INFINITT ULite

K163290 · Infinitt Co., Ltd. · LLZ · Mar 24, 2017 · Radiology

Device Facts

• Record ID: K163290
• Device Name: INFINITT ULite
• Applicant: Infinitt Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Mar 24, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

INFINITT ULite, PACS is a software device that receives medical images and data from various images. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary inage interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians.

Device Story

INFINITT ULite is a PACS software application for viewing, handling, and processing DICOM 3.1 medical images. It functions as a web-based viewer requiring no local component installation (e.g., ActiveX, Flash). The system consists of a viewer application and a server component; it enables remote access to studies stored on a server. Users (physicians, radiologists, nurses, technicians) perform tasks such as windowing, zoom, pan, measurement, cine play, and report viewing. The device facilitates clinical decision-making by allowing healthcare providers to review and approve medical images across distributed networks. It benefits patients by enabling timely access to diagnostic imaging data for clinical interpretation.

Clinical Evidence

No clinical data. Bench testing only. The system passed all in-house pre-determined testing criteria per Software Requirements Specification and User Manual, with no errors impacting safety or efficacy.

Technological Characteristics

Software-only PACS for DICOM 3.1 image handling. Operates on Microsoft Windows (32-bit and 64-bit editions). Built using Microsoft Visual C++ 2010, MFC library, and .NET framework. Web-based deployment model; no local component installation required. Hazard analysis classified as Moderate Level of Concern.

Indications for Use

Indicated for trained professionals (physicians, radiologists, nurses, medical technicians) to store, communicate, process, and display medical images and data. Supports primary diagnosis in mammography only for preprocessed DICOM for presentation images. Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• INFINITT G3 PACS (K052545)

Submission Summary (Full Text)

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Image /page/0/Picture/1 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 image of three human profiles facing to the right, with flowing lines connecting them.

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

March 24, 2017

INFINITT Co., Ltd. INFINITT Healthcare Corporation % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071

Re: K163290

Trade/Device Name: INFINITT ULite Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 14, 2016 Received: November 22, 2016

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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. 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) K163290

Device Name INFINITT ULite

# Indications for Use (Describe)

INFINITT ULite, PACS is a software device that receives medical images and data from various images. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary inage interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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This 510(k) Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

November 14, 2016

Submitter's Information: 21 CFR 807.92(a)(1) Mr. Sang Wook Cho Chief Quality Officer, Research and Development Center, INFINITT Healthcare Corporation 12FI Daerung Post Tower III, 27 Digital-ro 34th Street Guro-gu, Seoul 152-746, South Korea Fax [phone]

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

| Trade Name: | INFINITT ULite™ |
|------------------------|-----------------------------------------|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 System, Image Processing |
| Product Code: | LLZ |

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

| Device Classification Name | system, image processing, radiological |
|------------------------------|----------------------------------------|
| 510(k) Number | K052545 |
| Device Name | INFINITT G3 PACS |
| Applicant | INFINITT CO., LTD. |
| Regulation Number | 892.2050 |
| Classification Product Code | LLZ |
| Date Received | 09/15/2005 |
| Decision Date | 11/08/2005 |
| Decision | substantially equivalent (SE) |
| Regulation Medical Specialty | Radiology |
| 510k Review Panel | Radiology |
| summary | summary |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |

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

The INFINITT ULIte™ system is PACS software capable of viewing and handling DICOM 3.1 medical images. The System allows displaying studies that are not in the same place where the system is placed. With its Web features, it is possible to review, modify, and approve studies located in a server.

ULite is a device that displays medical images (including mammograms) and data from various imaging sources. In the Web environments, it is not needed to download any components, for example Active X, flash, flex, sliver lite, and the user can use this viewer

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# 510(k) Summary of Safety and Effectiveness

in the browser. Typical users of this system are professionals of clinic (e.g. physicians, radiologists, nurses, medical technicians, and assistants).

INFINITT ULite (subject device) is based upon the INFINITT G3 PACS (predicate device). The features and functions of ULite have a sub-set of the features and functions of G3 PACS with an updated operating system due to current advances in computer technology.

| INFINITT<br>ULite<br>Viewer | INFINITT ULIte is a medical image viewing application.<br>It communicates with the INFINITT ULite Server to view the medical<br>images. It supports various functions such as Windowing, Zoom, Pan,<br>measurement, Cine play, and Report viewing. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INFINITT<br>ULite<br>Server | INFINITT ULite Server only supports Microsoft Windows family<br>INFINITT ULite Server has been built by using Microsoft Visual C++<br>2010, MFC library and .net framework. |

ULite software provides both 32-bit and 64-bit editions. When running on x64 editions of Microsoft Windows, the native x64-bit application of ULite must be provided for largememory support. The 32-bit application of ULite can be running on both 32bit and 64bit windows, while the maximum memory capacity might be different. Except the maximum memory support, the 32-bit edition and 64-bit edition must be virtually same in terms of functionalities.

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

INFINITT ULite. PACS is a software device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians.

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

INFINITT ULite™ device is a software product that handles 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.

#### Testing

The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures. The data presented in the submission demonstrates that INFINITT ULite™ performs all required actions according to the functional requirements specified in the Software Requirements Specification and the User Manual with no errors that had an impact on safety or efficacy.

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

The 510 (k) Pre-Market Notification for INFINITT ULite™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. INFINITT ULIte™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Moderate".