(127 days)
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Unknown
The summary mentions "Algorithm" and "processing of ultrasound images" but does not explicitly state the use of AI or ML. While image processing algorithms can sometimes incorporate AI/ML, there is no direct evidence in this summary to confirm it. The lack of mention of training or test sets specifically for AI/ML models further contributes to the uncertainty.
No.
The device is intended for image processing and providing quality scores for ultrasound images, not for treating or preventing disease.
No
The device processes ultrasound images to detect, measure, and calculate medical parameters and provides "Quality Score feedback" for real-time ultrasound scanning. It is an "additional Algorithm with API that will be able to provide a Quality Score in real time to the Left Ventricle". While it processes medical images for relevant parameters, its primary stated function is to provide a quality score and feedback on image acquisition, rather than directly diagnosing a disease or condition. It is described as a medical device accessory intended to be integrated into other legally marketed ultrasound imaging devices. It aids in data acquisition quality, which might indirectly support diagnosis, but it does not perform the diagnosis itself.
Yes
The device description explicitly states that the LVivo IQS is a "software component to be integrated by another computer programmer into their legally marketed ultrasound imaging device." It is described as an "Algorithm and API, which is a module," and a "medical device accessory" that is software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The LVivo platform and its IQS component are described as processing ultrasound images to detect, measure, and calculate medical parameters. This is a non-invasive process that analyzes images generated by an external device (the ultrasound machine), not specimens taken from the body.
- Intended Use: The intended use is focused on processing images for information related to structures and function, and providing quality feedback on those images. This is distinct from analyzing biological samples.
The device is clearly described as a software component that processes imaging data, which falls under the category of medical imaging software or image analysis software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
L Vivo 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. In addition, it has the ability to provide Quality Score feedback.
Product codes
QIH
Device Description
The LVivio IQS is an extension to the LVivio Software Application (K210053), as an additional Algorithm with API that will be able to provide a Quality Score in real time to the Left Ventricle from the 4 chamber apical view of the heart. In addition, the LVivo IQS will be provided as a software component to be integrated by another computer programmer into their legally marketed ultrasound imaging device. Essentially, the Algorithm and API, which is a module, will be a medical device accessory. The QIS Meter concept is similar to the legally marketed Caption Guidance Software Device.
Mentions image processing
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.
Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasound
Anatomical Site
Left Ventricle from the 4 chamber apical view of the heart.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
- 100 patient examinations were used for the validation. Inclusion criteria: Age>18, patients referred to routine Echo examination. Exclusion criteria: Subjects who fail to meet any inclusion criteria. Total of 22,663 frames were analvzed. The overall agreement was agreement between the LVivo IQS and quality tagging by the experienced sonographers was 81%.
- 64 patients were included in the study and the saved scans were analyzed. Inclusion criteria: Age >=18. indication for POCUS, image quality 3-5 according to ACEP Guidelines, Exclusion criteria: subjects who fail to meet any inclusion criteria, image quality 1-2 according to ACEP Guidelines.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
Study Type: Performance evaluation. The performance of the LVivo IQS system was validated using already data acquired with different ultrasound devices and various cardiac pathologies, compared to quality tagging by experienced sonographer.
Sample Size: 100 patient examinations, 22,663 frames.
Key Results: The overall agreement between the LVivo IQS and quality tagging by the experienced sonographers was 81%. -
Study Type: Performance evaluation. The performance of the LVivo IQS system was validated using data acquired after using the LVivo IQS in real time while scanning the LV from the 4CH apical view. The scans were done by POC interns in POC environment. The obtained quality score before saving a clip was recorded.
Sample Size: 64 patients.
Key Results:
a. In 90% of the patients with image quality 3-5 by visual estimation it was possible to obtain at least “Medium” quality score by LVivo IQS.
b. 93% of the above saved clips were clinically interpretable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/0 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.
DiA Imaging Analysis Ltd. % George Hattub Senior Project Manager Medicsense USA LLC 291 Hillside Avenue SOMERSET MA 02726
February 1, 2023
Re: K222970
Trade/Device Name: LVivo IQS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: December 20, 2022 Received: December 21, 2022
Dear George 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: 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
Enclosure
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Indications for Use
510(k) Number (if known) K222970
Device Name LVivo IOS
Indications for Use (Describe)
L Vivo 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. In addition, it has the ability to provide Quality Score feedback.
Type of Use (Select one or both, as applicable)
| ❌ 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 |
|--------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | December 20, 2022 |
| 2. | Device &
Classification
Name: | Medical Image Management and Processing System –
classified as Class 2 QIH, Regulation Number 21 CFR 892.2050
LVivo IQS |
| 3. | Predicate Devices: | LVivo Software Application K210053 |
| 4. | Description: | The LVivio IQS is an extension to the LVivio Software Application
(K210053), as an additional Algorithm with API that will be able to provide a
Quality Score in real time to the Left Ventricle from the 4 chamber apical
view of the heart. In addition, the LVivo IQS will be provided as a software
component to be integrated by another computer programmer into their
legally marketed ultrasound imaging device. Essentially, the Algorithm and
API, which is a module, will be a medical device accessory. The QIS Meter
concept is similar to the legally marketed Caption Guidance Software
Device. |
| 5. | 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. In addition, it has
the ability to provide Quality Score feedback |
| 6. | Comparison of
Technological
Characteristics: | With respect to technology and intended use, DiA's LVivo IQS is
substantially equivalent to its predicate devices. Based upon the outcomes
from the risk analysis and Performance Testing Evaluation, DiA believes
that the extension of LVivo IQS module to the LVivo Software Application
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
K210053 |
|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features/ Characteristics | LVivo IQS as an addition to
the LVivo Software
Application | LVivo Software
Application |
| Product Code | same | QIH |
| Indication 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. In addition, it has the
ability to provide Quality Score
feedback | 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 | LVivo IQS, LVivo EF, LVivo
SG, LVivo SAX, LVivo RV &
LVivo Bladder | 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 LV RV and
Bladder evaluation using
DICOM clips of any
vendor | same | yes |
| Automated ED and ES
frames selection | same | yes |
| Manual editing by user
capability | same | yes |
| Visually confirm
results | same | yes |
| Automated rejection
of false results | same | yes |
| Volume calculation
By standard
Simpson's
method of discs for EF | same | yes |
| Volume\Area curve
Presentation | same | yes |
| EF, Strain, SWM, RV,
SAX, Bladder results
presentation | same | yes |
| Enables presentation
cardiac function results
for different cycle | same | yes |
| Algorithm | same | yes |
| Calculation speed | same | yes |
| Capability or a part of a
bigger package (device)
for LV function
evaluation and Bladder | 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) |
| Quality score feedback | Yes | No |
| 510(k) # | Pending | K219953 |
510k Notification: LVivo IQS
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-
- Performance A summary of the Performance Evaluation, which was based upon well-Evaluation: established test methods, demonstrated conformity to the intended use:
- The performance of the LVivo IQS system was validated using already data acquired with different ultrasound devices and various cardiac pathologies, compared to quality tagging by experienced sonographer.
Success criteria:
Overall agreement of 75% between the LVivo IQS results and the data tagging by experienced sonographers
100 patient examinations were used for the validation. Inclusion criteria: Age>18, patients referred to routine Echo examination. Exclusion criteria: Subjects who fail to meet any inclusion criteria. Total of 22,663 frames were analvzed.
The overall agreement was agreement between the LVivo IQS and quality tagging by the experienced sonographers was 81%
- The performance of the LVivo IQS system was validated using data acquired after using the LVivo IQS in real time while scanning the LV from the 4CH apical view. The scans were done by POC interns in POC environment. The obtained quality score before saving a clip was recorded.
Success criteria: a. 80% of the saved Exams with image quality 3-5 by visual estimation, received at least "Medium" image quality by LVivo IQS. b. 90% of these cases are clinically interpretable by expert echocardiologist
64 patients were included in the study and the saved scans were analyzed. Inclusion criteria: Age ≥18. indication for POCUS, image quality 3-5 according to ACEP Guidelines, Exclusion criteria: subjects who fail to meet any inclusion criteria, image quality 1-2 according to ACEP Guidelines. The results are summarized in Table-1:
| End point number | Results |
|---|---|
| a. | In 90% of the patients with image quality 3-5 |
| by visual estimation it was possible to obtain | |
| at least “Medium” quality score by LVivo IQS | |
| b. | 93% of the above saved clips were clinically |
| interpretable |
Table-1: Results summary
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-
- Conclusion: The Intended Use and the technological characteristics in the current device are the same as those in the LVivo software application predicate device, including the addition of the IQS Module, 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 IQS is substantially equivalent to the predicate device.