ViewStation supports image and information flow among health care facility personnel. ViewStation can be used whenever digital images and associated data are the means for communicating information. ViewStation is not intended for use in diagnosis.

The intended use of ViewStation is to provide health care facility personnel with an effective means to utilize patient images during the course of therapy or treatment. ViewStation allows users to import, view, annotate, manipulate, enhance, manage, and archive patient images and associated information are stored in a database, providing users access to the information necessary to perform their functions.

Device Description

The primary function of ViewStation is to provide a means to more effectively manage image information in a therapy or treatment environment. ViewStation provides the ability to import, view, annotate, manipulate, enhance, and archive patient images during the course of therapy, treatment, and follow-up.

ViewStation imports existing digital images acquired or generated by other products. ViewStation retains the original image, which was acquired or generated by a third party product. With these facts in mind, the goal of ViewStation is to make electronic patient image information more accessible throughout the department. IMPAC is providing a tool to increase department productivity since digital images, unlike films, do not have to be physically transferred from one station to another.

AI/ML Overview

The ViewStation is an Image Management System which is explicitly not intended for diagnostic use but rather for managing images and information flow in a healthcare facility. Given this, the submission does not contain a study involving clinical efficacy or diagnostic performance. Instead, the "acceptance criteria" and "study" are focused on demonstrating that the updated software maintains the safety and effectiveness of the predicate device for its intended non-diagnostic use.

Here's an breakdown:

1. A table of acceptance criteria and the reported device performance

The submission does not present a table of acceptance criteria in the traditional sense of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the requirements for regulatory compliance, internal quality standards, and successful software development and testing. The "reported device performance" is the successful completion of these processes, affirming that the updated ViewStation maintains its intended non-diagnostic functionality and safety.

Aspect of Acceptance/Performance	Reported Performance/Method of Meeting
Safety and Effectiveness	Product change does not diminish safety or effectiveness. System Hazard Analysis (SHA2102) performed, documented, reviewed, and implemented. Hazard identification traced through evaluation, design, specification, implementation, and testing. Design Review Team confirmed no increased health or safety risk.
Intended Use	Identical indications for use to predicate device. "The total sum of all feature enhancements does not affect the intended use of ViewStation."
Technological Characteristics	"Technological characteristics remain principally the same." "Evolutionary product changes does not raise any new questions of safety and effectiveness, nor do the changes require novel methods of verification or validation."
Basic Functionality	"The sum of the changes does not affect the basic functionality of ViewStation remains dedicated to providing healthcare personnel with a means to import, view, annotate, manage, and archive patient images."
Software Quality	Developed according to IMPAC Software Design Control Procedure (SDCP). IMPAC Quality System complies with ISO 9001:2000, ISO 13485:2003, ISO 14971:2000, EN 60601-1-4:1996, ISO/IEC 9003:2004, and 93/42/EEC.
Verification and Validation	Traceability Matrix created. System Test Plan for full application, integration, and system testing. Test Procedures capture detailed parameters, results, and certification. Test certification statement confirms planned testing completed successfully. Design Reviews performed at each phase.
Algorithm/Technical Changes	Engineering performed to ensure algorithms and all other technical changes function exactly as intended. Testing demonstrated successful implementation.
Regulatory Compliance	Submitted under 510(k) Premarket Notification as substantially equivalent to predicate devices (K011694 and K942346).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and therefore not provided in the submission. Since the device is explicitly not intended for diagnosis and the changes are evolutionary software updates to an existing image management system, no clinical "test set" of patient data (images) was used to evaluate diagnostic performance. The testing performed was related to software verification and validation, hazard analysis, and functional integrity.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not provided in the submission. As no clinical "test set" using patient data for diagnostic evaluation was involved, no experts were required to establish ground truth for such a purpose. The "experts" involved would be software engineers, quality assurance personnel, and potentially medical professionals (users) providing feedback on the system's usability and functionality, but not establishing diagnostic ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided in the submission. Adjudication methods are typically used in studies involving expert review of diagnostic performance. The testing described focuses on software functionality, safety, and compliance with quality systems, not diagnostic accuracy.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not done. The ViewStation is an image management system and explicitly states it is "not intended for use in diagnosis." Therefore, there is no AI component for diagnostic assistance, and no study to evaluate reader improvement with or without AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The ViewStation is a software system with human-in-the-loop functionality, and not a standalone diagnostic algorithm. Its purpose is to manage images for human users.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable. The device is not for diagnosis, so there is no "ground truth" related to disease presence or absence established from pathology, expert consensus, or outcomes data. The "ground truth" for the software testing would be the expected functional behavior and safety requirements defined in the design specifications.

8. The sample size for the training set

This information is not applicable and therefore not provided in the submission. The ViewStation is a conventional image management software, not a machine learning or AI-driven diagnostic algorithm that requires a "training set" of data in the typical sense. The software's development is guided by established engineering principles and quality systems rather than data-driven machine learning.

9. How the ground truth for the training set was established

This information is not applicable. As there is no "training set" in the context of machine learning, there is no ground truth establishment for such a set. The "ground truth" for software development is based on user requirements, regulatory standards, and design specifications.

Summary

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KO434/2

DEC 20 2004

Thursday, December 09, 2004

ViewStation, Image Management System Premarket Notification (510(k)) 510(K) Summary

Introduction

This document provides a summary of the safety and effectiveness information contained in the Viewstation Premarket Notification (510(k)). The Summary of Safety and Effectiveness contains no confidential or trade secret information and is intended for full public disclosure and distribution. For additional information, feel free to contact the submitter's Management Representative listed below.

Premarket Notification Information

1. Previous Notification Information:
- Previous Premarket Notification # K011694, K 942346 a.
- Previous Submission Date 05/31/01, 05/16/94 b.
- 08/29/01, 05/15/95 Previous FDA Clearance Date c.
- ViewStation/Image RT d. Product Name

2. Product Information

a.	Product Name	ViewStation
b.	Release Version Number	Version 8.2
c.	Product Size	4.9 MB

Classification Information 3.

Picture Archiving and Communications System a. Classification Name
Class II

Radiology

21 CFR 892.2050

Common/Usual Name Image Management System
Product Classification ದಿ.
90 LLZ Product Code b.
- CFR Reference
Review Panel d.

4. Establishment Information

Submitter IMPAC Medical Systems, Inc. e. f. Manufacturer (no sterilization) Submitter Type 2950347 Establishment Number g. Contact Thomas H. Faris, VP RA/QA h. 650-623-8807 i. Contact Phone Contact Email TFaris@impac.com j

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Predicate Device

ViewStation is substantially equivalent to the original ViewStation product, which is currently marketed by IMPAC Medical Systems, Inc., and was the subject of Premarket Notifications K011694 and K942346. The new ViewStation and previous ViewStation products are equivalent in intended use and safety and effectiveness.

ViewStation Indications for Use

Description of the Product

Summary of the Product Change

The only modifications made to the product are the following evolutionary software changes:

. Image viewing and image management feature improved annotation layer overlay, and image registration for calculation of relative reference position shifts.
. Privacy and security functionality to support customer HIPAA compliance.
User interface and product registration improvements. .
. Other minor workflow enhancements that do not affect product safety or efficacy.

Clinical Demonstration of Efficacy

No additional or changed diagnostic or therapeutic claims arise as the result of the ViewStation product. Therefore, demonstration of clinical efficacy is not a required element of this Premarket Notification. Further, clinical performance data is not required for determination of substantial equivalence for this type and class of device.

Substantial Equivalence Comparison

ViewStation is substantially equivalent to the original ViewStation product, which is currently being marketed by IMPAC Medical Systems, Inc. This was the subject of Premarket Notifications K011694 and K942346.

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This Premarket Notification is a resubmission for ViewStation, triggered by enhancement of existing functionality. A I his realler incremental changes that are typical with routine software maintenance also accompany this change, but are too insignificant to merit discussion. The total sum of all feature enhancements does not affect the intended use of ViewStation. The technological characteristics remain principally the same. The evolutionary product changes does not raise any new questions of safety and effectiveness, nor do the changes require novel methods of verification or validation. The product change does not diminish the safety or effectiveness of ViewStation.

The modified ViewStation Image Management System has the following similarities to the previous product that received FDA 510(k) clearance:

Identical indications for use; .
. The same operating principles;
Incorporation of the same basic product design; .
Same materials a software only product; and .
Sterility, biocompatibility, materials, mechanical safety, energy use, environmental . compatibility, and electrical safety all remain non-applicable issues.

The sum of the changes does not affect the basic functionality of ViewStation remains dedicated to providing healthcare personnel with a means to import, view, annotate, manage, and archive patient More simply, the changes do not affect the premise of the basic intended use of ViewStation: to provide images. healthcare facility personnel with an effective means to utilize patient images during the course of therapy or treatment. Once cleared by the FDA, IMPAC will continue to market and distribute ViewStation to be used in this manner.

In summary, the ViewStation Image Management System changes described in this submission are substantially equivalent to the predicate ViewStation device.

Device Safety

ViewStation is a medical device that is to be used in a treatment or therapy setting under the use of appropriately trained health care professionals who are responsible for ensuring the correct and accurate use of medical images.

The ViewStation System Hazard Analysis was performed to determine and evaluate all areas that represent potential safety or health hazards during ViewStation system operation. For all system hazards, effects, and mitigations have all been documented (SHA2102), reviewed, and implemented. This System Hazard Analysis is reviewed with every change and release of the product, including the above-mentioned changes. Validation and verification activities trace the hazard identification through evaluation, design, specification, implementation, and testing. The Design Review Team has reviewed the product change and System Hazard Analysis and has determined that the product change does not increase health or safety risk to patients, users, or other third parties.

Quality System

The fundamental goal of IMPAC's quality program is to provide value to customers and internal operations by producing better and safer products that are less expensive to build and maintain, simpler to use, and easier to support. IMPAC has implemented the IMPAC Ouality System to operate in a manner that has proven to be the most effective. Organizational experience and expertise is built into the management system to ensure that each process consistently meets defined specifications and continuously seeks improvement. All employees receive Quality System training and take pride in the value that they contribute to IMPAC products and to the final customer and their patients.

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ViewStation was developed according to the IMPAC Software Design Control Procedure (SDCP). This procedure governs the process by which system and software development are to be planned, dested, and released.

DOC. ID	TITLE
ISO 9001:2000	Quality Management Systems - Requirements
ISO 13485:2003	Medical Devices - Quality Management Systems - System Requirements forRegulatory Purposes
ISO 14971:2000	Medical Devices - Application of Risk Management to Medical Devices
EN 60601-1-4 :1996	Medical Electrical Equipment - Part 1: General Requirements for Safety - 4.Collateral Standard: Programmable Electrical Medical Systems
ISO/IEC 9003 :2004	Software Engineering - Guidelines for the Application of ISO 9001:2000 toComputer Software
93/42/EEC	Medical Device Directive

The IMPAC Quality System was developed in compliance with all of the following standards and regulations:

Verification and Validation Testing

A Traceability Matrix has been created, based upon the project plan, to ensure the completion of the specification, implementation, and testing of all requirements of the feature enhancement, including performance of full system hazard mitigation and basic operational testing. The System Test Plan for completing full application, integration, and system testing of ViewStation, while the Test Procedures capture the detailed testing parameters, results, and certification. A test certification statement certifies that the planned testing requirements were completed successfully. Design Reviews have been performed at the conclusion of each software design and development phase to review and validate the fulfillment of all of the phase requirements and deliverables. All of the above have been completed for ViewStation and representative documents are available for review.

Summary of Test Conclusions

IMPAC's Quality Engineering department has completed all product operation and hazard mitigation testing and has certified passing test results. Engineering was also performed to ensure that the algorithms and all other technical changes function exactly as intended. The testing demonstrated that the algorithms and all other functionality of ViewStation were successfully implemented.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2004

Mr. Thomas H. Faris Vice President RA/QA, Management Representative IMPAC Medical Systems, Inc. 100 West Evelyn Avenue MOUNTAIN VIEW CA 94041 Re: K043412 Trade/Device Name: ViewStation, Image Processing System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 9, 2004 Received: December 10, 2004

Dear Mr. Faris:

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 do not require approvisions 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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter witi anow you to oegh manceing of substantial equivalence of your device to a legally premarket nothreation. The I DA maing of batism 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 If you desire specific advice of your correst on our of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation on your responsibilities under the Act from the 807.97). You may obtain other general missistance at its toll-free number (800) Division of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmaldsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ViewStation Indications for Use Statement

510(k) Number (if known): _ic o4 3412

Device Name: ViewStation, Image Processing System

Indications for Use:

The intended use of ViewStation is to provide health care facility personnel with an efficient and effective means to utilize patient images during the with an of therapy or treatment. ViewStation allows users to import, view, annotate, manipulate, enhance, manage, and archive patient images. The images and associated information are stored in a database, providing users access to the information necessary to perform their functions.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

(Posted July 1, 1998)

Prescription Use

(Division Sign-Off Division of Reproductive, A and Radiological Dev 510(k) Number

Regulation Number and Section

§ 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).