AMALGA PACS

K023246 · Global Care Solutions, S.A. · LLZ · Dec 23, 2002 · Radiology

Device Facts

• Record ID: K023246
• Device Name: AMALGA PACS
• Applicant: Global Care Solutions, S.A.
• Product Code: LLZ · Radiology
• Decision Date: Dec 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Amalga™ is a device that receives digital images and data from various sources (e.g. 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

Amalga™ PACS receives digital medical images/data from diverse sources (CT, MR, ultrasound, R/F, CR/DR); stores, communicates, processes, and displays data across facility networks. Operated by trained professionals (physicians, nurses, technicians) in clinical environments. System facilitates simultaneous multi-user access to patient information and images. Provides centralized storage and transmission; supports clinical decision-making by enabling image interpretation and reporting by physicians. Does not contact patients or control life-sustaining equipment.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Computer hardware and software-based PACS. Functions as a networked image management system. Does not contact patients. No life-sustaining functions. Software-based image processing and communication. Manufactured in accordance with voluntary standards.

Indications for Use

Indicated for trained professionals (physicians, nurses, technicians) to receive, store, communicate, process, and display medical images and data from various imaging sources (CT, MR, ultrasound, R/F, CR/DR) across computer 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 (PiView) PACS (K010259)

Submission Summary (Full Text)

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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: September 20, 2002

Submitter's Information: 21 CFR 807.92(a)(1) Global Care Solutions, S.A. BH Tower - 19th Floor 33 Sukhumvit Soi 3 Bangkok, Thailand 10110

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

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

| Manufacturer: | Mediface Co., Ltd |
|-----------------|------------------------------|
| | 997-4 Daechi-Dong, 5th floor |
| | Kangnam-Ku |
| | Seoul, Korea 135-280 |
| Device Name: | Mediface (PiView) PACS |
| 510(k) Number: | K010259 |
| Decision Date: | 04/26/2001 |
| Product Code: | LLZ |
| Classification: | Class II - 892.2050 |

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

The Amalga™ System handles various images and data objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.

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

Amalga™ is a device that receives digital images and data from various sources (e.g. 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.

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

The device is a computer hardware and software medical image picture archiving and communications system. 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 Amalga™ System contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The Amalga™ system 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle symbol. The logo is printed in black ink on a white background.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 23 2002

Global Care Solutions, S.A. % Mr. Carl Alletto OTech. Inc. 2001 East Oakshores Drive CROSSROADS TX 76227 Re: K023246

Trade/Device Name: Amalga™ PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: September 9, 2002 Received: September 30, 2002

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 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:

| 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" (21 CFR Part 807.97). 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. Snogdon

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:

Device Name:

AMALGA PACS by Global Care Solutions, S.A.

Indications for Use:

AMALGA PACS is a device that receives medical images and data from various sources (e.g. 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 (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Yairt A. Stagm

(Division Sign-Off) Division of Reproductive. Al and Radiological Devi 510(k) Number

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