Who is the manufacturer of Lumify Diagnostic Ultrasound System?

Philips Ultrasound filed the 510(k) submission for Lumify Diagnostic Ultrasound System (K232500).

What is the FDA product code for Lumify Diagnostic Ultrasound System?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Lumify Diagnostic Ultrasound System?

510(k) clearance (submission type: Traditional).

Does Lumify Diagnostic Ultrasound System use AI or machine learning?

Yes. Lumify Diagnostic Ultrasound System (K232500) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for Lumify Diagnostic Ultrasound System?

Lumify Diagnostic Ultrasound System (K162549).

Who can help prepare an FDA 510(k) submission like Lumify Diagnostic Ultrasound System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Lumify Diagnostic Ultrasound System get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Lumify Diagnostic Ultrasound System

K232500 · Philips Ultrasound · IYN · Oct 26, 2023 · Radiology

Device Facts

Record ID	K232500
Device Name	Lumify Diagnostic Ultrasound System
Applicant	Philips Ultrasound
Product Code	IYN · Radiology
Decision Date	Oct 26, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler (PWD), and M-modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung. The Lumify system is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

Device Story

Lumify is a mobile, software-controlled ultrasound system using COTS Android/iOS devices and USB-connected transducers (C5-2, L12-4, S4-1). It acquires and displays B-mode, Color Doppler, PWD, and M-mode images. The system includes an AI-based 'Auto EF Quantification' feature (derived from DiA LVivo EF) for cardiac imaging. Using apical 4-chamber (A4CH) view clips, the algorithm automatically traces LV borders to calculate Ejection Fraction (EF), End Diastolic Volume (EDV), and End Systolic Volume (ESV). Clinicians use the output to assess left ventricular function; the tool allows manual review and editing of contours before result acceptance. The system is used by healthcare professionals in various clinical settings to support diagnostic and procedural decision-making.

Clinical Evidence

Clinical performance study evaluated the Auto EF algorithm using 80 apical 4-chamber (A4CH) view clips from patients with varying LV function (normal to severe dysfunction). Automated EF results were compared to manual tracing by sonographers. Results showed strong correlation: EF r=0.82 (95% CI: 0.72, 0.88); EDV r=0.95 (95% CI: 0.91, 0.96); ESV r=0.94 (95% CI: 0.90, 0.96). The algorithm successfully processed 95% (76/80) of clips.

Technological Characteristics

Mobile ultrasound system utilizing COTS Android/iOS hardware and USB-connected transducers (C5-2, L12-4, S4-1). Imaging modes: B, Color Doppler, PWD, M-mode. Software-based AI algorithm (Auto EF) for cardiac quantification. Complies with IEC 62304 (software life cycle), IEC 62366-1 (usability), and ISO 14971 (risk management). Non-sterile.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients requiring Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, or Lung assessment. Intended for use by healthcare professionals in clinical environments.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

Lumify Diagnostic Ultrasound System (K162549)

Reference Devices

DiA LVivo Software Application (K210053)
Lumify Diagnostic Ultrasound System (K223771)
Lumify Diagnostic Ultrasound System (K203406)

Related Devices

K253593 — Clarius Ejection Fraction AI · Clarius Mobile Health Corp. · Mar 2, 2026
K243862 — LVivo Software Application · Dia Imaging Analysis, Ltd. · Mar 17, 2025
K251110 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems · Philips Ultrasound, LLC · May 9, 2025
K232145 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Oct 30, 2023
K200497 — Vivid S60N, Vivid S70N · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jul 16, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ October 26, 2023 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 the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. Philips Ultrasound % Sudipta Chakrabarti Sr. Regulatory Affairs Specialist 22100 Bothell Everett Hwy BOTHELL WA 98021-8431 Re: K232500 Trade/Device Name: Lumify Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, QIH Dated: August 17, 2023 Received: August 17, 2023 Dear Sudipta Chakrabarti: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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, # Yanna S. Kang -S Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use Submission Number (if known) K232500 Device Name Lumify Diagnostic Ultrasound System Indications for Use (Describe) The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler (PWD), and M-modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung, The Lumify system is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(k) Number: K232500 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(s) | Manufacturer: | Philips Ultrasound 22100 Bothell Everett Hwy Bothell, WA 98021-8431 | |--------------------|------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Sudipta Chakrabarti Sr. Regulatory Affairs Specialist TEL: +1 (203) -213-6862 sudipta.chakrabarti@philips.com | | Secondary Contact: | Tamara Daniels Sr. Regulatory Affairs Manager TEL: +1 (203) -213-6862 tamara.daniels@philips.com | | Date Prepared: | October 26, 2023 | - 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: | Lumify Diagnostic Ultrasound System | | | |-------------------------|------------------------------------------------|----------|--------------| | Common Name: | Diagnostic ultrasound system and transducers | | | | Regulation Description: | Classification Name | 21 CFR § | Product Code | | | Primary | | | | | Ultrasonic pulsed doppler imaging system | 892.1550 | IYN | | | Secondary | | | | | Ultrasonic pulsed echo imaging system | 892.1560 | IYO | | | Diagnostic ultrasonic transducer | 892.1570 | ITX | | | Medical image management and processing system | 892.2050 | QIH | | Device Class: | Class II | |-----------------------|-----------| | Classification Panel: | Radiology | {4}------------------------------------------------ # 3. Indications for Use and Intended Use There is no change to the intended use and indications for use of the subject device as compared to the currently commercialized version of Lumify Diagnostic Ultrasound System, except lung indication was added through K203406 for Lumify Diagnostic Ultrasound System with B-line Detection and Bline Counting, and Pulsed Wave Doppler was added during Lumify 4.0 (Android) release through a Letter to File. #### 3.1 Indications for Use The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B(2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler, and M-modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung. The Lumify system is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals. #### 3.2 Intended Use The intended use of the product is to collect ultrasound image data that may be used by clinicians for diagnostic and procedural purposes. The product shall provide the ability for gathering clinically acceptable images and ultrasound data for the clinical presets and anatomies listed under the indications for use. This product is intended to be installed, used, and operated only in accordance with safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces the user's responsibility for sound clinical judgement and best clinical procedure. #### 4. Device Description Summary The Philips Lumify Diagnostic Ultrasound System (Lumify) is a mobile, durable, and reusable, software-controlled medical device, which is intended to acquire high-resolution ultrasound data and to display the data in B (2D), Pulsed Wave Doppler, Color Doppler, Combined (B+ Color), and M modes. The Lumify Diagnostic Ultrasound System (Android) utilizes: - A commercial off-the-shelf (COTS) Android mobile device (smart phone or tablet) - The Philips Ultrasound Lumify software running as an application on the COTS device - The Philips C5-2 Curved array USB transducer - The Philips L12-4 Linear array USB transducer ● - . The Philips S4-1 Sector array USB transducer - Lumify Micro B Transducer Cable ● {5}------------------------------------------------ - Lumify Micro C Transducer Cable ● Image /page/5/Picture/2 description: The image shows a tablet displaying an ultrasound image. The tablet is connected to a handheld ultrasound probe via a white cable. The ultrasound probe is white with a gray transducer and a green ring around the cable connection. The screen of the tablet displays a black and white ultrasound image, along with various controls and settings. Figure 4-1: Hardware components of Lumify Diagnostic Ultrasound System. The Lumify system is compatible with iOS or Android operating systems. The Lumify system software provides various imaging features, including an Android-specific feature with artificial intelligence (AI) based, Auto EF Quantification (ejection fraction) technology during cardiac imaging. Ejection fraction (EF) is a measurement, expressed as a percentage, of how much blood the left ventricle pumps out with each contraction of the heart. The End Diastolic Volume (EDV) and the End Systolic Volume (ESV) are the volumes used to calculate the blood ejected from the left ventricle per heartbeat. Auto EF is a new Artificial Intelligence (AI) feature available on the S4-1 transducer in the Cardiac Preset on the Lumify application based on the LVivo EF algorithm developed by DiA. Lumify Auto EF Quantification feature is a subset of LVivo platform. It provides automated assessment of the LV EF supporting evaluation from only apical four chamber (A4CH) view. The software automatically traces and tracks LV borders in each frame of the cardiac cycle and provides only the results for Ejection Fraction (EF), End Diastolic Volume (EDV), and End Systolic Volumes (ESV). Auto EF only includes a mechanism for automatically rejecting false results. If the algorithm fails to compute the results, then the user is notified by displaying an error dialog. Additionally, the tool offers editing functionality to review and adjust the LV contour before accepting it for calculating the results. The Auto EF Quantification feature will be available on version 5.0 (Android) of Lumify Diagnostic Ultrasound System. The Auto EF Quantification has no impact on the clinical indication or intended users of the predicate. This software enhancement does not alter the intended use of the device but provides additional functionality to clinical workflows during cardiac related applications. # 5. Substantially Equivalent Devices #### Predicate Device: K 162549, Philips Ultrasound - Lumify Diagnostic Ultrasound System {6}------------------------------------------------ # TRADITIONAL 510(k) SUMMARY Philips Ultrasound Lumify Diagnostic Ultrasound System with Auto EF Quantification | Reference Device: | K210053, DiA LVivo Software Application | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------| | Additional Reference Devices | K223771, Philips Ultrasound – Lumify Diagnostic Ultrasound System K203406, Philips Ultrasound – Lumify Diagnostic Ultrasound System | #### 6. Technological Comparison to Predicate Devices The Lumify Diagnostic Ultrasound System with Auto EF Quantification and associated transducers are substantially equivalent to the predicate device (K162546) and reference device (K210053). The following Table 6.1 provides an overview of the comparison between the subject devices and predicate and reference devices. | Standard Feature | Lumify Diagnostic Ultrasound System K# Pending (Subject Device) | Lumify Diagnostic Ultrasound System K162549 (Predicate Device) | DiA LVivo Software Application K210053 (Reference Device) | Comparison/ Discussion | |------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation Number | 892.1550 | 892.1550 | 892.2050 | Remains unchanged from predicate Lumify Ultrasound System | | Device Classification Name | System, Imaging, Pulsed Doppler, Ultrasonic | System, Imaging, Pulsed Doppler, Ultrasonic | Automated Radiological Imaging Processing Software | Remains unchanged | | Device Classification Primary Product Code | II IYN | II IYN | II QIH | Remains unchanged from predicate Lumify Ultrasound System QIH is a secondary product for subject device | | Feature Trade Name | Auto EF Quantification | Not Applicable This feature was not available with this version | LVivo EF | LVivo software application has been incorporated in Lumify Ultrasound System as Auto EF Quantification | | Scientific Technology | Ultrasound Imaging | Ultrasound Imaging | Relies on Ultrasound imaging to perform the assessment | Remains unchanged for the predicate and similar for the reference | | Principles of Operation (subject Auto EF Quantification Feature) | Lumify Auto EF Quantification is a software only feature. The core system software architecture remains | Not Applicable This feature was not available with this version | The LVivo platform is a software system for automated analysis of ultrasound examinations. | With Auto EF Quantification feature the user is offered an automated measurement of Ejection Fraction (EF), End Diastolic | | | unchanged. This | | | Volume (EDV), and | | Standard Feature | Lumify Diagnostic Ultrasound System K# Pending (Subject Device) | Lumify Diagnostic Ultrasound System K162549 (Predicate Device) | DiA LVivo Software Application K210053 (Reference Device) | Comparison/ Discussion | | | additional feature is added in the Cardiac preset of the Lumify system to assess left ventricular function using a 4 Chamber Apical view of the heart. This feature provides automated tracing of the Left Ventricular (LV) border and quantification of End Systolic Volume (ESV) and End Diastolic Volumes (EDV) as well as the Ejection Fraction (EF) for LV assessment. | | | End Systolic Volume (ESV). The Lumify features are a subset of the LVivo platform | | Artificial Intelligence/Machine Learning | Auto EF Quantification, is a derivative of the previously cleared LVivoEF module (K210053) that enables automated evaluation of end diastolic volume (EDV), end systolic volume (ESV) and Ejection Fraction (EF) from the Four Chamber (4CH) apical view. | Not Applicable This feature was not available with this version | Automated analysis of echocardiographic examinations is done based on ultrasound imaging data by analyzing already acquired clip (cine loop). The imaging data can be provided in DICOM format that includes required metadata or RGB format together with metadata that is provided through software API. The global LV function is evaluated from two of the apical views: four- | The subject device with the automation of the Auto EF Quantification feature, the user is now offered measurements including Ejection Fraction (EF), End Diastolic Volume (EDV) and End Systolic Volume (ESV). The AL/ML functionality is same in the subject device in comparison to the reference device. | | Standard Feature | Lumify Diagnostic Ultrasound System K# Pending (Subject Device) | Lumify Diagnostic Ultrasound System K162549 (Predicate Device) | DiA LVivo Software Application K210053 (Reference Device) | Comparison/ Discussion | | Automation | Yes | Not Applicable This feature was not available with this version | Yes | Same as the reference device (DiA LVivo) | | Manual editing by user capability | Yes | Not Applicable This feature was not available with this version | Yes | Same as the reference device (DiA LVivo) | | Automated ED and ES frames selection | Yes | Not Applicable This feature was not available with this version | Yes | Same as the reference device (DiA LVivo) | | Volume calculation by Simson's method of discs | Yes | Not Applicable This feature was not available with this version | Yes | Same as the reference device (DiA LVivo) | | EF results presentation | Displaying full clip with border tracking. The results for selected ED and ES frames for default beat is displayed. | Not Applicable This feature was not available with this version | Displaying full clip with border tracking. And table with results for each cycle for selected ED & ES frames for each beat. | Auto EF for Lumify does not have the table with results for each cycle. Only results for ED & ES frames for default beat is displayed. | | Algorithm | Image segmentation for border detection and tracking includes processing by neural network | Not Applicable This feature was not available with this version | Image segmentation for border detection and tracking includes processing by neural network | Same as reference device | | Standard Feature | Lumify Diagnostic Ultrasound System K# Pending (Subject Device) | Lumify Diagnostic Ultrasound System K162549 (Predicate Device) | DiA LVivo Software Application K210053 (Reference Device) | Comparison/ Discussion | | Automated rejection of false results | Yes | Not Applicable This feature was not available with this version | Yes | Same as the reference device (DiA LVivo) | | Transducers | L12-4 S4-1 C5-2 Auto EF is only available on S4-1 Transducer (Cardiac Phased Array) | L12-4 S4-1 C5-2 | Cardiac Phased Array | Auto EF Quantification feature is only available on S4-1 transducer | {7}------------------------------------------------ # TRADITIONAL 510(k) SUMMARY # Philips Ultrasound Lumify Diagnostic Ultrasound System with Auto EF Quantification {8}------------------------------------------------ # TRADITIONAL 510(k) SUMMARY Philips Ultrasound # Lumify Diagnostic Ultrasound System with Auto EF Quantification {9}------------------------------------------------ Table 6.1 Technological Comparison of Proposed Subject Device & Predicate Device. # 7. Non-Clinical Performance Data The proposed modification of the Lumify Diagnostic Ultrasound System was tested in accordance with Philips internal procedures. Philips Ultrasound tested the subject device per the following standards to ensure the continued safe and effective performance: - . IEC 62304 Medical device software - Software life cycle processes, 2006 + A 2015 - . IEC62366-1 Medical devices - Part 1: Application of usability engineering to medical devices, 2015 - . ISO 14971 Medical devices- Application of risk management to medical devices, 2019 Non-clinical verification testing was conducted to address the change and performance test data were provided to support the introduction of the subject software algorithm for the Auto EF software feature. The activities to assure the safe and effective performance of the software revision included, but are not limited to, the following: - Requirements Review - . Risk Analysis and Management Review - . Product Specification Review - Design Reviews Non-Clinical Verification Testing of requirements, consisted of feature-specific functional testing. transducer compatibility, user interface and workflow testing related to Auto EF Software Feature introduced in this submission as part of the software verification activities for the system and for S4-1 transducer supporting the Auto EF Software feature. Since this is a software-only change and no new hardware was added, no acoustic output, cleaning and disinfectant, thermal, electromagnetic, and mechanical safety testing were required. Biocompatibility testing is not needed for the subject Lumify Ultrasound System with Auto EF Quantification. The transducer patient contact materials and manufacturing processes are not {10}------------------------------------------------ impacted by the release of the subject Lumify Diagnostic Ultrasound System with Auto EF Quantification. #### 8. Clinical Performance Data #### Summary of Clinical Tests There was no clinical investigation needed for this premarket submission of the Lumify Diagnostic Ultrasound System with Auto EF Quantification feature, which is an artificial intelligence-based feature. The LVivo EF was developed by DiA Imaging Analysis Ltd. and integrated into Lumify Diagnostic Ultrasound device as Auto EF Quantification. #### Artificial Intelligence Summary The LVivo EF algorithm is an Artificial Intelligence (AI) based tool that enables automated assessment of the global LV function. A clinical performance study using Apical 4 Chamber (A4CH) view clips from 80 patients acquired with the Lumify Diagnostic Ultrasound System, compared the automated EF evaluation by LVivo EF to Ejection Fraction (EF) evaluation by manual tracing performed by sonographers. The data used for clinical performance study were completely distinct from that used during training of the algorithm. and there was no overlap between the two data sets. #### Dataset The data set consisted of Apical 4CH view clips obtained from 80 subjects who were referred for cardiac evaluation. These subjects were selected based on their eligibility for study. The data were acquired consecutively for patients with normal LV function and then for patients with impaired LV function. For each patient, a scan of the 4CH apical view was performed using Lumify Diagnostic Ultrasound System when EF by visual estimation on the Lumify device was possible. The examinations were identified by patient number and collected anonymized. {11}------------------------------------------------ | Variables | Values | N | % | Mean | |---------------------------------|---------------------------------------------------------------------|-----|-------|------------------| | Gender | Female | 23 | 29 | -- | | | Male | 57 | 71 | -- | | Age | 19 - 92 years | 80 | -- | 64 ± 14 years | | BMI | 15.9-43.0 | 74* | -- | 26.4 | | LV Function | Normal or preserved LV function | 30 | 37.5 | -- | | | Mild LV dysfunction | 13 | 16.25 | -- | | | Moderate LV dysfunction | 20 | 25 | -- | | | Severe LV dysfunction | 17 | 21.25 | -- | | Population disease distribution | Coronary artery disease (CAD) | 34 | 42 | -- | | | Left Ventricular Hypertrophy | 9 | 11 | -- | | | Thickened leaflet, Calcified or prosthetic mitral valve | 19 | 24 | -- | | | Moderate to Severe Mitral regurgitation | 7 | 9 | -- | | | Normal LV Function | 11 | 14 | -- | The demographic distribution of the study population includes the following: *BMI data were not available for 6 patients. {12}------------------------------------------------ A comparison was conducted between the automated EF results obtained by the LVivo EF application, and the average Ejection Fraction (EF) results obtained through manual tracing, which is a conventional method for echocardiographic LV function evaluation. #### Results Strong correlation was demonstrated between LVivo EF ejection (EF) measurements and the average results by manual tracing, r=0.82, 95% CI (0.72, 0.88), meeting the end point criteria. Additionally, strong correlations were demonstrated for end-diastolic volume (EDV) and end-systolic volume (ESV) with r=0.95, 95% CI (0.91, 0.96) and r=0.94, 95% CI (0.90, 0.96), respectively. The LVivoEF automatically processed 76 out of 80 clips (95%). The automated results were compared to EF results by manual tracing. #### Conclusion Auto EF application accurately measured LV function when applied to 4CH clips collected with the Lumify Diagnostic Ultrasound Device. The Auto EF application can be used as an analysis tool for EF evaluation on clips acquired with the Lumify device. #### 9. Sterilization Not applicable. The ultrasound transducers are not supplied sterile. #### 10. Conclusion For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed subject device meets its intended use. The changes made to the subject device do not affect the use of the device, nor do they introduce any new or significantly modified risks. The results of the relevant performance and compatibility tests support a determination that the proposed subject device does not raise new questions of safety or effectiveness. Therefore, the subject device is substantially equivalent to the primary predicate device in terms of indications for use, design, technological characteristics, modes of operations, safety, and effectiveness.