(70 days)
Yes
The device description explicitly states that the Lumify system software provides an Android-specific feature with artificial intelligence (AI) based, Auto EF Quantification technology during cardiac imaging.
No
The device is described as a "Diagnostic Ultrasound System" intended for "diagnostic ultrasound imaging" and "fluid flow analysis," without mention of any therapeutic function.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is a "Diagnostic Ultrasound System" and is "intended for diagnostic ultrasound imaging."
No
The device description explicitly lists hardware components beyond the COTS device, including USB transducers and cables, which are integral to the system's function of acquiring ultrasound data.
Based on the provided information, the Philips Lumify Diagnostic Ultrasound System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging" and "fluid flow analysis." These are procedures performed on the patient's body using external energy (ultrasound waves) to create images and assess physiological processes.
- Device Description: The device description details a system that acquires and displays ultrasound data. This involves interacting with the patient's body, not analyzing samples taken from the patient's body.
- Anatomical Site: The listed anatomical sites are all parts of the human body that are imaged externally or internally via a transducer, not biological samples.
- IVD Definition: An In Vitro Diagnostic (IVD) device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
The Philips Lumify system is a diagnostic imaging device that uses ultrasound technology to visualize internal structures and processes within the body. This falls under the category of in vivo diagnostics, not in vitro diagnostics.
No
The provided text does not contain any explicit language stating that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device. While it mentions AI/ML functionality, there is no direct reference to PCCP authorization.
Intended Use / 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 (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.
Product codes
IYN, IYO, ITX, QIH
Device Description
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. 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Mentions AI.
Input Imaging Modality
Ultrasound Imaging
Anatomical Site
Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung. Specifically for Auto EF Quantification: Left Ventricular (LV) from A4CH (apical four chamber) view.
Indicated Patient Age Range
19 - 92 years (for the dataset used in the clinical performance study).
Intended User / Care Setting
Healthcare professionals in environments where healthcare is provided.
Description of the training set, sample size, data source, and annotation protocol
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. Further details not found.
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Performance Study. No clinical investigation was 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.
Sample Size: 80 patients
Key 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%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficients (r), 95% Confidence Intervals (CI), and percentage of clips automatically processed.
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)
Automatic processing rate: 95% (76 out of 80 clips).
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found.
§ 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.
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)
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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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 |
-
- 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 ●
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.
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| 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.
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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.