(27 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.
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 evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF module which performs automatic evaluation. The results are sent to the PACS and are evaluated by a healthcare professional.
Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and the supporting study:
The provided document describes the LVivo Seamless device, a standalone application that extends the LVivo Platform for processing ultrasound images. The key function highlighted is the automatic selection of clips for EF (Ejection Fraction) evaluation and then applying the FDA-cleared LVivo EF module for automatic evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative, pass/fail format for the LVivo Seamless's performance relative to a specific metric. Instead, it relies on demonstrating substantial equivalence to a predicate device (K200232 LVivo Software Application). The performance evaluation is summarized as having "demonstrated conformity to intended use" based on "well-established test methods."
Therefore, I cannot populate a table with specific acceptance criteria and reported numerical performance for the LVivo Seamless itself. The performance is assessed by its similarity to the predicate and the general statement of conformity.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance Evaluation" based on "well-established test methods."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method used for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The focus is on the device's standalone performance in relation to the predicate.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance assessment was conducted for the LVivo Seamless. The description states: "The system accepts echo examinations in DICOM format that are sent from an Ultrasound device and automatically selects the adequate clips for EF evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF module which performs automatic evaluation." This indicates the algorithm's performance without direct human intervention in the interpretation process. The results are then sent to PACS for evaluation by a healthcare professional, implying the initial automated steps are standalone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used. Given the context of "EF evaluation" and "automatic evaluation," it's highly probable that the ground truth for the underlying LVivo EF module (which the LVivo Seamless activates) would have been established through expert consensus by cardiologists or sonographers reviewing and measuring Ejection Fraction on the ultrasound images. However, this is an inference and not explicitly stated for the LVivo Seamless's specific performance evaluation.
8. The sample size for the training set
The document does not specify the sample size for the training set.
9. How the ground truth for the training set was established
The document does not specify how the ground truth for the training set was established.
Summary of what's provided for LVivo Seamless (K202546):
The submission focuses heavily on demonstrating substantial equivalence to its predicate device (K200232 LVivo Software Application) based on technological characteristics and intended use. The performance evaluation is broadly stated as confirming conformity to intended use via "well-established test methods," rather than providing detailed quantitative results against specific acceptance criteria. A standalone performance was evaluated for the automated steps of clip selection and EF calculation. Details regarding sample sizes, data provenance, expert involvement, ground truth establishment methods, or MRMC studies are not provided in this specific FDA clearance document.
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September 29, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of a human figure, while the right side features the FDA acronym 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 MA 02726
Re: K202546
Trade/Device Name: LVivo Seamless Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QIH Dated: August 31, 2020 Received: September 2, 2020
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 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
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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 (QS) 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, Ph.D. 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) K202546
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.
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) | SubmitterAddress: | George J. HattubMedicsense USA LLC291 Hillside AvenueSomerset, MA 02726ghattub@comcast.nethttps://www.upwork.com/freelancers/~0196e832ca4b82a2f3?viewMode=1 |
|---|---|---|
| 1. (b) | ManufacturerAddress: | DiA Imaging Analysis LtdHaEnergia Street 77Beer-Sheva, Israel 8470912 |
| Mfg. Phone: | Tel.: +972 77 7648318 | |
| Contact Person: | Mrs. Michal Yaacobi | |
| Date: | September 21, 2020 | |
| 2. | Device &ClassificationName: | Automated Radiological Imaging Processing Software - classified as Class 2QIH, Regulation Number 21 CFR 892.2050LVivo Seamless |
| 3. | Predicate Device: | K200232 LVivo Software Application |
| 4.5. | Description:Intended Use: | The LVivo Seamless is a standalone application that extends the LVivoPlatform and runs offline on a server in a healthcare environment. Thesystem accepts echo examinations in DICOM format that are sent from anUltrasound device and automatically selects the adequate clips for EFevaluation. After the clip selection, the LVivo Seamless activates the FDAcleared LVivo EF module which performs automatic evaluation. The resultsare sent to the PACS and are evaluated by a healthcare professional.LVivo platform is intended for non-invasive processing of ultrasound images |
| to detect, measure, and calculate relevant medical parameters of structuresand function of patients with suspected disease | ||
| 6. | Comparison ofTechnologicalCharacteristics: | With respect to technology and intended use, DiA's LVivo Seamless issubstantially equivalent to its predicate device. Based upon the outcomesfrom the risk analysis and Performance Testing Evaluation, DiA believesthat the modification of the predicate device does not raise additional safetyof efficacy concerns. The following comparison table depicts the changes |
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| Submitted Device | Predicate Device | |
|---|---|---|
| Features/Characteristics | LVivo Seamless | LVivo SoftwareApplication |
| Product Code | QiH | QIH |
| Indication for Use | LVivo platform isintended for non-invasive processing ofultrasound images todetect, measure, andcalculate relevantmedical parameters ofstructures and functionof patients withsuspected disease. | LVivo platform isintended for non-invasive processing ofultrasound images todetect, measure, andcalculate relevantmedical parameters ofstructures and functionof patients withsuspected disease. |
| Modules | LVivo EF | LVivo EF, LVivo SG,LVivo SAX, LVivo RV &LVivo Bladder |
| Automation | same | yes |
| Manual Adjustment | no | yes |
| Bi plane EF evaluation | same | yes |
| Simultaneous 2CH and4CH evaluation | same | yes |
| Off-line EF evaluationusing DICOM clips of anyvendor | same | yes |
| Automated ED and ESframes selection | same | yes |
| Dynamic left ventricular | no | yes |
| Manual editing byuser capability | no | yes |
| Visually confirm EF | same | yes |
| Automated rejectionof false results | same | yes |
| Volume calculation bystandard Simpson'smethod of discs | same | yes |
| Volume curvePresentation | no | yes |
| EF results presentation | same | yes |
| Enables presentation EFresults for differentcycle | Same results arepresented for thedefault beats | yes |
| Algorithm | same | yes |
| Calculation speed | same | yes |
| Capability or a part of abigger package (device)for LV function | same | yes |
| Segmental LongitudinalStrain Measure | no | yes |
| Global LongitudinalStrain Measure | same | yes |
| Segmental wall motionevaluation | no | yes |
| Operating System | same | Windows/Linux(with Androidoption for LVivoEF |
| 510(k) # | Pending | K200232 |
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Performance Evaluation: A summary of the Performances Evaluation, which was based upon well-established test methods, demonstrated conformity to intended use.
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Conclusion: The Intended Use and the technological characteristics in the current device are the same as those in the predicate device, and the minor changes from the predicate device, including the offline application in the institutional server and changes in the user input on the final images, 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 that LVivo Seamless software 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).