ADVANTAGE WORKSTATION 4.1

K020483 · GE Medical Systems · LLZ · Feb 28, 2002 · Radiology

Device Facts

• Record ID: K020483
• Device Name: ADVANTAGE WORKSTATION 4.1
• Applicant: GE Medical Systems
• Product Code: LLZ · Radiology
• Decision Date: Feb 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Advantage Workstation 4.1 is a review station, which allows easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis.

Device Story

Advantage Workstation 4.1 is a multi-modality medical imaging review station; operates on Sun Ultra 60/80 workstations; inputs DICOM images from various diagnostic systems (CT, MR, X-ray, PET, NM, US); allows physician selection, processing, and filming of images; output used by physicians as an element for diagnosis; integrates into radiology department workflows; supports standard 10/100 Base-T Ethernet networking.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and risk management/software validation processes.

Technological Characteristics

Hardware: Sun Ultra 60 (Dual UltraSPARC-II, 1GB RAM) or Ultra 80 (Quad UltraSPARC-II, 2GB RAM). Monitors: SONY Trinitron Color or SUN 18.1 LCD. Connectivity: 10/100 Base-T Ethernet. Software: DICOM-compliant image processing and review platform.

Indications for Use

Indicated for use by trained physicians to select, review, process, film, and interchange multi-modality diagnostic images (CT, MR, Vascular/Cardiac/Digital X-ray, PET, PET/CT, MG, NM, US, SR) to assist in clinical diagnosis.

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

• Advantage Windows Review Workstation (K960613)

Reference Devices

• K913770
• K942120

Submission Summary (Full Text)

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General Electric Medical Systems

FEB 2 8 2002

# Advantage Workstation 4.1 510 (k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87 (h)

- 1. Identification of submitter: Scott R. Evans Regulatory Affairs Specialist Telephone: [phone] Fax: [phone] Date Prepared: November 22nd, 2001
#### 2. Identification of Product:

| Device name | Advantage Workstation 4.1 | Advantage Workstation 4.1 |
|------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Classification name | PACS per 21CFR Section 892 2050 | PACS per 21CFR Section 892 205 |
| Manufacturer/<br>Distributor | General Electric Medical Systems<br>283, Rue de la Minière<br>78533 BUC Cedex France | General Electric Medical Systems<br>800E. Business Center Drive<br>Mount Prospect, IL 60056<br>USA |

#### 3. Marketed Devices

Advantage Workstation is substantially equivalent to the devices listed below:

| Model: | Advantage Windows Review Workstation |
|---------------|--------------------------------------|
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K960613 |

### Device Description :

Advantage Workstation 4.1 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as a basis for a diagnosis.

The AW 4.1 is positioned to be the system of choice for all users of CT, MR. Vascular Xray, Cardiac Xray, Digital Xray, PET or even PET/CT systems, MG, NM, US, SR.

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The GE Advantage Workstation 4.1 support the following Sun stations:

- . Ultra 60
- Dual processor 2x450MHz .
- . Dual UltraSPARC-II* CPU
- 1 GB RAM (expandable to 2GB) .
- . Two 36 GB internal disc
- 644 MB Internal CD writer (16x write/40x read). .
- . UltraSparc 80
- QUAD Processor 4X450 MHz .
- Ouad UltraSPARC-II* CPU .
- . 2 GB RAM (expandable to 4 GB)
- Two 36 GB internal disc internal disc .
- 644 MB Internal CD writer (12x write/40x read). .
- Monitors specifications .
- SONY* Trinitron Color Monitor .
- SUN Flat Panel Monitor 18.1 LCD .

Advantage Workstation 4.1 supports the following image networking:

- Standard 10/100 Base-T Ethernet .
The GE Advantage Workstation 4.1 is designed and produced by GE Medical Systems and has been previously submitted to PMN (K913770, K942120, K960613).

#### 5. Indications for Use

The Advantage Windows Workstation 4.1 is a review station which allows easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis.

#### 6. Comparison with Predicate Device

The GE Advantage Workstation 4.1 is substantially equivalent to the following workstation:

Advantage Windows Review Workstation

Manufacturer: GE Medical Systems

510(k): K960613

Both of these workstations allow easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.

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## 7. Conclusions

Advantage Workstation 4.1 brings additional features in order to integrate seamlessly into the Radiology Department Workflow.

The entire potential new hazards has been studied and controlled by a Risk Management Plan:

- A hazard analysis/ Risk Management Summary .
- A software development and validation process .
- A software verification plan .

Advantage Workstation 4.1 provides images comparable to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2002

General Electric Medical Systems % Mr. Wolfram Gmelin Technical Manager TÜV Rheinland of North America 12 Commerce Road NEWTON CT 06470

Re: K020483

Trade/Device Name: Advantage Workstation 4.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: February 1, 2002 Received: February 13, 2002

Dear Mr. Gmelin:

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 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.

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. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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# STATEMENT OF INTENDED USE

510(k) Number (if known): KC20483

Device name: Advantage Workstation 4.1

Indication For Use:

The Advantage Workstation 4.1 is a review station, which allows easy selection, The Advantage Tronicalor - The Change of multi-modality images from a review, processing, himing and systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel G. Ayres

(Division Sim Division in to more to ans in 510kr Numner

Prescription Use _ (Per 21 CFR 801.109) -OR-

Over-The-Counter Use _