(127 days)
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.
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.
Acceptance Criteria and Device Performance for LVivo IQS
The LVivo IQS device was evaluated through two performance studies. Below is a summary of the acceptance criteria and the reported device performance, along with details of the studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Study | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Retrospective Study (Agreement with Experienced Sonographer) | Overall agreement of 75% between LVivo IQS results and quality tagging by experienced sonographers | Overall agreement between LVivo IQS and quality tagging by experienced sonographers was 81% |
| Prospective Study (POC Interns & Expert Echocardiologist) | a. 80% of saved Exams with image quality 3-5 (visual estimation) receive at least "Medium" image quality by LVivo IQS | a. In 90% of patients with image quality 3-5 (visual estimation), it was possible to obtain at least "Medium" quality score by LVivo IQS |
| b. 90% of these cases are clinically interpretable by expert echocardiologists | b. 93% of the above saved clips were clinically interpretable |
2. Sample Size and Data Provenance
Retrospective Study (Agreement with Experienced Sonographer):
- Sample Size (Test Set): 100 patient examinations (22,663 frames)
- Data Provenance: Data was "already acquired with different ultrasound devices and various cardiac pathologies." The document does not specify the country of origin.
- Retrospective/Prospective: Retrospective.
Prospective Study (POC Interns & Expert Echocardiologist):
- Sample Size (Test Set): 64 patients
- Data Provenance: Data acquired after using the LVivo IQS in real-time by POC interns in a POC environment. The document does not specify the country of origin.
- Retrospective/Prospective: Prospective.
3. Number of Experts and their Qualifications (Ground Truth for Test Set)
Retrospective Study:
- Number of Experts: Not explicitly stated, but refers to "experienced sonographer" (singular or plural not clear from the text, but implies a consensus or single expert for tagging each case).
- Qualifications: "experienced sonographer." No further details on years of experience or certification are provided.
Prospective Study:
- Number of Experts: At least one "expert echocardiologist."
- Qualifications: "expert echocardiologist." No further details on years of experience or certification are provided.
4. Adjudication Method for the Test Set
The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1) for either study.
- Retrospective Study: Implies a direct comparison of LVivo IQS results against "quality tagging by experienced sonographer," suggesting a single "expert" assessment served as the ground truth without further multi-reader adjudication.
- Prospective Study: The "clinical interpretability" was determined by an "expert echocardiologist," again suggesting single expert assessment rather than a multi-reader adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or performed according to the provided text. The studies focus on the performance of the LVivo IQS directly against expert assessment or clinical interpretability.
6. Standalone (Algorithm Only) Performance
Yes, standalone performance was done. The studies explicitly evaluate the LVivo IQS system's performance.
- The Retrospective Study directly compares the algorithm's output ("LVivo IQS results") with expert quality tagging.
- The Prospective Study assesses the "quality score by LVivo IQS" and the subsequent "clinical interpretability" of clips identified by the system as having sufficient quality.
7. Type of Ground Truth Used
- Retrospective Study: Expert Consensus/Tagging. The ground truth was established by "quality tagging by experienced sonographer(s)."
- Prospective Study: Expert Clinical Interpretability. The ground truth for clinical utility was established by "expert echocardiologist" interpreting the saved clips. Initial quality (3-5) was based on visual estimation, presumably by POC interns.
8. Sample Size for the Training Set
The document does not report the sample size for the training set. It only describes the validation/test sets for performance evaluation.
9. How the Ground Truth for the Training Set was Established
Given that the sample size for the training set is not reported, the method for establishing ground truth for the training set is also not described in the provided text.
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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) | SubmitterAddress: | George J. HattubMedicsense USA LLC291 Hillside AvenueSomerset, MA 02726ghattub@comcast.net |
|---|---|---|
| 1. (b) | ManufacturerAddress: | DiA Imaging Analysis LtdHaEnergia Street 77Beer-Sheva, Israel 8470912 |
| Mfg. Phone: | Tel.: +972 77 7648318 | |
| Contact Person: | Mrs. Michal Yaacobi | |
| Date: | December 20, 2022 | |
| 2. | Device &ClassificationName: | Medical Image Management and Processing System –classified as Class 2 QIH, Regulation Number 21 CFR 892.2050LVivo 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 aQuality Score in real time to the Left Ventricle from the 4 chamber apicalview of the heart. In addition, the LVivo IQS will be provided as a softwarecomponent to be integrated by another computer programmer into theirlegally marketed ultrasound imaging device. Essentially, the Algorithm andAPI, which is a module, will be a medical device accessory. The QIS Meterconcept is similar to the legally marketed Caption Guidance SoftwareDevice. |
| 5. | Indications forUse: | LVivo platform is intended for non-invasive processing of ultrasoundimages to detect, measure, and calculate relevant medical parameters ofstructures and function of patients with suspected disease. In addition, it hasthe ability to provide Quality Score feedback |
| 6. | Comparison ofTechnologicalCharacteristics: | With respect to technology and intended use, DiA's LVivo IQS issubstantially equivalent to its predicate devices. Based upon the outcomesfrom the risk analysis and Performance Testing Evaluation, DiA believesthat the extension of LVivo IQS module to the LVivo Software Applicationpredicate device does not raise additional safety of efficacy concerns. Thefollowing comparison table depicts the changes. |
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| Submitted Device | Predicate DeviceK210053 | |
|---|---|---|
| Features/ Characteristics | LVivo IQS as an addition tothe LVivo SoftwareApplication | LVivo SoftwareApplication |
| Product Code | same | QIH |
| Indication for Use | LVivo platform isintended for non-invasive processingof ultrasoundimages to detect,measure, andcalculate relevantmedical parameters ofstructures andfunction of patientswith suspecteddisease. In addition, it has theability to provide Quality Scorefeedback | LVivo platform is intendedfor non-invasiveprocessing of ultrasoundimages to detect,measure, andcalculate relevant medicalparameters of structuresand function of patientswith suspected disease. |
| Modules | LVivo IQS, LVivo EF, LVivoSG, LVivo SAX, LVivo RV &LVivo Bladder | LVivo EF, LVivo SG, LVivoSAX, LVivo RV & LVivoBladder |
| Automation | same | yes |
| Manual Adjustment | same | yes |
| Bi plane EF evaluation | same | yes |
| Simultaneous 2CH and4CH evaluation | same | yes |
| Off-line LV RV andBladder evaluation usingDICOM clips of anyvendor | same | yes |
| Automated ED and ESframes selection | same | yes |
| Manual editing by usercapability | same | yes |
| Visually confirmresults | same | yes |
| Automated rejectionof false results | same | yes |
| Volume calculationBy standardSimpson'smethod of discs for EF | same | yes |
| Volume\Area curvePresentation | same | yes |
| EF, Strain, SWM, RV,SAX, Bladder resultspresentation | same | yes |
| Enables presentationcardiac function resultsfor different cycle | same | yes |
| Algorithm | same | yes |
| Calculation speed | same | yes |
| Capability or a part of abigger package (device)for LV functionevaluation and Bladder | same | yes |
| Segmental LongitudinalStrain Measure | same | yes |
| Global LongitudinalStrain Measure | same | yes |
| Segmental wall motionevaluation | same | yes |
| Operating System | same | Windows/Linux(with Android optionfor 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 3-5by visual estimation it was possible to obtainat least “Medium” quality score by LVivo IQS |
| b. | 93% of the above saved clips were clinicallyinterpretable |
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.
§ 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).