Who is the manufacturer of LVivo IQS?

Dia Imaging Analysis, Ltd. filed the 510(k) submission for LVivo IQS (K240769).

What is the FDA product code for LVivo IQS?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for LVivo IQS?

510(k) clearance (submission type: Special).

Does LVivo IQS use AI or machine learning?

Yes. LVivo IQS (K240769) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like LVivo IQS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like LVivo IQS get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

LVivo IQS

K240769 · Dia Imaging Analysis, Ltd. · QIH · May 24, 2024 · Radiology

Device Facts

Record ID	K240769
Device Name	LVivo IQS
Applicant	Dia Imaging Analysis, Ltd.
Product Code	QIH · Radiology
Decision Date	May 24, 2024
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

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. In addition, it has the ability to provide Quality Score feedback.

Device Story

LVivo IQS is a software-based medical device accessory that processes ultrasound images to provide real-time quality score feedback for the right ventricle (RV) from 4-chamber apical views. It functions as an extension to the predicate LVivo IQS (K222970), integrating via API into third-party ultrasound imaging systems. The device uses AI-based algorithms to analyze image quality, grading it as poor (0-60%), medium (60-80%), or good (80-100%). It is intended for use in clinical environments, including point-of-care (POCUS) settings, by medical professionals. By providing automated quality assessment, the device assists clinicians in ensuring images are clinically interpretable, potentially improving diagnostic accuracy and workflow efficiency during cardiac ultrasound examinations.

Clinical Evidence

Validation included two studies. Study 1: 100 patients (>18 years), 49,623 frames analyzed; compared LVivo IQS results to expert sonographer tagging, achieving 77% overall agreement (success criteria 75%). Study 2: 182 patients (POCUS environment); evaluated real-time RV scanning. Results: 85% of exams with ACEP scores 3-5 received at least 'Medium' quality scores (success criteria 80%); 92% of these clips were clinically interpretable by expert cardiologists (success criteria 90%).

Technological Characteristics

Software-based module; AI-based algorithm; operates on Windows 10 or higher (min 8GB RAM, Intel Core i3 or higher); provides I/O support via API for integration into ultrasound systems; provides quality index feedback (0-100% scale).

Indications for Use

Indicated for patients >18 years old undergoing routine echocardiography or POCUS examinations for suspected cardiac disease. Used to process ultrasound images to detect, measure, and calculate cardiac parameters and provide image quality feedback.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

LVivo IQS (K222970)

Related Devices

K222970 — LVivo IQS · Dia Imaging Analysis, Ltd. · Feb 1, 2023
K240953 — AI Platform 2.0 (AIP002) · Exo Imaging · Aug 5, 2024
K200755 — Caption Guidance · Caption Health · Apr 16, 2020
K260217 — AI Platform 2.2 (AIP002) · Exo Imaging · Feb 24, 2026
K243065 — Cardiac Guidance · Caption Health, Inc. · Jan 15, 2025

Submission Summary (Full Text)

{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) | | |------------------------------|--| |------------------------------|--| K240769 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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}------------------------------------------------ - 7. Performance A summary of the Performance Evaluation, which was based upon well-Evaluation: established test methods, demonstrated conformity to the intended use: 1. 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% 2. 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}------------------------------------------------ - 8. 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.