Same	Same
Cineloop	Same	Immediate review of a frozen imaging data set iscalled Cineloop (also known as Quick Review).The feature covers the behavior of all of theimaging modalities.	Same	Same	Same

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	Philips Ultrasound, Inc.	Quality, Regulatory and SustainabilityXperius Traditional 510(k)	254784COct 19, 2018
Features	Proposed XperiusUltrasound System	PredicateXperius Ultrasound System (K163020)	ReferenceClearVue 850Ultrasound System(K153480)	ReferenceCX50 UltrasoundSystem(K162329)	ReferenceLumify UltrasoundSystem(K162549)
Color	In addition to ColorFlow , CPA was addedColor Power Angio(CPA): Real time two-dimensional imagingcomposed of a grayscale image with flowamplitude displayed asa color overlay.	The feature covers Color Flow.	The feature coversColor Flow, CPA, TDI(Tissue DopplerImaging) and BFlow.	2D ColorDopplerImagingTissueDopplerImaging andHarmonics(Tissue andContrast)Combination modes	The feature coversColor Flow
Connectivity	Same	DICOM protocol support for networks, printers,servers, and removable media.	Same	Same	Same
DNL	Same	The Digital Navigation Link (DNL) provides apeer-topeer network connection to an externalinterventional workstation transmitting 2D and3D ultrasound image data in real-time.Communication between the two systems ishandled over a DICOM-like communicationprotocol.	Same	Same	Same
Echo	Same	2D black and white image generation, acquiredblack and white Mmode data, and anatomicalMmode are covered by this feature.	Same	Same	Same
External AVSupport	Same	Ultrasound systems support connections toexternal audio/visual devices, such as externalmonitors (for operating room or additionalviewing during scans, and for trade-showexhibits with large screen monitors), external	Same	N/A	N/A

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Features	Proposed XperiusUltrasound System	PredicateXperius Ultrasound System (K163020)	ReferenceClearVue 850Ultrasound System(K153480)	ReferenceCX50 UltrasoundSystem(K162329)	ReferenceLumify UltrasoundSystem(K162549)
		real-time capture devices (e.g. VCR and DVR),and external single frame capture devices (e.g.printers). We may also have support of anintegrated (i.e. controlled by the system) VCR orDVR with the system – both the recording ofvoice and video onto the device and replay ofthe device back into the system.
Help	Same	The display of helpful information to the userduring the use of the ultrasound system.	Same	Same	Same
iSPI	Same	The intelligent Service Platform Interface thatprovides common service features across Philipsproducts.	Same	N/A	N/A
Install andUpgrades	Same	Installation of software and hardwarecapabilities by all affected users of the system:field service, manufacturing, engineers, and endusers (for upgrades and patches).	Same	Same	Same
Localization	No new languages.Additional usermanuals: Czech, Slovakand Korea	Provides the user with the ability to use thesystem with their localization settings. Thisincludes the user interface language, thekeyboard language, and the locale for numeric,and time display settings.	Same	Same	Same
Output ControlSystem	Same	The Output Control System (OCS) monitors andcontrols acoustic and thermal output emittedfrom the system throughthe transducer. Its design must meet systemrequirements imposed by regulating industries.OCS exposes the Auto-Test Interface (ATI) usedby the	Same	Same	Same

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Philips Ultrasound, Inc.			Quality, Regulatory and SustainabilityXperius Traditional 510(k)			Doc. ID:Revision:Doc. date:Page 8 of 95
Features	Proposed XperiusUltrasound System	PredicateXperius Ultrasound System (K163020)	ReferenceClearVue 850Ultrasound System(K153480)	ReferenceCX50 UltrasoundSystem(K162329)	ReferenceLumify UltrasoundSystem(K162549)
Peripherals	Same	Acoustic Measurement Department (AMD) tocollect system data and verify OCS operation.Peripherals assigns external devices, such asprinters and VCRs, to system hard keys and footswitches, and manages tertiary devices such asambient light sensor and barcode scanner.	Same	Same	Same
PowerManagement	Touch power switch atthe front of the tablet,Lock button for lockingthe screen, Increasedbattery run time, Userreplaceable battery	Peripheral : PrinterSystem startup and shutdown is more complexwith the portable nature of the system. Treatingpower management as a feature allows us tolook at all the user interactions surroundingturning on and off the system with and withoutwall power (battery operations), portable mode,low and	Same	Same	Same
Presets	New: FAST and Lungpresets and M-Modeand CPA Mode addedin Xperius 1.5 ColorPower Angio (CPA):Real time two-dimensional imagingcomposed of a grayscale image with flowamplitude displayed asa color overlay.M-Mode (MM): Grayscale time motiondisplay having a	Presets manages persistent collections ofsystem settings. Preset collections are stored,loaded, activated, backed-up, exported, andimported. Activation of a preset collectionenhances clinical workflow by configuring thesystem for a specific use. Factory presets canbe fine- tuned by the user's creating a custompreset. The menu that offers presets foractivation can also be tailored by the user.Tissue specific Presets" Nerve 0-4. Nerve 4-6and vascular access	Same ClearVue 850supports Modes ofOperation: B (or 2-D),M-mode (includingAnatomical M- mode),Pulse Wave Doppler,Continuous WaveDoppler, ColorDoppler, TissueHarmonics, iSCAN, X-Res, Color PowerAngio, 3D (freehand),4D and SonoCT,Combined modes	CX50 Supports FASTand Lung Presets	Lumify Supports FASTand Lung Presets
		Philips Ultrasound, Inc. Quality, Regulatory and SustainabilityXperius Traditional 510(k)			Doc. ID:Revision:Doc. date:Page 9 of 95	254784COct 19, 2018
	Features	Proposed XperiusUltrasound System	PredicateXperius Ultrasound System (K163020)	ReferenceClearVue 850Ultrasound System(K153480)	ReferenceCX50 UltrasoundSystem(K162329)	ReferenceLumify UltrasoundSystem(K162549)
		selectable scroll rate.In some screen formatsincludes a 2D modeimage.IQ (Image Quality)Optimization of thepreviously clearedpresets - Nerve 0-4 ,Nerve 4-6 and VascularAccess to enhancenerve and vesselvisualization		includes FloVue,Elastography (strain).
	Reporting	Same	Creation of a patient report from the dataentered into and acquired with the ultrasoundsystem.	Same	Same	Same
	Review	Same	Review of stored images, measurements andpatient information has unique workflow.Display and replay of the images, along withpost-processing capabilities is explored for theplatform. Includes ability to de-identify imageand exam information on both the display andin exported images.	Same	Same	Same
	Security	Same	A collection of system capabilities that allowthe ultrasound device to integrate withcustomer sites protecting the device andcustomer infrastructure from malware and	Same	Same	Same
Philips Ultrasound, Inc.			Quality, Regulatory and Sustainability			Doc. ID: 254784
Xperius Traditional 510(k)			Revision:	C
			Doc. date:	Oct 19, 2018
			Page 10 of 95
Features	Proposed XperiusUltrasound System	PredicateXperius Ultrasound System (K163020)	ReferenceClearVue 850Ultrasound System(K153480)	ReferenceCX50 UltrasoundSystem(K162329)	ReferenceLumify UltrasoundSystem(K162549)
		protecting patient data from unauthorizedaccess.Features include: Auditing, Encryption,Whitelisting, and network time service.
Service	Same	System capabilities for the user of field servicepersonnel to install, diagnose and repair anultrasound system. Special workflow isconsidered as well as special tools or softwarenot used by the end clinical user. Local andRemote service workflows and tools arediscussedRemote Self Test is also included in this featureas a special topic.	Same	Same	Same
StudyManagement	Same	Overall creation, addition to and deletion ofa patient's information, images,quantification findings and reports.	Same	Same	Same
Transducers	SameC5-2 and L12-4Nonew or additionaltransducers areadded to XperiusUltrasound System1.5 revision	Transducers detects the presence of atransducer in a connector, recognizesthetransducer model, manages the system filesand stored parameters associated with thetransducer, and selects the active transduceramong those connected.Transducers implements the specialfunctions for TEE, bi-plane, matrix, andmechanical 3D transducers.C5-2 , L12-4	ClearVue850 supportsS4-1 C5-2 , C9-4v,L12-4,3D9-3V,V6-2,L12-5 D2CWc	CX50Supports C5-1 C8-5C9-3io C9-3vC10-3vD2cwc D5cwcL10-4 lap L12-3L12-5 50 L15-7ioS5-1 S8-3 S12-4S7-3t	Lumify supportsC5-2, L12-4,
		Philips Ultrasound, Inc.Quality, Regulatory and SustainabilityXperius Traditional 510(k)		Doc. ID: 254784Revision: CDoc. date: Oct 19, 2018Page 11 of 95
Features		Proposed XperiusUltrasound System	PredicateXperius Ultrasound System (K163020)	ReferenceClearVue 850Ultrasound System(K153480)	ReferenceCX50 UltrasoundSystem(K162329)	ReferenceLumify UltrasoundSystem(K162549)
UserManagement		Same	User Management authenticates, identifies,and grants rights and privileges to users. Itsupports identifying, auditing, and trackingsystem usage and customization andconfiguration of the system. The presence orabsence of an authenticated user also	Same	Same	Same
SonoCT		Same	Acquires multiple lines of sight and compoundsthem in real time. The images have fewerartifacts, improved contrast resolution andbetter defined tissue margins.	Same	Same	N/A
XRes		Same	Adaptive image processing enhances imagequality through millions of calculations. XRESworks in tandem with SonoCT to furtherreduce artifacts, and improve contrastresolution and border definition	Same	Same	N/A

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Quality, Regulatory and Sustainability	Doc. ID:	254784
	Revision:	C
Xperius Traditional 510(k)	Doc. date:	Oct 19, 2018
	Page 12 of 95

Determination of Substantial Equivalence ର୍ଚ୍ଚ

Non-clinical performance data

Non-clinical tests performed on in this premarket notification submission for a determination of substantial equivalence demonstrates compliance with the following standards

AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012 Medical electrical equipment Part 1: ● General requirements for basic safety and essential performance). IEC 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance
. AAMI/ANSI/IEC 60601-1-2: 2014: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests and IEC 60601-1-2:2014: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
ISO 10993: Biological evaluation of medical devices ●
IEC 60601-2-37: Medical electrical equipment. Particular requirements for the safety of ultrasonic ● medical diagnostic and monitoring equipment

Quality assurance measures applied to the system design and development include, but were not limited to the following:

Risk Analysis
Product Specifications
Design Reviews ●
Verification and Validation

Summary of Clinical Tests

The proposed Xperius Ultrasound System did not require clinical studies since substantial equivalence to the currently marketed predicate devices, Philips Xperius Ultrasound System was demonstrated with the following attributes:

Design features; ●
Indication for use;
Fundamental scientific technology; ●
Non-clinical performance testing; and
. Safety and effectiveness.

7) Conclusions

Proposed Xperius system is substantially equivalent to the currently marketed and predicates in terms of indications for use, design, indications for use and technological characteristics.

Xperius Ultrasound system is same as Philips Xperius Ultrasound System (K163020) with additional indications and modes of operation.

514 Performance Standards

There are no Sec. 514 performance standards for this device.

Prescription Status

This is a prescription device. The prescription device statement appears in the labeling.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.