CLARISO PACS is a software Teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. CLARISO PACS is used by hospitals, imaging centers, radiologist reading practices.

CLARISO PACS is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.

Device Description

CLARISO PACS™ is a software system to be used to view DICOM compliant studies, which are stored within the CLARISO PACS™ . CLARISO PACS™ is intended for professional use only as a viewing tool for studies within a medical facility. CLARISO PACS™ 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.). Since there is no direct patient interaction with the device, there is no possibility that CLARISO PACS™ might lead to a fatal fault or injury to the patient. The only two most likely causes of a fault would be the change of the computing environment of the Client system, or a mislabeling of the DICOM studies used by the Viewer. In the best-case scenario, CLARISO PACS™ would be able to operate safely in spite of such faults. The strategy of CLARISO PACS™ in fault handling is to keep its normal operation as much as it can. The CLARISO PACS™ is intended to work as a standalone service that provides common PACS functionality. The main objective of CLARISO PACS™ is to be a service that can be embedded in other applications that require PACS functionality.

CLARISO PACS™ has four main uses:

Hard copy 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.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical performance study for an AI-powered diagnostic device.

The document, K132799 for CLARISO PACS™, is a 510(k) premarket notification for a Picture Archiving and Communication System (PACS). Its purpose is to demonstrate substantial equivalence to a predicate device (ERAD PACS), not to prove the clinical performance of a new diagnostic algorithm.

Here's an analysis based on the information provided, highlighting why some requested information is not applicable or unavailable in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on comparing the functionalities and technical characteristics of CLARISO PACS™ with its predicate device, ERAD PACS. The "acceptance criteria" here are implicit in demonstrating that CLARISO PACS™ performs similarly to the predicate while not introducing new safety or efficacy risks.

Item	Acceptance Criteria (Implicit)	Reported Device Performance (CLARISO PACS™)
Overall Functionality	Perform core PACS functionalities (image viewing, storage, organization, manipulation, security, DICOM conformance).	Performs all core PACS functionalities as the predicate.
Web Browser Support	Provide access via a web browser without compromising safety/efficacy.	Uses Google Chrome for all features (and IE/Firefox for some), offering more convenience than the predicate's custom Windows application.
Thumbnail Viewing	Offer thumbnail viewing capability without negative impact.	Supports three sizes of thumbnails (small, medium, large), offering more flexibility than the predicate's single size.
Audit Trail Access	Provide audit trail capabilities without negative impact.	Offers real-time access to audit logs, an improvement over the predicate's offline generation with a lag.
Safety Risks	No new potential safety risks introduced by device differences.	"No impact on safety or efficacy" stated for all differences.
Equivalence	Performance equivalent to existing legally marketed devices (predicate).	"Equivalent in performance to existing legally marketed devices."
DICOM Conformance	Be DICOM 3.0 conformant.	Yes.
HIPAA Compliance	Comply with HIPAA regulations regarding patient privacy.	Compliant with HIPAA regulations.

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

This information is not provided in the document as it's not a clinical performance study. The testing described is non-clinical verification and validation testing of the software itself. It refers to "all input functions, output functions, and actions performed."

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

This information is not provided and is not applicable to this type of submission. Ground truth for clinical diagnostic performance is not relevant for a PACS system which is a viewing and archiving tool, not a diagnostic algorithm.

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable. Adjudication methods are typically used in clinical studies involving human readers to establish a definitive diagnosis or outcome.

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:

No, a MRMC comparative effectiveness study was not done. This type of study is used for AI algorithms that assist in diagnosis, which is not the primary function of CLARISO PACS™. CLARISO PACS™ is a system for archiving and viewing images, not for providing diagnostic AI assistance.

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

No, a standalone AI algorithm performance study was not done. Again, the device is a PACS system, not a diagnostic AI algorithm.

7. The type of ground truth used:

This information is not applicable as there is no diagnostic algorithm being evaluated for clinical performance. The "ground truth" for a PACS system would pertain to its functional correctness (e.g., does it display images correctly, store them reliably, etc.), which is verified through non-clinical testing.

8. The sample size for the training set:

This information is not provided and is not applicable. CLARISO PACS™ is a software system, not a machine learning model that requires a training set of medical images for learning.

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

This information is not provided and is not applicable for the same reason as point 8.

Summary

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K132799
Page 1 of 5

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

Date Prepared:

October 27, 2013

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

Mr. Cody D. Ebberson, CEO Clariso, Inc. 55 Page Street #824 San Francisco, CA 94102 Email: cody@clariso.com

NOV 07 2013

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

Trade Name:	CLARISO PACSTM
Common Name:	Picture, archive and communications system
Classification Name:	System, Image Processing, Radiological
Product Code:	LLZ

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

Device Classification Name	system, image processing, radiological
510(k) Number	K061421
Device Name	ERAD PACS
Original Applicant	ERAD, INC.16303 Panoramic WaySan Leandro, CA 94578
Regulation Number	892.2050
Classification Product Code	LLZ
Decision Date	07/25/2006
Decision	substantially equivalent (SE)
Classification Advisory Committee	Radiology
Review Advisory Committee	Radiology
summary	summary
Type	Traditional
Reviewed by Third Party	No
Expedited Review	No
Combination Product	No

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

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intended to work as a standalone service that provides common PACS functionality. The main objective of CLARISO PACS™ is to be a service that can be embedded in other applications that require PACS functionality.

CLARISO PACS™ has four main uses:

Hard copy 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)

CLARISO PACS™ is a software Teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. CLARISO PACS™ is used by hospitals, imaging centers, radiologist reading practices. CLARISO PACS™ is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.

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

CLARISO PACS™ is a software application 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 documents, may be incorporated using consumer industry standard formats like PDF (Portable Document Format), once encapsulated in DICOM. The new 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, and intended use. The predicate device and the new device are compared below:

ltem	Functionality	Predicate device(ERAD PACS)	CLARISO PACS™	If different, Impact on Safetyand or Efficacy
	Web Browser Software	Custom MicrosoftWindows application	Google Chrome for allfeatures. MicrosoftInternet Explorer &Mozilla Firefox for featuresexcept the DICOM Viewer	Provides access in the GoogleChrome web browser instead ofusing a custom Windowsapplication. See reference #1below.
2	Intended use	Acquiring, viewing,editing and storingradiographs andrelated patients images	Same	No difference
3	Intended user	Radiologist	Radiologist	No difference
4	Network	10/100/100 Ethernet	Same	No difference
5	Monitor	Above 19inch monitor(Above 1280x900)	Same, Using 1280x1024	No difference
6	User interaction/input	Mouse and keyboard	Same	No difference
7	Import / export images	Yes	Yes	No difference
8	Acquisition devices	CT, MR, US, PET	Same	No difference
9	Image organization	Yes. Patient ID, Name.study instance UID	Same	No difference
10	Image search available	Yes	Yes	No difference
11	Image storage	Yes	Yes	No difference
12	Database software	MySQL	MySQL	No difference
13	Greyscale ImageRendering	Yes	Yes	No difference
14	RGB Image Rendering	Yes	Yes	No difference
15	Localizer Lines	Yes	Yes	No difference
16	Localizer Point	Yes	Yes	No difference
17	Orientation Markers	Yes	Yes	No difference
18	Distance Markers	Yes	Yes	No difference
19	Study Data Overlays	Yes	Yes	No difference
20	Stack Navigation	Yes	Yes	No difference
21	Window Level	Yes	Yes	No difference
22	Zoom in on images	Yes	Yes	No difference
23	Panning	Yes	Yes	No difference
24	Horizontal/Vertical Flip	Yes	Yes	No difference
25	Clockwise/Counterclockwise rotate	Yes	Yes	No difference
26	Invert image	Yes	Yes	No difference
27	Text Annotation	Yes	Yes	No difference
28	Area measurementannotation	Yes	Yes	No difference
29	Angle measurementannotation	Yes	Yes	No difference
30	Cobb Angle MeasurementAnnotation	Yes	Yes	No difference
31	Image annotation	Yes	Yes	No difference
32	Image operations	Yes	Yes	No difference
33	Security	Yes	Yes	No difference
34	DICOM 3.0 conformance	Yes	Yes	No difference
35	Worklist	Yes	Yes	No difference
36	Thumbnail viewing	Yes	Different sizes ofthumbnails available	Provides 3 sizes of thumbnailsinstead of just one size. SeeReference #2 below.
37	Login	Yes	Yes	No difference
38	Audit	Yes	Yes	Provides the ability to see theaudit trail at any time in realtime. See Reference #3 below.

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Ref #related todifferences	Functionality or Item	Impact on Safety and or Efficacy
1	Software/HardwareRequirements	The new device CLARISO PACS™ requires Google Chrome Browser to viewimage data. The predicate device, eRAD PACS installs a custom Windowsapplication to view image data. The new device uses the Google Chrome webbrowser. Increasingly, practitioners prefer to use Google Chrome instead ofinstalling a Windows Application because web browsers are more convenient andusers already know how to use them. The function of the hardware and softwareare the same and the use of a Google Chrome web browser in the subject devicedoes not raise any new potential safety risks. The subject device is equivalent inperformance to existing legally marketed devices and was based upon thesoftware developed for the predicate eRAD PACS. Therefore, it is ourdetermination that there is "No impact on safety or efficacy"
36	Thumbnail viewing	There are slight differences in Thumbnail Viewing, The new device CLARISOPACS™ supports three sizes of thumbnails on preview, small, medium and large.The old device only supports medium sized thumbnails. This differencedifferences does not raise any new potential safety risks and gives the useradditional flexibility. The subject device is equivalent in performance to existinglegally marketed devices and was based upon the software developed for thepredicate eRAD PACS. Therefore, it is our determination that there is "No impacton safety or efficacy"
38	Audit	The new device adds a tool to view access logs in real time. The predicate deviceeRAD PACS doesn't have this kind of tool. In ERAD PACS audit trails need to begenerated offline with a lag. Since the subject device has real time log access itgives the user added flexibility and does not raise any new potential safety risks.The subject device is equivalent in performance to existing legally marketeddevices and was based upon the software developed for the predicate eRADPACS. Therefore, it is our determination that there is "No impact on safety orefficacy"

Nonclinical Testing:

The complete CLARISO PACS™ 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 CLARISO PACS™ software in each operational mode and followed the process documented in the Validation Test Plan.

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KB2799
Page 5 of 5

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 CLARISO Inc., 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 CLARISO PACS™ 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, CLARISO PACS™ is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES, USA

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO06-G609 Silver Spring, MD 20993-0002

November 7, 2013

Clariso, Inc. % Mr. Carl Alletto Consultant OTech, Inc. 111 Melanic Drive AUBREY TX 76227

Re: K132799

Trade/Device Name: CLARISO PACS" Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 1.LZ Dated: October 28, 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 10 devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmativ 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. Ilisting 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/Resources/orYou/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/ReportaProblem/dcfault.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): K132799

Device Name: CLARISO PACS

Indications for Use:

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

ming ma
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(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K132799

Page 1 of 1

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).