Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard digital mammography technology and image processing improvements, but does not mention AI or ML.

Therapeutic

No
The device is described as an imaging system used for diagnostic purposes like mammography exams, screening, diagnostics, and biopsies, not for treating conditions.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the MAMMOMAT Revelation is intended for "diagnostics." The "Device Description" also mentions its use for "diagnostic, and biopsy procedures."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a floor-mounted system with hardware components like an x-ray generator, gantry, detector, and workstation, in addition to software updates.

IVD (In Vitro Diagnostic)

Based on the provided information, the MAMMOMAT Revelation is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states it's for mammography exams, screening, diagnostics, biopsies, and dual energy procedures. These are all procedures performed on the patient, not on samples taken from the patient.
Device Description: The description details a physical system for generating and capturing X-ray images of the breast. This is an imaging device, not a device used to test biological samples.
IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The MAMMOMAT Revelation does not perform this function.

While the device is used in conjunction with a biopsy procedure (which involves taking a tissue sample), the device itself is used to image the specimen after it has been taken, primarily for verification purposes (the InSpect feature). This is still an imaging function, not an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

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 system software to VC20, including new detector software for faster system calibration, and improvements to the contrast enhanced mammography feature and biopsy workflow. Improvements include adjustments to the image processing for contrast enhanced mammography to present a more homogeneous image. The biopsy attachment was complemented with a spacer plate to be used for easier access to the biopsy region.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-Ray (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

The image sets consisted of 8 FFDM cases including one case with diagnostic images; three DBT biopsy cases with the new spacer plate; and 4 contrast enhanced mammography cases.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Siemens conducted a clinical image evaluation to determine if the FFDM images, when reviewed by expert radiologists, are of acceptable quality for mammographic usage. The image evaluation was carried out according to the Class II Special Controls Guidance Document: Full-Field Digital Mammography System. The image sets consisted of 8 FFDM cases including one case with diagnostic images; three DBT biopsy cases with the new spacer plate; and 4 contrast enhanced mammography cases. It was determined that the images from the subject device are substantially equivalent to those from the predicate device.

Non-clinical performance testing included:

Detector characteristics: Objective - Ensure non-inferiority to predicate; Test Method - As described in FDA's Class II Special Controls Guidance Document: Full-Field Digital Mammography System; Acceptance Criteria - Same or better than predicate; Results - Passed.
Dual energy imaging: Objective - Ensure diagnostic image quality; Test Method - Images have been evaluated by Radiologists; Acceptance Criteria - Image quality equivalent to images acquired with VC10; Results - Passed.
Targeting accuracy: Objective - Ensure accuracy of the biopsy device; Test Method - Accuracy tests with phantom and 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.
Biopsy procedure with spacer plate: Objective - Ensure safety and effectiveness of biopsy; Test Method - Workflow tests with and without spacer plate; Acceptance Criteria - Same results with and without spacer plate; Results - Passed.
Cleaning of the spacer plate: Objective - Ensure effectiveness of cleaning procedure; Test Method - Cleaning and disinfection validation; Acceptance Criteria - According to AAMI TIR 30 and AAMI ST58; Results - Passed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K173408

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

June 12, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Siemens Medical Solutions USA, Inc. % Mr. Martin Rajchel Sr. Regulatory Affairs Specialist 40 Liberty Boulevard, 65-1A MALVERN PA 19355

Re: K193166

Trade/Device Name: MAMMOMAT Revelation Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: Class II Product Code: MUE Dated: May 15, 2020 Received: May 18, 2020

Dear Mr. Rajchel:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

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regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K193166

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 interpreted by etther 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."

FORM FDA 3881 (7/17)

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Image /page/3/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots that are arranged in a pattern.

510(k) Summary: MAMMOMAT Revelation-K193166

Siemens Medical Solutions USA. Inc. Company: 40 Liberty Boulevard, 65-1A Malvern, PA 19355

May 13, 2020 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 Systems USA, Inc. 40 Liberty Boulevard, 65-1A 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:

Martin Rajchel Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, US

3. Device Name and Classification:

MAMMOMAT Revelation Trade Name: Classification Name: Full Field Digital, System, X-Ray Mammographic Classification Panel: Radiology Classification Regulation: 21 CFR §892.1715 Device Class: 2 Product Code: MUE

4. Legally Marketed Predicate Device

Trade Name:	MAMMOMAT Revelation
510(k) #:	K173408
Classification Name:	Full Field Digital, System, X-Ray Mammographic
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1715
Device Class:	2
Product Code:	MUE

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.

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Image /page/4/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.

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 system software to VC20, including new detector software for faster system calibration, and improvements to the contrast enhanced mammography feature and biopsy workflow. Improvements include adjustments to the image processing for contrast enhanced mammography to present a more homogeneous image. The biopsy attachment was complemented with a spacer plate to be used for easier access to the biopsy region.

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 with VC20 is substantially equivalent to the commercially available Siemens MAMMOMAT Revelation with VC10 (K173408).

| Attributes | Subject device
MAMMOMAT Revelation
VC20 | Predicate device
MAMMOMAT Revelation
VC10, K173408 | Remarks |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| 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 | 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.

Table 1: Comparison of the Subject to the Primary Predicate

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Image /page/6/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots.

1. Summary of Technological Characteristics of the Su with the Predicate Devices:
  The MAMMOMAT Revelation is based on the same mechanical stand as the predicate device. X-ray generation and control are also the same. The collimator, compression unit, and AEC technology are the same. The image processing algorithms for FFDM are identical to those of the predicate. There are no new features but improvements to the detector handling, biopsy workflow, and dual energy image processing.

9. Summarv of Non-Clinical Tests:

The Siemens MAMMOMAT Revelation was tested and complies with the voluntary standards listed in the table below:

Table 2: Non-clinical performance testing

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, 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 60601-2-28 Ed 2.0, 2010, Medical electrical equipment - Part 2: Particular requirements 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: 2015, Ed 1.0 Medical devices - Application of usability engineering to medical devices

ISO 14971:2007, Medical devices - application of risk management to medical devices

IEC 62304: 2015-06 Edition 1.1, 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

In addition, the following tests were conducted:

| Test | Objective | Test Method | Acceptance
Criteria | Results |
|-----------------------------|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------|---------|
| Detector
characteristics | Ensure non-
inferiority to
predicate | As described in
FDA's Class II
Special Controls
Guidance Document:
Full-Field Digital
Mammography
System | Same or better
than predicate | Passed |

Table 3: Summary of Tests

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Image /page/7/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.

| Dual energy
imaging | Ensure
diagnostic
image
quality | Images have been
evaluated by
Radiologists | Image quality
equivalent to
images
acquired with
VC10 | Passed |
|---------------------------------------------|-----------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Targeting
accuracy | Ensure
accuracy of
the biopsy
device | Accuracy tests with
phantom and
calibration needle. | 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 |
| Biopsy
procedure
with spacer
plate | Ensure
safety and
effectiveness
of biopsy | Workflow tests with
and without spacer
plate | Same results
with and
without spacer
plate | Passed |
| Cleaning of
the spacer
plate | Ensure
effectiveness
of cleaning
procedure | Cleaning and
disinfection validation | According to
AAMI TIR 30
and
AAMI ST58 | Passed |

The following quality assurance measures were applied to the development of the system:

Risk Analvsis .
Requirement Specification Reviews ●
Design Reviews
Integration testing (System verification) ●

10. Summary of Clinical Tests:

Siemens conducted a clinical image evaluation to determine if the FFDM images, when reviewed by expert radiologists, are of acceptable quality for mammographic usage. The imaqe evaluation was carried out according to the Class II Special Controls Guidance Document: Full-Field Digital Mammography System. The image sets consisted of 8 FFDM cases including one case with diagnostic images; three DBT biopsy cases with the new spacer plate; and 4 contrast enhanced mammography cases. It was determined that the images from the subject device are substantially equivalent to those from the predicate device.

11. 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 is continuously 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.

12. Conclusion as to Substantial Equivalence:

The MAMMOMAT Revelation with VC20 has the same intended use, fundamental scientific technology, and performance characteristics as the predicate, MAMMOMAT

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Revelation with VC10 (K173408). Therefore, the MAMMOMAT Revelation with VC20 is substantially equivalent to the predicate MAMMOMAT Revelation with VC20.

13. Guidance documents

The following FDA quidance documents were utilized in this Premarket Notification:

. Content of Premarket Submission for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff Document Issued on October 2, 2014
. Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - Guidance for Industry and Food and Drug Administration Staff Document issued on July 11, 2016
Guidance for Industry and Food and Drug Administration Staff Class II Special . Controls Guidance Document: Full-Field Digital Mammography System Document issued on March 27, 2012
Guidance for Industry and FDA Staff Guidance for the Content of Premarket . Submissions for Software Contained in Medical Devices Document issued on May 11, 2005
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for . Medical Devices - Guidance for Industry and Food and Drug Administration Staff Document issued on September 14, 2018.
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications . - Guidance for Industry and Food and Drug Administration Staff Document issued on July 28, 2014