EPIQ:
The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Cardiac), intra-luminal, intra-luminal, intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transveginal, Lung.

Modes of operation include: B Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.

The clinical environments where EPIQ Series Diagnostic ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healtheare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

Affiniti:
The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculosketal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

Modes of operation include: B Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.

The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

Device Description

The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Auto ElastQ software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The proposed EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound Systems with new Auto ElastQ software feature, which is a workflow-enhancement software feature, is equivalent to predicate device, K240850.

The Auto ElastQ software feature is intended to assist users in making stiffness measurements using 2D-SWE in the liver by recommending specific frames and ROI positions to the user.

No hardware changes to the EPIQ or Affiniti Systems are reguired when using the Auto ElastQ software feature, and existing, commercialized Philips transducers are used for the Auto ElastQ software feature. The feature is supported by EPIQ and Affiniti models running software version 12.0.

AI/ML Overview

Here's a summary of the acceptance criteria and the study conducted for the Philips Auto ElastQ software feature, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit for high agreement)	Reported Device Performance
Agreement with Manual Elastography Measurements	High agreement between algorithm-generated measurements and manual measurements.	Demonstrated high agreement of Auto ElastQ algorithm-generated measurements with manual elastography measurements based on statistical analysis.

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

Test Set Sample Size: Not explicitly stated. The document mentions "a retrospective data analysis study was conducted to evaluate the performance of the Auto ElastQ software compared to manual measurements."
Data Provenance: Retrospective data analysis. Country of origin not specified.

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

Number of Experts: Not explicitly stated. The ground truth was established by "manual measurements performed by expert readers."
Qualifications of Experts: Not explicitly stated beyond "expert readers."

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The ground truth was established by "manual measurements performed by expert readers," implying an expert consensus or single expert reading for the manual measurements. No information suggestive of a 2+1 or 3+1 method is provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This document describes a study comparing the algorithm's performance to expert manual measurements, not a comparative effectiveness study of human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: Yes. The "retrospective data analysis study" directly evaluated the performance of the Auto ElastQ software (algorithm) "compared to manual measurements performed by expert readers." This indicates a standalone performance assessment of the algorithm.

7. Type of Ground Truth Used

Ground Truth Type: Expert consensus/manual measurements. The summary states, "with the manual measurements used as ground truth for the study."

8. Sample Size for the Training Set

Training Set Sample Size: Not explicitly stated. The document focuses on the performance study and does not detail the training set size for the AI algorithm.

9. How Ground Truth for the Training Set Was Established

Training Set Ground Truth Establishment: Not explicitly stated. The document describes the "Auto ElastQ software feature is intended to assist users in making stiffness measurements using 2D-SWE in the liver by recommending specific frames and ROI positions to the user." While the testing involves expert manual measurements as ground truth, the method for establishing ground truth for the training data used to develop the algorithm is not detailed in this summary.

Summary

{0}------------------------------------------------

December 12, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Philips Ultrasound LLC Chanrasmey White Senior Regulatory Affairs Specialist 22100 Bothell Everett Hwy Bothell, Washington 98021

Re: K242020

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound Trade/Device Name: Svstem Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, OBJ, OIH Dated: November 12, 2024 Received: November 12, 2024

Dear Chanrasmey White:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pm.cfm identifies combination product submissions. The general controls 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements. the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket

{1}------------------------------------------------

review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/unique-deviceidentification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-how-report-medicaldevice-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/cdrh-learn). 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 (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

YANNA S. KANG -S

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K242020

Device Name

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Indications for Use (Describe) EPIO:

The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

Modes of operation include: B Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.

The clinical environments where EPIQ Series Diagnostic ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

Affiniti:

The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

Modes of operation include: B Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.

The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

{3}------------------------------------------------

professionals for the purposes for which they were designed. However, nothing stated in the user information reduces
your responsibility for sound clinical judgement and best clinical procedure.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary

#K242020

This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92. Date Prepared: December 9, 2024

I.	Submitter
	Manufacturer Name and Address	Philips Ultrasound LLC22100 Bothell Everett HwyBothell, WA 98021-8431 USA
	Contact Information	Chanrasmey WhiteSenior Regulatory Affairs Specialist22100 Bothell Everett HwyBothell, WA 98021-8431 USAsmey.white@philips.com1-207-249-5503
	Secondary Contact	Amy YangRegulatory Affairs Director22100 Bothell Everett HwyBothell, WA 98021-8431 USAamy.yang@philips.com1-304-266-8208
II.	Device
	Proprietary Name	EPIQ Series Diagnostic Ultrasound SystemAffiniti Series Diagnostic Ultrasound System
	Common Name	Diagnostic Ultrasound System and Transducers
	Product Code;Regulation Description;Regulation Number	IYN; Ultrasonic Pulsed Doppler Imaging System; 21 CFR 892.1550 (Primary)IYO; Ultrasonic Pulsed Echo Imaging System; 21 CFR 892.1560ITX; Diagnostic Ultrasonic Transducer; 21 CFR 892.1570OBJ; Diagnostic Intravascular Catheter; 21 CFR 870.1200QIH; Medical image management and processing system; 21 CFR 892.2050
	Device Class	Class II
	Review Panel	Radiology
	Predicate Device	K240850; EPIQ Series Diagnostic Ultrasound System andAffiniti Series Diagnostic Ultrasound System

lll. Device Description

The Auto ElastQ software feature is intended to assist users in making stiffness measurements using 2D-SWE in the liver by recommending specific frames and ROI positions to the user.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters against a white background. The font is sans-serif and the letters are evenly spaced. The word is horizontally oriented and fills most of the frame.

IV. Indications for Use

EPIQ:

The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult). Cephalic (Neonatal). Fetal/Obstetric. Gynecological. Intraoperative (Vascular). Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.

The clinical environments where EPIQ Series Diagnostic ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

Affiniti:

The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

Abdominal. Cardiac Adult. Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

Modes of operation include: B Mode. PW Doppler. CW Doppler. Color Doppler. Color M Mode, Power Doppler, and Harmonic Imaging.

The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

Image /page/5/Picture/16 description: The image shows the Philips logo, which is a blue shield with the word "PHILIPS" at the top and a wavy line with stars inside the shield. Below the logo is the number 2 in a simple, sans-serif font. The logo is a well-known brand symbol, and the number 2 is likely an identifier or label.

{6}------------------------------------------------

PHILIPS

V. Comparison of Technological Characteristics with the Predicate

The purpose of the submission is to introduce the Auto ElastQ software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The proposed EPIQ and Affiniti Series Diagnostic Ultrasound Systems are all Track 3 Devices and comply with the referenced standards as well as the FDA Ultrasound Guidance Document, Guidance for Industrly and FDA Staff – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued in February 2023. The subject devices are substantially equivalent to the predicate devices (K240850).

	EPIQ Series DiagnosticUltrasound SystemAffiniti Series DiagnosticUltrasound SystemProposed Devices	EPIQ Series DiagnosticUltrasound SystemAffiniti Diagnostic UltrasoundSystem(K240850)Predicate Device	Comparison
Feature
USA FDAClassification	Class II	Class II	Identical
Primary ProductCode	IYN	IYN	Identical
Primary RegulationNumber	21 CFR 892.1550	21 CFR 892.1550	Identical
Marketing Name ofApplication	Auto ElastQ	ElastQ	Subject of thissubmission
ApplicationDescription	The Auto ElastQ software featureis intended to assist the user inmaking liver stiffnessmeasurements using 2D-SWEthrough recommended particularframes and ROI positions to theuser.The system software will select upto three frames that are assessedto be the most stable and presentthese to the user. The circle ROIwill be launched in the locationsthat are identified to behomogenous and temporallystable.	The ElastQ feature ("manualworkflow") is a tool for measuringthe stiffness of the target organ(liver) which requires the user toreview a loop of elastographyimages displayed on the systemand uses the trackball to cine tothe frame(s) that are visuallyperceived to be the most stable.The circle ROI is then launched inthe center of the shear waveimaging box, and the usermanually positions the ROI withinthe box in a location that appearsto be homogenous andrepresentative of the tissue in theentire box.	Subject of thissubmissionThe difference betweenthe predicate and thesubject device is:The proposed AutoElastQ featurerecommends particularframes and ROI locationsthat are assessed to bemost stable homogenousto the user.The predicate devicerequires users to reviewa loop of elastographyimages and then use thetrackball to cine to theframes that are visuallyperceived to be the moststable. Then the usermust manually positionsthe ROI in a location thatappears to be moststable and homogenous.
	EPIQ Series Diagnostic	EPIQ Series DiagnosticUltrasound System
Feature	Ultrasound SystemAffiniti Series DiagnosticUltrasound System	Affiniti Diagnostic UltrasoundSystem(K240850)Predicate Device	Comparison
	Proposed Devices
User InterfacePresentation	The Auto ElastQ workflowanalyzes the frames present inthe cineloop buffer. The systemsoftware will automatically cine tothree frames that are assessed tobe the most stable and presentthese to the user. Themeasurement ROI willautomatically launch and beplaced on locations identified tobe homogeneous and temporallystable.Even though the Auto ElastQfeature will suggest a particularROI placement, the user mustinspect the results and ensurethat it meets intended clinical use.Otherwise, the user can makeadjustments to what the featureproposes, by either selecting adifferent frame or a different ROIposition.	In the current released software("manual workflow"), the userreviews a loop of elastographyimages displayed on the systemdisplay and then uses thetrackball to cine to the frame(s)that are visually perceived to bethe most stable. The circle ROI isthen launched in the center of theshear wave imaging box, and theuser manually positions the ROIwithin the box in a location thatappears to be homogeneous andrepresentative of the tissue in theentire box.	Subject of thissubmissionThe proposed AutoElastQ will provide arecommendation to theuser where the predicatedevice requires the userto navigate the systemmanually.
Compatibletransducers	Auto ElastQ Feature:C5-1	ElastQ Feature:C5-1	Identical, no newtransducers or modesare being introduced inthis submission.
MeasurementsPerformed	The Auto ElastQ featurecalculates stiffnessmeasurements based on selectedframes and ROI positionsrecommended to the user orbased on user adjustments towhat the feature recommended.	The ElastQ feature calculatesstiffness measurements based onthe manually selected frames andROI positions.	No new measurementsare being introduced inthis submission. Thesubject of thissubmission is to provideworkflow enhancements.
Applicationperformance	A retrospective data analysisstudy was conducted to evaluatethe performance of the AutoElastQ software compared tomanual measurements performedby expert readers.The results demonstrated highagreement of Auto ElastQalgorithm-generatedmeasurements, based onstatistical analysis, with manualelastography measurements.	N/A - the equivalent functionalityis performed manually by theusers to select the mostappropriate frames and ROIpositions.	Subject of thissubmission

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in blue letters. The letters are bold and sans-serif. The background is a light gray color.

VI. Safety Considerations

{8}------------------------------------------------

The subject device comply with the referenced standards as well as the FDA ultrasound guidance document. Guidance for Industry and FDA Staff – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued on February 2023.

VII. Non-Clinical Performance Data

The proposed modification of the EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems was tested in accordance with Philips Internal Procedures. The design process incorporated IEC 62304 Medical Device Software - Software life cycle processes, 2006 + A 2015 and Risk Management procedures were applied in accordance with ISO 14971 Medical devices - Application of risk management to medical devices, to ensure the continued safe and effective performance. All software verification tests met the acceptance criteria.

Non-clinical verification testing was conducted to address the change and performance test data were provided to support the introduction of the subject software algorithm for the Auto ElastQ software feature. All software verification tests met the acceptance criteria.

A retrospective data analysis study was conducted to evaluate the performance of the Auto ElastQ software compared to manual measurements performed by expert readers, with the manual measurements used as ground truth for the study. The results demonstrated high agreement of Auto ElastQ algorithm-generated measurements with manual elastography measurements, meeting the acceptance criteria for the study.

VIII. Clinical Data

The proposed EPIQ and Affiniti Series Diagnostic Ultrasound System did not require clinical data for determination of substantial equivalence since substantial equivalence was demonstrated based on the following attributes:

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

IX. Conclusion

For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed Auto ElastQ software feature meets the intended use. The proposed devices and predicate device:

Are indicated for the diagnostic ultrasonic imaging and fluid flow analysis. ●
Have identical intended users and use environments. ●
. Have the same device classification, product codes.
Have identical software. ●
Are introducing no new hardware or transducers. ●

The differences between the proposed device and predicate device do not raise new questions of safety and/or effectiveness. The major differences include:

The Auto ElastQ feature recommends particular frames that are assessed to be most stable and ROI locations that are assessed to be the most stable and homoqenous to the user, where the predicate devices require users to review a loop of elastography images then uses the trackball to cine to the frames that are visually perceived to be the most stable and manually positions the ROI in a location that appears to be most stable and homogenous.
Image /page/8/Picture/22 description: The image shows the Philips logo at the top, which is a blue shield with stars and waves inside. Below the logo, there is a large number 5. The number is in a simple, sans-serif font and is the most prominent element in the image.

{9}------------------------------------------------

PHILIPS

Therefore, the proposed Auto ElastQ feature for the EPIQ and Affiniti Series Diagnostic Ultrasound Systems is substantially equivalent to the predicate EPIQ and Affiniti Series Diagnostic Ultrasound Systems in terms of safety and effectiveness.

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.