CharruaPACS System™ is a software based device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.). Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor.

Device Description

The CharruaPACS System™ consists of the CharruaPACS Workstation/Server and the DICOM Viewer (CWS). The device is a software system to be used to handle and view DICOM compliant studies, which are stored within the device or specified network locations. The System supports DICOM C-STORE SCP for most used SOP classes, with uncompressed Transfer Syntax and JPEG lossless, JPEG lossy and JPEG 2000 Transfer Syntaxes, C-FIND and C-MOVE SCP Study Root model and C-ECHO Verification as SCP. It is composed of four applications: Admin, DICOM Server, WEB Server, and HTTP Client. The servers run as Windows Services. It also uses the Independent JPEG group library for JPEG compression/decompression and the OpenJPEG group library for JPEG 2000 compression/decompression. The advanced version uses PostgreSQL as database. WebServer is based on Indy Project TIdHTTPServer. The CharruaPACS System™ is intended for professional use, as a viewing tool for imaging studies, and is a 'Continuous Use' device. This device is also compliant with HIPAA regulations regarding patient privacy. There is no direct patient interaction with the device. The CharruaPACS System is intended to work as a standalone service that provides common PACS functionality.

AI/ML Overview

The provided text describes a 510(k) submission for the CharruaPACS System™, a Picture Archiving and Communications System (PACS). For devices like PACS, substantial equivalence is often demonstrated through a comparison with a predicate device and verification that the new device does not introduce new safety or efficacy issues. The testing performed for such devices typically focuses on functional performance, cybersecurity, and adherence to relevant standards, rather than clinical performance for diagnostic accuracy.

Based on the provided text, the device itself (CharruaPACS System™) is a PACS for handling and displaying medical images, not an AI-powered diagnostic tool. Therefore, the "acceptance criteria" and "device performance" are related to its functionality as a PACS, and the "study" is a nonclinical verification and validation process against these functional requirements.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that CharruaPACS System™'s performance was assessed against its predicate device (InstaRad K080334) through a feature-by-feature comparison and nonclinical testing. The "acceptance criteria" can be inferred from the features listed as "No difference" or where differences were determined to have "no impact on safety or efficacy" after testing. The "reported device performance" is that these criteria were met.

Feature/Function	Acceptance Criteria (Implied)	Reported Device Performance
Hardware Server	Functional operation with Intel i5 processor, Windows 7, Minimum 4GB RAM, Minimum 400GB HDD.	Tested and validated; no impact on safety or efficacy.
Workstation Client Hardware	Functional operation with Intel i5 processor, Windows 7, Minimum 4GB RAM, Minimum 400GB HDD.	Tested and validated; no impact on safety or efficacy.
Image Viewing Layout	Display standard formats (at least up to 2*3).	Meets this criterion; deemed a user preference and no impact on safety or efficacy.
Report Formats	Support DICOM SR for reporting.	Supports DICOM SR; deemed superior to predicate's MS Word for interoperability, no impact on safety or efficacy.
Other Shared PACS Features	Must provide features like WW/WL, Zoom, Hounsfield Measurement, Linear/Angle measurements, Series Comparison, Scout line, Stack mode, Gray scale invert, Filters, Rotate, Key Image selection, DICOM Print, Windows print, Query/Retrieve, Image compression (lossless streaming), Selection tools (thumbnails), Reporting Interface, Report Template Support, Digital Signature, Link to HIS/RIS, Electronic patient record (via broker), HIPAA compliance, RAID storage.	All these features were present and deemed equivalent ("No difference") or differences had no impact on safety or efficacy after testing.
General Functionality	Handle and view DICOM compliant studies, store within device/network, support DICOM C-STORE SCP, C-FIND, C-MOVE SCP Study Root model, C-ECHO Verification.	Confirmed through description and assumed to be validated by nonclinical testing.
Safety and Efficacy Equivalence	No new potential safety risks, equivalent in performance to existing legally marketed devices.	Nonclinical tests demonstrated device is as safe, as effective, and performs as well as the predicate device.
Integration and Installation Verification	Performance against acceptance criteria prior to release to client (if installed by CharruaSoft SA).	Performed by designated individuals; results demonstrated predetermined acceptance criteria were met.
All Input/Output Functions & Actions	All functions and actions in each operational mode must pass.	Passed all in-house testing criteria and verification/validation.

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

The document does not specify a "sample size" in terms of patient cases or images for testing the PACS system's functionality. The testing described is "nonclinical testing" against functional requirements and a comparison to a predicate device's features. There is no mention of patient data.

Test Set Sample Size: Not explicitly stated as a number of cases/images. The testing appears to be functional validation of the software system itself.
Data Provenance: Not applicable, as this is a nonclinical validation of a PACS system's functionality, not an AI diagnostic algorithm tested on patient data.

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

This is not applicable. The CharruaPACS System™ is a PACS for image management and display, not an AI-powered diagnostic device requiring expert-established ground truth for diagnostic accuracy. The "ground truth" for this device relates to its functional specifications and adherence to DICOM standards, which would be assessed by software testers, engineers, and potentially quality assurance personnel familiar with PACS systems and relevant standards.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of multiple reviewers or an adjudication process for establishing a "ground truth" related to diagnostic findings, as this is a functional validation of a PACS.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance:

No. An MRMC study is typically performed for AI-powered diagnostic tools to assess their impact on human reader performance. The CharruaPACS System™ is a PACS, not an AI diagnostic algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The CharruaPACS System™ is a PACS, whose primary function is to manage and display images for human interpretation, not to provide standalone diagnostic interpretations.

7. The Type of Ground Truth Used:

For a PACS system, the "ground truth" for validation typically refers to:

Functional Specifications: Whether the system performs its intended functions (e.g., storing images correctly, displaying them, executing tools like zoom, measurements).
DICOM Conformance: Adherence to DICOM standards for image storage, transfer, and display.
System Stability and Reliability: Absence of crashes, data corruption.

The document refers to "predetermined acceptance criteria" and "all verification and validation activities" confirming these criteria were met during nonclinical testing.

8. The Sample Size for the Training Set:

Not applicable. The CharruaPACS System™ is a PACS and is not described as involving machine learning or AI algorithms that require a "training set" of data.

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

Not applicable, as no training set for an AI algorithm is mentioned or implied.

Summary

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K133357
Page 1 of 6

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

November 22, 2013

Submitter's Information: 21 CFR 807.92(a)(1)

Mr. Rafael Sanguinetti Director, CharrauSoft SA Avda. Brasil 2807, Ap. 403 Montevideo, Uruguay, 11300 Tel: +598.270.92850 Email: rafael@charrua.com

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Product Name:	CharruaPACS System™
Common Name:	Picture, archive and communications system
Classification Name:	System, Image Processing, Radiological
Product Code:	LLZ

Predicate Device: 21 CFR 807. 92(a)(3)

CharruaPACS™ system is substantially equivalent to:

Device Classification Name	system, image processing, radiological
510(k) Number	K080334
Device Name	INSTARAD
Original Applicant	MEDSPHERE TECHNOLOGIES PVT LTD.
Regulation Number	892.2050
Classification Product Code	LLZ
Date Received	02/07/2008
Decision Date	02/21/2008
Decision	substantially equivalent (SE)
Classification Advisory Committee	Radiology
Review Advisory Committee	Radiology
summary	summary
Type	Traditional
Reviewed by Third Party	Yes
Expedited Review	No
Combination Product	No
Device Classification Name	system, image processing, radiological

Device Description: 21 CFR 807 92(a)(4)

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It is composed of four applications:

Admin: for the initial configuration. .
. DICOM Server.
. WEB Server: WEB server running on port 80, it allows to change CharruaPACS configuration and to access images through a web browser
HTTP Client: a visualization application that accesses the images in the PACS . through the HTTP port.

The servers run as Windows Services. It also uses the Independent JPEG group library for JPEG compression/decompression and the OpenJPEG group library for JPEG 2000 compression/decompression. The advanced version uses PostgreSQL as database. WebServer is based on Indy Project TIdHTTPServer.

The CharruaPACS System™ is intended for professional use, as a viewing tool for imaging studies, and is a 'Continuous Use' device. This device is also compliant with HIPAA regulations regarding patient privacy (such as restricting access to particular studies, logging access to data). There is no direct patient interaction with the device, therefore, there is no possibility that the CharruaPACS System might lead to a fatal fault or injury to the patient. The CharruaPACS System is intended to work as a standalone service that provides

common PACS functionality.

The System has four main uses:

. Hard copy media replacement: PACS replaces hard-copy based means of managing medical images, such as film archives.
. Remote access: It expands on the possibilities of conventional systems by providing capabilities of off-site viewing and reporting (distance education, tele-diagnosis). It enables practitioners in different physical locations to access the same information simultaneously for teleradiology.
. Electronic image integration platform: PACS provides the electronic platform for radiology images interfacing with other medical automation systems such as Hospital Information System (HIS), Electronic Medical Record (EMR), Practice Management Software, and Radiology Information System (RIS).
Radiology Workflow Management: PACS is used by radiology personnel to manage . the workflow of patient exams.

Indications for Use: 21 CFR 807 92(a)(5)

CharruaPACS System™ is a software based device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.). lmages and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor.

Technological Characteristics: 21 CFR 807 92(a)(6)

CharruaPACS System™ is a software product that handles and manipulates digital medical images. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed. In general, a PACS (Picture Archiving and Communication System) is a medical imaging technology which provides storage of, and convenient access to, images from multiple modalities. Electronic images and reports are transmitted digitally via PACS: this eliminates the need to manually file, retrieve, or transport film jackets. The universal format for PACS image storage and transfer is DICOM 3.x (Digital Imaging and Communications in Medicine). Non-image data, such as scanned

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documents, may be incorporated using consumer industry standard formats like PDF (Portable Document Format), once encapsulated in DICOM. The modified device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices. Both systems have been developed to replace traditional film handling in radiology. The 2 devices are substantially equivalent in the areas of design, architecture, general function, application, and intended use.

Any difference between the two devices does not affect safety or efficacy. The predicate device and the new device are compared below:

Feature/Functions		CharruaPACSDevice	InstaRadK080334Predicate	If different, Impact on Safety and orEfficacy
Indications for Use		Picture.Archiving,CommunicationsSystem	Picture.Archiving,CommunicationsSystem	No difference.
Hardware server(recommended)	Computerprocessor	Intel i5 processor	Pentium dualcore Intel Xeon2.0+ GHzprocessor	Yes, differences.The predicate was based upon the latestcomputer platform at the time ofdevelopment. Pentium dual core Intel xeon2.0+ GHz processor are older technologyand have been basically replaced with acurrent technology with an Intel i5 processor.The current system configuration has beentested and validated and the results oftesting verified that there is no impact onsafety or efficacy and that no additional riskshave been identified.
	OperatingSystem	Windows 7Professional	Windows 2003	Yes, difference.The predicate was based upon the availableMicrosoft operating system for that time,Windows 2003 (server OS) which is nolonger available or supported by Microsoft.Windows 2003 OS been replaced byMicrosoft Windows 7. The system has beentested and validated with Windows 7 and theresults of testing verified that there is noimpact on safety or efficacy and that noadditional risks have been identified.
	Hard disk array	Capacitydepends on theusage volume.Minimum 400GB	Capacitydepends on theusage volume.Minimum 400GB	No difference
	Ram	Minimum 4 GB	Minimum 1GB	Yes, differences.Microsoft Windows 7 OS and the Intel i5processor require a larger RAM foroperating. The system has been tested andvalidated with Windows 7 and the results oftesting verified that there is no impact onsafety or efficacy and that no additional riskshave been identified.
WorkstationClient Hardware(recommended)	Processor	Intel i5 processor	Pentium2.0+Ghz. Dualcore	Yes, differences.The predicate was based upon the latestcomputer platform at the time ofdevelopment. Pentium dual core Intel Xeon2.0+ GHz processor are older technologyand have been replaced with Intel i5processor or equivalent. The current systemconfiguration with the Intel i5 processor hasbeen tested and validated and the results oftesting verified that there is no impact onsafety or efficacy and that no additional risks
Feature/Functions	CharruaPACSDevice	InstaRadK080334Prodicato	If different, Impact on Safety and orEfficacy
	OperatingSystem	Windows 7	Windows XP	Yes, difference.The predicate was based upon the availableMicrosoft operating system for that time.Windows XP which is no longer available orsupported by Microsoft and Windows XP OSbeen replaced by Microsoft Windows 7. Thesystem has been tested and validated withWindows 7 and the results of testing verifiedthat there is no impact on safety or efficacyand no additional risks have been identified.
	Display	Medical GradeMonitor isrecommended.Resolutiondepends on themodality type.	Medical GradeMonitor isrecommended.Resolutiondepends on themodality type.	No difference
	RAM	Minimum 4 GBRAM	Minimum 1GBRAM	Yes, differences.Microsoft Windows 7 OS requires largerRAM then the old technology of Windows XP(which is no longer sold or supported byMicrosoft). The system has been tested andvalidated with Windows 7 and the results oftesting verified that there is no impact onsafety or efficacy and that no additional riskshave been identified.
	Hard Disk	400 GBminimum	400 GBminimum	No difference
	SystemArchitecture	Web based	Web based	No difference
	Hardware	Vendor Neutral	Vendor Neutral	No difference
	Security	Log-on user ID &password	Log-on user ID &password	No difference
	Remotemonitoring	Yes	Yes	No difference
	Server features	Database	PostgreSQL	mySQL
Feature/Functions	CharruaPACS Device	InstaRad K080334Prodicato	If different, Impact on Safety and or Efficacy
	Storage	RAID	RAID	and the results of testing verified that there isno impact on safety or efficacy and that noadditional risks have been identified.
				No difference
Viewer Features:	Image Viewing Layout	Std formats(up to 2*3)	Std formats(up to 4*4)	Yes, Differences.In CharruaPACS there is one less "standard"format than the predicate. This difference isa user preference and does not directlyaffect the image or intended use. The systemhas been tested and validated and theresults of testing verified that there is noimpact on safety or efficacy and that noadditional risks have been identified.
	WW/WL	Yes	Yes	No difference
	Zoom in/Zoom out	yes	yes	No difference
	Hounsfield Measurement	Yes	Yes	No difference
	Linear and anglemeasurements	Yes	Yes	No difference
	Series Comparison	Yes	Yes	No difference
	Scout line display	Yes	Yes	No difference
	3D capabilities	No	No	No difference
	Stack mode	Yes	Yes	No difference
	Gray scale invert	Yes	Yes	No difference
	Filters	Yes	Yes	No difference
	Rotate	Yes	Yes	No difference
	Key Image selection	Yes	Yes	No difference
	DICOM Print	Yes	Yes	No difference
	Windows print	Yes	Yes	No difference
	Query/Retrieve	Yes	Yes	No difference
	Image compression	Lossless streaming	Lossless streaming	No difference
	Selection tools	Thumbnails	Thumbnails	No difference
Reportingmodule	Reporting Interface	Can be openedfrom the vieweror from study list	Can be openedfrom the vieweror from study list	No difference
	Report Template Support	User Defined templates	User Defined templates	No difference
	Digital Signature	Yes	Yes	No difference
	Report Formats	DICOM SR	MS Word	Yes, Differences.MS Word documents are proprietary andonly readable by Microsoft Word orcompatible applications. DICOM SR is aopen standard document readable by anycompetent DICOM Viewer. DICOM SR is

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4 | 17 :

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Feature/Functions		CharruaPACSDevice	InstaRadK080334Predicate	If different, impact on Safety and orEfficacy
				Word documents require some kind ofreference to keep them linked to the studyimages and is not automatically linked as areDICOM SR reports. The system has beentested and validated and the results oftesting verified that there is no impact onsafety or efficacy and that no additional riskshave been identified.
Other features	Link to HospitalInformationSystem (HIS)	Yes	Yes	No difference
	Link toRadiologyInformationSystem RIIS)	Yes	Yes	No difference
	Electronicpatient record	Through BrokerSoftware	Through BrokerSoftware	No difference
	HIPAA	Compliant	Compliant	No difference

Nonclinical Testing:

The complete CharruaPACS System™ configuration has been assessed and tested at the factory and has passed all in-house testing criteria. The Verification & Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the CharruaPACS System™ software in each operational mode and followed the process documented in the Validation Test Plan.

Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met. If the device is installed by ChurrauSoft SA, integration and installations verification tests are conducted against acceptance criteria prior to release to the client.

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for CharruaPACS System™ contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The subject device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The subject and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The modification to the subject device does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.

Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

Therefore, CharruaPACS System™ is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with three lines extending from its body, possibly representing the department's mission or services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 25, 2013

CharruaSoft SA % Mr. Carl Alletto Consultant 111 Melanie Drive AUBREY TX 76227

Re: K133357

Trade/Device Name: CharruaPACS System™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 25, 2013 Received: November 1. 2013 .

Dear Mr. Alletto:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Mr. Alletto

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYow/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K133357

Device Name: CharruaPACS System™

Indications For Use:

Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation.

Mammographic images may only be interpreted using an FDA cleared monitor.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Smh7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

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).