(64 days)
Not Found
Yes
The document explicitly states "AI based" under the "Mentions AI, DNN, or ML" section.
No
Explanation: The device is intended for non-invasive processing of ultrasound images to detect, measure, and calculate medical parameters and provide quality score feedback. It does not directly treat or cure a disease; rather, it provides information for diagnosis and assessment.
No
The device is described as providing "Quality Score feedback" and being an "accessory" that generates a "Quality Score in real time." Its function is to assess the quality of ultrasound images, not to diagnose a disease or condition itself.
Yes
The device is described as a "software component to be integrated by another computer programmer into their legally marketed ultrasound imaging device," and is referred to as an "Algorithm and API, which is a module." This strongly indicates it is a software-only device intended to function within existing hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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 describes a device that analyzes images from the patient's body, not a device that analyzes samples from the patient's body (like blood, urine, tissue, etc.).
- Device Description: The device is described as a "software component to be integrated by another computer programmer into their legally marketed ultrasound imaging device." Ultrasound imaging devices are not IVDs.
- Input Imaging Modality: The input is "ultrasound images." IVDs typically analyze biological samples.
- Anatomical Site: The analysis is performed on the "Right Ventricle from the 4-chamber apical view of the heart," which is an anatomical structure within the patient's body.
- Performance Studies: The performance studies involve comparing the device's output to sonographer quality tagging, ACEP scores, and clinical interpretability of ultrasound clips. These are all related to the quality and analysis of medical images, not the analysis of biological samples.
In summary, the LVivo platform and its extension, the LVivo IQS, are designed to process and analyze medical images acquired from within the patient's body using ultrasound technology. This falls under the category of medical imaging analysis software, not in vitro diagnostics.
No
The provided text explicitly states "Not Found" for "Control Plan Authorized (PCCP) and relevant text," meaning there is no mention of FDA review, approval, or clearance of a PCCP for this 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. 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 IQS (K222970), as an additional Algorithm with API that will be able to provide a Quality Score in real time to the Right 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, is a medical device accessory.
Mentions image processing
Yes
Mentions AI, DNN, or ML
AI based
Input Imaging Modality
Ultrasound
Anatomical Site
Right Ventricle from the 4-chamber apical view of the heart
Indicated Patient Age Range
Age>18
Intended User / Care Setting
Not Found
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
-
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.
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. A total of 49,623 frames were analvzed. -
The performance of the LVivo IQS system was validated using data acquired after using the LVivo IQS in real time while scanning the RV from the 4CH apical view. The scans were acquired in the Point of Care environment by medical doctors in their internship. The obtained quality score was documented before saving the clip. The ACEP score (1-5) and the obtained quality score by LVivo IQS were documented.
182 patients were included in the study and the saved scans were analyzed. Inclusion criteria: Age >18, indication for POCUS, Exclusion criteria: subjects who fail to meet any inclusion criteria.
Summary of Performance Studies
- 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.
- Study type: Validation
- Sample size: 100 patient examinations, 49,623 frames
- Key results: The overall agreement of 77% between the LVivo IQS (RV) and quality tagging by the experienced sonographers was 77%.
- The performance of the LVivo IQS system was validated using data acquired after using the LVivo IQS in real time while scanning the RV from the 4CH apical view.
- Study type: Validation
- Sample size: 182 patients
- Key results:
a. In 85% 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. 92% of the above saved clips were clinically interpretable.
Key Metrics
- Overall agreement of 77% between the LVivo IQS (RV) and quality tagging by the experienced sonographers.
- 85% of patients with image quality 3-5 by visual estimation obtained at least "Medium" quality score by LVivo IQS.
- 92% of saved clips by LVivo IQS were clinically interpretable by the majority of three expert cardiologists.
Predicate Device(s)
LVivo IQS K222970
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
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 ADMINISTRATION" in blue.
DiA Imaging Analysis Ltd. % George Hattub Medical Device Regulatory Affairs Specialist Medicsense USA LLC 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K240769
May 24, 2024
Trade/Device Name: LVivo IOS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: May 3, 2024 Received: May 3, 2024
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 (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 OS 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 medical devices and radiation-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 DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
| Submission Number (if known) | |
|---|---|
| ------------------------------ | -- |
Device Name
LVivo IQS
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. 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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3
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: | March 19, 2024 |
| 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 IQS K222970 |
| 4. | Description: | The LVivio IQS is an extension to the LVivio IQS (K222970), as an
additional Algorithm with API that will be able to provide a Quality Score in
real time to the Right 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, is a medical device accessory. |
| 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 device. Based upon the outcomes
from the risk analysis and Performance Testing Evaluation, DiA believes
that the incremental extension of the LVivo IQS module to the LVivo IQS
predicate device does not raise additional safety of efficacy concerns. The
following comparison table depicts the changes. |
4
| # | Features/ Characteristics | Submitted Device | Predicate Device
K222970 |
|----|---------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | LVivo IQS | LVivo IQS |
| 1 | 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. In addition, it
provides Quality Index
Score Feedback. |
| 2 | Product Code | Same | QIH |
| 3 | LVivo IQS Module | LVivo IQS for LV from 4-
Chamber View
LVivo IQS for RV from 4-
Chamber View | LVivo IQS for LV from 4-
Chamber View |
| 4 | Operating System | Same | Ram: 8 GB
Windows 10 or higher
Processor: Intel core i3
compatible or higher |
| 5 | Automated IQS | Same | Yes |
| 6 | Algorithm | AI based | AI Based |
| 7 | Grading system ranges | Same | 0-60% poor (red),
60-80 % medium (orange)
80-100 % good (green) |
| 8 | I/O support through API | yes | yes |
| 9 | User group | same | same |
| 10 | 510(k) # | K240769 | K222970 |
5
-
- 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. A total of 49,623 frames were analvzed.
The overall agreement was agreement between the LVivo IQS (RV) and quality tagging by the experienced sonographers was 77%
- The performance of the LVivo IQS system was validated using data acquired after using the LVivo IQS in real time while scanning the RV from the 4CH apical view. The scans were acquired in the Point of Care environment by medical doctors in their internship. The obtained quality score was documented before saving the clip. The ACEP score (1-5) and the obtained quality score by LVivo IQS were documented.
Success criteria: a. 80% of the saved Exams with image quality ACEP score 3-5. received at least "Medium" image quality by LVivo IQS, b. 90% of these cases were clinically interpretable by the majority of three expert cardiologists specializing in echo.
182 patients were included in the study and the saved scans were analyzed. Inclusion criteria: Age >18, indication for POCUS, Exclusion criteria: subjects who fail to meet any inclusion criteria. The results are summarized in Table-1:
| End point number | Results |
|---|---|
| a. | In 85% 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. | 92% of the above saved clips were clinically |
| interpretable |
Table-1: Results summary
6
-
- Conclusion: The Intended Use and the technological characteristics of the subject device are the same as those in the LVivo IQS predicate device, and do not affect the safety and effectiveness of the device. The performance testing has been completed and has successfully verifed the performance of the device. Therefore, DiA Imaging Analysis concludes the LVivo IQS is substantially equivalent to the predicate device.