(88 days)
No
The description mentions "semi-automated preliminary border... based on greyscale intensity differentiation with some shape regularization," which is a common image processing technique and does not explicitly indicate the use of AI/ML. There is no mention of AI, ML, or related terms like neural networks or deep learning in the document.
No.
This device is a software application designed to measure the area, circumference, and diameter of a Left Atrial Appendage (LAA) orifice from 3D image data acquired by ultrasound systems. It provides quantitative information for clinicians but does not directly treat or diagnose a disease or condition, which is characteristic of therapeutic devices.
Yes
Explanation: The device is a software application designed to quantify 3D image data from ultrasound systems by measuring the area, circumference, and diameter of the Left Atrial Appendage (LAA) orifice, which are diagnostic measurements. It is explicitly described as a "cardiac quantification application" for use on "Diagnostic Ultrasound systems."
No
The device is described as a software application for use on specific Philips Ultrasound Systems (EPIQ and Affiniti). While it is a software application, it is integrated into and dependent on the hardware of the ultrasound system for image acquisition and processing, and the 510(k) submission is for the application as part of the system software release.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The 3D Auto LAA software application processes image data acquired directly from a Philips Ultrasound System. It does not analyze biological specimens.
- Intended Use: The intended use is to view and quantify measurements of the Left Atrial Appendage orifice from ultrasound images. This is a form of medical image analysis, not in vitro testing.
The device falls under the category of medical image processing software, specifically for use with ultrasound systems.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D image data acquired by Philips Ultrasound Systems
Anatomical Site
Left Atrial Appendage (LAA) orifice
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies
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. 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). Testing performed demonstrated that the proposed 3D Auto LAA application meets the defined requirements and performance claims.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
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Indications for Use
510(k) Number (if known) K201352
Device Name 3D Auto LAA
Indications for Use (Describe)
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.
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)
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| Philips Ultrasound, Inc. | Traditional 510(k) | Page 1 of 7 |
|---|---|---|
| 3D Auto LAA |
Section 8: 510(k) Summary K201352
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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 Hwy
Bothell, WA 98021-8431 | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Travis Catania
Senior Regulatory Affairs Specialist
22100 Bothell Everett Hwy
Bothell, WA 98021-8431
Phone: (908) 227-9423
Fax: 425-402-3481 | | |
| Secondary Contact: | Hebe Sun
Senior 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, and
the classification name, if known: | | | |
| Proprietary Name: | 3D Auto LAA |
|---|---|
| Common Name: | 3D Auto LAA |
| Picture 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
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3. Indications for Use
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 4.
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.
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 Communications | ||||
| System (PACS) | System, Image processing, Radiological - | |||
| Picture Archiving and Communications System | ||||
| (PACS) | The Regulation Number, Regulation Name, | |||
| Classification, and Product Code are identical | ||||
| between the subject device and the primary | ||||
| predicate device. | ||||
| Classification | Class II | Class II | ||
| Product Code(s) | LLZ | LLZ | ||
| Indications for Use | 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. | QLAB Quantification software is a software | |||
| application package. It is designed to view and | ||||
| quantify image data acquired on Philips | ||||
| ultrasound systems. | The Indications for Use of the subject 3D Auto | |||
| LAA application and the primary predicate | ||||
| QLAB System are equivalent with the | ||||
| underlying difference being that the 3D Auto | ||||
| LAA application specifically identifies the | ||||
| anatomical structure / region (the LAA) and | ||||
| the measurements that are reported to the | ||||
| end user (area, circumference, etc.). | ||||
| System Components | Software only system | Software only system | The System Components of the subject 3D | |
| Auto LAA application and the QLAB System | ||||
| are identical as they both are software only | ||||
| systems. | ||||
| Availability | 3D Auto LAA application is available only | |||
| on-cart for the Philips Ultrasound EPIQ and | ||||
| Affiniti Ultrasound Systems | The QLAB System is available either as a stand- | |||
| alone product that can function on a standard | ||||
| PC, a dedicated workstation, and on-board | ||||
| Philips Ultrasound Systems | The availability of the 3D Auto LAA and the | |||
| QLAB System are similar in that both | ||||
| software systems are available on the Philips | ||||
| Diagnostic Ultrasound Systems as dedicated | ||||
| on-cart applications. However, the QLAB | ||||
| System 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 | None | |
| off-cart in variable capacities whereas the 3D Auto LAA application does not allow for this. | ||||
| Software | ||||
| Design | Application | |||
| Description | The 3D Auto LAA cardiac quantification | |||
| application is a semi-automatic tool that is | ||||
| intended to assist the end user with LAA | ||||
| border detection and provide specific | ||||
| measurements for the orifice. This | ||||
| application is provided as an on-cart option | ||||
| only. | The 3DQ Q-App provides a manual way to view, | |||
| slice, and display 3D volumes and measure | ||||
| distance and areas from MPR views to get | ||||
| biplane volume and ejection fraction in addition | ||||
| to mass calculations. QLAB Q-Apps are available | ||||
| both on and off-cart options. | The subject 3D Auto LAA application | |||
| introduces a semi-automated workflow to | ||||
| provide the user with a dedicated tool for | ||||
| LAA quantification for on-cart use only.. The | ||||
| primary predicate QLAB 3DQ Q-App does also | ||||
| allow the user to measure and quantify | ||||
| several various cardiac structures but this is | ||||
| an all manual process | ||||
| Quantification | ||||
| Technology for | ||||
| Cardiac | Manual MPR alignment that results in semi- | |||
| automated border generation of the LAA | ||||
| orifice and provides measurements based on | ||||
| preliminary border generated by algorithm. | ||||
| The border and the measurements can be | ||||
| further refined by the end user. | Manual border drawing / tracing ability in | |||
| addition to manual MPR alignment and | ||||
| provides preliminary measurement estimates | ||||
| based on user defined border. | The subject 3D Auto LAA application | |||
| introduces a semi-automatic border detection | ||||
| functionality for the LAA orifice while | ||||
| specifying the measurements specific to the | ||||
| LAA. The ability to align the MPRs based on | ||||
| the anatomical structure is a shared feature | ||||
| across both the primary and reference | ||||
| predicate devices. | ||||
| Contour | ||||
| Generation | LAA border is semi-autonomously generated | |||
| following the MPR alignment by the end user | ||||
| by utilizing greyscale intensity | ||||
| differentiation with some shape | ||||
| regularization. The user can then modify the | ||||
| entire contour (utilizing the rotary knob) or | ||||
| an individual point(s) utilizing the trackball. | Contour is generated manually by the end user | |||
| utilizing the trackball and if the contour needs | ||||
| modification, the end user must retrace the | ||||
| contour. | The 3D Auto LAA introduces a semi- | |||
| automated workflow for the border | ||||
| generation as compared to both predicate | ||||
| devices. Similarly to the 3D Auto LAA | ||||
| application, the predicate devices both allow | ||||
| for the user to modify and adjust the MPRs to | ||||
| better fit the anatomy. However, the | ||||
| predicate devices both allow | ||||
| for the user to modify and adjust the MPRs to | ||||
| better 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 the | ||||
| trackball. | ||||
| Measurements | ||||
| Parameters | *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 line | ||||
| and quantify both the max and min diameters) | The measurements provided by the 3D Auto | |||
| LAA application are presented to the user as | ||||
| specific to the LAA orifice, however; the | ||||
| primary predicate and reference predicate | ||||
| devices are also capable of quantifying those | ||||
| measurement parameters as the 3D Auto LAA | ||||
| application. |
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.