(140 days)
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.
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.
The Siemens MAMMOMAT Revelation device was evaluated in non-clinical bench tests. Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Objective | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Detector characteristics | Ensure non-inferiority to predicate | Same or better than predicate | Passed |
| Dual energy imaging | Ensure diagnostic image quality | As described in System Test Record Dual Energy (Appendix E) | Passed |
| Targeting accuracy (biopsy) | Ensure accuracy of the biopsy device | 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 |
2. Sample Size and Data Provenance for Test Set:
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the bench tests. These tests are non-clinical and conducted in a laboratory setting.
3. Number of Experts and Qualifications for Ground Truth of Test Set:
Not applicable. The tests described are bench tests focused on technical performance metrics (detector characteristics, image quality, targeting accuracy) and do not involve human readers or expert-established ground truth in the traditional sense of a clinical study. The "ground truth" for these tests would be the established physical and technical specifications or reference measurements.
4. Adjudication Method for Test Set:
Not applicable. As these are bench tests, an adjudication method for human interpretation is not relevant. The results are based on direct measurement and comparison against defined technical criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document describes non-clinical bench tests. There is no mention of an MRMC comparative effectiveness study involving human readers.
6. Standalone (Algorithm Only) Performance:
The document describes tests of the physical device's characteristics and its features. It does not specifically detail a "standalone" algorithm performance study without a human-in-the-loop, as the device is a medical imaging system. The "algorithm" here would refer to the internal image processing and AEC calculations, which are components of the system test.
7. Type of Ground Truth Used:
The ground truth for these non-clinical tests is based on:
- Established specifications and performance of the predicate device (for detector characteristics).
- Defined technical standards and internal system test records (for dual energy image quality).
- Physical measurements against a known target in a phantom (for targeting accuracy).
8. Sample Size for Training Set:
Not applicable. The document describes tests for a medical imaging device, not an AI or machine learning algorithm that typically requires a separate training set. The "MAMMOMAT Revelation" is a physical mammography system.
9. How Ground Truth for Training Set Was Established:
Not applicable, as there is no mention of a separate training set for an AI algorithm.
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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
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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
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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)
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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 |
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| 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.
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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 deviceMAMMOMAT Revelation | Primary PredicateMAMMOMAT InspirationPRIMEK123520 | Remarks |
|---|---|---|---|
| Intended use | The MAMMOMATRevelation is intended to beused for mammographyexams, screening, diagnostics,biopsies and dual energyprocedures under thesupervision of medicalprofessionals.The Mammography imagescan be interpreted by eitherhard copy film or soft copyworkstation. | The MAMMOMAT Inspirationsystem is intended formammography exams,screening, diagnosis, andstereotactic biopsies under thesupervision of medicalprofessionals.Mammographic images can beinterpreted by either hard copyfilm or soft copy workstation. | Same butbiopsyterm moregeneral anddual energyadded |
| Product Code | MUE | MUE | Same |
| System configuration | |||
| X-ray Stand | Floor mounted X-ray system | Floor mounted X-ray system | Same |
| X-rayGeneratorkV range | 5 kW23kV to 49kV | 5 kW23kV to 35kV | kV rangeincreasedforCEDEM |
| X-ray Tube | Same tube but shielding ofTHA improved for higher kV | Same tube | No Mofocus |
| Attributes | Subject deviceMAMMOMAT Revelation | Primary PredicateMAMMOMAT InspirationPRIMEK123520 | Remarks |
| and the Molybdenum focus isnot being used anymore | anymore | ||
| BeamLimitingDevice | Automatic for all sizes | Automatic for all sizes | Same |
| Compressionunit | Automatic and manualoperation | Automatic and manualoperation | Same |
| Object table | Carbon fiber mammographysupport system | Carbon fiber mammographysupport system | Same |
| Detector | LMAM2v2 | LMAM2 | Improvedreadoutelectronics |
| Detectormanufacturer | 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 |
| Magnificationtable | Magnification 1.5 and 1.8 | Magnification 1.5 and 1.8 | Same |
| Biopsyattachment | 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 |
| processingalgorithms | |||
| DICOM | Yes | Yes | Same |
| Attributes | Subject deviceMAMMOMAT Revelation | Secondary predicateHologic, Affirm Breast BiopsyGuidance System, K122836 | Remarks |
| BiopsyIntended use | The MAMMOMATRevelation is intended to beused for mammographyexams, screening, diagnostics,biopsies and dual energyprocedures under thesupervision of medicalprofessionals.The Mammography imagescan be interpreted by eitherhard copy film or soft copyworkstation.With Biopsy Option:The InSpect feature forMAMMOMAT Revelationwith HD Biopsy options isintended to provide digital X-ray images of core biopsyspecimens in order to allowrapid verification that thecorrect tissue has been excisedwith the biopsy procedure. | The Affirm Breast BiopsyGuidance System is an optionalaccessory for the SeleniaDimensions MammographySystem. It is designed to allowthe accurate localization oflesions in the breast in threedimensions. It is intended toprovide guidance forinterventional purposes (such asbiopsy, pre-surgical localizationor treatment devices). | BothincludebiopsyWithspecimenimagingadded tosubjectdevice |
| Product Code | MUE | IZH | Bothcontainaccessoriesformammography |
| Hardware | Biopsy unit slides onto objecttable | Biopsy unit slides onto objecttable | Same |
| Patientpositioning | Stereotactic biopsy can beperformed on seated andrecumbent patients | Stereotactic biopsy can beperformed on seated andrecumbent patients | Same |
| Accuracy | +/-1 mm in X, Y and Z axis | +/-1 mm in X, Y and Z axis | Same |
| Biopsyvolume(verticalneedleguidance) | 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 deviceMAMMOMAT Revelation | Secondary predicateHologic, Affirm Breast BiopsyGuidance System, K122836 | Remarks |
| volume(lateral needleguidance) | x 1.6" x 2.4") | 1.6" x 2.4") | |
| Tube swivelrange instereo mode | $- 15^\circ$ and $+ 15^\circ$ | $- 15^\circ$ and $+ 15^\circ$ | Same |
| Biopsycompressionplate withwindow | 96 mm x 100 mm (3.8" x 3.9")(window size 52 mm x 42 mm(2" x 1.7"), vertical needleguidance | 96 mm x 100 mm (3.8" x 3.9")(window size 52 mm x 42 mm(2" x 1.7"), vertical needleguidance | Same |
| Biopsycompressionplate withoutwindow | 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
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SIEMENS
Table 2: Comparison of the Subject to the Secondary Predicate for tomosynthesis guided biopsy
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| Table 3: Comparison of the Subject to the Secondary Predicate for Contrast Enhanced | |
|---|---|
| Dual Energy Mammography (CEDEM): |
| Attributes | Subject deviceMAMMOMAT Revelationwith CEDEM option | Secondary predicateHologic, Contrast EnhancedDigital MammographyK123873 | Remarks |
|---|---|---|---|
| Intended use | The MAMMOMATRevelation is intended to beused for mammographyexams, screening, diagnostics,biopsies and dual energyprocedures under thesupervision of medicalprofessionals.The Mammography imagescan be interpreted by eitherhard copy film or soft copyworkstation. | Contrast Enhanced DigitalMammography (CEDM) is anextension of the existingindication for diagnosticmammography with the SeleniaDimension system. The CEDMapplication shall enable contrastenhanced breast imaging usinga dual energy technique. Thisimaging technique can be usedas an adjunct followingmammography and/orultrasound exams to localize aknown or suspected lesion. | Bothincludedual energy |
| Product Code | MUE | MUE | Same |
| High energy image | |||
| kV range | 45kV to 49kV | 45kV to 49kV | Same |
| Processing | Weighted subtraction | Weighted subtraction | Same |
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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
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SIEMI
Table 5: Summary of Bench Tests
| Test | Objective | Test Method | AcceptanceCriteria | Results |
|---|---|---|---|---|
| Detectorcharacteristics | Ensurenon-inferioritytopredicate | As described byFFDM specialcontrol guidance | Same or betterthan predicate | passed |
| Dual energyimaging | Ensurediagnosticimagequality | As described inSystem TestRecord DualEnergy -Appendix E | As described inSystem TestRecord DualEnergy | passed |
| Targetingaccuracy | Ensureaccuracyof thebiopsydevice | Accuracy testswith phantom andcalibration needleSystem TestRecord DualEnergy appendix E | The needle tipmust be no morethan +/-1 mm inx, y, z directionfrom theselected targetpoint. | Within 1mm oftarget |
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.
§ 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.