The 3D Auto LAA is a software application designed to view and quantify 3D image data acquired by Philips Ultrasound Systems for use in measuring the area, circumference, and diameter of a Left Atrial Appendage (LAA) orifice.

Device Description

The purpose of this Traditional 510(k) Pre-market Notification is to introduce the new 3D Auto LAA cardiac quantification application for use on the Philips EPIQ and Affiniti Diagnostic Ultrasound systems, which were most recently cleared under K201012. The 3D Auto LAA application is compatible with 3D images generated via Philips Transesophageal Echocardiogram (TEE) transducers such as the X8-2t and X7-2t. The Philips 3D Auto LAA cardiac quantification application is a semi-automated application intended to provide measurements of the Left Atrial Appendage. The 3D Auto LAA application is designed to provide automatic and editable area, circumference, and diameter measurements of the Left Atrial Appendage (LAA) orifice. When the 3D Auto LAA application is launched, going through the workflow provides the clinician with a semi-automated preliminary border of the LAA in three planes based on greyscale intensity differentiation with some shape regularization.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Philips 3D Auto LAA device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific acceptance criteria with numerical targets (e.g., accuracy > 90%) or directly reported performance metrics tied to such criteria. Instead, it states that the device was tested to "meet the defined requirements and performance claims." The "performance claims" are implicitly about the functionality of providing semi-automated measurements of LAA area, circumference, and diameter.

Here's an interpretation based on the document's content, focusing on the functionality described:

Acceptance Criterion (Inferred from functionality)	Reported Device Performance (Inferred from "successful V&V testing" and description)
Ability to view 3D image data	Device successfully views 3D image data.
Ability to quantify LAA orifice measurements (area, circumference, diameter)	Device provides semi-automated and editable measurements of LAA area, circumference, and diameter.
Semi-automated border detection	Device provides a semi-automated preliminary border of the LAA in three planes.
Measurable LAA Area	Device generates LAA Area (mm²).
Measurable LAA Circumference	Device generates LAA Circumference (mm).
Measurable LAA Max Diameter	Device generates LAA Max Diameter (mm).
Measurable LAA Minimum Diameter	Device generates LAA Minimum Diameter (mm).
Editability of generated borders	User can modify the entire contour or individual points.
Compatibility with Philips Ultrasound Systems	Compatible with Philips EPIQ and Affiniti Diagnostic Ultrasound systems and Philips Transesophageal Echocardiogram (TEE) transducers.

Important Note: The document focuses on demonstrating substantial equivalence to a predicate device by comparing intended use and technological characteristics, and by conducting internal V&V testing. It does not provide a detailed performance study with quantitative results against specific, pre-defined acceptance metrics.

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

Test Set Sample Size: The document does not specify a numerical sample size for the "Performance Validation Study" or any other non-clinical V&V testing. It only mentions that testing was performed.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a non-clinical performance validation study and not a clinical trial, it's likely internal engineering data or synthetic data, but this is not explicitly stated.

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

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for the non-clinical test set. As this was a "Performance Validation Study" for a software application for quantification, it's more likely that the "ground truth" was derived from predefined technical specifications, comparison to manual measurements by engineers, or comparison to the predicate device's output, rather than expert clinical consensus on images.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this document. The document explicitly states: "The subject Philips 3D Auto LAA cardiac quantification did not require clinical data in order to make a determination for substantial equivalence when compared to the predicate device(s)." This indicates no human-in-the-loop performance study for regulatory submission purposes.

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

Yes, a standalone performance assessment was done implicitly. The "Performance Validation Study" and "Software Verification and Validation testing" address the algorithm's performance in generating semi-automated borders and measurements. However, it's important to note the device is described as "semi-automated," implying a human-in-the-loop is part of the intended use (to refine the borders). The testing reported here focuses on the algorithm's capability to generate these preliminary borders and measurements.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the non-clinical V&V testing. Given the nature of a software quantification tool, it's highly probable the ground truth involved:

Comparison against measurements obtained manually by trained individuals (engineers or potentially clinicians) using existing validated methods.
Comparison against the performance of the predicate device (QLAB System's 3DQ Q-App) manual tracing options, to ensure equivalence.
Internal gold standards derived from expert-generated manual segmentations on a subset of images used for development and testing.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set. This information is typically not included in a 510(k) summary focused on substantial equivalence and non-clinical testing.

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

The document does not provide any information on how the ground truth for the training set was established.

Summary

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

August 17, 2020

Image /page/0/Picture/1 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Philips Healthcare % Travis Catania Senior Regulatory Affairs Specialist 22100 Bothell Everett Highway BOTHELL WA 98021

Re: K201352

Trade/Device Name: 3D Auto LAA Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: July 21, 2020 Received: July 22, 2020

Dear Travis Catania:

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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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 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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/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-device-advice-comprehensive-regulatoryassistance/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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K201352

Device Name 3D Auto LAA

Indications for Use (Describe)

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."

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

Philips Ultrasound, Inc.	Traditional 510(k)	Page 1 of 7
	3D Auto LAA

Section 8: 510(k) Summary K201352

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

Philips 3D Auto LAA Cardiac Quantification Application

This summary of safety and effectiveness information is submitted in accordance with 21 CFR §807.92

1. Submitter's name, address, telephone number, contact person

Sponsor:	Philips Ultrasound, Inc.22100 Bothell Everett HwyBothell, WA 98021-8431
Contact Person:	Travis CataniaSenior Regulatory Affairs Specialist22100 Bothell Everett HwyBothell, WA 98021-8431Phone: (908) 227-9423Fax: 425-402-3481
Secondary Contact:	Hebe SunSenior Manager, Regulatory Affairs
Date Prepared	May 20, 2020
2.Name of the device, including the trade of proprietary name if applicable, the common or usual name, andthe classification name, if known:

Proprietary Name:	3D Auto LAA
Common Name:	3D Auto LAAPicture Archiving and Communications System (PACS)

Regulation Description:

Classification Description	21 CFR Section	Product Code
Picture Archiving and Communications System	892.2050	LLZ

As stated in 21 CFR, part 892.2050, each of the generic types of devices that meet this classification description have been classified as Class II.

Device Class:

Class II

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

3. Indications for Use

Device Description 4.

ഗ് Substantially Equivalent Devices

Primary Predicate Device

Philips QLAB Advanced Quantification Software System K191647 December 20, 2019

6. Technological Comparison to Predicate Devices

The introduction of the new 3D Auto LAA cardiac quantification has an equivalence intended use and similar technological characteristics as the legally marketed primary QLAB System predicate device with the distinction being that the 3D Auto LAA application is specific to LAA viewing and quantification. A comparison of the subject 3D Auto LAA application to the currently marketed predicate QLAB System device is provided in the table below:

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

Table 8-1: Comparison of The Subject Philips 3D Auto LAA Cardiac Quantification Application to the predicate Philips QLAB System(the 3DQ Q-App)
	Subject Device	Predicate Device	Explanation of Differences
Manufacturer	Philips Ultrasound, Inc.	Philips Ultrasound, Inc.	None
Trade Name	3D Auto LAA	QLAB System	None
Feature	3D Auto LAA	3DQ	None
510(k) Number	Pending	K191647	None
Regulation Number	21 CFR 892.2050	21 CFR 892.2050
Regulation Name	System, Image processing, Radiological -Picture Archiving and CommunicationsSystem (PACS)	System, Image processing, Radiological -Picture Archiving and Communications System(PACS)	The Regulation Number, Regulation Name,Classification, and Product Code are identicalbetween the subject device and the primarypredicate device.
Classification	Class II	Class II
Product Code(s)	LLZ	LLZ
Indications for Use	The 3D Auto LAA is a software applicationdesigned to view and quantify 3D image dataacquired by Philips Ultrasound Systems foruse in measuring the area, circumference,and diameter of a Left Atrial Appendage(LAA) orifice.	QLAB Quantification software is a softwareapplication package. It is designed to view andquantify image data acquired on Philipsultrasound systems.	The Indications for Use of the subject 3D AutoLAA application and the primary predicateQLAB System are equivalent with theunderlying difference being that the 3D AutoLAA application specifically identifies theanatomical structure / region (the LAA) andthe measurements that are reported to theend user (area, circumference, etc.).
System Components	Software only system	Software only system	The System Components of the subject 3DAuto LAA application and the QLAB Systemare identical as they both are software onlysystems.
Availability	3D Auto LAA application is available onlyon-cart for the Philips Ultrasound EPIQ andAffiniti Ultrasound Systems	The QLAB System is available either as a stand-alone product that can function on a standardPC, a dedicated workstation, and on-boardPhilips Ultrasound Systems	The availability of the 3D Auto LAA and theQLAB System are similar in that bothsoftware systems are available on the PhilipsDiagnostic Ultrasound Systems as dedicatedon-cart applications. However, the QLABSystem offers the added freedom to be used
		Subject Device	Predicate Device	Explanation of Differences
Manufacturer		Philips Ultrasound, Inc.	Philips Ultrasound, Inc.	None
Trade Name		3D Auto LAA	QLAB System	None
Feature		3D Auto LAA	3DQ	Noneoff-cart in variable capacities whereas the 3D Auto LAA application does not allow for this.
SoftwareDesign	ApplicationDescription	The 3D Auto LAA cardiac quantificationapplication is a semi-automatic tool that isintended to assist the end user with LAAborder detection and provide specificmeasurements for the orifice. Thisapplication is provided as an on-cart optiononly.	The 3DQ Q-App provides a manual way to view,slice, and display 3D volumes and measuredistance and areas from MPR views to getbiplane volume and ejection fraction in additionto mass calculations. QLAB Q-Apps are availableboth on and off-cart options.	The subject 3D Auto LAA applicationintroduces a semi-automated workflow toprovide the user with a dedicated tool forLAA quantification for on-cart use only.. Theprimary predicate QLAB 3DQ Q-App does alsoallow the user to measure and quantifyseveral various cardiac structures but this isan all manual process
	QuantificationTechnology forCardiac	Manual MPR alignment that results in semi-automated border generation of the LAAorifice and provides measurements based onpreliminary border generated by algorithm.The border and the measurements can befurther refined by the end user.	Manual border drawing / tracing ability inaddition to manual MPR alignment andprovides preliminary measurement estimatesbased on user defined border.	The subject 3D Auto LAA applicationintroduces a semi-automatic border detectionfunctionality for the LAA orifice whilespecifying the measurements specific to theLAA. The ability to align the MPRs based onthe anatomical structure is a shared featureacross both the primary and referencepredicate devices.
	ContourGeneration	LAA border is semi-autonomously generatedfollowing the MPR alignment by the end userby utilizing greyscale intensitydifferentiation with some shaperegularization. The user can then modify theentire contour (utilizing the rotary knob) oran individual point(s) utilizing the trackball.	Contour is generated manually by the end userutilizing the trackball and if the contour needsmodification, the end user must retrace thecontour.	The 3D Auto LAA introduces a semi-automated workflow for the bordergeneration as compared to both predicatedevices. Similarly to the 3D Auto LAAapplication, the predicate devices both allowfor the user to modify and adjust the MPRs tobetter fit the anatomy. However, thepredicate devices both allowfor the user to modify and adjust the MPRs tobetter fit the anatomy. However, the
Table 8-1: Comparison of The Subject Philips 3D Auto LAA Cardiac Quantification Application to the predicate Philips QLAB System(the 3DQ Q-App)
	Subject Device	Predicate Device	Explanation of Differences
Manufacturer	Philips Ultrasound, Inc.	Philips Ultrasound, Inc.	None
Trade Name	3D Auto LAA	QLAB System	None
Feature	3D Auto LAA	3DQ	None
			draw / trace the contour utilizing thetrackball.
	MeasurementsParameters	LAA Area (mm²)LAA Circumference (mm)LAA Max Diameter (mm)LAA Minimum Diameter (mm)	Area (cm²)Circumference (cm)*Distance (cm) (can be utilized to draw a lineand quantify both the max and min diameters)	The measurements provided by the 3D AutoLAA application are presented to the user asspecific to the LAA orifice, however; theprimary predicate and reference predicatedevices are also capable of quantifying thosemeasurement parameters as the 3D Auto LAAapplication.

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

Table 8-1: Comparison of The Subject Philips 3D Auto LAA Cardiac Quantification to the predicate Philips QLAB System (the 3DQ Q-App)

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

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

Non-Clinical Testing 7.

The proposed introduction of the subject Philips 3D Auto LAA cardiac quantification was tested in accordance with Philips internal processes. Verification and software validation test data are provided to support the newest cardiac quantification application, the 3D Auto LAA application, relative to the currently marketed manual LAA tracing and measuring options.

Design Control activities to assure the safe and effective performance of the 3D Auto LAA application include but are not limited to the following:

Requirements Review O
Risk Analysis and Management O
Product Specifications O
Design Reviews O
Software Verification and Validation O

Non-clinical V&V testing also included the Performance Validation Study for the proposed 3D Auto LAA clinical application.

Software Verification and Validation testing were used to support substantial equivalence of the new 3D Auto LAA cardiac quantification application (as part of the EPIQ / Affiniti System software release version 7.0) to the currently marketed manual LAA tracing and measuring options.

8. Clinical Testing

The subject Philips 3D Auto LAA cardiac quantification did not require clinical data in order to make a determination for substantial equivalence when compared to the predicate device(s).

9. Conclusion

Based on the conformance to standards, development under Philips Ultrasound's Quality Management System, the successful verification and validation testing, Philips Ultrasound believes that the proposed Philips 3D Auto LAA cardiac quantification application is substantially equivalent to the predicate device Philips QLAB System (K191647). Testing performed demonstrated that the proposed 3D Auto LAA application meets the defined requirements and performance claims.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).