(133 days)
Not Found.
Yes
The device description mentions "automatically selects the adequate clips for EF and GLS evaluation" and "activates the FDA cleared LVivo EF and LVivo Strain modules which perform automatic EF and Strain evaluation". While not explicitly stating "AI" or "ML", the automated selection and evaluation of complex medical parameters from images strongly suggests the use of advanced algorithms, likely including AI/ML, for image analysis and feature extraction. The performance study also focuses on the accuracy of these automated processes.
No.
The device is intended for non-invasive processing of ultrasound images to detect, measure, and calculate medical parameters. It does not exert any direct therapeutic action or deliver therapy to the patient. It focuses on diagnostic evaluation rather than treatment.
Yes
The device detects, measures, and calculates relevant medical parameters of structures and function of patients with suspected disease, which are all characteristics of a diagnostic device.
Yes
The device description explicitly states it is a "standalone application that extends the LVivo Platform and runs offline on a server in a healthcare environment." It processes DICOM images received from an ultrasound device and utilizes other FDA-cleared software modules. There is no mention of any hardware component being part of the submitted device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The LVivo platform processes ultrasound images, which are generated externally and are not biological samples.
- The intended use is image processing for medical parameters: The description clearly states the device is for "non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters." This is characteristic of medical image analysis software, not an IVD.
Therefore, while this device is a medical device used in a healthcare setting, it falls under the category of medical image analysis software rather than an In Vitro Diagnostic.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
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 of patients and Age >18.
Product codes
QIH
Device Description
The LVivo Seamless is a standalone application that extends the LVivo Platform and runs offline on a server in a healthcare environment. The system accepts echo examinations in DICOM format that are sent from an Ultrasound device and automatically selects the adequate clips for EF and GLS evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF and LVivo Strain modules which perform automatic EF and Strain evaluation or EF and Strain analysis by FDA cleared 3rd party software. The results are sent to the PACS and are evaluated by a healthcare professional.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found.
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
Total of 166 examinations were included in the validation: 71 exams acquired with EPIQ (Philips Healthcare). Age 61.0 ± 16.3, 53.5% male. BMI was 29.7 ± 6.6. 62.0% of the patients in this dataset were Black or African American. LV function was Normal in 64.8%. 7.0% of the patients had Mild LV dysfunction, 14.1% had Moderate LV dysfunction and 14.1% of the patients had severe LV dysfunction.
96 acquired with Vivid E95(74%), Vivid S70(12.5%), Vivid E9 (12%) (GE Healthcare). Average age was 64 ± 17 ranging from 25 to 92, 59% male. 51 patients (53%) had Normal LV systolic function, 45 patients (47%) had impaired LV function (21% severely impaired, 15% moderately impaired and 11% mildly impaired). For 90 patients (94%) BMI measurements were available and the average BMI was 26.6± 4.9, ranging from 17.8 to 45.4.
The analysis (e.g Pearson's Correlation and Bland Altman) results are provided for 139 exams (84%) in which the system correctly identified 4, 2 and 3 chamber views.
Summary of Performance Studies
Performance Evaluation: The agreement between the device's output and the ground truth is comparable to the predicate device. A summary of the Performance Evaluation, which was based upon well-established test methods, demonstrated conformity to the intended use.
Success criteria:
- 85% of the exams will be processed automatically based on correctly identified 4 chamber, 2 chamber and 3 chamber views
- 80% correlation between the Ground Truth Biplane EF measurements and automated Biplane EF results.
- 80% correlation between Ground Truth GLS measurements and automated GLS results
Key Metrics
Biplane EF: Pearson's Correlation (r) 0.95
GLS: Pearson's Correlation (r) 0.92
Predicate Device(s)
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
March 6, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "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: K243331
Trade/Device Name: LVivo Seamless Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: February 13, 2025 Received: February 13, 2025
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.
1
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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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
2
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,
Samul for
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
LVivo Seamless
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 of patients and Age >18.
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
K243331
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
-
- (a) Submitter George J. Hattub Address: Medicsense USA LLC 291 Hillside Avenue Somerset, MA 02726 ghattub@comcast.net 1. (b) Manufacturer DiA Imaging Analysis Ltd Address: HaEnergia Street 77 Beer-Sheva, Israel 8470912 Mfg. Phone: Tel.: +972 77 7648318 Contact Person: Mrs. Michal Yaacobi Date: March 6, 2025 Device & Medical Image Management and Processing System -2. Classification classified as Class 2 QIH, Regulation Number 21 CFR 892.2050 Name: LVivo Seamless Predicate Device: K212466 LVivo Seamless 3. The LVivo Seamless is a standalone application that extends the LVivo 4. Description: Platform and runs offline on a server in a healthcare environment. The system accepts echo examinations in DICOM format that are sent from an Ultrasound device and automatically selects the adequate clips for EF and GLS evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF and LVivo Strain modules which perform automatic EF and Strain evaluation or EF and Strain analysis by FDA cleared 30d party software. The results are sent to the PACS and are evaluated by a healthcare professional. 5. Indications for LVivo platform is intended for non-invasive processing of ultrasound images Use: to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease and Age>18. 6. Comparison of The difference between the subject device and the predicate device is that Technological in addition to the ability to use LVivo EF and LVivo Strain for automated EF Characteristics: and Strain analysis, it is now includes the ability to use Automated EF and automated Strain analysis by another FDA cleared 3rd party software. With respect to technology and intended use. DiA's LVivo Seamless 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.
5
| Submitted Device | Predicate Device | |
|---|---|---|
| Features/Characteristics | LVivo Seamless | LVivo Seamless |
| 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 and Age |
- | 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
and Age >18. |
| Modules | same | LVivo EF and LVivo Strain |
| 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
Manual editing by
user capability | 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
calculation | same | yes |
| EF results presentation | same | yes |
| Enables calculation EF
results for different
cycle | same | yes |
| Algorithm | same | same |
| Calculation speed | same | yes |
| Capability or a part of a
bigger package
(device) for LV function
evaluation | same | yes |
| Segmental Longitudinal
Strain Measure | yes | yes |
| Global Longitudinal
Strain (GLS) Measure | yes | yes |
| Operating System | Windows | Windows |
| Ability to activate 3rd
party Auto EF and
Auto Strain
applications (TOMTEC) | yes | No |
| 510(k) # | K242331 | K212466 |
6
7
| 7. | Performance
Evaluation: | The agreement between the device's output and the ground truth is
comparable to the predicate device. A summary of the Performance
Evaluation, which was based upon well-established test methods,
demonstrated conformity to the intended use.
Success criteria: |
| ---- | ---------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
-
- 85% of the exams will be processed automatically based on correctly identified 4 chamber, 2 chamber and 3 chamber views
-
- 80% correlation between the Ground Truth Biplane EF measurements and automated Biplane EF results.
-
- 80% correlation between Ground Truth GLS measurements and automated GLS results
Total of 166 examinations were included in the validation: 71 exams acquired with EPIQ (Philips Healthcare). Age 61.0 ± 16.3, 53.5% male. BMI was 29.7 ± 6.6. 62.0% of the patients in this dataset were Black or African American. LV function was Normal in 64.8%. 7.0% of the patients had Mild LV dysfunction, 14.1% had Moderate LV dysfunction and 14.1% of the patients had severe LV dysfunction.
96 acquired with Vivid E95(74%), Vivid S70(12.5%), Vivid E9 (12%) (GE Healthcare). Average age was 64 ± 17 ranging from 25 to 92, 59% male. 51 patients (53%) had Normal LV systolic function, 45 patients (47%) had impaired LV function (21% severely impaired, 15% moderately impaired and 11% mildly impaired). For 90 patients (94%) BMI measurements were available and the average BMI was 26.6± 4.9, ranging from 17.8 to 45.4.
The analysis (e.g Pearson's Correlation and Bland Altman) results are provided for 139 exams (84%) in which the system correctly identified 4, 2
| Measurement | Bland Altman: Mean,
(LOA) (% points) | Data Range (%
points) | Pearson's
Correlation (r) |
|-------------|-----------------------------------------|--------------------------|------------------------------|
| Biplane EF | 1.22, (-8.49, 10.93) | 8.8 - 73.6 | 0.95 |
| GLS | -1.27 (-5.16, 2.62) | -3.35 - -25.41 | 0.92 |
and 3 chamber views:
- 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 ability to run TomTec Auto EF and Strain, 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 Seamless is substantially equivalent to the predicate device.