(140 days)
Not Found
No
The summary describes a digital mammography system with updated hardware and software, including contrast-enhanced mammography and tomosynthesis-guided biopsy capabilities. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on image acquisition, processing, and biopsy guidance, not on automated interpretation or analysis using AI/ML.
No.
The device is used for imaging, screening, diagnostics, and biopsies, which are diagnostic procedures, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states that the MAMMOMAT Revelation is intended to be used for "diagnostics".
No
The device description clearly outlines a physical, floor-mounted system with hardware components like an X-ray generator, gantry, detector, and workstation, indicating it is not software-only.
Based on the provided information, the MAMMOMAT Revelation 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- MAMMOMAT Revelation's Function: The MAMMOMAT Revelation is a medical imaging system that uses X-rays to create images of the breast within the patient's body. It is used for screening, diagnosis, and guiding biopsy procedures.
- No Sample Analysis: The device does not analyze samples taken from the body. Its primary function is to generate images of the breast tissue in vivo.
While the device has a biopsy option that involves taking a tissue sample, the MAMMOMAT Revelation's role in this process is to guide the biopsy and image the excised specimen (InSpect feature) to verify tissue removal. It does not perform the diagnostic analysis of the tissue sample itself. That analysis would be done separately in a laboratory, potentially using IVD devices.
Therefore, the MAMMOMAT Revelation falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MAMMOMAT Revelation is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals. The Mammography images can be interpreted by either hard copy film or soft copy workstation.
With Biopsy Option:
The InSpect feature for MAMMOMAT Revelation with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure.
Product codes (comma separated list FDA assigned to the subject device)
MUE
Device Description
MAMMOMAT Revelation is a floor-mounted full field digital mammography system for screening, diagnostic and biopsy procedures on standing, seated or recumbent patients.
The system consists of an examination stand with X-ray generator, a gantry with tube housing assembly and mammography support table including detector, and an acquisition workstation with a radiation shield. The MAMMOMAT Revelation comes with a variety of compression plates and a biopsy attachment for diagnostic adjunct procedures.
The MAMMOMAT Revelation features an updated detector (LMAM 2v2), an upgrade to the MS Windows 10 operating system, the capability to do contrast enhanced mammography and tomosynthesis guided biopsy.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professionals / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
The Siemens MAMMOMAT Revelation was tested and complies with the voluntary standards listed in Table 4 (Conformance to Standards).
Table 5: Summary of Bench Tests
- Detector characteristics: Objective - Ensure non-inferiority to predicate. Test Method - As described by FFDM special control guidance. Acceptance Criteria - Same or better than predicate. Results - passed.
- Dual energy imaging: Objective - Ensure diagnostic image quality. Test Method - As described in System Test Record Dual Energy - Appendix E. Acceptance Criteria - As described in System Test Record Dual Energy. Results - passed.
- Targeting accuracy: Objective - Ensure accuracy of the biopsy device. Test Method - Accuracy tests with phantom and calibration needle System Test Record Dual Energy appendix E. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. % Ms. Denise Adams Regulatory Affairs Specialist 40 Liberty Boulevard, 65-1A MALVERN PA 19355
Re: K173408
Trade/Device Name: MAMMOMAT Revelation Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: February 19, 2018 Received: February 20, 2018
Dear Ms. Adams:
We have reviewed vour 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 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.
March 21, 2018
1
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. 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) K173408
Device Name MAMMOMAT Revelation
Indications for Use (Describe)
The MAMMOMAT Revelation is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals. The Mammography images can be inter hard copy film or soft copy workstation.
With Biopsy Option:
The InSpect feature for MAMMOMAT Revelation with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K173408 510(k) Summary: MAMMOMAT Revelation
Company: Siemens Medical Solutions, Inc. 40 Liberty Boulevard Malvern, PA 19355
Date Prepared: February 16, 2018
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.
-
- General Information: Importer / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number: 2240869 Location of Manufacturing Site Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number 3004977335
2. Contact Person:
Denise Adams, RAC Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 adams.denise@siemens-healthineers.com
Alternate Contact Person
Patricia Jones Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 patricia.d.jones@siemens-healthineers.com
3. Device Name and Classification:
| Trade Name: | MAMMOMAT Revelation |
|---|---|
| Classification Name: | Full Field Digital, System, X-Ray Mammographic |
| Classification Panel: | Radiology |
4
Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word.
| Classification Regulation: | 21 CFR §892.1715 |
|---|---|
| Device Class: | 2 |
| Product Code: | MUE |
4. Legally Marketed Predicate Devices
| Primary predicate: | |
|---|---|
| Trade Name: | MAMMOMAT Inspiration Prime |
| 510(k) #: | K123520 |
| Classification Name: | Full Field Digital, System, X-Ray Mammographic |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1715 |
| Device Class: | Class II |
| Product Code: | MUE |
Secondary predicates:
| Trade Name: | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM |
|---|---|
| 510(k) #: | K122836 |
| Classification Name: | System, X-ray, Mammographic |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1710 |
| Device Class: | Class II |
| Product Code: | IZH |
| Trade Name: | CONTRAST ENHANCED DIGITAL MAMMOGRAPHY |
|---|---|
| 510(k) #: | K123873 |
| Classification Name: | Full Field Digital, System, X-Ray Mammographic |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1715 |
| Device Class: | Class II |
| Product Code: | MUE |
Recalls: There are no recalls for these predicate devices.
5. Device Description:
MAMMOMAT Revelation is a floor-mounted full field digital mammography system for screening, diagnostic and biopsy procedures on standing, seated or recumbent patients.
The system consists of an examination stand with X-ray generator, a gantry with tube housing assembly and mammography support table including detector, and an acquisition workstation with a radiation shield. The MAMMOMAT Revelation comes with a variety of compression plates and a biopsy attachment for diagnostic adjunct procedures.
5
SIEMENS
The MAMMOMAT Revelation features an updated detector (LMAM 2v2), an upgrade to the MS Windows 10 operating system, the capability to do contrast enhanced mammography and tomosynthesis guided biopsy.
6. Indication for Use:
The MAMMOMAT Revelation is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals. The Mammography images can be interpreted by either hard copy film or soft copy workstation.
With Biopsy Option:
The InSpect feature for MAMMOMAT Revelation with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure.
7. Substantial Equivalence:
The Siemens MAMMOMAT Revelation is substantially equivalent to the commercially available Siemens MAMMOMAT Inspiration PRIME (primary predicate) (K123520), the Hologic Contrast Enhanced Digital Mammography (secondary predicate) (K123873) and the Hologic Affirm Breast Biopsy Guidance System (secondary predicate) (K122836).
| Attributes | Subject device
MAMMOMAT Revelation | Primary Predicate
MAMMOMAT Inspiration
PRIME
K123520 | Remarks |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Intended use | The MAMMOMAT
Revelation is intended to be
used for mammography
exams, screening, diagnostics,
biopsies and dual energy
procedures under the
supervision of medical
professionals.
The Mammography images
can be interpreted by either
hard copy film or soft copy
workstation. | 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 but
biopsy
term more
general and
dual energy
added |
| Product Code | MUE | MUE | Same |
| System configuration | | | |
| X-ray Stand | Floor mounted X-ray system | Floor mounted X-ray system | Same |
| X-ray
Generator
kV range | 5 kW
23kV to 49kV | 5 kW
23kV to 35kV | kV range
increased
for
CEDEM |
| X-ray Tube | Same tube but shielding of
THA improved for higher kV | Same tube | No Mo
focus |
| Attributes | Subject device
MAMMOMAT Revelation | Primary Predicate
MAMMOMAT Inspiration
PRIME
K123520 | Remarks |
| | and the Molybdenum focus is
not being used anymore | | anymore |
| 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 |
| Detector | LMAM2v2 | LMAM2 | Improved
readout
electronics |
| Detector
manufacturer | Anrad | Anrad | Same |
| Detector TFT | Amorphous Silicon (a-Si) | Amorphous Silicon (a-Si) | Same |
| Detector size | 24 cm x 30 cm | 24 cm x 30 cm | Same |
| Array size | 2816 x 3585 | 2816 x 3585 | Same |
| Pixel size | 85 μm x 85 μm | 85 μm x 85 μm | Same |
| Grid | Reciprocating 5:1 ratio | Reciprocating 5:1 ratio | Same |
| PRIME | Same as in K123520 | Cleared with K123520 | Same |
| Magnification
table | Magnification 1.5 and 1.8 | Magnification 1.5 and 1.8 | Same |
| Biopsy
attachment | Yes | Yes | Improved |
| Monitor/
Display | 19" and 21" TFT display | 19" and 21" TFT display | Same |
| Software controlled functions | | | |
| AEC | AEC calculation is done in the | AEC calculation is done in the | Same |
| Calculation | acquisition workstation | acquisition workstation | |
| Operating | Windows 10 | Windows XP | upgraded |
| System | | | |
| Image | Opview | Opview | Same |
| processing
algorithms | | | |
| DICOM | Yes | Yes | Same |
| Attributes | Subject device
MAMMOMAT Revelation | Secondary predicate
Hologic, Affirm Breast Biopsy
Guidance System, K122836 | Remarks |
| Biopsy
Intended use | The MAMMOMAT
Revelation is intended to be
used for mammography
exams, screening, diagnostics,
biopsies and dual energy
procedures under the
supervision of medical
professionals.
The Mammography images
can be interpreted by either
hard copy film or soft copy
workstation.
With Biopsy Option:
The InSpect feature for
MAMMOMAT Revelation
with HD Biopsy options is
intended to provide digital X-
ray images of core biopsy
specimens in order to allow
rapid verification that the
correct tissue has been excised
with the biopsy procedure. | The Affirm Breast Biopsy
Guidance System is an optional
accessory for the Selenia
Dimensions Mammography
System. It is designed to allow
the accurate localization of
lesions in the breast in three
dimensions. It is intended to
provide guidance for
interventional purposes (such as
biopsy, pre-surgical localization
or treatment devices). | Both
include
biopsy
With
specimen
imaging
added to
subject
device |
| Product Code | MUE | IZH | Both
contain
accessories
for
mammography |
| 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 | 50 mm x 40 mm x 60 mm (2" | 50 mm x 40 mm x 60 mm (2" x | Same |
| Attributes | Subject device
MAMMOMAT Revelation | Secondary predicate
Hologic, Affirm Breast Biopsy
Guidance System, K122836 | Remarks |
| volume
(lateral needle
guidance) | x 1.6" x 2.4") | 1.6" x 2.4") | |
| Tube swivel
range in
stereo mode | $- 15^\circ$ and $+ 15^\circ$ | $- 15^\circ$ and $+ 15^\circ$ | 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 |
Table 1: Comparison of the Subject to the Primary Predicate
6
Image /page/6/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word.
7
SIEMENS
Table 2: Comparison of the Subject to the Secondary Predicate for tomosynthesis guided biopsy
8
Image /page/8/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. A black line is underneath the word.
| Table 3: Comparison of the Subject to the Secondary Predicate for Contrast Enhanced | |
|---|---|
| Dual Energy Mammography (CEDEM): |
| Attributes | Subject device
MAMMOMAT Revelation
with CEDEM option | Secondary predicate
Hologic, Contrast Enhanced
Digital Mammography
K123873 | Remarks |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Intended use | The MAMMOMAT
Revelation is intended to be
used for mammography
exams, screening, diagnostics,
biopsies and dual energy
procedures under the
supervision of medical
professionals.
The Mammography images
can be interpreted by either
hard copy film or soft copy
workstation. | Contrast Enhanced Digital
Mammography (CEDM) is an
extension of the existing
indication for diagnostic
mammography with the Selenia
Dimension system. The CEDM
application shall enable contrast
enhanced breast imaging using
a dual energy technique. This
imaging technique can be used
as an adjunct following
mammography and/or
ultrasound exams to localize a
known or suspected lesion. | Both
include
dual energy |
| Product Code | MUE | MUE | Same |
| High energy image | | | |
| kV range | 45kV to 49kV | 45kV to 49kV | Same |
| Processing | Weighted subtraction | Weighted subtraction | Same |
9
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Devices:
The MAMMOMAT Revelation is based on the same mechanical stand as the primary device. Xray 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 primary predicate. The novel features Contrast Enhanced Mammography and tomosynthesis guided biopsy are similar to the technology used with the secondary predicates from Hologic.
9. Summary of Non-Clinical Tests:
The Siemens MAMMOMAT Revelation was tested and complies with the voluntary standards listed in the table below:
Table 4: Conformance to Standards
Reference Number, Date and Title of Standard
IEC 60601-1: 2012, Ed 3.1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: Ed 4, 2014, 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 Ed 2.1, 2012 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-2-28 Ed 2.0. 2010. Medical electrical equipment - Part 2: Particular reguirements for the safety and essential performance of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
IEC 60601-2-45: 2015, Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
IEC 62366: 2014, Ed 1.1 Medical devices - Application of usability engineering to medical devices
ISO 14971:2007, 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
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
10
SIEMI
Table 5: Summary of Bench Tests
| Test | Objective | Test Method | Acceptance
Criteria | Results |
|-----------------------------|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Detector
characteristics | Ensure
non-
inferiority
to
predicate | As described by
FFDM special
control guidance | Same or better
than predicate | passed |
| Dual energy
imaging | Ensure
diagnostic
image
quality | As described in
System Test
Record Dual
Energy -
Appendix E | As described in
System Test
Record Dual
Energy | passed |
| Targeting
accuracy | Ensure
accuracy
of the
biopsy
device | Accuracy tests
with phantom and
calibration needle
System Test
Record Dual
Energy appendix E | 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 |
In addition, the following bench tests were also conducted:
The following quality assurance measures were applied to the development of the system:
- Risk Analysis ●
- Requirement Specification Reviews
- Design Reviews ●
- Integration testing (System verification)
10. 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 Revelation continually is 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 Xray examinations to be performed. To minimize electrical and radiation hazards, Siemens adheres to recognized and established industry practice and all equipment is subject to final performance testing.
11. Conclusion as to Substantial Equivalence:
The MAMMOMAT Revelation has the same intended use, fundamental scientific technology and performance characteristics as the predicate devices. Therefore the MAMMOMAT Revelation is substantially equivalent to the primary predicates the MAMMOMAT Inspiration PRIME and the secondary predicates from Hologic, Affirm Breast Biopsy Guidance System and Contrast Enhanced Digital Mammography.