(90 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware and software for stereotactic positioning based on 2D image pairs, not AI/ML algorithms.
No
The device is used for locating lesions and guiding interventional procedures, not for treating or rehabilitating a disease or condition.
No
The device is designed for accurate lesion localization in three dimensions to guide interventional procedures (biopsy, pre-surgical localization, or treatment devices), rather than for diagnosing a disease or condition.
No
The device description explicitly lists hardware components such as a stereotactic positioner, lateral arm, and vertical adapter, in addition to software.
Based on the provided information, the Senographe Stereo is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Senographe Stereo's Function: The Senographe Stereo is described as an accessory for a mammography system. Its purpose is to locate lesions in the breast using imaging data and provide guidance for interventional procedures like biopsies. It does not perform tests on biological samples.
- Input and Output: The input is mammographic X-ray images, and the output is guidance for procedures based on the location of lesions within the breast. This is an imaging-based guidance system, not a diagnostic test performed on a sample.
Therefore, the Senographe Stereo falls under the category of an imaging accessory and guidance system for interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / 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).
Product codes
IZH
Device Description
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
The stereotactic positioner is a device that attaches to Senographe DS by sliding onto the image receptor. It has its own manual compression system and provides needle positioning based on (X,Y,Z) coordinates. The stereotactic software is activated when the system is in stereotactic mode and includes a stereotaxy viewer and exposure modes (manual and AOP). The lateral arm is a mechanical accessory for lateral access. The vertical adapter is a mechanical accessory for installing vacuum assisted devices. Senographe Stereo attaches to Senographe DS for fine needle aspiration, core biopsy, vacuum assisted biopsy or hook wire placement in upright or recumbent positions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
steroetactic pairs of two-dimensional images (Mammographic X-ray system)
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1710 Mammographic x-ray system.
(a)
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.(b)
Classification. Class II.
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Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.
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: 262-544-3894 Fax: 262-544-3863 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.
Image /page/3/Picture/17 description: The image is a blank white canvas. There are no objects, shapes, or colors present. The image is completely uniform and featureless.
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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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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).
(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 | -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 |