(265 days)
Yes
The device description explicitly states that it uses a "machine learning algorithm" to generate semi-automatic segmentations.
No.
The device is described as an "aid in diagnostic review and analysis of echocardiographic data" and provides an "automated estimation of LVEF" to "assist the clinician in a cardiac evaluation," but it does not directly treat or prevent a disease or condition. It is a diagnostic support tool.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device "can be used to assist the clinician in a cardiac evaluation," and the "Device Description" section states it is "intended as an aid in diagnostic review and analysis of echocardiographic data."
Yes
The device description explicitly states "InVision Precision LVEF is a software as a medical device (SaMD)". It processes previously acquired images and interfaces with existing hardware (ultrasound device, PC, PACS) but is not described as including any hardware components itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics 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 InVision Precision LVEF software processes previously acquired cardiac ultrasound images. It does not interact with or analyze any biological samples.
The device is a software tool that aids in the interpretation and measurement of medical images, specifically for estimating Left Ventricular Ejection Fraction (LVEF) from echocardiograms. This falls under the category of medical image analysis software, not In Vitro Diagnostics.
No
The input clearly states "PCCP and relevant text: Not Found", meaning the letter does not confirm PССР approval or clearance.
Intended Use / Indications for Use
InVision Precision LVEF is used to process previously acquired trans thoracic cardiac ultrasound images, and manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM compliant PACS system to provide an automated estimation of LVEF. This measurement can be used to assist the clinician in a cardiac evaluation. In Vision Precision is indicated for use in patients 22 years and older by sonographers and physicians evaluating cardiac ultrasound.
Product codes
QIH
Device Description
InVision Precision LVEF is a software as a medical device (SaMD), manufactured by InVision Medical Technology Corporation, intended as an aid in diagnostic review and analysis of echocardiographic data, including the evaluation of left ventricular ejection fraction (LVEF) in cardiovascular ultrasound images in DICOM format.
The software interfaces with data files uploaded to a PACS by any ultrasound or data collection equipment. It selects a set of echocardiogram videos of the correct view and generates semi-automatic segmentations of the left ventricle using a machine learning algorithm to form the basis for the calculator of the LVEF output. The analysis results are visualized by the clinician's integrated image view application as adjustable annotations. The user has the option to modify the semi-automatic segmentations suggested by the software. The EF calculation is updated in real-time with the user's modification of the segmentation. A cardiologist can adjust the annotations and the downstream measurement of LVEF prior to finalization.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac / Left Ventricle
Indicated Patient Age Range
22 years and older
Intended User / Care Setting
Sonographers and physicians evaluating cardiac ultrasound. The software interfaces with data files uploaded to a PACS.
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
Images and cases used for verification and validation testing were separate and carefully segregated from training datasets. A retrospective, multicenter study was designed to evaluate the capability of the Precision machine learning model in calculating LVEF against ground truth. A variety of imaging equipment manufacturers included Philips, GE and Siemens were used for the input data.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Retrospective, multicenter study.
Sample Size: Not specified.
Key Results: The average RMSD (Root Mean Square Deviation) for the device's biplane view was around 6.06, for A4C view was 6.17, for A2C view was 7.12. The Dice score for A4C segmentation was 0.89 and for A2C segmentation was 0.90. Data analysis of subgroups included race/ ethnicity, age, gender, BMI, imaging site and equipment, and ejection fraction values. The Precision device met all endpoints.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
RMSD (Root Mean Square Deviation), Dice score.
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).
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Image /page/0/Picture/0 description: The image shows 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.
InVision Medical Technology Corporation Golnaz Moeini Regulatory and Strategy Consultant 9702 Cisco St. Los Angeles, CA 90034
Re: K232331
April 25, 2024
Trade/Device Name: InVision Precision LVEF (LVEF) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: March 27, 2024 Received: March 27, 2024
Dear Golnaz Moeini:
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).
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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 QS 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 Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K232331
Device Name InVision Precision LVEF (LVEF)
Indications for Use (Describe)
In Vision Precision LVEF is used to process previously acquired trans thoracic cardiac ultrasound images, and manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM compliant PACS system to provide an automated estimation of LVEF. This measurement can be used to assist the clinician in a cardiac evaluation. In Vision Precision is indicated for use in patients 22 years and older by sonographers and physicians evaluating cardiac ultrasound.
| 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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Image /page/3/Picture/1 description: The image contains the logo for InVision Medical Technology. The logo features a stylized heart shape at the top, formed by interconnected lines in a teal color, resembling a circuit or network. Below the heart shape, the word "InVision" is written in a bold, blue font. Underneath "InVision", the words "Medical Technology" are written in a smaller, lighter font, also in blue.
510(k) Summary
Correspondent Information
InVision Medical Technology Corporation % Golnaz Moeini MedEdge Consulting Email: golnaz.moeini@gmail.com Phone: (408) 504-3187 Date prepared: March 27, 2024
Device
| Proprietary name: | InVision Precision LVEF (LVEF) |
|---|---|
| Common name: | InVision Precision |
| Classification name: | Medical image management and processing system |
| Regulation: | 21 CFR 892.2050 |
| Regulatory class: | II |
| Product code: | QIH Automated Radiological Image Processing Software |
Predicate Device
Caption Interpretation Automated Ejection Fraction, K210747.
Device Description
InVision Precision LVEF is a software as a medical device (SaMD), manufactured by InVision Medical Technology Corporation, intended as an aid in diagnostic review and analysis of echocardiographic data, including the evaluation of left ventricular ejection fraction (LVEF) in cardiovascular ultrasound images in DICOM format.
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Image /page/4/Picture/0 description: The image contains the logo for InVision Medical Technology. The logo features a stylized heart shape constructed from interconnected teal lines, suggesting a modern and technological approach to healthcare. Below the heart is the company name, "InVision," in a bold, sans-serif font, with the words "Medical Technology" in a smaller font size underneath.
The software interfaces with data files uploaded to a PACS by any ultrasound or data collection equipment. It selects a set of echocardiogram videos of the correct view and generates semi-automatic segmentations of the left ventricle using a machine learning algorithm to form the basis for the calculator of the LVEF output. The analysis results are visualized by the clinician's integrated image view application as adjustable annotations. The user has the option to modify the semi-automatic segmentations suggested by the software. The EF calculation is updated in real-time with the user's modification of the segmentation. A cardiologist can adjust the annotations and the downstream measurement of LVEF prior to finalization.
Intended Use/ Indications for Use
InVision Precision LVEF is used to process previously acquired transthoracic cardiac ultrasound images, store images, and manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system to provide an automated estimation of LVEF. This measurement can be used to assist the clinician in a cardiac evaluation. InVision Precision is indicated for use in patients 22 years and older by sonographers and physicians evaluating cardiac ultrasound.
Summary of Technological Characteristics
A comparison of technological similarities and differences between the subject and predicate devices is as follows:
| Feature/
Function | Subject Device:
InVision Precision | Predicate Device:
Caption Interpretation
Automated Ejection
Fraction Software
K210747 |
|--------------------------------------|---------------------------------------|---------------------------------------------------------------------------------------------------|
| General Principles of Operation | | |
| Machine Learning-
Based Algorithm | Yes | Yes |
| Operates on DICOM
clips | Yes | Yes |
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Image /page/5/Picture/0 description: The image shows the logo for InVision Medical Technology. The logo features a stylized heart shape made of teal lines, with a small circle connected to the lines on the left side. Below the heart shape, the word "InVision" is written in a bold, dark blue font. Underneath "InVision", the words "Medical Technology" are written in a smaller, lighter blue font.
| Feature/
Function | Subject Device:
InVision Precision | Predicate Device:
Caption Interpretation
Automated Ejection
Fraction Software
K210747 |
|--------------------------------------------------------------------------|-----------------------------------------------|---------------------------------------------------------------------------------------------------|
| Automation level | Semi automated | Fully automated |
| Automated View
Selection | Yes | Yes |
| Views for EF Calculation | Single view or Biplane | Single view or Biplane |
| Automated Ejection
Fraction Calculation | Yes | Yes |
| Ejection Fraction
reported | Numerical estimate | Numerical estimate |
| User Interface | Uses the interface of
approved PACS system | Includes own user
interface |
| Quantitative feedback to
enable clinician to
assess EF calculation | Adjustable annotation | Confidence Metric |
| EF result shown with
video clip | Yes, with adjustable
annotation | Yes |
| User confirmation/
rejection of result | Yes | Yes |
| Technological Characteristics | | |
| Network Architecture | Spatiotemporal Pooling | Simple Pooling |
Both subject and predicate devices have similar technological characteristics and principles of operation. Any differences do not raise new concerns of safety and efficacy.
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Image /page/6/Picture/0 description: The image shows a logo for InVision Medical Technology. The logo features a stylized heart shape made of teal lines, with a small circle connected to one of the lines, resembling a circuit or connection point. Below the heart shape, the word "InVision" is written in a bold, dark blue font, and below that, the words "Medical Technology" are written in a smaller, lighter blue font.
Performance Data
The InVision Precision software was developed and tested in accordance with InVision Medical Technology's Design Control processes and has been subjected to extensive safety and performance testing. Verification and validation testing was conducted to demonstrate the substantial equivalence of the subject device to the predicate. The primary success criterion was that the subject device would produce an ejection fraction number with a Root Mean Square Deviation below a set threshold as compared to the reference ground truth EF as well as Dice score above a set threshold compared to the consensus annotation of three cardiologists.
Extensive algorithm development and software verification and clinical validation testing, assessed the performance of the software's image video clip selection function and performance characteristics of the algorithm, including accuracy and overall functional performance. Images and cases used for verification and validation testing were separate and carefully segregated from training datasets. Non-clinical verification and validation test results established that the device meets its design requirements and intended use.
Machine Learning Performance Evaluation Summary
A retrospective, multicenter study was designed to evaluate the capability of the Precision machine learning model in calculating LVEF against ground truth. A variety of imaging equipment manufacturers included Philips, GE and Siemens were used for the input data. The average RMSD (Root Mean Square Deviation) for the device's biplane view was around 6.06, for A4C view was 6.17, for A2C view was 7.12. The Dice score for A4C segmentation was 0.89 and for A2C segmentation was 0.90. Data analysis of subgroups included race/ ethnicity, age, gender, BMI, imaging site and equipment, and ejection fraction values. The Precision device met all endpoints.
Conclusions
Performance testing demonstrated that the InVision Precision software performs as expected and in a manner that is substantially equivalent to the predicate device. The InVision Precision software has the same intended use, and similar indications for use, principles of operation and technological characteristics as the predicate device. The
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Image /page/7/Picture/0 description: The image contains a logo for InVision Medical Technology. The logo features a stylized, geometric heart shape in teal, positioned above the company name. The text "InVision" is written in a bold, dark blue font, and below it, "Medical Technology" is written in a smaller, lighter font.
differences do not raise new concerns of safety and effectiveness, therefore the InVision Precision software is substantially equivalent to the predicate device.