(88 days)
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.
Mammomat Fusion is a floor-mounted full field digital mammography system for screening and diagnostic procedures on standing, seated or recumbent patients. The system consists of an examination stand with integrated microprocessor-controlled high-voltage generator as well as an optional radiation shield with a height-adjustable control desk with an integrated Acquisition Workstation (AWS). The moveable swivel arm on the examination stand contains the X-ray tube on the top end and the object table with the detector on the bottom end. The detector is a full field digital mammoqraphy detector.
The provided text describes the Siemens Mammomat Fusion Full Field Digital Mammography System and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, reported device performance metrics, or the details of a study designed to explicitly prove the device meets said acceptance criteria. Instead, it outlines the basis for substantial equivalence for FDA 510(k) clearance.
Here's an analysis of what can be extracted and what is missing based on your request:
Missing Information:
- A table of explicit acceptance criteria and specific reported device performance metrics. The document states "All test results were satisfactory" but does not quantify them.
- Sample size used for a test set in the context of proving acceptance criteria.
- Data provenance (e.g., country of origin, retrospective/prospective) for a test set.
- Number of experts and their qualifications used to establish ground truth for a test set.
- Adjudication method for a test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers improving with AI assistance. (This device is a mammography system, not an AI CAD system, so such a study would not be expected in this context).
- Details of a standalone (algorithm only) performance study. (Again, this is a hardware system, not an AI algorithm).
- The type of ground truth used (pathology, outcomes data, etc.) for any specific performance study related to acceptance criteria.
- Sample size for a training set. (This pertains to AI/machine learning, which is not the primary focus of this submission for a hardware device).
- How ground truth for a training set was established.
Information that can be inferred or is directly stated (though not in the format you requested for acceptance criteria):
1. Acceptance Criteria and Reported Device Performance (Inferred/General)
The document primarily relies on "substantial equivalence" to predicate devices and compliance with recognized standards.
| Acceptance Criteria (Inferred from standards and predicate comparison) | Reported Device Performance (General Statement in document) |
|---|---|
| Safety and Essential Performance: Adherence to IEC 60601-1:2005 (General requirements), IEC 60601-1-2 (Electromagnetic compatibility), IEC 60601-1-3 (Radiation protection). | "All test results were satisfactory." "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 is continually monitored and if an error occurs, the system functions will be blocked and an error message will be displayed." "Siemens adheres to recognized and established industry practice and all equipment is subject to final performance testing." |
| Mammographic Imaging Performance: Compliance with IEC 61223-3-2:2007 (Acceptance tests - Imaging performance) and IEC 60601-2-45:2011 (Particular requirements for mammographic equipment). | "All test results were satisfactory." "The performance data of the Mammomat Fusion are compared to the GE Senographe DS as they have same physical detector characteristics." "The subject device has the same or better performance data as the secondary predicate." "The detector technology has been changed to Cesium Iodide technology. The performance of the detector has been compared to the secondary predicate the GE Senographe DS and the results of the non-clinical tests provide evidence of substantial equivalence to the secondary predicate." |
| Risk Management: Compliance with ISO 14971:2007. | "Risk Analysis" performed as a quality assurance measure. |
| Software Life Cycle: Compliance with IEC 62304:2006. | "Requirement Specification Reviews," "Design Reviews," "Integration testing (System verification)" performed. |
| Biological Evaluation: Compliance with ISO 10993-1:2009. | (Not explicitly detailed as performance, but compliance implied by "All test results were satisfactory" and adherence to standards.) |
2. Sample Size for Test Set and Data Provenance:
- Not specified. The document mentions "Clinical and Non-clinical testing was conducted in accordance with the 'Guidance for industry and FDA Staff: Class II Special Control Guidance Document: Full-Field digital Mammography System,' (issued on March 27, 2012) and 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' (issued August 6, 1999)." These guidances would outline typical testing requirements, but the specifics for this particular submission's test set (e.g., number of images, patients, type of breast density, etc.) are not provided. The data provenance is also not mentioned.
3. Number of Experts and Qualifications for Ground Truth:
- Not specified. No mention of expert consensus or qualifications for a test set's ground truth. The submission focuses on device performance data compared to predicates and adherence to technical standards, not diagnostic accuracy studies with expert review.
4. Adjudication Method:
- Not applicable/Not specified. Not relevant to the type of device performance testing described (primarily technical and safety compliance).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is typically performed for Computer-Aided Detection (CAD) or AI systems where human reader performance is a direct outcome measure. The Mammomat Fusion is a hardware imaging system, and the submission does not describe an MRMC study comparing human readers with and without AI assistance from this device.
6. Standalone Performance Study:
- Yes (for technical parameters). The document claims "The subject device has the same or better performance data as the secondary predicate" and that "The performance of the detector has been compared to the secondary predicate the GE Senographe DS." This implies standalone technical performance testing (e.g., image quality metrics like spatial resolution, contrast-to-noise ratio, detective quantum efficiency related to the detector technology change from Selenium to Cesium Iodide TFT). However, the specific metrics and quantitative results are not provided in this summary.
7. Type of Ground Truth Used:
- Technical Benchmarks / Predicate Device Performance. For the technical performance aspects, the "ground truth" seems to be established through measurements against recognized technical standards (e.g., IEC standards for imaging performance, safety) and direct comparison to the physical detector characteristics of the GE Senographe DS predicate device. It is not an assessment of diagnostic accuracy against pathology or outcomes data.
8. Sample Size for Training Set:
- Not applicable/Not specified. This pertains to AI/machine learning model training. The Mammomat Fusion is a digital mammography system (hardware and associated control/processing software), not an AI algorithm requiring a training set in the typical sense.
9. How Ground Truth for Training Set Was Established:
- Not applicable/Not specified. See point 8.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design that suggests movement or progress.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 14, 2015
Siemens Medical Solutions USA, Inc. % Mr. Darren Dorman Regulatory Affairs Specialist III 51 Valley Stream Parkway MALVERN PA 19355
Re: K151645
Trade/Device Name: Mammomat Fusion Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: June 17, 2015 Received: June 18, 2015
Dear Mr. Dorman:
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.
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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,
Robert Ocks
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)
K151645
Device Name Mammomat Fusion
Indications for Use (Describe)
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.
| 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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Image /page/3/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a teal or turquoise shade. The letters are evenly spaced and appear to be a logo or brand name.
Healthcare
510(k) Summary: Mammomat Fusion
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
June 17, 2015 Date Prepared:
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 AG Sector Healthcare Siemensstr. 1 91301 Forchheim Germany
Establishment Registration Number: 3004977335
2. Contact Person:
Darren A. Dorman. Requlatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 448-6483 Fax: (610) 640-4481 Email: darren.dorman@siemens.com
Alternate Contact Person:
Patricia D. Jones, Requlatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty boulevard, 65-1A
Siemens Medical Solutions USA, Inc.
Tel · +1-888-826-9702 www.usa.siemens.com/healthcare
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Malvern, PA 19355 Phone: (610) 448-6474 Fax: (610) 640-4481 Email: patricia.d.jones@siemens.com
3. Device Name and Classification:
Trade Name: Mammomat Fusion Device: Full Field Digital Mammographic X-Ray system Regulation Medical Specialty: Radiology Review Panel: Radiology Product Code: MUE Submission Type: Traditional 510(k) Requlation Number: 21 CFR 892.1715 Device Class: 2
4. Legally Marketed Predicate Devices:
Primary predicate: Trade Name: Mammomat Inspiration Full Field Digital Mammographic X-Ray system Device: Requlation 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 Recall Information: There have been no recalls for this device Secondary predicate: GE Senographe DS
Trade Name: Device: Regulation Medical Specialty: Review Panel: Product Code: Submission Type: Regulation Number: Device Class: Recall Information:
Full Field Digital Mammographic X-Ray system
Radiology Radiology MUE PMA (P990066, S019 05/25/2005). 21 CFR 892.1715 2 Recall No. Z-1044-2011 Recall No. Z-0115-2012
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Image /page/5/Picture/0 description: The image shows the word "SIEMENS" in a teal, sans-serif font. The letters are bold and evenly spaced. The logo is simple and modern, with a clean design.
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 system consists of an examination stand with integrated microprocessor-controlled high-voltage generator as well as an optional radiation shield with a height-adjustable control desk with an integrated Acquisition Workstation (AWS). The moveable swivel arm on the examination stand contains the X-ray tube on the top end and the object table with the detector on the bottom end. The detector is a full field digital mammoqraphy detector.
6. Indication for Use:
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 filmscreen mammography systems. The Mammomat Fusion system may also be used for additional diagnostic workup of the breast.
7. Substantial Equivalence:
The Siemens Mammomat Fusion is substantially equivalent to the commercially available Siemens Mammomat Inspiration (Primary predicate) and the GE Senographe DS (Secondary predicate).
| Predicate Device Name andManufacturer | 510(k) / PMANumber | Clearance /Approval Date | Comparable properties |
|---|---|---|---|
| Primary:MammomatInspiration, SiemensMedical SolutionsUSA, Inc. | K122286 | 02/22/2013 | - (FFDM)- Mechanical design- Software- Image processingalgorithms |
| SecondarySenographe DS, GEHealthcare | P990066, S019 | 05/25/2005 | - FFDM- Detectorcharacteristics |
X-ray generation and control used with the Mammomat Fusion is identical to the Mammomat Inspiration. The Detector technology has been changed from a Selenium to a Cesium lodide Thin film transistor (TFT). Updated software controls the system. Image processing algorithms are unchanged from the predicate Mammomat Inspiration. The Acquisition Workstation (AWS) is identical. The Mammomat Fusion does not feature the stereotactic biopsy option.
40 I iherty Boulevard Malvern PA 19355-1406
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The performance data of the Mammomat Fusion are compared to the GE Senographe DS as the have same physical detector characteristics.
The subject device - the Mammomat Fusion system is within the same classification requlation for a similar intended use as the modified Mammomat Inspiration system, the primary predicate device. The subject device has the same fundamental scientific technology as the primary predicate device. The subject device has the same or better performance data as the secondary predicate. Documentation is provided to support a claim of substantial equivalence to Siemens' predicate device the Mammomat Inspiration (K122286. 02/22/2013) and to the GE Senographe DS (P990066, S019 05/25/2005).
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Devices:
Mammomat Fusion is based on the same mechanical stand as the primary predicate – MAMMOMAT Inspiration system. 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 primary predicate. Mammomat Fusion does not feature the biopsy option. Similar tests and the same scope of voluntary standards have been applied to the Mammomat Fusion as compared to the primary predicate, the Mammomat Inspiration.
The detector technology has been changed to Cesium lodide technology. The performance of the detector has been compared to the secondary predicate the GE Senographe DS and the results of the non-clinical tests provide evidence of substantial equivalence to the secondary predicate.
9. Summary of Non-Clinical Tests:
The Siemens Mammomat Fusion complies with the voluntary standards as listed in the following table:
| Reference Number, Date and Title of Standard | ||
|---|---|---|
| AAMI ANSI 60601-1: 2005, Medical electrical equipment -- Part 1: Generalrequirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | ||
| IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral standard: Electromagneticcompatibility - Requirements and tests | ||
| IEC 60601-1-3 2008, Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection indiagnostic X-ray equipment |
IEC 62366: 2007, Medical devices - Application of usability engineering to medical
40 Liberty Boulevard Malvern, PA 19355-1406 USA
Tel・+1-888-826-9702 www.usa.siemens.com/healthcare
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Reference Number, Date and Title of Standard
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
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: 2011, 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
The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Requirement Specification Reviews
- Design Reviews ●
- Integration testing (System verification) .
Clinical and Non-clinical testing was conducted in accordance with the "Guidance for industry and FDA Staff: Class II Special Control Guidance Document: Full-Field digital Mammography System," (issued on March 27, 2012) and "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" (issued August 6, 1999). All test results were satisfactory.
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
40 I iherty Roulevard Malvern, PA 19355-1406 Tel: +1-888-826-9702 www.usa.siemens.com/healthcare
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Mammomat Fusion 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.
11. Conclusion as to Substantial Equivalence:
The Mammomat Fusion is intended for similar indications for use as the predicate FFDM systems. The system design (Mammography stand, X-ray generator, tube, collimator and image processing algorithms) are similar, if not the same, as with the primary predicate, Mammomat Inspiration. Detector material and performance are compared to the secondary predicate system the GE Senographe DS. Siemens considers the Mammomat Fusion to be substantially equivalent to the predicate devices - Mammomat Inspiration and GE Senographe DS.
§ 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.