AAA Model
Device Facts
| Record ID | K200603 |
|---|---|
| Device Name | AAA Model |
| Applicant | Philips Ultrasound, Inc. |
| Product Code | LLZ · Radiology |
| Decision Date | Sep 20, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| 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.
Indications for Use
Indicated for trained and qualified healthcare professionals in clinics, hospitals, and point-of-care facilities to view and quantify 3D ultrasound image data for measuring abdominal aortic aneurysm (AAA) dimensions (anterior-posterior, lateral, maximum diameter, and partial volume) in patients >18 years old, including native and post-surgical (EVAR) cases.
Regulatory Classification
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)
Reference Devices
- VPQ in QLAB Advanced Quantification Software (K121223)
Submission Summary (Full Text)
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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
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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
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## 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) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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## 510(k) Summary
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## 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.
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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.
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# 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<br>Number and<br>Regulation<br>Name | 21 CFR 892.2050;<br>System, Image processing,<br>Radiological<br>Picture Archiving and<br>Communications System<br>(PACS) | 21 CFR 892.2050;<br>System, Image<br>processing, Radiological<br>Picture Archiving and<br>Communications System<br>(PACS) | 21 CFR 892.2050;<br>System, Image<br>processing, Radiological<br>Picture Archiving and<br>Communications System<br>(PACS) | Identical | | |
| Indication for<br>Use | Philips QLAB<br>Quantification software<br>application package is<br>designed to view and<br>quantify image data<br>acquired on Philips<br>ultrasound products | Philips QLAB<br>Quantification<br>software<br>application package is<br>designed to view and<br>quantify image data<br>acquired on Philips<br>ultrasound products.<br>The Vascular Plaque<br>Quantification (VPQ)<br>plug-in provides<br>protocol driven tools | Philips QLAB<br>Quantification<br>software<br>application package is<br>designed to view and<br>quantify image data<br>acquired on Philips<br>ultrasound products.<br>The AAA Model is a<br>software application<br>designed to view and<br>quantify 3D image data | The primary predicate GI-<br>3DQ in QLAB is intended to<br>be used for computing 3D<br>measurements for any<br>regions of interest, which can<br>be used in the situation of<br>abdominal aortic aneurysm.<br>The subject device, AAA<br>model application in QLAB,<br>is designed to measure<br>diameter of a previously<br>detected abdominal aortic<br>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-<br>automated analysis of<br>plaques in the carotid<br>artery. | acquired by Philips EPIQ<br>Diagnostic ultrasound<br>systems for use in<br>measuring Anterio-<br>posterior diameter.<br>Optionally, Lateral<br>diameter, Maximum<br>diameter, and partial<br>volume of the<br>Abdominal Aorta<br>Aneurysm can also be<br>provided. It is intended<br>to be used by trained and<br>qualified healthcare<br>professionals in clinics,<br>hospitals, and clinical<br>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<br>description | GI-3DQ computes linear<br>measurements, area<br>measurements, stacked<br>contour volume<br>measurements, and<br>ellipsoid volume<br>measurements, of any<br>regions of interest that<br>users select. | VPQ provides semi-<br>automatic analysis of<br>plaque in the carotid<br>artery. it calculates<br>plaque and lumen areas,<br>and also the percent<br>reduction for each<br>tracked frame. | AAA generates semi-<br>automatic structural<br>measurements of<br>abdominal aortic<br>aneurysm, including<br>volume and diameter<br>measurements. | Predicate GI-3DQ is for<br>general imaging analysis of<br>any regions of interest, while<br>subject device AAA is<br>specifically designed for<br>abdominal aortic aneurysm<br>analysis. The impact of the<br>difference in clinical<br>application on device safety<br>and effectiveness is<br>addressed by the clinical<br>performance study. | | |
| Contour<br>Generation | Borders are created<br>manually to create a 3D<br>model. | Preliminary borders and<br>3D model are created<br>automatically without<br>user interaction.<br>User is required to edit,<br>accept or reject the<br>contours. | Preliminary borders and<br>3D model are created<br>automatically without<br>user interaction.<br>User is required to edit,<br>accept or reject the<br>contours prior to 3D<br>volume and diameter<br>measurements. | Subject device AAA semi-<br>automated border detection<br>function is equivalent to<br>VPQ. User is required to<br>accept border prior to<br>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<br>Technology | Manual border tracing<br>over multiple slices;<br>Creates 3D mesh to derive<br>volume measurement;<br>diameter measurement<br>done via manual distance<br>measurement tool | Automated preliminary<br>border detection;<br>Creates 3D mesh to<br>derive volume<br>measurement; diameter<br>measurement done via<br>manual distance<br>measurement tool | Automated preliminary<br>border detection; creates<br>3D mesh and<br>auto-segmentation of<br>AAA to derive volume<br>and diameter<br>measurements once<br>preliminary borders are<br>confirmed by user | Both subject device and<br>predicate create 3D mesh to<br>derive volume measurement.<br>The difference is predicate<br>GI-3DQ use manual distance<br>measurement tool for<br>diameter measurement, while<br>the subject device AAA can<br>derive the diameter<br>measurements from the 3D<br>mesh and auto-segmentation<br>of the 3D model. The impact<br>of the difference on safety<br>and effectiveness is<br>addressed by the<br>measurement accuracy test<br>from bench performance<br>testing | | |
| | Measurement<br>Parameters | This app computes<br>linear measurements, area<br>measurements, stacked<br>contour volume<br>measurements, and | This app calculates<br>plaque and lumen areas,<br>and also the percent<br>reduction for each<br>tracked frame. | AAA model provides<br>Max Anteroposterior<br>(AP) diameter, Max<br>Lateral Diameter (LAT),<br>Max any direction | The measurements function<br>of AAA model, including the<br>diameter measurement and<br>volume measurement, is<br>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<br>measurements. | | (MAD) diameter, and<br>partial volume<br>measurement. | | |
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Traditional 510(k)
AAA Model K200603
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## 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<br>Testing | Test Method | Sample | Acceptance<br>Criteria | Result |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Measurement<br>Accuracy<br>Verification | EPIQ diagnostic<br>ultrasound<br>system was used<br>to take 3D<br>ultrasound<br>images of 3<br>phantoms with<br>various diameter.<br>AAA model was<br>used to measure<br>the<br>AP/LAT/MAD<br>diameter and<br>partial volume. | 7 samples were<br>used for each<br>measurement. | ± 9% accuracy<br>for volume<br>measurement and<br>± 5% for all<br>diameter<br>measurements,<br>with 90%<br>confidence<br>interval. | All<br>measurements<br>met the<br>acceptance<br>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. |
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## Traditional 510(k) AAA Model K200603
| Clinical testing | Test Method | Sample | Acceptance<br>Criteria | Result |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| | 2D ultrasound<br>measurement,<br>and from 3D<br>ultrasound<br>measurement<br>with AAA<br>model are<br>compared. | patients age> 18<br>years old. | measurements to<br>within ± 10% | |
| Post -EVAR<br>AAA clinical<br>evaluation | Post-EVAR<br>AAA ultrasound<br>images were<br>acquired during<br>normal<br>ultrasound<br>examination in<br>hospital. AP<br>diameter from<br>2D ultrasound<br>measurement,<br>and from 3D<br>ultrasound<br>measurement<br>with AAA<br>model are<br>compared. | 77 Post-EVAR<br>AAA datasets<br>were gathered<br>from one<br>hospital in<br>Copenhagen,<br>Denmark. 45 of<br>the exams met<br>the inclusion<br>criteria. All<br>patients age> 18<br>years old. | At least 80% of<br>all cases in<br>which Philips<br>AAA Model<br>provides<br>maximum AP<br>diameter results<br>that match<br>standard of care<br>measurements to<br>within ± 10% | Result met the<br>target<br>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.
