Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states that the device "does not use artificial intelligence or machine learning."

Therapeutic

No.
The device is for viewing and quantifying 3D image data for measuring abdominal aortic aneurysms, which falls under diagnostic imaging rather than therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" states that the device is "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." The "Device Description" also notes that it is "designed for structural measurements of an Abdominal Aortic Aneurism (AAA), including volume measurement and diameter measurements" to "assist in monitoring a previously diagnosed Abdominal Aortic Aneurisms." These functions directly support the diagnosis and monitoring of medical conditions.

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as a "software application" and "software only" within the document. While it processes data from a Philips ultrasound system, the device itself is the software component for viewing and quantifying that data.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
Device Function: The AAA Model software application processes image data acquired directly from a Philips diagnostic ultrasound system. It does not analyze biological samples taken from the patient.
Intended Use: The intended use is to view and quantify 3D image data for measuring the anterior diameter of abdominal aortic aneurysms. This is an imaging-based measurement, not a diagnostic test performed on a biological sample.

The device is a software tool that assists healthcare professionals in interpreting and quantifying medical images, which falls under the category of medical imaging software, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

LLZ

Device Description

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
1. 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

No

Input Imaging Modality

3D image data acquired by Philips diagnostic ultrasound systems

Anatomical Site

abdominal aortic aneurysms

Indicated Patient Age Range

patients age > 18 years old

Intended User / Care Setting

trained and qualified healthcare professionals in clinics, hospitals, and clinical point-of-care facilities.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Native AAA clinical evaluation:
Sample: 129 Native AAA datasets were gathered from one hospital in Copenhagen, Denmark. 91 of the exams met the inclusion criteria. All patients age> 18 years old.
Test Method: Native 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.

Post -EVAR AAA clinical evaluation:
Sample: 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.
Test Method: 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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing:
Study type: Measurement Accuracy Verification
Sample size: 7 samples were used for each measurement (AP/LAT/MAD diameter and partial volume).
Key results: All measurements met the acceptance criteria (± 9% accuracy for volume measurement and ± 5% for all diameter measurements, with 90% confidence interval).

Clinical testing:
Study type: Native AAA clinical evaluation
Sample size: 129 Native AAA datasets, 91 met inclusion criteria.
Key results: Result met the target successful rate (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%).

Study type: Post -EVAR AAA clinical evaluation
Sample size: 77 Post-EVAR AAA datasets, 45 met inclusion criteria.
Key results: Result met the target successful rate (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%).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K200974

Reference Device(s)

K121223

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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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

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)

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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

1. 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
1. 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.

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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.