SENO ADVANTAGE

K033400 · Ge Medical Systems W-400 · LLZ · Dec 4, 2003 · Radiology

Device Facts

• Record ID: K033400
• Device Name: SENO ADVANTAGE
• Applicant: Ge Medical Systems W-400
• Product Code: LLZ · Radiology
• Decision Date: Dec 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.

Device Story

Seno Advantage is a multi-modality medical image review workstation used in radiology departments. It ingests diagnostic images (CT, MR, XR, RF, XA, CR, DX, MG, NM, PET, US, SC) via DICOM 3.0 protocols over Ethernet. The system features an HP XW8000 workstation with dual Intel Xeon processors, high-resolution monitors (including 5MP grayscale CRT for mammography), and a dedicated keypad to enhance clinician productivity. Physicians use the workstation to select, process, and review images to support clinical diagnosis. The device facilitates workflow integration through image networking, storage, and filming capabilities. It provides clinicians with high-resolution visualization tools to aid in the interpretation of medical images, potentially improving diagnostic accuracy and departmental efficiency.

Clinical Evidence

No clinical data. The submission relies on bench testing, including software verification and validation, and a risk management summary to demonstrate substantial equivalence.

Technological Characteristics

Workstation: HP XW8000, Dual Intel Xeon 3.06GHz, 2GB RAM, 15,000rpm SCSI hard disks. Displays: NEC 18.1" LCD (1280x1024) and 21" Grayscale 5MP CRT (2560x2048). Connectivity: 10/100/1000 Base-T Ethernet, DICOM 3.0, TCP/IP. Input: Keyboard, mouse, dedicated mammography keypad. Power: 110-240VAC.

Indications for Use

Indicated for use by trained physicians for the review, processing, and interpretation of multi-modality diagnostic images, including mammography, for 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 Workstation 4.1 (K020483)

Submission Summary (Full Text)

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General Electric Medical Systems

## K033400 Seno Advantage 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:
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager Telephone: [phone] Fax: [phone] GE Medical Systems W-400 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: August 4, 2003

#### 2. Identification of Product:

| Device name | Seno Advantage |
|--------------------------|-------------------------------------------|
| Classification<br>Panel: | Radiology PACS per 21CFR Section 820 2050 |

| Manufacturer/<br>Distributor | General Electric Medical System<br>283, Rue de la Minière<br>78533 BUC Cedex France |
|------------------------------|-------------------------------------------------------------------------------------|
|------------------------------|-------------------------------------------------------------------------------------|

#### 3. Marketed Devices

Seno Advantage is substantially equivalent to the devices listed below:

| Model: | Advantage Windows Review Workstation |
|---------------|--------------------------------------|
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K020483 |

#### 4. Device Description :

The Seno Advantage Workstation is a multi-modality review workstation. It includes a color flat panel for the multi-modality image review and two specific B&W high resolution

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General Electric Medical Systems

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# 033400

monitors for the mammographic images review. Moreover, a dedicated keypad is provided to increase productivity.

The Seno Advantage is positioned to be the system of choice for all users of Modality: CT, MR, XR, RF, XA, CR, DX, MG, NM, PET, US, SC.

The Hardware configuration of Seno Advantage is the following:

- HP XW8000 Workstation: .
- Dual Intel® Xeon™ Processor .
- 2 x 3.06GHz CPU Clock Speed with 512KB Cache per CPU ●
- 2GB RAM (expandable to 4GB) ●
- 2 x 73 GB: Ultra160 SCSI 15,000rpm Hard Disks .
- 130 GB can be used for image storage as follows: .
- . 991,821 2562 images OR
- 247,995 5122 images OR .
- . 61,989 10244 images OR
- 12,398 2048 x 2560 images .
- Internal CD-ROM drive (48x read/write) for read/write of DICOM media, . read/write of Data Export data and service use.
- 1 internal 3½" Floppy Drive .
- 1 US QWERTY Keyboard.
- 1 mechanical 3-buttons mouse ●
- 1 Mammography dedicated keypad. .
- 1 B&W Video board 5Mpixels Dual Head .
- Monitors specifications : Two types of monitors are used. Specifications for each of these monitors is given here:
- · 1 NEC* Flat Panel 18.1" LCD
- · NEC MultiSync* LCD1880SX
- · 18.1 inch diagonal width
- · 1280x1024 Landscape display
- · 60 Hz refresh rate
- · Height: 44.5cm (17.5in.)
- · Width: 39.8cm (15.7in.)
- · Depth: 21.8cm (8.6in.)
- Weight: 8.5kg (18.7lb.) .
- 110-240VAC, 47-63Hz, 0.35-0.8Amps. .
- 2 Graysacale 5 Mpixels CRT ●
- 21 inch diagonal width .
- 2560x2048 portrait display .

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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters are stylized and have a flowing, cursive appearance. The logo is in black and white.

K033400

- 76 Hz refresh rate ●
- Height: 52cm (20.4in.) ●
- Width: 40.5cm (16in.) ●
- Depth: 50.5cm (19.8in.) �
- Weight: 35kg (78.7lb.) .
- . 110-240VAC, 47-65Hz

Seno Advantage supports the following image networking:

- . Standard Standard 10/100/1000 Base-T Ethernet Protocols supported:
- DICOM 3.0 Storage SCU/SCP and Query/Retrieve SCU/SCP .
- . InSite
- TCP/IP network layer .
- SdCNet supported to query/retrieve from AW 3.1 and AW 4.0 .

#### 5. Indications for Use

Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.

#### 6. Comparison with Predicate Device

The Seno Advantage is substantially equivalent to the following workstation: Advantage Workstation 4.1 Manufacturer: GE Medical Systems 510(k): K020483 Both of these workstations allow easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.

#### 7. Conclusions

Seno Advantage 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 .

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Image /page/3/Picture/0 description: The image shows the text "General Electric Medical Systems". The text is in a serif font and is black. The background is white.

Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters and the border are in black, set against a white background. The logo is a well-known symbol associated with the multinational conglomerate.

- A software verification plan .
Seno Advantage provides images comparable to the predicate device.

K032400

### 8. Other – table of acronyms

In the whole submission, the DICOM acronyms are used to describe the various imaging modalities supported by the Seno Advantage workstation. The following table defines these acronyms:

| Term | Definition |
|-----------------------|------------------------------------------------------------------------|
| CR (modality) | Computerized Radiology or Computed Radiography |
| CRT | Cathode Ray Tube |
| CT (modality) | Computerized Tomography |
| DICOM (standard) | Digital Imaging and Communications in Medicine |
| DX (modality) | Digital X-ray |
| MG (modality) | Digital Mammography |
| MR (modality) | Magnetic Resonance |
| MX (modality) | Mixed modality (i.e. the exam contains series of different modalities) |
| NM (modality) | Nuclear Medicine |
| OT (modality) | Other modality |
| PET or PT (modality) | Positron Emission Tomography |
| RF or XRF (modality) | Xray Radio &Fluoro |
| RT (modality) | Radiation Therapy |
| SC or SCPT (modality) | Secondary Capture |
| SR (modality) | Structured Report |
| US (modality) | Ultra Sound |
| XA (modality) | Xray Angio (vascular and cardio exams) |
| XR (modality) | X-ray |

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing segments, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 4 2003

GE Medical Systems W-400 % Mr. Juergen Welte Acting Program Manager 510(k) TUV Rheinland of North America 12 Commerce Road NEWTON CT 06470

Re: K033400

Trade/Device Name: Seno Advantage Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: November 18, 2003 Received: November 19, 2003

Dear Mr. Welte:

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 he 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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Page 2

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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## STATEMENT OF INDICATION FOR USE

KU33400

Device name: Seno Advantage

Indication for use:

Seno Advantage is a medical image review station that allows easy selection, processing, filming Scho revelings is a modical minger ality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution which interpreted by a named for diagnosis. Furthermore filmed images from all modalities may also be used as an clement for diagnosis.

(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

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033400