← Product Code [LLZ](/productcode/LLZ) · K200603 # AAA Model (K200603) _Philips Ultrasound, Inc. · LLZ · Sep 20, 2020 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K200603 ## Device Facts - **Applicant:** Philips Ultrasound, Inc. - **Product Code:** [LLZ](/productcode/LLZ.md) - **Decision Date:** Sep 20, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device, Real-World Evidence ## Real-World Evidence | Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags | | --- | --- | --- | --- | --- | --- | | K200603 · Sep 20, 2020 | AAA Model | Philips Ultrasound, Inc. | Retrospective hospital ultrasound image datasets (Native AAA and Post-EVAR AAA) | Retrospective clinical datasets were used to evaluate the accuracy of the AAA Model's AP diameter measurements by comparing them against standard-of-care 2D ultrasound measurements. | Retrospective clinical evaluation; Abdominal Aortic Aneurysm (AAA); Ultrasound imaging; Post-EVAR | ### Clinical Evidence | Study Design | Population | Comparator | Key Endpoints | | --- | --- | --- | --- | | Native AAA clinical evaluation; Retrospective clinical evaluation | Patients > 18 years old with Native AAA; Sample Size: 91 datasets (from 129 gathered); Number of Sites: 1 | Standard of care 2D ultrasound measurement | Agreement of AP diameter measurements within ± 10% | | Post-EVAR AAA clinical evaluation; Retrospective clinical evaluation | Patients > 18 years old with Post-EVAR AAA; Sample Size: 45 datasets (from 77 gathered); Number of Sites: 1 | Standard of care 2D ultrasound measurement | Agreement of AP diameter measurements within ± 10% | ## Indications for Use The AAA Model is a software application designed to view and quantify 3D image data acquired by Philips diagnostic ultrasound systems for use in measuring the anterior diameter of abdominal aortic aneurysms. Optionally, lateral diameter, maximum diameter, and partial volume of an abdominal aortic aneurysm can also be provided. It is intended to be used by trained and qualified healthcare professionals in clinical point-of-care facilities. ## Device Story AAA Model is a software application for structural quantification of abdominal aortic aneurysms (AAA). It processes 3D ultrasound image data acquired by Philips diagnostic ultrasound systems (e.g., EPIQ). The device performs semi-automated border detection to generate a 3D mesh and segment the aneurysm; the user must review, edit, and confirm these contours. It calculates maximum anteroposterior (AP) diameter, lateral diameter, maximum diameter, and partial volume. Used in clinics, hospitals, and point-of-care settings by trained healthcare professionals. Output is displayed to the clinician to assist in monitoring previously diagnosed native or post-surgical (EVAR) AAA. It is not a CADe device and does not use AI or machine learning. It functions as part of the QLAB Advanced Quantification Software suite, which can operate on standard PCs, dedicated workstations, or on-board ultrasound systems. ## Clinical Evidence Clinical evaluation included two prospective studies: 91 Native AAA datasets and 45 Post-EVAR AAA datasets (patients >18 years). Primary endpoint: agreement between 3D AAA Model measurements and 2D ultrasound standard of care. Success criteria: ≥80% of cases matching within ±10%. Both studies met the target success rate. ## Technological Characteristics Software-only application; part of QLAB Advanced Quantification Software. Operates on standard PCs, workstations, or on-board Philips ultrasound systems (e.g., EPIQ). Uses semi-automated border detection and 3D mesh generation for quantification. No AI/ML algorithms. Not a CADe device. ## Regulatory 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. ## Special Controls *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). ## Predicate Devices - GI-3DQ in QLAB Advanced Quantification Software ([K200974](/device/K200974.md)) ## Reference Devices - VPQ in QLAB Advanced Quantification Software ([K121223](/device/K121223.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ September 20, 2020 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, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that. Philips Ultrasound, Inc. % Hebe Sun Regulatory Affairs Manager 22100 Bothell Everett Highway BOTHELL WA 98021 Re: K200603 Trade/Device Name: AAA Model Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 12, 2020 Received: August 17, 2020 Dear Hebe Sun: 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/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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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) K200603 Device Name AAA Model ### Indications for Use (Describe) The AAA Model is a software application designed to view and quantify 3D image data acquired by Philips diagnostic ultrasound systems for use in measuring the anterior diameter of abdominal aortic aneurysms. Optionally, lateral diameter, maximum diameter, and partial volume of an abdominal aortic aneurysm can also be provided. It is intended to be used by trained and qualified healthcare professionals in clinical point-of-care facilities. | 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) | ## 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}------------------------------------------------ ## 510(k) Summary {4}------------------------------------------------ ## THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION ## IS SUBMITTED IN ACCORDANCE WITH 21CFR § 807.92 ## 1. Submitter's name, address, telephone number, contact person. Philips Ultrasound, Inc. 22100 Bothell Everett Hwy Bothell, WA 98021-8431 | Contact: | Hebe Sun | |----------------|--------------------------------| | Title: | Sr. Regulatory Affairs Manager | | Email: | hebe.sun@philips.com | | Tel: | 425-219-1223 | | Fax: | 425-487-8666 | | Date prepared: | Aug 11, 2020 | - 2. Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known. Common name: Picture archiving and communications system Proprietary name: AAA Model Regulation Number: 21 CFR 892.2050 Classification name: System, Image Processing, Radiological Product code: LLZ, Class II Classification: ## 3. Indications for Use The AAA Model is a software application designed to view and quantify 3D image data acquired by Philips diagnostic ultrasound systems for use in measuring the anterior-posterior diameter of abdominal aortic aneurysms. Optionally, lateral diameter, maximum diameter, and partial volume of an abdominal aortic aneurysm can also be provided. It is intended to be used by trained and qualified healthcare professionals in clinics, hospitals, and clinical point-of-care facilities. #### Device Description 4. {5}------------------------------------------------ AAA Model for QLAB Advanced Quantification Software is a software application designed for structural measurements of an Abdominal Aortic Aneurism (AAA), including volume measurement and diameter measurements. AAA Model is designed to assist in monitoring a previously diagnosed Abdominal Aortic Aneurisms in two ways: - 1) to follow the anteroposterior (AP) maximum diameter for a Native AAA, and - 2) to follow the anteroposterior (AP) maximum diameter for a post-surgical AAA. AAA model is not a computer-assisted detection (CADe) device, and does not use artificial intelligence or machine learning. Philips QLAB Advanced Quantification Software (QLAB) is designed to view and quantify image data acquired on Philips ultrasound systems. QLAB is available either as a stand-alone product that can function on a standard PC, a dedicated workstation, and on-board Philips' ultrasound systems. AAA Model is compatible with the Philips EPIQ Diagnostic Ultrasound System. ## 5. Substantially Equivalent Devices | Primary Predicate Device | | |-------------------------------------------------|---------| | GI-3DQ in QLAB Advanced Quantification Software | K200974 | | Reference Device | | | VPO in QLAB Advanced Quantification Software | K121223 | A comparison of technical characteristics for subject device and the currently marketed predicate device is provided on the following table. {6}------------------------------------------------ # Traditional 510(k) AAA Model K200603 ## Comparison of Technical Characteristics | | Primary Predicate | Reference Device | Subject Device | Explanation of Differences | | | |------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Trade Name | QLAB System | QLAB System | QLAB System | N/A | | | | Feature | GI-3DQ | VPQ | AAA Model | N/A | | | | 510(k) number | K200974 | K121223 | K200603 | N/A | | | | Product Code | QIH | LLZ | LLZ | Identical | | | | Regulation
Number and
Regulation
Name | 21 CFR 892.2050;
System, Image processing,
Radiological
Picture Archiving and
Communications System
(PACS) | 21 CFR 892.2050;
System, Image
processing, Radiological
Picture Archiving and
Communications System
(PACS) | 21 CFR 892.2050;
System, Image
processing, Radiological
Picture Archiving and
Communications System
(PACS) | Identical | | | | Indication for
Use | Philips QLAB
Quantification software
application package is
designed to view and
quantify image data
acquired on Philips
ultrasound products | Philips QLAB
Quantification
software
application package is
designed to view and
quantify image data
acquired on Philips
ultrasound products.
The Vascular Plaque
Quantification (VPQ)
plug-in provides
protocol driven tools | Philips QLAB
Quantification
software
application package is
designed to view and
quantify image data
acquired on Philips
ultrasound products.
The AAA Model is a
software application
designed to view and
quantify 3D image data | The primary predicate GI-
3DQ in QLAB is intended to
be used for computing 3D
measurements for any
regions of interest, which can
be used in the situation of
abdominal aortic aneurysm.
The subject device, AAA
model application in QLAB,
is designed to measure
diameter of a previously
detected abdominal aortic
aneurysm. | | | | | Primary Predicate | Reference Device | Subject Device | Explanation of Differences | | | | Trade Name | QLAB System | QLAB System | QLAB System | N/A | | | | Feature | GI-3DQ | VPQ | AAA Model | N/A | | | | 510(k) number | K200974 | K121223 | K200603 | N/A | | | | | | for performing a semi-
automated analysis of
plaques in the carotid
artery. | acquired by Philips EPIQ
Diagnostic ultrasound
systems for use in
measuring Anterio-
posterior diameter.
Optionally, Lateral
diameter, Maximum
diameter, and partial
volume of the
Abdominal Aorta
Aneurysm can also be
provided. It is intended
to be used by trained and
qualified healthcare
professionals in clinics,
hospitals, and clinical
point-of-care facilities. | | | | | | Primary Predicate | Reference Device | Subject Device | Explanation of Differences | | | | Trade Name | QLAB System | QLAB System | QLAB System | N/A | | | | Feature | GI-3DQ | VPQ | AAA Model | N/A | | | | 510(k) number | K200974 | K121223 | K200603 | N/A | | | | Application
description | GI-3DQ computes linear
measurements, area
measurements, stacked
contour volume
measurements, and
ellipsoid volume
measurements, of any
regions of interest that
users select. | VPQ provides semi-
automatic analysis of
plaque in the carotid
artery. it calculates
plaque and lumen areas,
and also the percent
reduction for each
tracked frame. | AAA generates semi-
automatic structural
measurements of
abdominal aortic
aneurysm, including
volume and diameter
measurements. | Predicate GI-3DQ is for
general imaging analysis of
any regions of interest, while
subject device AAA is
specifically designed for
abdominal aortic aneurysm
analysis. The impact of the
difference in clinical
application on device safety
and effectiveness is
addressed by the clinical
performance study. | | | | Contour
Generation | Borders are created
manually to create a 3D
model. | Preliminary borders and
3D model are created
automatically without
user interaction.
User is required to edit,
accept or reject the
contours. | Preliminary borders and
3D model are created
automatically without
user interaction.
User is required to edit,
accept or reject the
contours prior to 3D
volume and diameter
measurements. | Subject device AAA semi-
automated border detection
function is equivalent to
VPQ. User is required to
accept border prior to
calculation for all apps. | | | | | Primary Predicate | Reference Device | Subject Device | Explanation of Differences | | | | Trade Name | QLAB System | QLAB System | QLAB System | N/A | | | | Feature | GI-3DQ | VPQ | AAA Model | N/A | | | | 510(k) number | K200974 | K121223 | K200603 | N/A | | | | Quantification
Technology | Manual border tracing
over multiple slices;
Creates 3D mesh to derive
volume measurement;
diameter measurement
done via manual distance
measurement tool | Automated preliminary
border detection;
Creates 3D mesh to
derive volume
measurement; diameter
measurement done via
manual distance
measurement tool | Automated preliminary
border detection; creates
3D mesh and
auto-segmentation of
AAA to derive volume
and diameter
measurements once
preliminary borders are
confirmed by user | Both subject device and
predicate create 3D mesh to
derive volume measurement.
The difference is predicate
GI-3DQ use manual distance
measurement tool for
diameter measurement, while
the subject device AAA can
derive the diameter
measurements from the 3D
mesh and auto-segmentation
of the 3D model. The impact
of the difference on safety
and effectiveness is
addressed by the
measurement accuracy test
from bench performance
testing | | | | | Measurement
Parameters | This app computes
linear measurements, area
measurements, stacked
contour volume
measurements, and | This app calculates
plaque and lumen areas,
and also the percent
reduction for each
tracked frame. | AAA model provides
Max Anteroposterior
(AP) diameter, Max
Lateral Diameter (LAT),
Max any direction | The measurements function
of AAA model, including the
diameter measurement and
volume measurement, is
similar to GI3DQ. | | | | | | Primary Predicate | Reference Device | Subject Device | Explanation of Differences | | | | Trade Name | QLAB System | QLAB System | QLAB System | N/A | | | | Feature | GI-3DQ | VPQ | AAA Model | N/A | | | | 510(k) number | K200974 | K121223 | K200603 | N/A | | | | ellipsoid volume
measurements. | | (MAD) diameter, and
partial volume
measurement. | | | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ Traditional 510(k) AAA Model K200603 {11}------------------------------------------------ ## 6. Nonclinical Performance Data AAA Model was tested in accordance with Philips internal processes. Non-Clinical verification testing has been performed addressing system level requirements according to system and design specifications, and risk control measures. Software verification and clinical performance accuracy data were used to support substantial equivalence of the AAA Model application to the predicate QLAB Advanced Quantification Software applications. | Bench
Testing | Test Method | Sample | Acceptance
Criteria | Result | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | Measurement
Accuracy
Verification | EPIQ diagnostic
ultrasound
system was used
to take 3D
ultrasound
images of 3
phantoms with
various diameter.
AAA model was
used to measure
the
AP/LAT/MAD
diameter and
partial volume. | 7 samples were
used for each
measurement. | ± 9% accuracy
for volume
measurement and
± 5% for all
diameter
measurements,
with 90%
confidence
interval. | All
measurements
met the
acceptance
criteria. | ## 7. Clinical testing Clinical performance evaluation study showed that the aneurysm AP diameter measurement from AAA model is in agreement with the measurement from 2D ultrasound as the current standard of care, which supports that the performance of AAA model is appropriate for its intended use of AP diameter measurement for the evaluation of abdominal aorta aneurysm. | Clinical testing | Test Method | Sample | Acceptance Criteria | Result | |--------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Native AAA clinical evaluation | Native AAA ultrasound images were acquired during normal ultrasound examination in hospital. AP diameter from | 129 Native AAA datasets were gathered from one hospital in Copenhagen, Denmark. 91 of the exams met the inclusion criteria. All | At least 80% of all cases in which Philips AAA Model provides maximum AP diameter results that match standard of care | Result met the target successful rate. | {12}------------------------------------------------ ## Traditional 510(k) AAA Model K200603 | Clinical testing | Test Method | Sample | Acceptance
Criteria | Result | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------| | | 2D ultrasound
measurement,
and from 3D
ultrasound
measurement
with AAA
model are
compared. | patients age> 18
years old. | measurements to
within ± 10% | | | Post -EVAR
AAA clinical
evaluation | Post-EVAR
AAA ultrasound
images were
acquired during
normal
ultrasound
examination in
hospital. AP
diameter from
2D ultrasound
measurement,
and from 3D
ultrasound
measurement
with AAA
model are
compared. | 77 Post-EVAR
AAA datasets
were gathered
from one
hospital in
Copenhagen,
Denmark. 45 of
the exams met
the inclusion
criteria. All
patients age> 18
years old. | At least 80% of
all cases in
which Philips
AAA Model
provides
maximum AP
diameter results
that match
standard of care
measurements to
within ± 10% | Result met the
target
successful rate. | ## 8. Sterilization Not applicable. This is a software only device. ## 9. Conclusion For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed AAA Model meets the intended use. The differences between the subject device and predicate device do not raise new questions of safety and/or effectiveness. Therefore, the proposed AAA Model is substantially equivalent to the predicate QLAB Advanced Quantification Software applications in terms of intended use, technological characteristics, safety and effectiveness. --- **Source:** [https://fda-staging.innolitics.com/device/K200603](https://fda-staging.innolitics.com/device/K200603) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com