(125 days)
Yes
The device description mentions "automatically selects the adequate clips for EF and GLS evaluation" and "automatic evaluation" of EF and Strain. While AI/ML is not explicitly stated, the automated selection and evaluation of medical images are strong indicators of AI/ML technology being employed, especially in the context of modern medical image processing. The performance study also describes comparing the device's measurements to a predicate device that likely uses similar automated techniques.
No.
The device is intended for non-invasive processing of ultrasound images to detect, measure, and calculate medical parameters, which is a diagnostic function, not a therapeutic one.
Yes.
The device 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," which directly aligns with the definition of a diagnostic device.
Yes
The device is described as a "standalone application" that "runs offline on a server" and processes DICOM images from an ultrasound device. It does not mention any proprietary hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases or other conditions.
- Device Function: The LVivo platform processes ultrasound images. This is a non-invasive imaging technique that does not involve analyzing samples taken from the body.
- Intended Use: The intended use clearly states "non-invasive processing of ultrasound images".
Therefore, because the device operates on images acquired non-invasively rather than on biological samples, it falls outside the definition of an In Vitro Diagnostic device.
No
The provided text explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found," indicating no mention or approval of a PCCP in the clearance letter.
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 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 evaluation. The results are sent to the PACS and are evaluated by a healthcare professional.
Mentions image processing
LVivo platform is intended for non-invasive processing of ultrasound images
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
100 patient examinations were used for the validation. Inclusion criteria: Age>18, examinations in which GLS results by Automated Functional Imaging (AFI .GE) were available. No exclusion criteria were applied.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A summary of the Performance Evaluation, which was based upon well-established test methods, demonstrated conformity to the intended use. Success criteria:
- Correct identification of 4ch and 2ch and 3ch views in 90% of the examinations
- Correlation of 80% between GLS by AFI and GLS by LVivo Seamless
100 patient examinations were used for the validation. Inclusion criteria: Age>18, examinations in which GLS results by Automated Functional Imaging (AFI .GE) were available. No exclusion criteria were applied. The system was able to recognize all three 4CH, 2CH and 3CH clips in 95% of the examinations. The measurements by LVivo Strain running offline on the automatically selected clips were compared to the measurements done routinely in the Echo lab by AFI. The GLS by LVivo Strain was compared to GLS by AFI. Statistical analysis was done by Correlation, Bland-Altman:
Measurement: GLS
Accuracy (Mean±1.96STD): -1.4% ± 3.93%
Data Range: -4% - -24%
Correlation: 0.88
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity and specificity of 0.90, and 0.83 respectively. The Normal\Abnormal threshold used for GLS was -18%
Predicate Device(s)
Reference Device(s)
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
December 9, 2021
Image /page/0/Picture/1 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
DiA Imaging Analysis Ltd % George Hattub Senior Project Manager Medicsense USA 291 Hillside Avenue SOMERSET, MASSACHUSETTS 02726
Re: K212466
Trade/Device Name: LVivo Seamless v2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: November 8, 2021 Received: November 10, 2021
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
1
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,
For
Thalia T. Mills, Division Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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)
Device Name DiA LVivo Seamless
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 and Age >18.
Type of Use (Select one or both, as applicable)
X 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
https://www.upwork.com/freelancers/~0196e832ca4b82a2f3?viewMode=1 | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 7, 2021 | |
| 2. | Device &
Classification
Name: | Medical Image Management and Processing System -
classified as Class 2 QIH, Regulation Number 21 CFR 892.2050
LVivo Seamless | |
| 3. | Predicate Device: | K202546 LVivo Seamless (Reference Device K210053) | |
| 4. | 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
evaluation. The results are sent to the PACS and are evaluated by a
healthcare professional. | |
| 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 and Age>18 | |
| 6. | Comparison of
Technological
Characteristics: | 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. | |
| | Submitted Device | Predicate Device | Reference Device |
| Features/Characteristics | LVivo Seamless | LVivo Seamless | LVivo Software
Application |
| Product Code | same | QiH | QiH |
| Indication for Use | DiA's 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 | 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. | 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 EF, LVivo Strain | LVivo EF | LVivo EF, LVivo SG
(LVivo SWM & LVivo
Strain), LVivo SAX,
LVivo RV and LVivo
Bladder |
| Automation | same | yes | yes |
| Manual Adjustment | same | yes | yes |
| Bi plane EF evaluation | same | yes | yes |
| Simultaneous 2CH and
4CH evaluation | same | yes | yes |
| Off-line EF evaluation
using DICOM clips of any
vendor | same | yes | yes |
| Automated ED and ES
frames selection | same | yes | yes |
| Dynamic left ventricular | same | yes | yes |
| Manual editing by
user capability | Same, added editing
capabilities to the
output results | yes | yes |
| | | | |
| | | | |
| | | | |
| Visually confirm EF | same | yes | yes |
| Automated rejection of
false results | same | yes | yes |
| Volume calculation by
standard Simpson's
method of discs | same | yes | yes |
| Volume curve
calculation | same | yes | yes |
| EF results presentation | same | yes | yes |
| Enables calculation EF
results for different
cycle | same | yes | yes |
| Algorithm | same | same | yes |
| Calculation speed | same | yes | yes |
| Capability or a part of a
bigger package (device)
for LV function
evaluation | same | yes | yes |
| Segmental Longitudinal
Strain Measure | yes | no | yes |
| Global Longitudinal
Strain (GLS) Measure | yes | Yes (from LVivo
EF module) | yes |
| GLS calculation per view | yes | no | no |
| Operating System | Windows | Windows | Windows/Linux
(with Android
option for LVivo
EF) |
| 510(k) # | K212466 | K202546 | K210053 |
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5
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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. Success criteria:
-
Correct identification of 4ch and 2ch and 3ch views in 90% of the examinations
-
Correlation of 80% between GLS by AFI and GLS by LVivo Seamless
100 patient examinations were used for the validation. Inclusion criteria: Age>18, examinations in which GLS results by Automated Functional Imaging (AFI .GE) were available. No exclusion criteria were applied. The system was able to recognize all three 4CH, 2CH and 3CH clips in 95% of the examinations. The measurements by LVivo Strain running offline on the automatically selected clips were compared to the measurements done routinely in the Echo lab by AFI. The GLS by LVivo Strain was compared to GLS by AFI. Statistical analysis was done by Correlation, Bland-Altman:
| Measurement | Accuracy
(Mean±1.96STD) | Data Range | Correlation |
|-------------|----------------------------|------------|-------------|
| GLS | -1.4% ± 3.93% | -4% - -24% | 0.88 |
sensitivity and specificity and of 0.90, and 0.83 respectively. The Normal\Abnormal threshold used for GLS was -18%
-
- 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 GLS 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 Seamless is substantially equivalent to the predicate device.