SENOGRAPHIC STEREO

K040125 · Ge Medical Systems, Inc. · IZH · Apr 19, 2004 · Radiology

Device Facts

• Record ID: K040125
• Device Name: SENOGRAPHIC STEREO
• Applicant: Ge Medical Systems, Inc.
• Product Code: IZH · Radiology
• Decision Date: Apr 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1710
• Device Class: Class 2

Intended Use

Senographe Stereo is an optional accessory for the Senographe DS full field digital system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from steroetactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization, or treatment devices).

Device Story

Senographe Stereo is an accessory for the Senographe DS mammography system used for 3D breast lesion localization and interventional guidance (biopsy, localization, treatment). The device captures a stereo pair of 2D X-ray images at +15° and -15° angles. The system computes 3D (X, Y, Z) coordinates of a target lesion based on operator-identified points on the stereo images and known system geometry. The hardware includes a stereotactic positioner (attaches to image receptor, provides manual/motorized needle positioning, compression paddle), a lateral arm for lateral access, and a vertical adapter for vacuum-assisted devices. Software manages stereotactic mode, exposure (manual or AOP), and motion control. Used in clinical settings by healthcare professionals; output assists clinicians in guiding interventional tools to specific breast lesions, potentially improving biopsy accuracy and patient outcomes.

Clinical Evidence

Bench testing only. Evidence includes functional testing (Ref.#2363171), application accuracy testing (Ref.#2398779-2), and IQ Stereo testing (Ref.#2375268). No clinical data presented.

Technological Characteristics

Accessory for Senographe DS; carbon fiber breast holding plate; manual compression system (10-100mm); motorized or manual needle positioning; CAN bus communication; stereotactic software package; lateral arm and vertical adapter accessories. Operates via X-ray imaging and geometric coordinate calculation.

Indications for Use

Indicated for patients requiring breast lesion localization and interventional guidance, including biopsy, pre-surgical localization, or treatment device placement, using the Senographe DS mammography system.

Regulatory Classification

Identification

A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• SenoVision (K941191)

Submission Summary (Full Text)

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K040125

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General Electric Medical Systems

# Senographe Stereo 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 Program Manager 3000 N. Grandview Blvd Waukesha, 53188 USA Telephone: [phone] Fax: [phone] Date Propared: January 16th, 2004

#### 2. Identification of Product:

| Device name | Senographe Stereo |
|--------------------------|----------------------------------|
| Classification name | Mammographic X-ray system per |
| | 21CFR Section 892 1710 |
| Manufacturer/Distributor | General Electric Medical Systems |
| | 283, Rue de la Minière |
| | 78533 BUC Cedex France |

#### 3. Marketed Devices

Scnographe Stereo is substantially equivalent to the device listed below:

| Model: | SenoVision |
|---------------|----------------------------------|
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K941191 |

#### 4. Device Description :

#### SCIENTIFIC CONCEPT USED

If an image of the same object is taken with the tube arm at a different angle, the object appears to move along a line at right angles to the axis around which the

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Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are black, while the background is white, creating a high-contrast design. The logo is a well-known symbol associated with the multinational conglomerate corporation.

tube arm is rotated. The distance moved depends upon the tube arm angle, and is proportional to the height (Z) of the object above the image plane.

Image /page/1/Figure/4 description: The image shows a diagram with three lines intersecting at a point. The central line is dashed and labeled "0°". Two other lines intersect the dashed line at an angle, labeled "+15°" and "-15°" respectively.

Senographe Stereo uses a stereo pair of images, taken with the tube arm angled to +15° and -15° with respect to the image receptor. The position of the three coordintates (X, Y, and Z) is computed using the position of the object indicated by the operator, on each of the two images and the known geometry of the system

#### DESCRIPTION OF THE DEVICE

Senographe Stereo is an option of Senographe DS composed of the following elements:

- A stereotactic positioner .
- Display and stereo positioning software of the Senographe DS .
- A lateral arm for the lateral approach procedures .
- A vertical adapter for vertical approach procedures using a vacuum assisted . device

### 1)- The stereotactic positioner

The stereotactic positioner is a device that attaches to Senographe DS by sliding onto the image receptor. There are two connectors in the back of this device that plug into the image receptor connectors. One of these connectors (which is common to the bucky) is used to energize the stereotactic positioner. The second connector is used to plug the stereotactic positioner to the gantry CAN bus through which the communication with the rest of the system is performed. This positioner has the following functions:

- Compression: The breast is compressed between the compression paddle and . the breast holding plate (made of carbon fiber) of the stereotactic positioner. This piece of equipment has its own manual compression system, independent to the compression of the Senographe DS, controlled with two compression

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Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular frame. The letters are stylized and have a classic, vintage appearance. The logo is in black and white.

knobs, one at each side of the stereotactic positioner. The compression range of the stereotactic positioner is 10-100mm, with compression controlled manually.

- Needle positioning: The stereotactic positioner gets the (X,Y,Z) coordinates of . the target area from the acquisition workstation. It provides two ways for reaching this position:
- Manually by means of two sets of three knobs (one per X,Y and Z coordinate)
- Motorized driven -
- Safety features: the device has the following safety features: .
- A needle path lock: it ensures that all motorized motions are forbidden when the puncture tools is already in the breast
- A luminous light turns red when the tip of the puncture tool is near the breast holder plate.

#### 2) - The stereotactic software

The stereotactic software is a package that is activated only when the system is in stereotactic mode. The selection of the stereotactic mode is performed automatically upon hardware detection of the stereotactic positioner. In addition to the hardware detection, a software acknowledgment is provided through the CAN bus to confirm the selection.

The stereotactic software is a pre-installed package and consists of:

A stereotaxy viewer on the acquisition workstation independent from the . screening/diagnostic application.

- Exposure mode management.. Two exposure modes are provided: manual and ◆ one AOP (automatic optimization of parameters) modes ..
- A software on the Senographe DS gantry to allow stereotactic motion control . and specific interlocks to guarantec the safety during the stereotactic procedures, such as disabling all pre-set buttons.

#### 3)- The lateral arm

The lateral arm is a mechanical accessory allowing the user to accede the lession from both of the lateral sides of the stereotactic positioner. This device is basically the same as the one used on SenoVision. The only difference is the improvement of the sliding of the arm to enhance clinical effectiveness.

#### 4) - The vertical adapter

The vertical adapter is a mechanical accessory used to install a vacuum assisted devices (such as a Mammotome, manufactured by Ethicon Endo Surgery).

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# HOW THE DEVICE WORKS

Senographe Stereo simply attached to Senographe DS by sliding onto the image receptor for fine needle aspiration, core biopsy, vacuum assisted biopsy or hook wire placement in upright or recumbent positions.

#### 5. Indications for Use

Senographe Stereo is an optional accessory for the Senographe DS full field digital system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from steroetactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization, or treatment devices).

#### 6. Comparison with Predicate Device

The GE Senographe Stereo is substantially equivalent to the following device:

SenoVision Manufacturer: GE Medical Systems 510(k): K941191

Both of Senographe Stereo and Seno Vision are Mammographic X-Ray System which aid in the performance of breast biopsies, presurgical localization.

#### 7. Summary of Studies

Three kinds of tests have been performed to verify the Senographe Stereo:

- · Functional test (Ref.#2363171 TDR StereoPositioner revB)
- · Application accuracy test (Ref.#2398779-2 TDR revA)
- · IQ Stereo test results (Ref.#2375268 TDR revB)

These tests prove the safety and effectiveness of Senographe Stereo.

#### 8. Conclusions

The Senographe Stereo Principles of Operation, clinical effectiveness, Design, Construction and Materials are similar to existing marketed device. This system poses no added safety risk.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 9 2004

Larry Kroger, Ph.D. Senior Regulatory Program Manager GE Medical Systems, Inc. 3000 N. Grandview Blvd. WAUKESHA WI 53188

Rc: K040125

Trade/Device Name: Senographe Stereo Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: 90 IZH Dated: January 16, 2004 Received: January 20, 2004

Dear Dr. Kroger:

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 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 FI)A 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. Brogden

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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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular frame. The frame has decorative elements resembling stylized swirls or flourishes at the top, bottom, and sides of the circle.

General Electric Medical Systems

## STATEMENT OF INTENDED USE

Device name: Senographe Stereo

Indication For Use:

Senographe Stereo is an optional accessory for the Senographe DS full field digital system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from steroetactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization, or treatment devices).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div> <table style="border: none;"><tr><td>-OR-</td><td>Over-The-Counter Use</td></tr></table> </div> | -OR- | Over-The-Counter Use |
|---------------------------------------|-------------------------------------------------------------------------------------------------------|------|----------------------|
| -OR- | Over-The-Counter Use | | |

| (Division Sign-Off) | Nancy Brogdon |
|---------------------------------------------------------------|---------------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K040125 |