(77 days)
Not Found
No
The description focuses on quantitative analysis using standard formulas and protocols, with no mention of AI or ML techniques.
No
The device is a software program designed for quantitative analysis of ultrasound data, intended to assist in the performance of stress echocardiography by providing data analysis, review, and reporting functionalities. It does not exert a therapeutic action on the patient.
Yes
The device is described as assisting in the "quantitative analysis of M-mode, B-mode, and Doppler ultrasound data" and "may be employed adjunctively in the performance of stress echocardiography in patients with suspected coronary artery disease." It performs calculations and provides information for diagnosis, falling under the definition of a diagnostic device.
No
The device description explicitly states that "Certain dedicated hardware items are provided with the software" and lists specific hardware components like a real-time frame grabber, ECG trigger kit, control panel, hardlock, and video cable. This indicates it is not a software-only device.
Based on the provided information, the ECHO-COM for MS-Windows Version 2.0 cardiac software program is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The ECHO-COM software analyzes ultrasound data, which is generated by a medical imaging device (ultrasound system) and represents the physical structure and function of the heart. It does not process or analyze biological samples like blood, urine, or tissue.
- The intended use is for quantitative analysis of ultrasound data. The description clearly states its purpose is to analyze M-mode, B-mode, and Doppler ultrasound data, and to be used adjunctively in stress echocardiography. This is a function related to medical imaging analysis, not laboratory testing of biological specimens.
- The device description focuses on hardware for image capture and software for data analysis. The components mentioned (frame grabber, ECG trigger kit, control panel, software features) are all related to acquiring, processing, and analyzing ultrasound images and data.
Therefore, the ECHO-COM software falls under the category of medical imaging analysis software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ECHO-COM for MS-Windows Version 2.0 cardiac software program is recommended for quantitative analysis of M-mode, B-mode, and Doppler ultrasound data. The system may be employed adjunctively in the performance of stress echocardiography in patients with suspected coronary artery disease either on-line by direct connection to the video signal output port of a suitable diagnostic ultrasound system or off-line by retrieving and processing previously stored data. The system permits the use of either standard or customized examination protocols, data analysis formulae, and report formats.
Product codes (comma separated list FDA assigned to the subject device)
74 DQK, 870.1425
Device Description
The ECHO-COM device is a proprietary software program for cardiac data analysis designed for installation in an IBM-compatible personal computer (PC) and use with an MS-DOS Windows operating platform. Certain dedicated hardware items are provided with the software. The PC itself and the general-purpose peripheral hardware necessary to complete the system are supplied by or obtained from local vendors.
The dedicated hardware supplied with the ECHO-COM system consists of a real-time frame grabber, ECG trigger kit, control panel, hardlock, and video cable. The digitizer card interface for the frame grabber has sufficient memory for the processing and storage of color images. This frame grabber captures all available information from the ultrasound system with which it is used during on-line operation including ECG trigger pulses and scale markers for distance measurements. The ECG trigger pulses permit time-gated cine loop recording, optimizing the system for the performance of stress-echo examinations.
ECHO-COM software is designed to offer exceptional flexibility during either on-line or off-line operation. Images and cine loops may be archived in a variety of commonly used formats, including Macintosh, permitting integration into a wide range of networking systems such as InterNet and CompServe for convenient transfer of data to remote locations.
A Review Module is provided that enables users to perform measurement, calculation, and documentation of stored images and loops at the workstation. An Examination Scheme Editor permits the user to supplement the pre-programmed protocols with customized examination approaches to conform with local requirements and preferences. Data from 2-D, M-mode, and Doppler examinations can be combined as desired. Levels and scanning positions for stress-echo examinations can be freely selected. The Report and Formula Editor enables the user to add custom-designed report formats and supplementary calculation formulae to the standard menu.
A comprehensive range of cardiac ultrasound examination programs is provided including stress-echo test computations, semi-quantitative wall motion scoring, wall thickness evaluation, left ventricular volume studies, left ventricular function, color coding, M-mode functions, and Doppler functions.
The disc summation method for quantitation of left ventricular volumes by two-dimensional echocardiography, as recommended by the American Society of Echocardiography, is employed. The tolerance levels utilized in the ECHO-COM program are based directly on the range of normal values adopted by the American Society of Echocardiography. All other equations and formulae included in the ECHO-COM program are based on accepted mathematical principles or derived from the published literature.
Mentions image processing
The digitizer card interface for the frame grabber has sufficient memory for the processing and storage of color images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software performance has been successfully validated through checks conducted in hospitals under typical clinical operating conditions in addition to internal testing throughout the software development cycle.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
510(k) SUMARY
MAY - 7 1996
-
COMPANY INFORMATION. 1.
Individual Software GmbH Name (Manufacturer) : Cone Instruments, Inc. Name (U.S. Agent) Address (Manufacturer) ・・ Petersberger Strasse 24-26 D-36037 Fulda, Germany Address (U.S. Agent) 5201 Naiman Parkway : Solon, Ohio 44139 Telephone (Manufacturer): 011-49-661-76031 (216) 246-1035 Telephone (U.S. Agent) . • Jay C. Cone, President Contact Person : Cone Instruments, Inc. 5201 Naiman Parkway Solon, Ohio 44139 (216) 248-1035 Date Prepared ・・ February 16, 1996 -
- DEVICE NOMENCLATURE.
| Trade Name | : | ECHO-COM for MS-Windows Version 2.0 |
|---|---|---|
| Common Name | : | Cardiac Data Analysis Program |
| Classification Name | : | Computer Diagnostic, Programmable |
| [74 DQK, 870.1425] |
-
- PREDICATE DEVICE.
| Digisonics, Inc. | : | 'Echo Reading Station' (Modification of |
|---|---|---|
| 'Echo-Comp' echocardiography analysis | ||
| program | ||
| 510(k) Number | : | K800766 |
| SE Decision | : | April 24, 1980 |
DEVICE DESCRIPTION. 4.
The ECHO-COM device is a proprietary software program for cardiac data analysis designed for installation in an IBM-compatible personal computer (PC) and use with an MS-DOS Windows operating platform. Certain dedicated hardware items are provided with the software. The PC itself and the general-purpose peripheral hardware necessary to complete the system are supplied by or obtained from local vendors,
1
The dedicated hardware supplied with the ECHO-COM system consists of a real-time frame grabber, ECG trigger kit, control panel, hardlock, and video cable. The digitizer card interface for the frame grabber has sufficient memory for the processing and storage of color images. This frame grabber captures all available information from the ultrasound system with which it is used during on-line operation including ECG trigger pulses and scale markers for distance measurements. The ECG trigger pulses permit time-gated cine loop recording, optimizing the system for the performance of stress-echo examinations.
ECHO-COM software is designed to offer exceptional flexibility during either on-line or off-line operation. Images and cine loops may be archived in a variety of commonly used formats, including Macintosh, permitting integration into a wide range of networking systems such as InterNet and CompServe for convenient transfer of data to remote locations.
A Review Module is provided that enables users to perform measurement, calculation, and documentation of stored images and loops at the workstation. An Examination Scheme Editor permits the user to supplement the pre-programmed protocols with customized examination approaches to conform with local requirements and preferences. Data from 2-D, M-mode, and Doppler examinations can be combined as desired. Levels and scanning positions for stress-echo examinations can be freely selected. The Report and Formula Editor enables the user to add custom-designed report formats and supplementary calculation formulae to the standard menu.
A comprehensive range of cardiac ultrasound examination programs is provided including stress-echo test computations, semi-quantitative wall motion scoring, wall thickness evaluation, left ventricular volume studies, left ventricular function, color coding, M-mode functions, and Doppler functions.
The disc summation method for quantitation of left ventricular volumes by two-dimensional echocardiography, as recommended by the American Society of Echocardiography, is employed. The tolerance levels utilized in the ECHO-COM program are based directly on the range of normal values adopted by the American Society of Echocardiography. All other equations and formulae included in the ECHO-COM program are based on accepted mathematical principles or derived from the published literature.
5. INTENDED USES .
The ECHO-COM for MS-Windows Version 2.0 cardiac software program is recommended for quantitative analysis of M-mode, B-mode, and Doppler ultrasound data. The system may be employed adjunctively in the performance of stress echocardiography in patients with suspected coronary artery disease either on-line by direct connection to the video signal output port of a suitable diagnostic ultrasound system or off-line by retrieving and processing previously stored data. The system permits the use of either standard or customized examination protocols, data analysis formulae, and report formats.
2
6. COMPARISON WITH PREDICATE DEVICE.
The intended uses of the predicate device, the Digisonics cardiac analysis program, are very similar to those recommended for the subject device. Both are intended for use as work stations to organize findings generated during echocardiographic examina ions, and both facilitate calculations and quantitative analysis.
The subject device and the predicate device are also very similar in product concept. Both systems are software programs designed for use with an IBM-compatible PC using an MS-Windows operating platform. Both provide the clinician with computerized worksheets with graphics which are used to generate reports presenting the results of an echocardiographic examination.
Both systems may be employed on-line itilizing a data transfer linkage for interface to a suitable ultrasound instrument or off-line by either entering numeric values manually or calling up information from a database. Both programs incorporate formulae for quantitative data analysis based on the published work of recognized authorities in the field, and both allow the user to input additional formulae. Both program provide standard report formats and allow the user to customize formats when desired.
The principal differences between the ECHO-COM and the Digisonics system relate to on-line operation. The ECHO-COM is designed to accomplish ECG-gated cine loop recording which is valuable in the performance of stress-echo studies. Also, the ECHO-COM utilizes an advanced frame grabber which captures the distance measurement markers when transferring the ultrasound image, permitting operator verification of the accuracy of the dimensional information calculated by the ultrasound system in use.
The simularities and differences between the subject and predicate devices are presented in tabular form on the following page. It is concluded that the differences in technical characteristics between the two products are not significant in that there are no features of the subject device that raise new questions with respect to safety nor that could result in a decrease of effectiveness as compared to the predicate device.
7. PERFORMANCE DATA.
a. Hardware Performance. Hardware performance depends primarily on the PC and peripherals selected. Minimum and optimal specifications for use in the selection of hardware are given in the system operating manual to insure compatibility and proper performance. For the signal transfer functions performed by the dedicated hardware, an important consideration is the prevention of interference due to electrical potentials between interconnected units. This concern is addressed by the use of a UL listed high density mounting type photocoupler that provides an isolation voltage between input and output of 5,000V rms.
3
COMPARISON OF TECHNICAL FEATURES: SUBJECT DEVICE VS. PREDICATE DEVICE
| CHARACTERISTIC | SUBJECT DEVICE
Cone Instruments
ECHO-COM for Windows | PREDICATE DEVICE
Digisonics
Echo Reading Station |
|---------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Required
Computer | IBM-compatible PC
Minimum RAM 8 MB | IBM-compatible PC
RAM 8 MB |
| Operating
Platform | MS-DOS 3.3 or higher
MS-Windows 3.1 or
higher | MS-DOS 6.3
MS-Windows 3.11 |
| Operating
Options | On-line (interfaced
with ultrasound
system) or off-line | On-line (interfaced
with ultrasound
system) or off-line |
| Video Capture | Frame grabber, ECG-
gated cine loop
recording | "Echo-Link" (fiber
optics) |
| Downloading
Capabilities | Black & white or
color images,
numeric data, ECG
trigger pulses,
distance markers | Black & white or
color images,
numeric data |
| Ultrasound Modes
Accepted | 2-D, M-mode, Doppler | 2-D, M-mode, Doppler |
| Database | Archiving of images,
cine loops, and re-
ports with graphics;
convenient retrieval | Archiving of reports
with graphics; con-
venient retrieval |
| Report Formats | Standard or custom-
ized by user | Standard or custom-
ized by user |
| Calculation
Formulae | Standard (based on
published authors)
or user defined | Standard (based on
published authors)
or user defined |
| Measurement
Data Verifi-
cation | User can compare
against values
generated by basic
ultrasound system | User can compare
against values
generated by basic
ultrasound system |
| Data Transfer | Networking via
InterNet, Compi-
Serve, etc. | Network compatible;
fax capability |
4
b. Software Performance. Software performance can be evaluated by comparing the numeric values calculated by the ECHO-COM for MS-Windows program against corresponding values generated by the echocardiographic system itself. Software performance has been successfully validated through checks conducted in hospitals under typical clinical operating conditions in addition to internal testing throughout the software development cycle.
c. Quality Assurance. All product design, production, testing, and service procedures are conducted in accordance with the following international quality standards: ISO 9001":1994 and ISO 9004-2:1991.
8. CONCLUSION .
The ECHO-COM for MS-Windows Version 2.0 cardiac software program is closely similar in both intended use and technologic characteristics to the predicate device. The product raises no new questions regarding safety or effectiveness. All pertinent product data and all required certifications have been filed with the Food and Drug Administration. Cone Instruments, Inc. concludes that the subject device is substantially equivalent to devices of the same classification previously legally introduced into interstate commerce in the United States.