(25 days)
Not Found
No
The document describes a standard PACS system for image storage, communication, processing, and display. It mentions image processing but does not include any terms or descriptions related to AI, ML, deep learning, or neural networks. The focus is on DICOM compliance, server architecture, and standard image compression/decompression.
No
The device is described as a software system for handling and viewing DICOM compliant studies, intended for professional use as a viewing tool for imaging studies. It does not mention any therapeutic function.
No
The CharruaPACS System™ is a software-based device used to store, communicate, process, and display digital medical images and data. It is explicitly described as a "viewing tool for imaging studies" and provides "common PACS functionality." It does not perform any analysis or interpretation of the images to diagnose a condition, but rather facilitates their handling and viewing for professional use.
Yes
The device description explicitly states "The device is a software system" and details its components as applications and servers running as Windows Services, handling and viewing DICOM compliant studies. It does not mention any proprietary hardware components included with the device.
Based on the provided information, the CharruaPACS System™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device receives, stores, communicates, processes, and displays digital images and data from various medical imaging sources (CT, MR, ultrasound, etc.). It is described as a "viewing tool for imaging studies" and a "standalone service that provides common PACS functionality." This aligns with the definition of a Picture Archiving and Communication System (PACS), which is used for managing and viewing medical images.
- Device Description: The description reinforces its function as a software system for handling and viewing DICOM compliant studies. It details its technical capabilities related to image handling and network communication.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The CharruaPACS System™ does not interact with biological specimens or perform any analysis on them. Its function is solely related to the management and display of medical images.
Therefore, the CharruaPACS System™ falls under the category of medical image management and viewing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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: 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners, MR scanners, ultrasound systems, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.
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).
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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)
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.
1
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
2
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 | | CharruaPACS
Device | InstaRad
K080334
Predicate | If different, Impact on Safety and or
Efficacy |
|-------------------------------------------------|----------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | | Picture.
Archiving,
Communications
System | Picture.
Archiving,
Communications
System | No difference. |
| Hardware server
(recommended) | Computer
processor | Intel i5 processor | Pentium dual
core Intel Xeon
2.0+ GHz
processor | Yes, differences.
The predicate was based upon the latest
computer platform at the time of
development. Pentium dual core Intel xeon
2.0+ GHz processor are older technology
and have been basically replaced with a
current technology with an Intel i5 processor.
The current system configuration has been
tested and validated and the results of
testing verified that there is no impact on
safety or efficacy and that no additional risks
have been identified. |
| | Operating
System | Windows 7
Professional | Windows 2003 | Yes, difference.
The predicate was based upon the available
Microsoft operating system for that time,
Windows 2003 (server OS) which is no
longer available or supported by Microsoft.
Windows 2003 OS been replaced by
Microsoft Windows 7. The system has been
tested and validated with Windows 7 and the
results of testing verified that there is no
impact on safety or efficacy and that no
additional risks have been identified. |
| | Hard disk array | Capacity
depends on the
usage volume.
Minimum 400GB | Capacity
depends on the
usage volume.
Minimum 400GB | No difference |
| | Ram | Minimum 4 GB | Minimum 1GB | Yes, differences.
Microsoft Windows 7 OS and the Intel i5
processor require a larger RAM for
operating. The system has been tested and
validated with Windows 7 and the results of
testing verified that there is no impact on
safety or efficacy and that no additional risks
have been identified. |
| Workstation
Client Hardware
(recommended) | Processor | Intel i5 processor | Pentium
2.0+Ghz. Dual
core | Yes, differences.
The predicate was based upon the latest
computer platform at the time of
development. Pentium dual core Intel Xeon
2.0+ GHz processor are older technology
and have been replaced with Intel i5
processor or equivalent. The current system
configuration with the Intel i5 processor has
been tested and validated and the results of
testing verified that there is no impact on
safety or efficacy and that no additional risks |
| Feature/Functions | CharruaPACS
Device | InstaRad
K080334
Prodicato | If different, Impact on Safety and or
Efficacy | |
| | Operating
System | Windows 7 | Windows XP | Yes, difference.
The predicate was based upon the available
Microsoft operating system for that time.
Windows XP which is no longer available or
supported by Microsoft and Windows XP OS
been replaced by Microsoft Windows 7. The
system has been tested and validated with
Windows 7 and the results of testing verified
that there is no impact on safety or efficacy
and no additional risks have been identified. |
| | Display | Medical Grade
Monitor is
recommended.
Resolution
depends on the
modality type. | Medical Grade
Monitor is
recommended.
Resolution
depends on the
modality type. | No difference |
| | RAM | Minimum 4 GB
RAM | Minimum 1GB
RAM | Yes, differences.
Microsoft Windows 7 OS requires larger
RAM then the old technology of Windows XP
(which is no longer sold or supported by
Microsoft). The system has been tested and
validated with Windows 7 and the results of
testing verified that there is no impact on
safety or efficacy and that no additional risks
have been identified. |
| | Hard Disk | 400 GB
minimum | 400 GB
minimum | No difference |
| | System
Architecture | 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 |
| | Remote
monitoring | Yes | Yes | No difference |
| | Server features | Database | PostgreSQL | mySQL |
| Feature/Functions | CharruaPACS Device | InstaRad K080334
Prodicato | If different, Impact on Safety and or Efficacy | |
| | Storage | RAID | RAID | and the results of testing verified that there is
no impact on safety or efficacy and that no
additional risks have been identified. |
| | | | | No difference |
| Viewer Features: | Image Viewing Layout | Std formats(up to 23) | Std formats(up to 44) | Yes, Differences.
In CharruaPACS there is one less "standard"
format than the predicate. This difference is
a user preference and does not directly
affect the image or intended use. The system
has been tested and validated and the
results of testing verified that there is no
impact on safety or efficacy and that no
additional 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 angle
measurements | 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 |
| Reporting
module | Reporting Interface | Can be opened
from the viewer
or from study list | Can be opened
from the viewer
or 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 and
only readable by Microsoft Word or
compatible applications. DICOM SR is a
open standard document readable by any
competent DICOM Viewer. DICOM SR is |
3
4 | 17 :
.
4
5
| Feature/Functions | | CharruaPACS
Device | InstaRad
K080334
Predicate | If different, impact on Safety and or
Efficacy |
|-------------------|-----------------------------------------------------|----------------------------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | Word documents require some kind of
reference to keep them linked to the study
images and is not automatically linked as are
DICOM SR reports. The system has been
tested and validated and the results of
testing verified that there is no impact on
safety or efficacy and that no additional risks
have been identified. |
| Other features | Link to Hospital
Information
System (HIS) | Yes | Yes | No difference |
| | Link to
Radiology
Information
System RIIS) | Yes | Yes | No difference |
| | Electronic
patient record | Through Broker
Software | Through Broker
Software | 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.
6
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.
7
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
8
Indications for Use
510(k) Number (if known): K133357
Device Name: CharruaPACS System™
Indications For Use:
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.
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)