(137 days)
Not Found
Yes
The device description explicitly states that it uses a "locked artificial intelligence machine learning (AI/ML) algorithm" and an "artificial intelligence algorithm" to perform its function.
No.
The device is described as a software-only device designed to measure the maximal diameters of the right and left ventricles of the heart from CTPA acquisitions and report the ratio of those measurements. It is intended to assist physicians in assessment and its results are not for stand-alone use in clinical decision-making. These functions are diagnostic/assessment tools, not therapeutic interventions.
Yes
Explanation: The device measures the maximal diameters of the right and left ventricles of the heart from a CTPA acquisition and reports the ratio of those measurements. This information is used by physicians to assist in the assessment of right ventricle enlargement, which is a diagnostic purpose.
Yes
The device description explicitly states, "The Viz RV/LV is a software-only device".
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 Viz RV/LV Software analyzes volumetric CTPA acquisitions, which are medical images of the heart and lungs. It does not interact with or analyze any biological samples.
- The intended use is image analysis: The stated intended use is to "measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements." This is a function of medical image processing and analysis, not in vitro testing.
Therefore, the Viz RV/LV Software falls under the category of medical image processing or analysis software, not an In Vitro Diagnostic device.
No
The input explicitly states "Control Plan Authorized (PCCP): Not Found", indicating no PCCP was authorized for this device.
Intended Use / Indications for Use
The Viz RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. Viz RV/LV analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the ventricles. The Viz RV/LV software provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.
Product codes
QIH
Device Description
The Viz RV/LV is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) algorithm to measure the maximal diameters of the right and left ventricles of the heart from a computed tomography pulmonary angiogram (CTPA) and report the ratio of those measurements.
Viz RV/LV produces an Annotated Image Series (Figure 1) and an RV/LV Summary Report (Figure 2) in DICOM format. The Annotated Image Series shows an RGB overlay on each slice of the input scan:
- . The red and blue solid lines indicate the maximum ventricular diameter for each ventricle.
- . The dashed line indicates a diameter measured on a slice that is within 10 slices of the global maximum ventricular diameter.
- . The interventricular septum is marked in solid green on all images where diameters are marked.
- . The maximal diameter is presented along with solid lines on slices with global maximum diameter.
The RV/LV Summary Report summarizes the results of the ventricle analysis and shows the slices with the maximum right and left ventricular diameters. The lines measuring the maximum RV and LV diameters are displayed over the original CTPA slice image, along with the lengths of the largest RV and LV diameters, and the RV/LV ratio.
Viz RV/LV is hosted on Viz.ai's Backend Server and analyzes applicable CTPA scans that are acquired on CT scanners and are forwarded to Viz.ai's Backend Server. The results of the analysis are exported in DICOM format are sent to a PACS destination for review by thoracic radiologists, general radiologists, pulmonologists, cardiologists, or other similar physicians to assist in the assessment of right ventricle enlargement. The basic principle of operations is outlined in Figure 3 below.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
computed tomography pulmonary angiogram (CTPA)
Anatomical Site
heart, ventricles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
thoracic radiologists, general radiologists, pulmonologists, cardiologists, or other similar physicians
Description of the training set, sample size, data source, and annotation protocol
The 13 sites used as part of the training data set. There was no overlapping data between the training sets and the pivotal study in terms of time and patient images.
Description of the test set, sample size, data source, and annotation protocol
The 4 clinical sites used in the pivotal study were a subset of a larger 13 sites used as part of the training data set. There was no overlapping data between the training sets and the pivotal study in terms of time and patient images.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing was performed as a study comparing the Viz RV/LV's output to the ground truth as established by trained radiologists. There was a high degree of agreement between the different trained radiologist as demonstrated by statical analysis. The study demonstrated that the MAE (Mean absolute error) was less than 7.2 mm between the established ground truth, which was aligned with the performance goal. Additional statistical analysis was performed to describe the degree of agreement between the ventricle diameters measured by the RV/LV algorithm in comparison to the measurements that were obtained manually. The algorithm's ventricle diameter measurements were aligned when compared against the measurements that were obtained manually. Stratification of device performance was divided by clinical site, gender, age, slice thickness, scanner manufacture and model.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MAE (Mean absolute error) was less than 7.2 mm
Predicate Device(s)
Imbio RV/LV Software K203256
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 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Viz.ai, Inc. % Vi Ma Regulatory Affair Specialist 201 Mission Street, 12th Floor SAN FRANCISCO CA 94105
Re: K221100
August 29, 2022
Trade/Device Name: Viz RV/LV Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: August 4, 2022 Received: August 5, 2022
Dear Vi Ma:
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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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 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, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below
510(k) Number (if known)
K221100
Device Name
Viz RV/LV
Indications for Use (Describe)
The Viz RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. Viz RV/LV analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the ventricles. The Viz RV/LV software provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.
Type of Use (Select one or both, as applicable)
図 Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
□ Over-The-Counter Use (21 CFR 801
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510(k) SUMMARY-K221100
Viz.ai, Inc.'s Viz RV/LV
| Applicant Name: | Viz.ai, Inc. |
|---|---|
| 201 Mission Street, 12th Floor | |
| San Francisco, CA 94105 |
- Contact Person: Vi Ma Regulatory Affairs Specialist 201 Mission Street, 12th Floor San Francisco, CA 94105 Tel. (415) 663-6130 vi.ma@viz.ai
- Date Prepared: August 24, 2022
Device Name and Classification
| Name of Device: | Viz RV/LV |
|---|---|
| Common or Usual Name: | Automated Radiological Image Processing Software |
| Classification Panel: | Radiology |
| Regulation No: | 21 C.F.R. § 892.2050 |
| Regulatory Class: | Class II |
| Product Code: | QIH |
Predicate Device
| Manufacturer | Device Name | Application No. |
|---|---|---|
| Imbio | Imbio RV/LV Software | K203256 |
Device Description
The Viz RV/LV is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) algorithm to measure the maximal diameters of the right and left ventricles of the heart from a computed tomography pulmonary angiogram (CTPA) and report the ratio of those measurements.
Viz RV/LV produces an Annotated Image Series (Figure 1) and an RV/LV Summary Report (Figure 2) in DICOM format. The Annotated Image Series shows an RGB overlay on each slice of the input scan:
- . The red and blue solid lines indicate the maximum ventricular diameter for each ventricle.
- . The dashed line indicates a diameter measured on a slice that is within 10 slices of the global maximum ventricular diameter.
4
- . The interventricular septum is marked in solid green on all images where diameters are marked.
- . The maximal diameter is presented along with solid lines on slices with global maximum diameter.
Image /page/4/Picture/2 description: The image shows a CT scan of a human chest. The scan shows the heart, lungs, and other organs in the chest. The scan also shows the measurements of the right ventricle (RV) and left ventricle (LV) of the heart. The RV measures 58.3mm, and the LV measures 36.5mm.
Figure 1: Annotated Image Series
Image /page/4/Picture/4 description: The image shows a Viz RV/LV Analysis Summary. The RV/LV Diameter ratio is 1.6, the LV is 36.5mm (slice 218), and the RV is 58.3mm (slice 212). There are two CT scan images, one showing the Maximal RV Diameter Slice and the other showing the Maximal LV Diameter Slice. The image also includes a legend indicating the Largest RV diameter, Detected Interventricular Septum, and Largest LV diameter.
Figure 2: RV/LV Summary Report
The RV/LV Summary Report summarizes the results of the ventricle analysis and shows the slices with the maximum right and left ventricular diameters. The lines measuring the maximum RV and LV
5
diameters are displayed over the original CTPA slice image, along with the lengths of the largest RV and LV diameters, and the RV/LV ratio.
Viz RV/LV is hosted on Viz.ai's Backend Server and analyzes applicable CTPA scans that are acquired on CT scanners and are forwarded to Viz.ai's Backend Server. The results of the analysis are exported in DICOM format are sent to a PACS destination for review by thoracic radiologists, general radiologists, pulmonologists, cardiologists, or other similar physicians to assist in the assessment of right ventricle enlargement. The basic principle of operations is outlined in Figure 3 below.
Image /page/5/Figure/2 description: The image shows a diagram of a medical imaging workflow. It starts with a CT scanner, which sends data to a Viz.ai backend server. The server uses an RV/LV measurement algorithm to analyze the data and generate a report, which is then sent to a PACS server. Finally, the report is displayed on a monitor.
Figure 3. Data and Event Workflow
Intended Use / Indications for Use
Viz.ai RV/LV software and the predicate device, Imbio RV/LV software (K203256), are Medical Image Management and Processing System software intended to calculate of the ratio of right ventricular diameter to left ventricular diameter from contrast enhanced CT images of the chest acquired using a standard CT pulmonary angiogram acquisition.
Viz RV/LV has the following indications for use:
The Viz RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. Viz RV/LV analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the ventricles. The Viz RV/LV software provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.
The predicate device, Imbio RV/LV Software (K203256), has the following indications use:
The Imbio RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. RV/LV analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the ventricles. The RV/LV
6
software provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decisionmaking or otherwise preclude clinical assessment of CTPA cases.
In comparing the intended use and indications for use of Viz RV/LV and the predicate device, Viz RV/LV has the same intended use as its predicate device.
A substantial equivalence chart (Table 1) comparing the subject device, Viz RV/LV, and the predicate, the Imbio RV/LV software, is provided below:
| Table 1 Technological Characteristic Comparison | ||
|---|---|---|
| Predicate Device | Subject Device | |
| Imbio RV/LV Software | Viz RV/LV | |
| Device Class | 2 | 2 |
| Product Code | QIH | QIH |
| Regulation | ||
| Number: | 21 C.F.R. § 892.2050 | 21 C.F.R. § 892.2050 |
| Indications for | ||
| Use: | The Imbio RV/LV Software device is | |
| designed to measure the maximal | ||
| diameters of the right and left ventricles of | ||
| the heart from a volumetric CTPA | ||
| acquisition and report the ratio of those | ||
| measurements. RV/LV analyzes cases | ||
| using an artificial intelligence algorithm to | ||
| identify the location and measurements of | ||
| the ventricles. The RV/LV software | ||
| provides the user with annotated images | ||
| showing ventricular measurements. Its | ||
| results are not intended to be used on a | ||
| stand-alone basis for clinical decision- | ||
| making or otherwise preclude clinical | ||
| assessment of CTPA cases. | The Viz RV/LV Software device is | |
| designed to measure the maximal | ||
| diameters of the right and left ventricles of | ||
| the heart from a volumetric CTPA | ||
| acquisition and report the ratio of those | ||
| measurements. Viz RV/LV analyzes cases | ||
| using an artificial intelligence algorithm to | ||
| identify the location and measurements of | ||
| the ventricles. The Viz RV/LV software | ||
| provides the user with annotated images | ||
| showing ventricular measurements. Its | ||
| results are not intended to be used on a | ||
| stand-alone basis for clinical decision- | ||
| making or otherwise preclude clinical | ||
| assessment of CTPA cases. | ||
| Input Data | ||
| Requirements: | Non-gated, CT Pulmonary Angiography | |
| (CTPA) | Same | |
| DICOM | ||
| Compliant | Yes | Same |
| Left Ventricle | ||
| Segmentation | Yes | Same |
| Right Ventricle | ||
| Segmentation | Yes | Same |
| Diameter | ||
| Measurements | Yes - Automated | Same |
| Fully automated | ||
| segmentation | Yes | Same |
| Outputs | Reports, DICOM Secondary Capture | |
| Series | Same |
Table 1 Technological Characteristic Comparison
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Performance Data
Clinical testing was performed as a study comparing the Viz RV/LV's output to the ground truth as established by trained radiologists. There was a high degree of agreement between the different trained radiologist as demonstrated by statical analysis. The study demonstrated that the MAE (Mean absolute error) was less than 7.2 mm between the established ground truth, which was aligned with the performance goal.
Additional statistical analysis was performed to describe the degree of agreement between the ventricle diameters measured by the RV/LV algorithm in comparison to the measurements that were obtained manually. The algorithm's ventricle diameter measurements were aligned when compared against the measurements that were obtained manually.
Stratification of device performance was divided by clinical site, gender, age, slice thickness, scanner manufacture and model.
The 4 clinical sites used in the pivotal study were a subset of a larger 13 sites used as part of the training data set. There was no overlapping data between the training sets and the pivotal study in terms of time and patient images.
Conclusions
A comparison of intended use and technological characteristics, along with clinical performance data, demonstrated that the device is as safe and effective as the previously cleared Imbio RV/LV software (K203256). Thus, Viz RV/LV is substantially equivalent to Imbio RV/LV.