ProSolv® CardioVascular is intended for use by doctors and non-physicians (e.g., sonographers, technicians, nurses) who are affiliated with medical labs that use images obtained from digital-imaging DICOM instruments (echo, vascular, nuclear cardiology, cardiac catheterization, MRI, etc.) The ProSolv® CardioVascular image management and reporting system is software that operates on standard PC equipment using Windows 95 or later operating system. ProSolv® CardioVascular provides the functionality for archiving, viewing, measuring, analyzing, and reporting digital studies generated by digital-imaging instruments from a multitude of manufacturers. The software is available in several configurations: Administrator (report viewing, edit patient demographic information), Viewer (image and report viewing, basic measurements), and Analyzer (Viewer features plus measurements, qualitative assessment, and report creation and design). The software can be used in a variety of network configurations ranging from a stand-alone workstation to a network of workstations connected through TCP/IP networking to a ProSolv® DICOM Server. The DICOM Server permits studies to be transferred from DICOM compatible imaging instruments directly to a ProSolv® database using TCP/IP.

Device Description

The ProSolv® CardioVascular software operates on a PC computer using the Windows 95 or later operating system. ProSolv® CardioVascular Viewer allows the user to view medical images acquired from digital-imaging instruments, track examinations and patient data with a database, and view reports. The software can display DICOM images and most non-DICOM images. ProSolv® CardioVascular Analyzer includes all the functionality of the Viewer plus routine and stress echo regional wall motion analysis, qualitative and quantitative image evaluation, report generation, and customizable reports, measurements, and comment lists. Each of the products can be packaged with the optional ProSolv® CardioVascular Server capability to allow remote database access over a network.

AI/ML Overview

The provided document, a 510(k) summary for ProSolv® CardioVascular, does not contain information about specific acceptance criteria or a detailed study designed to prove the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in the document. The submission is a 510(k) for substantial equivalence, not a performance study with explicit acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable or not provided. This document describes a software system for image management and reporting, not an AI or diagnostic device that would typically undergo a test set evaluation for performance metrics like sensitivity or specificity. There's no mention of a "test set" in the context of clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable or not provided. As there's no mention of a test set with performance metrics requiring ground truth, expert involvement in this capacity is not discussed.

4. Adjudication Method for the Test Set:

Not applicable or not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document does not describe any human reader studies, with or without AI assistance. The device is a software system for managing and analyzing medical images, not an AI for diagnosing or assisting human readers in a comparative effectiveness setting.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study was not done in the context of reporting specific performance metrics like sensitivity, specificity, or accuracy for an algorithm. The device itself is a standalone software product, but the submission focuses on its functionalities, safety, and equivalence to a predicate, not on algorithmic performance against a defined ground truth.

7. Type of Ground Truth Used:

Not applicable or not provided. The submission focuses on the functionality of the software (archiving, viewing, measuring, analyzing, reporting) and its ability to handle DICOM and non-DICOM images. There's no mention of a specific ground truth (like pathology, expert consensus, or outcomes data) against which the device's analytical outputs were directly evaluated for accuracy. The "measurements" and "analysis" functions are presumably based on established medical formulas and protocols rather than a novel AI algorithm requiring ground truth validation.

8. Sample Size for the Training Set:

Not applicable or not provided. This device is a PACS component/image management system, not described as using machine learning or AI that would require a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable or not provided.

Summary of Acceptance Criteria and Study Approach from the Document:

The acceptance criteria and study approach in this 510(k) submission are based on the demonstration of substantial equivalence to a predicate device (ProSolv® Echo products), rather than formal performance testing against explicit acceptance criteria.

Acceptance Criteria (Implicit): The device is considered acceptable if its safety and effectiveness are not adversely affected by the expanded indications for use and added features compared to the predicate device. The core program is "basically the same," and differences "do not adversely affect the safety or effectiveness."
Study: The "study" here is primarily a comparison and analysis of features and functionalities between the ProSolv® CardioVascular and the predicate ProSolv® Echo products.
- The document highlights that the image viewer was already a generic DICOM viewer and few changes were made to it.
- The primary changes were the addition of new measurements and reports for expanded medical disciplines (vascular, nuclear cardiology, cardiac catheterization, MRI).
- The "beta site" mention implies some level of user feedback or validation for the vascular measurements and reports, but no formal study data from this beta site is presented regarding quantitative acceptance criteria.
- The flexibility and customizability of the software are presented as contributing to effectiveness without compromising safety.
Conclusion: The submission concludes that ProSolv® CardioVascular is substantially equivalent to ProSolv® Echo, meaning it meets the regulatory requirements for market clearance based on this comparison.

Summary

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DEC 1 7 2002

510(k) SUMMARY

Date Prepared: 21 June 2002

Submitter
Problem Solving Concepts, Inc.	Phone: (317) 594-743
8020 Castleway Drive, Suite 120	Fax: (317) 594-7439
Indianapolis, IN 46250

Registration number: 1836517

Contact Person

Thomas M. McClelland

(317) 594-7431

Device Name

Trade Names: ProSolv® CardioVascular, ProSolv® CardioVascular Viewer, ProSolv® CardioVascular Analyzer, and ProSolv® CardioVascular Server 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

Indications For Use

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(report viewing, edit patient demographic information), Viewer (image and report viewing, basic measurements), and Analyzer (Viewer features plus measurements, qualitative assessment, and report creation and design). The software can be used in a variety of network configurations ranging from a stand-alone workstation to a network of workstations connected through TCP/IP networking to a ProSolv® DICOM Server. The DICOM Server permits studies to be transferred from DICOM compatible imaging instruments directly to a ProSolv® database using TCP/IP.

General Safety and Effectiveness Concerns

The device labeling and manual provide operating instructions for the safe and effective use of ProSolv® CardioVascular software. The display, storage, retrieval, and analysis of information provide a minor level of hazard concern.

Substantial Equivalence

ProSolv® CardioVascular is substantially equivalent to the ProSolv® Echo products that are currently on the market. While there are some feature differences between the ProSolv device and the equivalent device, these differences do not affect the safety or effectiveness of the new device.

The ProSolv CardioVascular products have expanded on the ProSolv Echo products to include additional medical disciplines. As the image viewer was already a generic DICOM viewer, few changes were made in this area other than additional viewer features. The primary area of changes necessary to incorporate other medical fields was the addition of new measurements and reports. The customizing features of the software were already present in ProSolv Echo, so vascular measurements had to be added and vascular reports had to be developed with the aid of a beta site. With ProSolv CardioVascular being a general image viewer and reporting system, and with its advanced customizing features, the product can be expanded into other areas as well. This requires creating a list of measurements if needed, the necessary reports and appropriate comment files. This flexibility contributes to the effectiveness of the device, without compromising the safety.

Conclusions

With ProSolv® CardioVascular digital medical images, from virtually any digitalimaging instrument available today, can be reviewed, analyzed, reported, databased, and archived. The software can read DICOM images and most non-DICOM images. ProSolv® CardioVascular Server allows for remote access to a database located on a server.

The ProSolv® CardioVascular device meets applicable standards and several voluntary standards. The primary difference between the current ProSolv device and the equivalent device is in the expanded indications for use. The core program is basically the same, with some added features for the viewer, analyzer and reporting functions. These differences do not adversely affect the safety or effectiveness of the new device. Based on the comparison between the ProSolv® CardioVascular device and the legally marketed device, all indications are that the ProSolv® CardioVascular device is substantially equivalent to ProSolv® Echo.

2-3

K023112 p2/2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of an eagle with three stripes extending from its head, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2002

Problem Solving Concepts, Inc c/o Mr: Thomas M. McClelland Product Engineer 8020 Castleway Drive, Suite 120 Indianapolis, IN 46250

Re: K023112

Trade Name: ProSolv® CardioVascular Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: September 16, 2002 Received: September 19, 2002

Dear Mr. McClelland:

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. 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 class III (PMA). 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Thomas M. McClelland

Please be advised that FDA's issuance of a substantial equivalence determination docs 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

DaGa Tulle
Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page I of I

510(k) Number (if known):

ProSolv CardioVascular Device Name:

Indications For Use:

ProSoly® CardioVascular is intended for use by doctors and non-physicians (e.g., sonographers, technicians, nurses) who are affiliated with medical labs that use images obtained from digital-imaging DICOM instruments (echo, vascular, nuclear cardiology, cardiac catheterization, MRJ, etc.) The ProSolv® CardioVascular image management and reporting system is software that operates on standard PC equipment using Windows 95 or later operating system. ProSolv® CardioVascular provides the functionality for archiving, viewing, measuring, analyzing, and reporting digital studies generated by digital-imaging instruments from a multitude of manufacturers. The software is available in several configurations: Administrator (report viewing, edit patient demographic information), Viewer (image and report viewing, basic measurements), and Analyzer (Viewer features plus measurements, qualitative assessment, and report creation and design). The software can be used in a variety of network configurations ranging from a stand-alone workstation to a network of workstations connected through TCP/IP networking to a ProSolv® DICOM Server. The DICOM Server permits studies to be transferred from DICOM compatible imaging instruments directly to a ProSolv® database using TCP/IP.

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qulater

510(k) Number K023112

(Optional Format 3-10-98)

x Prescription Use

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).