Xelis Cardiac™ is intended for the manipulation, displaying, and distribution of medical images. It can display images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.

The device is used by physicians when doing preoperative planning and post-operative follow-up. Device functions are initiated manually by the user and are not performed automatically or semi-automatically by the software. The software does not provide any diagnostic assistance to the physician. Any diagnostic determination or treatment is solely determined by a physician and not by the software.

Typical users of this system are trained professionals, (for example: surgeons, physicians, and radiologists).

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Device Description

Xelis Cardiac™ is a software device intended for viewing and manipulating DICOMcompliant medical images from CT (computerized tomography), PET (positron emission tomography) or MRI (magnetic resonance imaging) scanners and other imaging modalities.

Xelis Cardiac™ is a software device that consists of INFINITT Server (Database), and the software application which supports the DICOM standard with such functions as advanced DICOM viewing.

The subject device allows users to take advantage of the images from various modalities in order to view data and images and the web based solution distributes images and relevant information to internal and external users at anytime. Remote diagnostic software configuration enables fast information delivery in a low bandwidth network environment and centralized management module enables automatic update.

Xelis Cardiac™ supports interoperability between IHE approved workstations (Integrating the Healthcare Enterprise) with security functions.

Xelis Cardiac™ does not perform computer aided diagnosis and does not include anv automated or semi-automated processes for the detection of nodules or other diseases and is not intended for use with or for the primary diagnostic interpretation of Mammography images.

The software does not provide diagnostic assistance to the physician. Any diagnostic determination or treatment is solely made by a physician and not the software.

AI/ML Overview

The provided document describes XELIS Cardiac™, a software device for viewing and manipulating medical images. Based on the content, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "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." And "If the device is installed by INFINITT CO., LTD, integration and installations verification tests are conducted against acceptance criteria prior to release to the client."

However, the specific "predetermined acceptance criteria" themselves (e.g., performance metrics, thresholds) are not detailed in the provided text. The document broadly states that the device "passed all in-house testing criteria" and "demonstrated that the predetermined acceptance criteria were met."

Therefore, a table of specific acceptance criteria and reported performance cannot be provided from this text. The study primarily focuses on demonstrating functional equivalence and safety (non-inferiority) to predicate devices rather than specific quantitative performance metrics.

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

The document does not explicitly state the sample size used for any specific test set related to image data or patient cases. It mentions "The complete system configuration has been assessed and tested at the factory and has passed all in-house testing criteria."

The data provenance (e.g., country of origin, retrospective or prospective) for any image data used in testing is not specified.

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

The document states that the software "does not provide diagnostic assistance to the physician. Any diagnostic determination or treatment is solely made by a physician and not the software." It also mentions "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."

However, there is no information provided regarding the number of experts, their qualifications, or their role in establishing ground truth for any test set (e.g., for diagnostic accuracy or image interpretation performance). The study appears to be primarily focused on the functional performance and reliability of the software as an image viewing and manipulation tool, rather than its diagnostic accuracy comparative to human experts.

4. Adjudication Method for the Test Set

Since no specific test set involving human interpretation or ground truth establishment based on expert consensus is described, there is no information provided on any adjudication method.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in the provided text. The document explicitly states that the software "does not perform computer aided diagnosis and does not include any automated or semi-automated processes for the detection of nodules or other diseases" and "does not provide any diagnostic assistance to the physician." Therefore, a study comparing human readers with and without AI assistance is not relevant to this device's intended use.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study of the algorithm without human-in-the-loop performance, in the context of diagnostic performance, was not conducted or reported. The device's primary function is as a PACS system for image viewing and manipulation, where the "human-in-the-loop" (the physician) is always the ultimate interpreter. The non-clinical testing focused on system functional performance and validation.

7. Type of Ground Truth Used

The document does not describe the use of any ground truth (e.g., expert consensus, pathology, outcomes data) in the context of evaluating diagnostic accuracy or similar performance metrics. The testing focused on validating the software's functional capabilities (input, output, actions) against internal criteria.

8. Sample Size for the Training Set

Since the device "does not perform computer aided diagnosis" and does not employ AI/ML algorithms that would typically require a training set for diagnostic tasks, there is no information provided regarding a training set sample size.

9. How Ground Truth for the Training Set Was Established

As no training set is described for diagnostic AI/ML algorithms, there is no information provided on how ground truth would have been established for such a set.

Summary

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K11660

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

Date Prepared:

June 8, 2011

SEP 1 3 2011

Submitter's Information: 21 CFR 807.92(a)(1) Mr. Tristan Choi, Program Manager INFINITT Co., Ltd. 12F Daerung Post Tower III, 182-4 Guro-dong, Guro-gu, Seoul, 152-050, Korea Tel: +82-2-2194-6673 Fax: +82-2-2194-1698

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

Trade Name:	XELIS Cardiac
Common Name:	Picture Archiving Communications System
Classification Name:	system, image processing, radiological
Product code:	LLZ
Device Classification:	892.2050

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

510(k) Number	K082990	K070831
Device ClassificationName	system, imageprocessing, radiological	system, imageprocessing, radiological
Device Name	INFINITT CARDIOLOGYPACS	VOXAR 3DENTERPRISE
Applicant	INFINITT CO., LTD	BARCOVIEW MISEDINBURGH
Regulation Number	892.2050	892.2050
Classification ProductCode	LLZ	LLZ
Decision Date	11/06/2008	05/22/2007
Classification AdvisoryCommittee	Radiology	Radiology
Type	Traditional	Traditional

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

Xelis Cardiac™ is a software device that consists of INFINITT Server (Database), and the software application which supports the DICOM standard with such functions as advanced DICOM viewing.

The subject device allows users to take advantage of the images from various modalities in order to view data and images and the web based solution distributes images and

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relevant information to internal and external users at anytime. Remote diagnostic software configuration enables fast information delivery in a low bandwidth network environment and centralized management module enables automatic update.

Xelis Cardiac™ supports interoperability between IHE approved workstations (Integrating the Healthcare Enterprise) with security functions.

The software does not provide diagnostic assistance to the physician. Any diagnostic determination or treatment is solely made by a physician and not the software.

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

The device is used physicians when doing preoperative planning and post-operative follow-up. Device functions are initiated manually by the user and is not performed automatically or semi-automatically by the software does not provide anv diagnostic assistance to the physician. Any diagnostic determination or treatment is solely determined by a physician and not the software.

Typical users of this system are trained professionals, (for example: surgeons, physicians, and radiologists).

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

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

Xelis Cardiac™ is a software device that does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians.

A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

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.
Nonclinical Testing:

The complete system configuration has been assessed and tested at the factory and has passed all in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the Xelis Cardiac™ software in each operational mode and followed the process documented in the System 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 INFINITT CO., LTD, integration and installations verification tests are conducted against acceptance criteria prior to release to the client. results are provided in the 510(k)

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

The 510(k) Pre-Market Notification for Xelis Cardiac™ 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 new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use 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 devices.

Therefore, Xelis Cardiac™ is substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a serpent winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

INFINITT Co.. Ltd. % Mr. Carl Alletto Consultant OTech, Inc. 1600 Manchester Way CORINTH TX 76521

SFP 13 2011

Re: K111660

Trade/Device Name: Xelis Cardiac™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 8, 2011 Received: June 14, 2011

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

ff you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/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/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

Typical users of this system are trained professionals, (for example: surgeons, physicians, and radiologists).

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Patil

Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number	K111660
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Page 1 of ___

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).