(70 days)
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.
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
- Lumify Micro C Transducer Cable
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.
Here's a breakdown of the acceptance criteria and the study details for the Philips Lumify Diagnostic Ultrasound System with Auto EF Quantification, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation of LVivo EF Ejection Fraction (EF) measurements with average manual tracing results. | Strong correlation demonstrated: r = 0.82, 95% CI (0.72, 0.88). The endpoint criteria were met. |
| Correlation of LVivo EF End-Diastolic Volume (EDV) measurements with average manual tracing results. | Strong correlation demonstrated: r = 0.95, 95% CI (0.91, 0.96). |
| Correlation of LVivo EF End-Systolic Volume (ESV) measurements with average manual tracing results. | Strong correlation demonstrated: r = 0.94, 95% CI (0.90, 0.96). |
| Percentage of clips successfully processed automatically by LVivo EF. | 76 out of 80 clips (95%) were automatically processed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 80 patients' Apical 4 Chamber (A4CH) view clips.
- Data Provenance: The data were acquired with the Lumify Diagnostic Ultrasound System, specifically for this clinical performance study. Patients were selected based on eligibility, and data were acquired consecutively for patients with normal and impaired LV function. This suggests a prospective acquisition for the purpose of the study. The document does not specify the country of origin for the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The ground truth was established by "manual tracing performed by sonographers."
- Number of Experts: The document refers to "sonographers" in the plural, but does not specify the exact number of sonographers involved in the manual tracing.
- Qualifications of Experts: The document implies that these were qualified "sonographers" experienced in echocardiographic LV function evaluation, but does not provide specific qualifications (e.g., years of experience, board certification). It can be inferred that they are healthcare professionals who routinely perform this task.
4. Adjudication Method for the Test Set
The ground truth for EF, EDV, and ESV was established by the "average results by manual tracing." This implies that IF multiple sonographers performed the manual tracings, their results were averaged. However, it does not explicitly state an adjudication method like 2+1 or 3+1 (where discrepancies are resolved by a third expert or consensus). It refers to "the average results by manual tracing," suggesting a quantitative aggregation rather than a specific adjudicative consensus process if multiple readers were used. If only one sonographer performed the tracing for each case, no adjudication would be necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done to evaluate how much human readers improve with AI vs. without AI assistance. The study focuses on the agreement between the AI's automated measurements and a "manual tracing" ground truth, not on reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, a standalone study was done. The clinical performance study directly compared the "automated EF evaluation by LVivo EF" (the algorithm's performance) against "Ejection Fraction (EF) evaluation by manual tracing performed by sonographers" (the ground truth). The results (correlation coefficients) reflect the algorithm's performance without a human-in-the-loop scenario. The LVivo EF automatically processed 95% of the clips, indicating its standalone capability.
7. Type of Ground Truth Used
The ground truth used was expert consensus/manual tracing. Specifically, it was defined as "Ejection Fraction (EF) evaluation by manual tracing performed by sonographers" and "the average results by manual tracing" for EF, EDV, and ESV. This is considered an expert-derived ground truth based on conventional, established methods for echocardiographic LV function evaluation.
8. Sample Size for the Training Set
The document explicitly states: "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." However, it does not provide the sample size for the training set used to develop the LVivo EF algorithm.
9. How the Ground Truth for the Training Set was Established
The document states that the clinical performance study data were "completely distinct from that used during training of the algorithm," but it does not describe how the ground truth for the training set was established. It implies that such a training process occurred ("training of the algorithm"), but details on its ground truth are not provided in this summary.
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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).
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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
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Indications for Use
Submission Number (if known)
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)
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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 Ultrasound22100 Bothell Everett HwyBothell, WA 98021-8431 |
|---|---|
| Contact Person: | Sudipta ChakrabartiSr. Regulatory Affairs SpecialistTEL: +1 (203) -213-6862sudipta.chakrabarti@philips.com |
| Secondary Contact: | Tamara DanielsSr. Regulatory Affairs ManagerTEL: +1 (203) -213-6862tamara.daniels@philips.com |
| Date Prepared: | October 26, 2023 |
-
- 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 |
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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 ●
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- 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
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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 UltrasoundSystemK203406, Philips Ultrasound – Lumify Diagnostic UltrasoundSystem |
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 | LumifyDiagnosticUltrasoundSystem K#Pending(Subject Device) | LumifyDiagnosticUltrasoundSystem K162549(PredicateDevice) | DiA LVivoSoftwareApplicationK210053(Reference Device) | Comparison/Discussion |
|---|---|---|---|---|
| Regulation Number | 892.1550 | 892.1550 | 892.2050 | Remains unchangedfrom predicateLumify UltrasoundSystem |
| Device ClassificationName | System, Imaging,Pulsed Doppler,Ultrasonic | System, Imaging,Pulsed Doppler,Ultrasonic | AutomatedRadiologicalImaging ProcessingSoftware | Remains unchanged |
| Device ClassificationPrimary ProductCode | IIIYN | IIIYN | IIQIH | Remains unchangedfrom predicateLumify UltrasoundSystemQIH is a secondaryproduct for subjectdevice |
| Feature Trade Name | Auto EFQuantification | Not ApplicableThis feature wasnot available withthis version | LVivo EF | LVivo softwareapplication has beenincorporated inLumify UltrasoundSystem as Auto EFQuantification |
| Scientific Technology | UltrasoundImaging | UltrasoundImaging | Relies onUltrasound imagingto perform theassessment | Remains unchangedfor the predicate andsimilar for thereference |
| Principles ofOperation (subjectAuto EFQuantificationFeature) | Lumify Auto EFQuantification isa software onlyfeature. The coresystem softwarearchitectureremains | Not ApplicableThis feature wasnot available withthis version | The LVivo platformis a software systemfor automatedanalysis ofultrasoundexaminations. | With Auto EFQuantification featurethe user is offered anautomatedmeasurement ofEjection Fraction(EF), End Diastolic |
| unchanged. This | Volume (EDV), and | |||
| Standard Feature | LumifyDiagnosticUltrasoundSystem K#Pending(Subject Device) | LumifyDiagnosticUltrasoundSystem K162549(PredicateDevice) | DiA LVivoSoftwareApplicationK210053(Reference Device) | Comparison/Discussion |
| additional featureis added in theCardiac preset ofthe Lumifysystem to assessleft ventricularfunction using a 4Chamber Apicalview of the heart.This featureprovidesautomated tracingof the LeftVentricular (LV)border andquantification ofEnd SystolicVolume (ESV)and End DiastolicVolumes (EDV)as well as theEjection Fraction(EF) for LVassessment. | End Systolic Volume(ESV). The Lumifyfeatures are a subsetof the LVivo platform | |||
| ArtificialIntelligence/MachineLearning | Auto EFQuantification, isa derivative of thepreviouslycleared LVivoEFmodule(K210053) thatenablesautomatedevaluation of enddiastolic volume(EDV), endsystolic volume(ESV) andEjection Fraction(EF) from theFour Chamber(4CH) apicalview. | Not ApplicableThis feature wasnot available withthis version | Automated analysisofechocardiographicexaminations isdone based onultrasound imagingdata by analyzingalready acquiredclip (cineloop). The imagingdata can beprovided in DICOMformat that includesrequired metadataor RGB formattogether withmetadata that isprovided throughsoftware API. Theglobal LV functionis evaluated fromtwo of the apicalviews: four- | The subject devicewith the automationof the Auto EFQuantificationfeature, the user isnow offeredmeasurementsincluding EjectionFraction (EF), EndDiastolic Volume(EDV) and EndSystolic Volume(ESV).The AL/MLfunctionality is samein the subject devicein comparison to thereference device. |
| Standard Feature | LumifyDiagnosticUltrasoundSystem K#Pending(Subject Device) | LumifyDiagnosticUltrasoundSystem K162549(PredicateDevice) | DiA LVivoSoftwareApplicationK210053(Reference Device) | Comparison/Discussion |
| Automation | Yes | Not ApplicableThis feature wasnot available withthis version | Yes | Same as the referencedevice (DiA LVivo) |
| Manual editing byuser capability | Yes | Not ApplicableThis feature wasnot available withthis version | Yes | Same as the referencedevice (DiA LVivo) |
| Automated ED andES frames selection | Yes | Not ApplicableThis feature wasnot available withthis version | Yes | Same as the referencedevice (DiA LVivo) |
| Volume calculationby Simson's methodof discs | Yes | Not ApplicableThis feature wasnot available withthis version | Yes | Same as the referencedevice (DiA LVivo) |
| EF resultspresentation | Displaying fullclip with bordertracking. Theresults forselected ED andES frames fordefault beat isdisplayed. | Not ApplicableThis feature wasnot available withthis version | Displaying full clipwith bordertracking. And tablewith results for eachcycle for selectedED & ES frames foreach beat. | Auto EF for Lumifydoes not have thetable with results foreach cycle. Onlyresults for ED & ESframes for defaultbeat is displayed. |
| Algorithm | Imagesegmentation forborder detectionand trackingincludesprocessing byneural network | Not ApplicableThis feature wasnot available withthis version | Image segmentationfor border detectionand trackingincludes processingby neural network | Same as referencedevice |
| Standard Feature | LumifyDiagnosticUltrasoundSystem K#Pending(Subject Device) | LumifyDiagnosticUltrasoundSystem K162549(PredicateDevice) | DiA LVivoSoftwareApplicationK210053(Reference Device) | Comparison/Discussion |
| Automated rejectionof false results | Yes | Not ApplicableThis feature wasnot available withthis version | Yes | Same as the referencedevice (DiA LVivo) |
| Transducers | L12-4S4-1C5-2Auto EF is onlyavailable on S4-1Transducer(Cardiac PhasedArray) | L12-4S4-1C5-2 | Cardiac PhasedArray | Auto EFQuantification featureis only available onS4-1 transducer |
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TRADITIONAL 510(k) SUMMARY
Philips Ultrasound Lumify Diagnostic Ultrasound System with Auto EF Quantification
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TRADITIONAL 510(k) SUMMARY Philips Ultrasound
Lumify Diagnostic Ultrasound System with Auto EF Quantification
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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
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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.
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| Variables | Values | N | % | Mean |
|---|---|---|---|---|
| Gender | Female | 23 | 29 | -- |
| Male | 57 | 71 | -- | |
| Age | 19 - 92 years | 80 | -- | 64 ± 14years |
| BMI | 15.9-43.0 | 74* | -- | 26.4 |
| LV Function | Normal orpreserved LVfunction | 30 | 37.5 | -- |
| Mild LVdysfunction | 13 | 16.25 | -- | |
| Moderate LVdysfunction | 20 | 25 | -- | |
| Severe LVdysfunction | 17 | 21.25 | -- | |
| Population disease distribution | Coronaryartery disease(CAD) | 34 | 42 | -- |
| LeftVentricularHypertrophy | 9 | 11 | -- | |
| Thickenedleaflet,Calcified orprostheticmitral valve | 19 | 24 | -- | |
| Moderate toSevere Mitralregurgitation | 7 | 9 | -- | |
| Normal LVFunction | 11 | 14 | -- |
The demographic distribution of the study population includes the following:
*BMI data were not available for 6 patients.
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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.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.