(89 days)
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Not Found
No
The description focuses on standard software functionalities like archiving, viewing, measuring, and reporting, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is described as stand-alone software for archiving, viewing, measuring, and reporting digital echocardiographic and cardiac catheterization studies. It does not perform any direct therapeutic action.
No
The device is described as software for archiving, viewing, measuring, and reporting digital studies, and tracking examinations and patient data. While it performs measurements, it processes existing images and generates reports, rather than detecting or diagnosing conditions itself. Its primary function appears to be data management and visualization, even with "Stress Echo regional wall motion analysis" and "quantitative image evaluation," which sound like post-processing and analysis tools rather than direct diagnostic capabilities. The predicate devices also appear to be image management and review systems.
Yes
The device is explicitly described as "stand-alone software" that operates on standard PC equipment. While it processes images from other medical devices (ultrasound and cardiac catheterization), the device itself is solely the software component.
Based on the provided information, ProSolv® Echo is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- ProSolv® Echo's Function: ProSolv® Echo is software that processes and displays medical images (echocardiographic and cardiac catheterization images). It's used for viewing, measuring, and reporting on these images.
- No Specimen Analysis: The description does not mention any analysis of biological specimens. The software operates on images generated by other medical devices (ultrasound and cardiac catheterization equipment).
Therefore, ProSolv® Echo falls under the category of medical imaging software, not an IVD.
N/A
Intended Use / Indications for Use
ProSolv Echo is stand-alone software that operates on standard PC equipment. The device is available in three configurations (EchoViewer, EchoViewer SE, and EchoAnalyzer) and is intended for use by echocardiographic labs. ProSolv® EchoViewer is also intended for use by cardiac catheterization labs. ProSolv® Echo incorporates the latest technology in archiving, viewing, measuring, analyzing, and reporting digital echocardiographic studies generated by a multitude of ultrasound manufacturers. The device configurations can be packaged with ProSolv® EchoServer to extend the capabilities for laboratories wanting to access a remote, secure database and archive images over the Internet.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
The ProSolv® Echo software operates on a PC computer using the Windows 95/98/NT operating system. ProSolv® EchoViewer allows the user to view echocardiographic and cardiac catheterization images from a variety of sources, track examinations and patient data with a database, and view reports. DICOM images and most non-DICOM images can be read by the software. ProSolv® EchoViewer SE adds to the EchoViewer by including Stress Echo regional wall motion analysis, qualitative image evaluation with a customizable comment list, and report generation. ProSolv® EchoAnalyzer includes all the functionality of EchoViewer SE, plus quantitative image evaluation, routine regional wall motion scoring, and customizable reports and measurements. Each of the products can be packaged with the optional ProSolv® EchoServer capability to allow remote database access via the Internet.
Mentions image processing
ProSolv® EchoViewer allows the user to view echocardiographic and cardiac catheterization images from a variety of sources, track examinations and patient data with a database, and view reports.
Mentions AI, DNN, or ML
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Input Imaging Modality
ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
echocardiographic labs, cardiac catheterization labs
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)
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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.
Not Found
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
Image /page/0/Figure/0 description: The image shows the text "FEB 2 2000" in bold font. Below the text is a graphic that appears to be a calendar. The calendar graphic is mostly blacked out, but the grid pattern of the calendar is still visible.
Problem Solving Concepts, Inc.
1980 E. 116th Street, Suite 220 Carmel, Indiana 46032 Tel .: (317) 848-7431 · Fax: (317) 848-7432
Page 1 of 2
510(k) SUMMARY
Date Prepared: 21 October 1999
Submitter
Problem Solving Concepts, Inc. 1980 E 116th St, Suite 220 Carmel, IN 46032
Phone: (317) 848-7431 Fax: (317) 848-7432
Registration number: Form FDA-2891 has been submitted
Contact Person
Thomas M. McClelland or Thomas D. Feigenbaum (if TMM not available) (317) 848-7431
Device Name
Trade Names: ProSolv® Echo, ProSolv® EchoViewer, ProSolv® EchoViewer SE, ProSolv® EchoAnalyzer, and ProSolv® EchoServer
Common Name: Picture Archiving and Communications Systems (PACS) Components
Class: No formal classifications have been issued for PACS components. Performance Standards: No performance standards have been issued for PACS components under the authority of section 514.
Device Description
The ProSolv® Echo software operates on a PC computer using the Windows 95/98/NT operating system. ProSolv® EchoViewer allows the user to view echocardiographic and cardiac catheterization images from a variety of sources, track examinations and patient data with a database, and view reports. DICOM images and most non-DICOM images can be read by the software. ProSolv® EchoViewer SE adds to the EchoViewer by including Stress Echo regional wall motion analysis, qualitative image evaluation with a customizable comment list, and report generation. ProSolv® EchoAnalyzer includes all the functionality of EchoViewer SE, plus quantitative image evaluation, routine regional wall motion scoring, and customizable reports and measurements. Each of the products can be packaged with the optional ProSolv® EchoServer capability to allow remote database access via the Internet.
Indications For Use
ProSolv Echo is stand-alone software that operates on standard PC equipment. The device is available in three configurations (EchoViewer, EchoViewer SE, and EchoAnalyzer) and is intended for use by echocardiographic labs. ProSolv® EchoViewer is also intended for use by cardiac catheterization labs. ProSolv® Echo incorporates the latest technology in archiving, viewing, measuring, analyzing, and reporting digital echocardiographic studies generated by a multitude of ultrasound
1
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K993750
manufacturers. The device configurations can be packaged with ProSolv® EchoServer to extend the capabilities for laboratories wanting to access a remote, secure database and archive images over the Internet.
General Safety and Effectiveness Concerns
The device labeling and manual provide operating instructions for the safe and effective use of the ProSolv® Echo software. The display, storage, retrieval, and analysis of information provide a minor level of hazard concern.
Substantial Equivalence
ProSolv® Echo is substantially equivalent to the following products that are currently on the market: HP 5500 Sonos (EnConcert software) and Digisonics' Doctor Review System (DigiView System). As the equivalent devices can contain hardware and software components, the ProSolv device is being compared only to the software components. While there are some technological differences between the ProSolv device and the equivalent devices, these differences do not affect the safety or effectiveness of the new device.
The primary difference between the ProSolv® EchoViewer and the two SE devices is in the image formats that are read and stored. The ProSoly software seems to have more flexibility in compression options, which adds to the safety and effectiveness of the device. Users have several options to try on their systems before deciding on a routine compression method.
The primary difference between the EchoAnalyzer and the equivalent devices is in the equations and measurements area. ProSolv has the unique ability for users to view the equations being used to make the calculations based on the measurements. In addition, new measurements and equations can be created to adapt to a laboratory's routine measurements. ProSolv software limits these modifications to only those users with the proper security level access. This flexibility contributes to the effectiveness of the device, without compromising the safety.
Conclusions
With ProSolv® Echo digital echocardiographic images, from virtually any digital ultrasound instrument available today, can be reviewed, measured, analyzed, reported, databased, and archived "off-line". The software can read DICOM images and most non-DICOM images. ProSolv® EchoServer allows for remote access to a database located on a server.
The ProSolv® Echo device meets applicable standards and several voluntary standards. While there are some technological differences between the ProSolv device and the equivalent devices, these differences do not affect the safety or effectiveness of the new device. Based on the comparison between the ProSolv® Echo device and the legally marketed devices, all indications are that the ProSolv® Echo device is substantially equivalent to HP Sonos 5500 (EnConcert) and Digisonics' Doctor Review System (DigiView).
2
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized human figure with three lines representing the head, body, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" which is arranged in a circular fashion around the figure. The text is in all caps and is smaller than the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2000 FEB
Thomas M. McClelland Project Engineer Problem Solving Concepts, Inc. 1980 E. 116th Street, Suite 220 Carmel. IN 46032
Re:
K993750 ProSolv® EchoViewer, ProSolv® EchoViewer SE, ProSolv® EchoAnalyzer, ProSolv® EchoServer, and ProSolv® Echo Dated: November 2, 1999 Received: November 5, 1999 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. McClelland:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or dass III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of
NUMBER (IF KNOWN) : 510 (k)
K993750
ProSolv EchoViewer, EchoViewer SE, and EchoAnalyzer DEVICE NAME :
INDICATIONS FOR USE:
ProSolv® Echo is stand-alone software that operates on standard PC equipment. The device is available in three configurations (EchoViewer, EchoViewer SE, and EchoAnalyzer) and is intended for use by echocardiographic labs. ProSolv® EchoViewer is also intended for use by cardiac catheterization labs. ProSolv® Echo incorporates the latest technology in archiving, viewing, measuring, and reporting digital echocardiographic studies generated by a multitude of ultrasound manufacturers. The device configurations can be packaged with ProSolv® EchoServer to extend the capabilities for laboratories wanting to access a remote, secure database and archive images over the Internet.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Ov
Over-The-Counter-Use (Optional Format 1-2-9
Elvind C. Styrron
Division Sign Off
OR
Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological Device 510(k) Number
1-7
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