(53 days)
No
The summary describes a digital mammography system with a stereotactic biopsy accessory. While it mentions image processing and computer-guided localization for biopsy, there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test data for algorithmic performance. The performance studies focus on mechanical accuracy and system functionality, not algorithmic performance metrics typically associated with AI/ML.
No
Explanation: The device is used for generating digital mammographic images for screening, diagnosis, and guiding biopsies, which are diagnostic procedures, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states that the images generated by the system "can be used for screening, diagnosis and stereotactic biopsies of the breast." The term "diagnosis" directly indicates a diagnostic purpose.
No
The device description clearly outlines a floor-mounted full field digital mammography system with a stereotactic biopsy accessory, including physical components like a control panel, needle holder, compression plates, and a face shield. The performance studies also describe bench tests involving physical components and phantom testing. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Mammomat Fusion system is an imaging device that generates digital mammographic images. It is used for screening, diagnosis, and guiding biopsies of the breast. The biopsy accessory helps in localizing a target lesion and guiding the removal of tissue for examination by a pathologist under a microscope.
- Lack of In Vitro Testing: The device itself does not perform any tests on biological samples in vitro. It is a medical imaging system used to visualize the breast and assist in obtaining tissue samples for subsequent in vitro analysis by a pathologist.
The device is a medical imaging system used for diagnostic and interventional procedures (biopsy guidance), not for performing diagnostic tests on biological samples outside the body.
N/A
Intended Use / Indications for Use
The Mammomat Fusion system generates digital mammographic images that can be used for screening, diagnosis and stereotactic biopsies of the breast under supervision of medical professionals. The Mammomat Fusion system is intended to be used in the same clinical applications as traditional film-screen mammography systems. The Mammomat Fusion system may also be used for additional diagnostic workup of the breast.
Product codes (comma separated list FDA assigned to the subject device)
MUE
Device Description
Mammomat Fusion is a floor-mounted full field digital mammography system for screening and diagnostic procedures on standing, seated or recumbent patients.
The stereotactic biopsy accessory uses a computer and imaging performed in at least two planes to localize a target lesion (such as a tumor or micro calcifications in the breast) in three-dimensional space and guide the removal of tissue for examination by a pathologist under a microscope.
The biopsy is attached to the Mammomat Fusion examination stand and comprises a control panel for automatic motorized movement of the needle holder to the pre-set position. There are special biopsy compression plates as well as a face shield to protect the patient from movements of the swivel arm.
The display and control of the biopsy unit are performed via the workstation. Biopsy examinations can be executed with vertical and horizontal needle guidance. For stereo exposures the swivel arm of the Mammomat Fusion is tilted ± 15° to both sides.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
full field digital mammography
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Siemens Mammomat Fusion with Stereotactic Biopsy was tested and complies with the voluntary standards listed in the table below:
Table 3: Conformance to Standards
Reference Number, Date and Title of Standard
AAMI ANSI, ES 60601-1: 2005 /( R ) 2012, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2007. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-3 2008 + A1: 2013 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 62366: 2007, Medical devices - Application of usability engineering to medical devices
ISO 14971:2012, Medical devices - application of risk management to medical devices
IEC 62304: 2006, Medical device software - Software life cycle processes
ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
IEC 60601-2-28: 2010. Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis -Ed. 1.0
IEC 61223-3-2:2007, Evaluation and routine testing in medical imaging departments -
Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
IEC 60601-2-45: 2011, Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
NEMA PS 3.1 - 3.20: 2016, Digital Imaging and Communications in Medicine (DICOM) Set
IEC 60336: 2005, Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
In addition, the following bench tests were also conducted and passed:
Table 4: Summary of Bench Tests
Test: Targeting accuracy
Objective: Ensure accuracy of the biopsy device
Test Method: Remove plastic tray, attach phantom and compress manually. Take a scout exposure and a stereo pair and check reference points. Set an accurate target mark then select needle. Select target mark with corresponding needle and needle holder. Transmit the target mark to the biopsy unit. Mount the calibration needle and check the needle tip position of the calibration needle.
Acceptance Criteria: The needle tip must be no more than +/-1 mm in x, y, z direction from the selected target point.
Results: Within 1 mm of target
Test: Biopsy needle
Objective: Correct biopsy needle will be used
Test Method: Position biopsy phantom on object table and compress. Acquire scout and check that target for biopsy is within the possible biopsy volume. Acquire stereo pair and check and adapt reference marks if applicable. Set target in both stereo images and select calibration needle. Check that target coordinates and calculated distance between needle tip and biopsy table are displayed. Set further target at the border of the biopsy volume. Select a needle that won't reach the target.
Acceptance Criteria: A message will appear that the target cannot be reached with this needle and an appropriate needle length is suggested.
Results: The message was received that the target could not be reached with that needle and an appropriate needle length was suggested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Targeting accuracy: +/-1 mm in X, Y and Z axis
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1715 Full-field digital mammography system.
(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 10, 2017
Siemens Medical Solutions USA, Inc. % Ms. Denise Adams Regulatory Affairs Specialist 40 Liberty Boulevard, Mail Code 65-1A MALVERN PA 19355
Re: K163252
Trade/Device Name: Mammomat Fusion with Stereotactic Biopsv Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: November 17, 2016 Received: November 18, 2016
Dear Ms. Adams:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Mammomat Fusion with Stereotactic Biopsy
Indications for Use (Describe)
The Mammomat Fusion system generates digital mammographic images that can be used for screening, diagnosis and stereotactic biopsies of the breast under supervision of medical professionals. The Mammomat Fusion system is intended to be used in the same clinical applications as traditional film-screen mammography systems. The Mammomat Fusion system may also be used for additional diagnostic workup of the breast.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Healthcare
510(k) Summary: Mammomat Fusion with Stereotactic Biopsy
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Date Prepared: January 10, 2017
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
1. General Information:
Importer / Distributor: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Establishment Registration Number: 2240869
Manufacturing Site: Siemens Healthcare GmbH Siemensstr. 1
91301 Forchheim Germany Establishment Registration Number:
3004977335
2. Contact:
Siemens Medical Solutions USA, Inc. Denise Adams, RAC Regulatory Affairs Specialist 40 Liberty Boulevard Mail Code: 65-1A Malvern, PA 19355-9998, USA Phone: +1.610.448.6139 Mobile: +1.610.944.4686 adams.denise@siemens.com
3. Device Name and Classification:
| Trade Name: | Mammomat Fusion with Stereotactic Biopsy |
|---|---|
| Device: | Full Field Digital Mammographic X-Ray system |
| Reg. Medical Specialty: | Radiology |
| Review Panel: | Radiology |
| Product Code: | MUE |
Siemens Medical Solutions USA, Inc.
4
| Submission Type: | Traditional 510(k) |
|---|---|
| Regulation Number: | 21 CFR 892.1715 |
| Device Class: | 2 |
4. Legally Marketed Predicate Devices:
| Primary predicate | |
|---|---|
| Trade Name: | Mammomat Inspiration |
| Device: | Full Field Digital Mammographic X-Ray system |
| Reg. Medical Specialty: | Radiology |
| Review Panel: | Radiology |
| Product Code: | MUE |
| Submission Type: | 510(k) (K122286, 02/22/2013) |
| Regulation Number: | 21 CFR 892.1715 |
| Device Class: | 2 |
| Reference predicate | |
| Trade Name: | Mammomat Fusion |
| Device: | Full Field Digital Mammographic X-Ray system |
| Reg. Medical Specialty: | Radiology |
| Review Panel: | Radiology |
| Product Code: | MUE |
| Submission Type: | 510(k) (K151645, 09/14/2015) |
| Regulation Number: | 21 CFR 892.1715 |
| Device Class: |
5. Device Description:
Mammomat Fusion is a floor-mounted full field digital mammography system for screening and diagnostic procedures on standing, seated or recumbent patients.
The stereotactic biopsy accessory uses a computer and imaging performed in at least two planes to localize a target lesion (such as a tumor or micro calcifications in the breast) in three-dimensional space and guide the removal of tissue for examination by a pathologist under a microscope.
The biopsy is attached to the Mammomat Fusion examination stand and comprises a control panel for automatic motorized movement of the needle holder to the pre-set position. There are special biopsy compression plates as well as a face shield to protect the patient from movements of the swivel arm.
The display and control of the biopsy unit are performed via the workstation. Biopsy examinations can be executed with vertical and horizontal needle guidance. For stereo exposures the swivel arm of the Mammomat Fusion is tilted ± 15° to both sides.
5
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6. Indication for Use:
The Mammomat Fusion system generates digital mammographic images that can be used for screening, diagnosis and stereotactic biopsies of the breast under supervision of medical professionals. The Mammomat Fusion system is intended to be used in the same clinical applications as traditional film-screen mammography systems. The Mammomat Fusion system may also be used for additional diagnostic workup of the breast.
7. Substantial Equivalence:
The Siemens Mammomat Fusion with Stereotactic Biopsy is substantially equivalent to the commercially available Siemens Mammomat Inspiration (primary predicate) (K122286) and Mammomat Fusion (reference predicate) (K151645).
The Mammomat Fusion with Stereotactic Biopsy is the same system as the reference predicate the Mammomat Fusion with the exception of the biopsy feature. The stereotactic biopsy accessory is identical to the stereotactic biopsy accessory used with the primary predicate the Mammomat Inspiration.
| Attributes | Subject device
Mammomat Fusion with
Stereotactic Biopsy | Primary predicate
K122286
Mammomat Inspiration | Remarks |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Stereotactic Biopsy Option | | | |
| Indications for
Use | The Mammomat Fusion system
generates digital mammographic
images that can be used for
screening and diagnosis, and
stereotactic biopsies of the breast
under supervision of medical
professionals. The Mammomat
Fusion system is intended to be
used in the same clinical
applications as traditional film-
screen mammography systems.
The Mammomat Fusion system
may also be used for additional
diagnostic workup of the breast. | The Mammomat Inspiration system
is intended for mammography
exams, screening, diagnosis, and
stereotactic biopsies under the
supervision of medical
professionals.
Mammographic images can be
interpreted by either hard copy film
or soft copy workstation. | Same for
biopsy |
| Hardware | Biopsy unit slides onto object
table | Biopsy unit slides onto object
table | Same |
| Patient
positioning | Stereotactic biopsy can be
performed on seated and
recumbent patients | Stereotactic biopsy can be
performed on seated and
recumbent patients | Same |
| Accuracy | +/-1 mm in X, Y and Z axis | +/-1 mm in X, Y and Z axis | Same |
| Biopsy volume
(vertical needle
guidance) | 50 mm x 40 mm x 110 mm (2" x
1.6" x 4.3") | 50 mm x 40 mm x 110 mm (2" x
1.6" x 4.3") | Same |
| Biopsy volume | 50 mm x 40 mm x 60 mm (2" x | 50 mm x 40 mm x 60 mm (2" x | Same |
Table 1: Comparison of the Subiect to the Primary Predicate
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| Attributes | Subject device
Mammomat Fusion with
Stereotactic Biopsy | Primary predicate
K122286
Mammomat Inspiration | Remarks |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------|
| (lateral needle
guidance) | 1.6" x 2.4" | 1.6" x 2.4" | |
| Tube swivel
range in stereo
mode | -15° and + 15° | -15° and + 15° | Same |
| Biopsy
compression
plate with
window | 96 mm x 100 mm (3.8" x 3.9")
(window size 52 mm x 42 mm
(2" x 1.7"), vertical needle
guidance | 96 mm x 100 mm (3.8" x 3.9")
(window size 52 mm x 42 mm
(2" x 1.7"), vertical needle
guidance | Same |
| Biopsy
compression
plate without
window | 96 mm x 100 mm (3.8" x 3.9")
(lateral needle guidance) | 96 mm x 100 mm (3.8" x 3.9")
(lateral needle guidance) | Same |
| Software controlled functions for stereotactic biopsy | | | |
| Workflow | Automated workflow | Automated workflow | Same |
| Image
processing | OpView, the image impression
for biopsy images and
screening/diagnostic images is
identical | OpView, the image impression for
biopsy images and
screening/diagnostic images is
identical | Same |
Table 2: Comparison of the Subject to the Reference Predicate
| Attributes | Subject device
Mammomat Fusion with
Stereotactic Biopsy | Reference predicate
K151645 Mammomat Fusion | Remarks |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Indications for
use | The Mammomat Fusion system
generates digital mammographic
images that can be used for
screening and diagnosis, and
stereotactic biopsies of the breast
under supervision of medical
professionals. The Mammomat
Fusion system is intended to be
used in the same clinical
applications as traditional film-
screen mammography systems.
The Mammomat Fusion system
may also be used for additional
diagnostic workup of the breast. | The Mammomat Fusion system
generates digital mammographic
images that can be used for
screening and diagnosis of the
breast under supervision of
medical professionals. The
Mammomat Fusion system is
intended to be used in the same
clinical applications as traditional
film-screen mammography
systems. The Mammomat Fusion
system may also be used for
additional diagnostic workup of
the breast. | Same except
for biopsy |
| System configuration | | | |
| X-ray Stand | Floor mounted X-ray system | Floor mounted X-ray system | Same |
| X-ray | 5 kW | 5 kW | Same |
| Generator | 30kV, 1s | 30kV, 1s | Same |
| X-ray Tube | Same tube but only Tungsten is
used | Same tube but only Tungsten is
used | Same |
| Attributes | Subject device
Mammomat Fusion with
Stereotactic Biopsy | Reference predicate
K151645 Mammomat Fusion | Remarks |
| Beam Limiting
Device | Automatic for all sizes | Automatic for all sizes | Same |
| Compression
unit | Automatic and manual operation | Automatic and manual operation | Same |
| Object table | Carbon fiber mammography
support system | Carbon fiber mammography
support system | Same |
| Grid | Reciprocating 5:1 ratio | Reciprocating 5:1 ratio | Same |
| Magnification
table | Magnification 1.5 and 1.8 | Magnification 1.5 | Adding 1.8
table |
| Biopsy unit | Yes | No | Reason for
510(k) |
| Power
requirements | 208V, 220V, 230V, 240V,
277V, ± 10%, single-phase
208V, 220V, 230V, 240V,
277V, ± 10%, two-phase,
50/60 Hz | 208V, 220V, 230V, 240V,
277V, ± 10%, single-phase
208V, 220V, 230V, 240V,
277V, ± 10%, two-phase, 50/60
Hz | Same |
| Monitor/
Display | 19" and 21" TFT display | 19" and 21" TFT display | Same |
| | | | |
| Software controlled functions | | | |
| AEC Calculation | AEC calculation is done in the | AEC calculation is done in the | Same |
| Calculation | acquisition workstation | acquisition workstation | |
| Detector
Controller
Software | detector controller software | detector controller software for | Same |
| Software | for PaxScan 3023M detector | PaxScan 3023M detector | |
| Operating
System | Windows 7 | Windows 7 | Same |
| Network
Interfaces
DICOM Send | Yes | Yes | Same |
| DICOM Print | Yes | Yes | Same |
| DICOM Query
/ Retrieve | Yes | Yes | Same |
| DICOM
Get work list /
MPPS | Yes | Yes | Same |
| DICOM Dose
Structured
Report | Yes | Yes | Same |
| Detector | | | |
| Detector
manufacturer | Varian | Varian | Same |
| Detector TFT | Cesium Iodide (Csl) and
amorphous Silicon (a-Si) | Cesium Iodide (Csl) and
amorphous Silicon (a-Si) | Same |
| Detector size | 23 cm x 30 cm | 23 cm x 30 cm | Same |
| Attributes | Subject device
Mammomat Fusion with
Stereotactic Biopsy | Reference predicate
K151645 Mammomat Fusion | Remarks |
| Array size | 2790 x 3580 | 2790 x 3580 | Same |
| Pixel size | 83 um x 83 um | 83 um x 83 um | Same |
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8
The Mammomat Fusion with Stereotactic Biopsy has the same intended use, fundamental scientific technology and performance characteristics as the predicates. Documentation is provided to support a claim of substantial equivalence to Siemens' predicate devices the Mammomat Inspiration and the Mammomat Fusion (K122286 and K151645).
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Devices:
Mammomat Fusion with Stereotactic Biopsy is based on the same mechanical stand as the primary. X-ray generation and control are the same. The Collimator, Compression unit and AEC technology are the same. The image processing algorithms are identical to those of the predicates. Mammomat Fusion with Stereotactic Biopsy will now feature the same biopsy accessory as the primary predicate Mammomat Inspiration.
9. Summary of Non-Clinical Tests:
The Siemens Mammomat Fusion with Stereotactic Biopsy was tested and complies with the voluntary standards listed in the table below:
Table 3: Conformance to Standards
Reference Number, Date and Title of Standard
AAMI ANSI, ES 60601-1: 2005 /( R ) 2012, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2007. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-3 2008 + A1: 2013 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 62366: 2007, Medical devices - Application of usability engineering to medical devices
ISO 14971:2012, Medical devices - application of risk management to medical devices
IEC 62304: 2006, Medical device software - Software life cycle processes
ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
IEC 60601-2-28: 2010. Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis -Ed. 1.0
IEC 61223-3-2:2007, Evaluation and routine testing in medical imaging departments -
9
Healthcare
Reference Number, Date and Title of Standard
Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
IEC 60601-2-45: 2011, Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
NEMA PS 3.1 - 3.20: 2016, Digital Imaging and Communications in Medicine (DICOM) Set
IEC 60336: 2005, Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
In addition, the following bench tests were also conducted and passed:
| Test | Objective | Test Method | Acceptance Criteria | Results | ||||
|---|---|---|---|---|---|---|---|---|
| Targeting | ||||||||
| accuracy | Ensure | |||||||
| accuracy | ||||||||
| of the | ||||||||
| biopsy | ||||||||
| device | Remove plastic tray, attach | |||||||
| phantom and compress manually. | The needle | |||||||
| tip must be | ||||||||
| no more | ||||||||
| than +/-1 | ||||||||
| mm in x, y, | ||||||||
| z direction | ||||||||
| from the | ||||||||
| selected | ||||||||
| target point. | Within 1 | |||||||
| mm of | ||||||||
| target | ||||||||
| Take a scout exposure and a stereo | ||||||||
| pair and check reference points. | ||||||||
| Set an accurate target mark then | ||||||||
| select needle. Select target mark | ||||||||
| with corresponding needle and | ||||||||
| needle holder. Transmit the target | ||||||||
| mark to the biopsy unit. Mount the | ||||||||
| calibration needle and check the | ||||||||
| needle tip position of the | ||||||||
| calibration needle. | ||||||||
| Biopsy | ||||||||
| needle | Correct | |||||||
| biopsy | ||||||||
| needle | ||||||||
| will be | ||||||||
| used | Position biopsy phantom on object | |||||||
| table and compress. Acquire scout | A message | |||||||
| will appear | ||||||||
| that the | ||||||||
| target | ||||||||
| cannot be | ||||||||
| reached | ||||||||
| with this | ||||||||
| needle and | ||||||||
| an | ||||||||
| appropriate | ||||||||
| needle | ||||||||
| length is | ||||||||
| suggested. | The | |||||||
| message | ||||||||
| was | ||||||||
| received | ||||||||
| that the | ||||||||
| target | ||||||||
| could not | ||||||||
| be reached | ||||||||
| with that | ||||||||
| needle and | ||||||||
| an | ||||||||
| appropriate | ||||||||
| needle | ||||||||
| length was | ||||||||
| suggested. | ||||||||
| and check that target for biopsy is | ||||||||
| within the possible biopsy volume. | ||||||||
| Acquire stereo pair and check and | ||||||||
| adapt reference marks if | ||||||||
| applicable. Set target in both | ||||||||
| stereo images and select | ||||||||
| calibration needle. Check that | ||||||||
| target coordinates and calculated | ||||||||
| distance between needle tip and | ||||||||
| biopsy table are displayed. Set | ||||||||
| further target at the border of the | ||||||||
| biopsy volume. Select a needle | ||||||||
| that won't reach the target. |
Table 4: Summary of Bench Tests
10
Healthcare
The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Requirement Specification Reviews
- Design Reviews
- Integration testing (System verification)
General Safety and Effectiveness Concerns:
Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition the Mammomat Fusion with Stereotactic Biopsy is continually monitored and if an error occurs the system functions will be blocked and an error message will be displayed.
Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards. Siemens adheres to recognized and established industry practice and all equipment is subject to final performance testing.
10. Conclusion as to Substantial Equivalence:
The Mammomat Fusion with Stereotactic Biopsy has the same intended use, fundamental scientific technology and performance characteristics as the predicate devices. Therefore the Mammomat Fusion with Stereotactic Biopsy is substantially equivalent to the primary predicate the Mammomat Inspiration and the reference predicate the Mammomat Fusion.