(227 days)
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No
The description explicitly states that the identification and tracing of the ventricular border is performed manually. There is no mention of automated analysis or algorithms that would suggest AI/ML is being used.
No
Explanation: This device is a measurement and analysis software used to evaluate heart function and assist in patient evaluation, but it does not directly provide therapy. It helps in measuring the effectiveness of therapy but is not a therapeutic device itself.
Yes
The software's intended use directly states its purpose is "to assist in evaluating a patient with suspected heart disease," "to measure the effectiveness of therapy," and "to assess risk or prognosis," all of which are diagnostic functions.
Yes
The device description explicitly states it is "software" and describes its functions as processing digital images and performing calculations. There is no mention of accompanying hardware components that are part of the device 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 UW LV Analysis Software processes digital images of the left ventricle to measure parameters like volume, ejection fraction, and wall motion. It does not interact with or analyze biological samples.
Therefore, while it is a medical device used for diagnosis and patient management, it falls under the category of imaging analysis software rather than an IVD.
N/A
Intended Use / Indications for Use
UW LV Analysis Software assists in measuring left ventricular volume at end diastole and end systole, ejection fraction, and regional wall motion around the ventricular contour. The intended applications of the software are: 1) to assist in evaluating a patient with suspected heart disease, 2) to measure the effectiveness of therapy, 3) to assess risk or prognosis, and 4) in clinical trials evaluating new therapies.
Product codes
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Device Description
The method comprises five main parts: a) reviewing the digital images, b) selecting the image frames to analyze, c) identifying and tracing the border of the left ventricle, d) measuring left ventricular volume from the traced border and calculating ejection fraction, and e) measuring regional wall motion. The UN LV Analysis Software allows the user to review a series of images in digital format, and manually select frames for analysis. Identifying and tracing the ventricular border is performed manually using the Of the techniques developed to measure left LV Analysis Software. UW ventricular volume from a traced border, the area length method is generally the most accurate, and is the method used by the UW LV Analysis accepted as Software. Of the techniques for measuring left ventricular wall motion, the centerline method has been proven useful for clinical trials, and is the method used by the UW LV Analysis Software. Calibration to correct for image magnification is required for volume measurement, but not for calculation of the ejection fraction or for analysis of regional wall motion.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
left ventricle
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The standard of accuracy applied to validation of this software when licensed to other companies and installed on their systems, was to demonstrate the installed programs differed from the programs at the University of Washington by less than 2.5%. In internal testing of upgrade versions at the University of Washington, the measurements of volume and regional wall motion differed from those of the preceding version by less than this. The measurement variability is 8 ml for volume, 0.04 for ejection fraction, and 0.24 and 0.33 SD/chord for motion in the anterior and inferior walls, respectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measurement variability:
- 8 ml for volume
- 0.04 for ejection fraction
- 0.24 SD/chord for motion in anterior walls
- 0.33 SD/chord for motion in inferior walls
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
JAN 17 1907
Application K962153
1962153
8462828
Summary of Safety and Effectiveness Information
UW LV Analysis Software assists in measuring left ventricular volume at end diastole and end systole, ejection fraction, and regional wall motion around the ventricular contour. The method comprises five main parts: a) reviewing the digital images, b) selecting the image frames to analyze, c) identifying and tracing the border of the left ventricle, d) measuring left ventricular volume from the traced border and calculating ejection fraction, and e) measuring regional wall motion. The UN LV Analysis Software allows the user to review a series of images in digital format, and manually select frames for analysis. Identifying and tracing the ventricular border is performed manually using the Of the techniques developed to measure left LV Analysis Software. UW ventricular volume from a traced border, the area length method is generally the most accurate, and is the method used by the UW LV Analysis accepted as Software. Of the techniques for measuring left ventricular wall motion, the centerline method has been proven useful for clinical trials, and is the method used by the UW LV Analysis Software. Calibration to correct for image magnification is required for volume measurement, but not for calculation of the ejection fraction or for analysis of regional wall motion.
There is no substantial hazard of death or injury to the patient associated with using this software. The intended applications of the software are: 1) to assist in evaluating a patient with suspected heart disease, 2) to measure the effectiveness of therapy, 3) to assess risk or prognosis, and 4) in clinical trials evaluating new therapies.
Although it is believed that no hazard to the patient exists this from software, considerable effort has been directed to analyzing the sources of error or variability in the measurements, and to developing methods of avoiding minimizing them. During software development, the author frequently or exercised all functions to assure proper operation. After upgrades of the software to improve performance, the data of thousands of patients were analyzed by both the new and previous versions and compared, to document that the revision had not introduced new errors or inconsistencies, or significantly altered the measurement results.
The standard of accuracy applied to validation of this software when licensed to other companies and installed on their systems, was to demonstrate the installed programs differed from the programs at the University of Washington by less than 2.5%. In internal testing of upgrade versions at the University of Washington, the measurements of volume and regional wall motion differed from those of the preceding version by less than this. The measurement variability is 8 ml for volume, 0.04 for ejection fraction, and 0.24 and 0.33 SD/chord for motion in the anterior and inferior walls, respectively.
Versions of these programs were used over the past 13 years at the University of Washington. They were also used to make endpoint measurements for a number of NIH-sponsored and agency-sponsored clinical trials. The selection of the UW LV Analysis Software programs for the NIH's TIMI trial is an indication of NIH's endorsement of their performance and accuracy.