Who is the manufacturer of DIGITAL IMAGE ANALYSIS SYSTEM?

University of Washington filed the 510(k) submission for DIGITAL IMAGE ANALYSIS SYSTEM (K962153).

What is the FDA product code for DIGITAL IMAGE ANALYSIS SYSTEM?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for DIGITAL IMAGE ANALYSIS SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DIGITAL IMAGE ANALYSIS SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DIGITAL IMAGE ANALYSIS SYSTEM

K962153 · University of Washington · LLZ · Jan 17, 1997 · Radiology

Device Facts

Record ID	K962153
Device Name	DIGITAL IMAGE ANALYSIS SYSTEM
Applicant	University of Washington
Product Code	LLZ · Radiology
Decision Date	Jan 17, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

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.

Device Story

Software assists clinicians in analyzing digital cardiac images; inputs include digital image series. User manually selects frames and traces left ventricular borders. Device applies area-length method for volume calculation and centerline method for regional wall motion analysis. Calibration required for volume measurement. Output includes left ventricular volume at end diastole/systole, ejection fraction, and regional wall motion metrics. Used in clinical settings and trials to evaluate heart disease, therapy effectiveness, and patient prognosis. Healthcare providers use outputs to inform clinical decision-making and assess cardiac function.

Clinical Evidence

Bench testing only. Validation involved comparing software versions using data from thousands of patients to ensure consistency. Accuracy standard required installed programs to differ from University of Washington master programs by less than 2.5%. Reported measurement variability: 8 ml for volume, 0.04 for ejection fraction, and 0.24-0.33 SD/chord for wall motion. Software utilized in NIH-sponsored clinical trials (e.g., TIMI trial) over 13 years.

Technological Characteristics

Software-based analysis tool. Implements area-length method for volume and centerline method for wall motion. Requires manual border tracing. Calibration feature for image magnification correction. Standalone software application.

Indications for Use

Indicated for patients with suspected heart disease requiring evaluation of left ventricular volume, ejection fraction, and regional wall motion.

Regulatory Classification

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.

Special Controls

*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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Submission Summary (Full Text)

{0} JAN 17 1907 K962153 # Application K962153 ## 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 UW 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 UW LV Analysis Software. Of the techniques developed to measure left ventricular volume from a traced border, the area length method is generally accepted as the most accurate, and is the method used by the UW LV Analysis 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 from this software, considerable effort has been directed to analyzing the sources of error or variability in the measurements, and to developing methods of avoiding or minimizing them. During software development, the author frequently 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.