INFINITT Cardiology PACS™ 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 assists Cardiology surgeons when doing preoperative planning and post-operative follow-up.

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

Device Description

INFINITT Cardiology PACS is a software device that consists of INFINITT Server (included Database), and INFINITT Cardiology PACS.

INFINITT Cardiology PACS is a web-based DICOM view station running on Windows 2000/XP. INFINITT Cardiology PACS fully supports the DICOM standard and such functions as advanced DICOM viewing, QCA and LVA. INFINITT Cardiology PACS allows users to take full advantage of the images from various modalities in order to obtain invaluable mission critical diagnostic data and images.

INFINITT supported modalities include: XA, Ultrasound/Echo, MRI, CT and CR/DR. In case of XA and Ultrasound, it offers numerous cardio-specific 2D analysis tools. Intuitive user interface and system architecture offer a configurable work list management and customizable display protocols.

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

INFINITT Cardiology PACS supports interoperability between IHE approved workstations (Integrating the Healthcare Enterprise) with security functions.

AI/ML Overview

This document is a 510(k) summary for the INFINITT Cardiology PACS™ and does not contain information regarding
acceptance criteria, device performance, or a study demonstrating that the device meets specific criteria. It primarily
focuses on establishing substantial equivalence to predicate devices for regulatory clearance.

Therefore, I cannot provide the requested information based solely on the provided text. The document states that the device is a software device that does not provide any diagnostic assistance to the physician. This implies that performance metrics like sensitivity, specificity, or accuracy, which are typical for diagnostic AI devices, would not be applicable or evaluated in the same manner for this type of system.

The closest relevant information is the indications for use, which outlines the intended functions of the device:

Manipulation, displaying, and distribution of medical images.
Display images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
Assists Cardiology surgeons when doing preoperative planning and post-operative follow-up.

For a device of this nature (a PACS for image management), acceptance criteria would typically revolve around:

Functionality: Does it correctly display, store, and distribute images? Does it support the specified modalities and standards (DICOM)? Are the specified analysis tools (QCA, LVA) present and operational?
Performance (technical): Speed of image retrieval, display quality, system stability, data integrity, security, and interoperability.
Usability: User interface effectiveness for trained professionals.

Without a specific study described in the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance.

The document concludes by stating that the 510(k) "contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device." This typically means that the device was shown to be as safe and effective as existing legally marketed devices for its stated intended use, based on its technological characteristics and performance specifications (which are not detailed here in quantifiable terms).

Summary

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(082706

510(k) Summary of Safety and Effectiveness

NOV - 6 2008

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

Date Prepared: July 22, 2008

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:	INFINITT Cardiology PACS ™
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	K034059	K042781	K051649
DeviceClassificationName	system, imageprocessing,radiological	system, imageprocessing,radiological	system, imageprocessing.radiological
Device Name	Sectra AngiographyPackage And SectraCardiology	Real Time Image Inc.	VericisCardiovascular
Applicant	SECTRA AB	IPACS CARDIO	Camtronics MedicalSystems (Emageon)
Regulation #	892.2050	892.2050	892.2050
Product Code	LLZ	LLZ	LLZ
Decision Date	03/09/2004	10/19/2004	08/02/2005

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

INFINITT Cardiology PACS is a software device that consists of INFINITT Server (included Database), and INFINITT Cardiology PACS.

INFINITT supported modalities include: XA, Ultrasound/Echo, MRI, CT and CR/DR. In case of XA and Ultrasound, it offers numerous cardio-specific 2D analysis tools. Intuitive

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510(k) Summary of Safety and Effectiveness

user interface and system architecture offer a configurable work list management and customizable display protocols.

INFINITT Cardiology PACS supports interoperability between IHE approved workstations (Integrating the Healthcare Enterprise) with security functions.

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

The device assists Cardiology surgeons when doing preoperative planning and postoperative follow-up.

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

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

INFINITT Cardiology PACS™ is a software device that does not contact the patient, nor does it control any life sustaining devices.

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

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

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

The 510(k) Pre-Market Notification for the INFINITT Cardiology PACS™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract caduceus, featuring three angled lines that resemble a bird in flight or a stylized representation of a staff with a serpent.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 6 2008

INFINITT Co., Ltd. % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

Re: K082706

Trade/Device Name: INFINITT Cardiology PACSTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 27, 2008 Received: October 29, 2008

Dear Mr. Devine:

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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

hope In Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): KoB2706

Device Name: INFINITT Cardiology PACS™

Indications for Use:

The device assists Cardiology surgeons when doing preoperative planning and post-operative follow-up.

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

Tristan, Choi

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Argu Khan

(Divis ) Division of Fabrettuctive, Abdonlinal and adio mea Deve

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).