INFINTT CO., LTD. STARPACS SYSTEM

K031013 · Infinitt Company · LLZ · Apr 17, 2003 · Radiology

Device Facts

• Record ID: K031013
• Device Name: INFINTT CO., LTD. STARPACS SYSTEM
• Applicant: Infinitt Company
• Product Code: LLZ · Radiology
• Decision Date: Apr 17, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

STARPACS ™ is a device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.

Device Story

STARPACS is a server-based software application for managing medical images within a PACS environment. It receives digital images and data from various sources (CT, MR, ultrasound, R/F, CR/DR, secondary capture devices, scanners, imaging gateways). The system stores, communicates, processes, and displays these images across computer networks. Implementation is based on the DICOM 3.0 standard, enabling communication with other DICOM-compliant imaging devices. Used in clinical settings by radiologists and physicians to access current and historical patient images and examination data. The system facilitates clinical practice by providing tools for viewing, retrieval, manipulation, and distribution of images. It does not contact the patient or control life-sustaining devices; a physician interprets the displayed information.

Clinical Evidence

No clinical data. The submission relies on bench testing and hazard analysis. Potential hazards were classified as Minor.

Technological Characteristics

Server-based software application; DICOM 3.0 compliant; distributed image management architecture; non-contact; no life-sustaining functions; relies on human interpretation of displayed data.

Indications for Use

Indicated for use by trained professionals (physicians, nurses, technicians) to receive, store, communicate, process, and display digital medical images and data from various imaging sources (CT, MR, ultrasound, R/F, CR/DR) across distributed networks.

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

• MEDIFACE PACS TM (K010259)

Submission Summary (Full Text)

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K031013

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# APR 1 7 2003

#### 510(k) Summary of Safety and Effectiveness

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

Date Prepared: March 18, 2003

Submitter's Information: 21 CFR 807.92(a)(1) INFINITT Co., Ltd. 275-5 Taeseok Bldg. 9F, Yangjae 2-dong, Seocho-gu, Seoul 137-943, South Korea

> (Note: Mediface Co., Ltd. has merged with 3Dmed Co., Ltd. and the new company name is INFINITT Co. Ltd.)

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) Trade Name: STARPACS™ Common Name: Picture Archiving Communications System Device Classification: 892.2050 System, Image Processing Name:

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

| Manufacturer: | . | MEDIFACE CO., LTD. |
|----------------------------------|---|--------------------------|
| Device: | . | MEDIFACE PACS TM |
| 510(k) Number: | . | K010259 |
| Date Received: | . | 01/29/2001 |
| Decision Date: | . | 04/26/2001 |
| Decision: | . | Substantially Equivalent |
| Panel Code device reviewed by: | . | Radiology |
| Panel Code device classified by: | . | Radiology |
| Product Code: | . | LLZ |
| Classification: | . | Class II - 892.2050 |

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

STARPACS ™ is a server-based software application that is a distributed image management system that manages the viewing, retrieval, manipulation, and distribution of medical images within a Picture Archiving and Communication System (PACS) environment. The system provides online access to patients' current and historical radiological images and relevant examination data and is designed for facilitating the clinical practice of radiologists and physicians. STARPACS ™ implementation is based on the Digital Imaging and Communication in Medicine (DICOM 3.0) standard. The standard allows communications of images and relevant information such as patient demographics and examination data between the system and other DICOM-compliant imaging devices such as CT

scanners, MR imager, CR systems, and image viewing workstations.

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

STARPACS ™ is a device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.

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

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.

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

The 510(k) Pre-Market Notification for STARPACS ™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. STARPACS ™ 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 potential hazards have been classified as Minor.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2003

Infinitt Co., Ltd. % Mr. Carl Alletto OTech, Inc. 1100 Lakeview Blvd. DENTON TX 76208

Re: K031013

Trade/Device Name: INFINITT Co., Ltd. STARPACS™ System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ

Dated: March 19, 2003 Received: March 31, 2003

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. Iisting 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 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); 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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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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon 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 Form)

510(k) Number: 长۵ 3 10 / 3

Device Name:

INFINITT Co. Ltd. STARPACS™

Indications for Use:

STARPACS ™ is a device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.

Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.

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

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Daniel A. Segura

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _