(28 days)
Not Found
Yes
The device description mentions "automated analysis" of ultrasound examinations, and the performance study section describes a test set and analysis of metrics like sensitivity and specificity, which are common in evaluating AI/ML models for image analysis. While "AI" or "ML" are not explicitly stated, the context of automated image processing and performance evaluation strongly suggests the use of these technologies.
No
The device is described as a software system for automated analysis of ultrasound images to detect, measure, and calculate medical parameters. It does not exert any direct therapeutic action or intervention on the patient.
Yes
The "Intended Use / Indications for Use" states that the platform is intended for "detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease," which directly indicates a diagnostic purpose.
Yes
The device description explicitly states "The LVivo platform is a software system". It processes existing ultrasound images (DICOM movies) and does not include or require any specific hardware for its function beyond the input data.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The LVivo platform processes ultrasound images of the human body. It does not analyze biological specimens taken from the body.
- Intended Use: The intended use is "non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease." This is consistent with a medical image analysis device, not an IVD.
The device is clearly focused on analyzing medical images obtained non-invasively, which falls outside the scope of In Vitro Diagnostics.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease.
Product codes (comma separated list FDA assigned to the subject device)
OIH
Device Description
The LVivo platform is a software system for automated analysis of ultrasound examinations. Automated analysis of echocardiographic examinations is done using DICOM movies. The LVivo platform supports global and segmental evaluation of the left ventricle (LV) of the heart. The global LV function is evaluated from two of the apical views: four-chamber (4CH) and two-chamber (2CH) by ejection fraction (EF). The segmental LV function is done from three apical views 4CH, 2CH and three chamber (3CH) and supports wall motion evaluation and strain. The LVivo platform supports also global and segmental evaluation of the LV from the parasternal short axis (SAX) view. In addition to the LV analysis, the cardiology toolbox includes a module for automated evaluation of the Right Ventricular function. The LVivo platform includes one additional non-cardiac module for the measurement of the bladder volume.
Mentions image processing
Yes
Mentions AI, DNN, or ML
neural network
Input Imaging Modality
Ultrasound images
Anatomical Site
Left ventricle (LV) of the heart, Right Ventricular, Bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A data set of 100 ambulatory and hospitalized patients referred for routine transthoracic echocardiography was previously collected according to GCP standards. The population was comprised of 59% male, mean age of 60.6 +/- 17.727. Inclusion criteria: age >18 in sinus rhythm without multiple premature beats. Patients with LBBB were excluded from the study. 27 patients had normal LV and 47 patients had coronary artery disease (CAD) function. Total of 96 examinations were used for the EF analysis (due to missing ref).
For SWM and GLS analysis, a total of 98 examinations were used from the same data set (due to missing ref).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A summary of the Performance Evaluation, which was based upon well-established test methods, demonstrated conformity to the intended use.
Acceptance criteria for EF analysis: biplane EF correlation >=80%, similar or better EF biplane results in terms of correlation, specificity, sensitivity, and kappa with respect to subject device.
For GLS acceptance criteria: cutoff value =75% compared to ref WSMI, similar or better results compared to subject device.
For SWM acceptance criteria: Sensitivity >=75%, similar or better results compared to subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, Specificity, correlation, kappa
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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February 5, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
DiA Imaging Analysis Ltd. % Mr. George J. Hattub Senior Project Manager Medicsense USA 291 Hillside Avenue SOMERSET MA 02726
Re: K210053
Trade/Device Name: LVivo Software Application Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: OIH Dated: December 31, 2020 Received: January 8, 2021
Dear Mr. Hattub:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210053
Device Name LVivo Software Application
Indications for Use (Describe)
LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease.
| 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) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | Submitter Address: | George J. Hattub
Medicsense USA LLC
291 Hillside Avenue
Somerset, MA 02726
ghattub@comcast.net
https://www.upwork.com/freelancers/~0196e832ca4b82a2f3?viewMode=1 |
|--------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | Manufacturer Address: | DiA Imaging Analysis Ltd
HaEnergia Street 77
Beer-Sheva, Israel 8470912 |
| | Mfg. Phone: | Tel.: +972 77 7648318 |
| | Contact Person: | Mrs. Michal Yaacobi |
| | Date: | January 27, 2021 |
| 2. | Device &
Classification
Name: | Automated Radiological Imaging Processing Software - classified as Class 2
QIH, Regulation Number 21 CFR 892.2050
LVivo Software Application |
| 3. | Predicate Device: | K200232 LVivo Software Application |
| 4. | Description: | The LVivo platform is a software system for automated analysis of
ultrasound examinations. Automated analysis of echocardiographic
examinations is done using DICOM movies. The LVivo platform supports
global and segmental evaluation of the left ventricle (LV) of the heart. The
global LV function is evaluated from two of the apical views: four-chamber
(4CH) and two-chamber (2CH) by ejection fraction (EF). The segmental LV
function is done from three apical views 4CH, 2CH and three chamber
(3CH) and supports wall motion evaluation and strain. The LVivo platform
supports also global and segmental evaluation of the LV from the
parasternal short axis (SAX) view. In addition to the LV analysis, the
cardiology toolbox includes a module for automated evaluation of the Right
Ventricular function. The LVivo platform includes one additional non-cardiac
module for the measurement of the bladder volume. |
| 5. | Intended Use: | LVivo platform is intended for non-invasive processing of ultrasound images
to detect, measure, and calculate relevant medical parameters of structures
and function of patients with suspected disease |
| 6. | Comparison of
Technological
Characteristics: | With respect to technology and intended use, DiA's LVivo Software
Application is substantially equivalent to its predicate device. Based upon
the outcomes from the risk analysis and Performance Testing Evaluation,
DiA believes that the modification of the predicate device does not raise
additional safety of efficacy concerns. The following comparison table
depicts the changes. |
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| Submitted Device | Predicate Device | |
|---|---|---|
| Features/Characteristics | LVivo Software | |
| Application | LVivo Software | |
| Application | ||
| Product Code | same | QIH |
| Indication for Use | same | LVivo platform is |
| intended for non- | ||
| invasive processing of | ||
| ultrasound images to | ||
| detect, measure, and | ||
| calculate relevant | ||
| medical parameters of | ||
| structures and function | ||
| of patients with | ||
| suspected disease. | ||
| Modules | same | LVivo EF, LVivo SG, |
| LVivo SAX, LVivo RV & | ||
| LVivo Bladder | ||
| Automation | same | yes |
| Manual Adjustment | same | yes |
| Bi plane EF evaluation | same | yes |
| Simultaneous 2CH and | ||
| 4CH evaluation | same | yes |
| Off-line EF evaluation | ||
| using DICOM clips of any | ||
| vendor | same | yes |
| Automated ED and ES | ||
| frames selection | same | yes |
| Dynamic left ventricular | same | yes |
| Manual editing by | ||
| user capability | same | yes |
| Visually confirm EF | same | yes |
| Automated rejection | ||
| of false results | same | yes |
| Volume calculation by | ||
| standard Simpson's | ||
| method of discs | same | yes |
| Volume curve | ||
| Presentation | same | yes |
| EF results presentation | same | yes |
| Enables presentation EF | ||
| results for different | ||
| cycle | same | yes |
| Algorithm | Modified in LVivo EF | yes |
| Calculation speed | same | yes |
| Capability or a part of a | ||
| bigger package (device) | ||
| for LV function | same | yes |
| Segmental Longitudinal | ||
| Strain Measure | same | yes |
| Global Longitudinal | ||
| Strain Measure | same | yes |
| Segmental wall motion | ||
| evaluation | same | yes |
| Operating System | same | Windows/Linux |
| (with Android | ||
| option for LVivo | ||
| EF | ||
| 510(k) # | Pending | K200232 |
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510k Notification: LVivo Software Application
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7. Performance A summary of the Performance Evaluation, which was based upon well-Evaluation: established test methods, demonstrated conformity to the intended use.
A data set of 100 ambulatory and hospitalized patients referred for routine transthoracic echocardiography was previously collected according to GCP standards. The population was comprised of 59% male, mean age of 60.6 ±17.727. Inclusion criteria: age >18 in sinus rhythm without multiple premature beats. Patients with LBBB were excluded from the study. 27 patients had normal LV and 47 patients had coronary artery disease (CAD) function. Total of 96 examinations were used for the EF analysis (due to missing ref).
Acceptance criteria for EF analysis: biplane EF correlation >=80%, similar or better EF biplane results in terms of correlation, specificity, sensitivity, and kappa with respect to subject device.
For SWM and GLS analysis, a total of 98 examinations were used from the same data set (due to missing ref).
For GLS acceptance criteria: cutoff value =75% compared to ref WSMI, similar or better results compared to subject device
For SWM acceptance criteria: Sensitivity >=75%, similar or better results compared to subject device
-
- Conclusion: The Intended Use and the technological characteristics in the current device are the same as those in the predicate device, including the addition of the neural network, do not affect the safety and effectiveness of the device. The performance tests have been completed and successfully support the device performance. Therefore, DiA Imaging Analysis concludes the LVivo Software Application is substantially equivalent to the predicate device.