MAMMOMAL INSPIRATION

K122286 · Siemens Medical Solutions USA, Inc. · MUE · Feb 22, 2013 · Radiology

Device Facts

• Record ID: K122286
• Device Name: MAMMOMAL INSPIRATION
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: MUE · Radiology
• Decision Date: Feb 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1715
• Device Class: Class 2

Intended Use

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.

Device Story

Mammomat Inspiration is a floor-mounted, full-field digital mammography (FFDM) system. It utilizes an examination stand with a high-frequency generator, X-ray tube, and detector-equipped object table. Operated by healthcare professionals in clinical settings, it supports screening, diagnostic, and stereotactic biopsy procedures. The system captures X-ray images, which are processed and displayed on an Acquisition Workstation (AWS) or hard copy film. It includes an optional 'Automatic Quality Control' feature to assist with regulatory quality testing and provides improved workflow functions and expanded biopsy accessories. The device is continuously monitored for errors, with automated system blocking and messaging to ensure safety. Clinical benefit is derived from high-quality imaging for breast cancer detection and diagnostic assessment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and bench testing of the system's functionality and safety features.

Technological Characteristics

Floor-mounted FFDM system; high-frequency microprocessor-controlled generator; X-ray tube; TFT detector. Features include 'Automatic Quality Control' software and expanded biopsy accessories. System is networked via Acquisition Workstation. Safety features include visual/audible warnings and automated error monitoring/blocking.

Indications for Use

Indicated for mammography exams, screening, diagnosis, and stereotactic biopsies in patients requiring such procedures, performed under the supervision of medical professionals.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Mammomat Inspiration with VB10 (PMA P030010/S006)

Submission Summary (Full Text)

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SIEMENS

Special 510(k) Submission: Mammomat Inspiration

# 510(k) Summary: Mammomat Inspiration

Company: Siemens Medical Systems, Inc. 51 Valley Stream Parkway · Malvern, PA 19355

Date Prepared: July 27, 2012

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:
lmporter / Distributor: Siemens Medical Systems, Inc. 51 Valley Stream Parkwav Malvern, PA 19355 Establishment Registration Number: 2240869

Manufacturing Site: SIEMENS AG Sector Healthcare Henkestraße 127 91050 Erlangen Establishment Registration Number: 8010024

#### 2. Contact Person:

Ms. Patricia D. Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway D-02 Malvern, PA 19355 Phone: [phone] Fax: [phone] Email: [e-mail]

3. Device Name and Classification:

Trade Name: Device:

Regulation: Review Panel Product Code Mammomat Inspiration Full Field Digital, system, X-Ray Mammographic Medical Specialty Radiology Radiology MUE

Special 510(k) for Mammomat Inspiration

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SIEMENS

## Special 510(k) Submission: Mammomat Inspiration

Submission Type Requlation Number Device Class

510(k) 892.1715 ನ

4. Legally Marketed Predicate Device

> Trade Name: Device:

Regulation:

Review Panel

Product Code

Submission Type

Regulation Number

Mammomat Inspiration Full Field Digital, system, X-Ray Mammographic Medical Specialty Radiology Radiology MUE PMA Supplement 892.1715 3

- . 5. Device Description:
Device Class

Mammomat Inspiration is a floor-mounted mammography system for screening, diagnostic and biopsy procedures on standing, seated or recumbent patients.

The system consists of an examination stand with integrated. microprocessor-controlled, high-frequency generator as well as a radiation shield with an optional height-adjustable control desk in which the Acquisition Workstation (AWS) can be integrated. A swivel arm contains the X-ray tube on the top end and the object table with the detector on the bottom end.

The Mammomat Inspiration was submitted as a supplement (S006) to PMA P030010. This supplement was approved on November 05, 2010. All Full Field Digital Mammography (FFDM) systems were reclassified to class 2 and currently require a 510(k) submission.

#### 6. Indication for Use:

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.

#### 7. Substantial Equivalence:

The Siemens Mammomat Inspiration with VB30 is substantially equivalent to the commercially available Siemens Mammomat Inspiration with VB10. The Mammomat Inspiration was described

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SIEMENS

as a supplement (S006) to PMA P030010. This supplement was approved on November 05, 2010. All Full Field

X-ray generation and control used with the Mammomat Inspiration VB30 is identical to the Mammomat Inspiration with VB10. Detector TFT specifications, image processing algorithms remain unchanged. The Acquisition Workstation (AWS) is identical.

### 8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:

Mammomat Inspiration with VB30 features the same functionality as the predicate Mammomat Inspiration with VB10 and in addition a feature called "Automatic Quality Control". "Automatic Quality Control" will assist the user in the quality tests required according to 21 CFR 900. "Automatic Quality Control" is an optional feature. VB30 also improves some workflow functions. The portfolio of accessories has been extended to include more options for biopsy systems to compliment the needs of the Mammography suite.

#### 9. 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 Inspiration is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.

Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.

#### 10. Conclusion as to Substantial Equivalence:

The Mammomat Inspiration VB30 is intended for the same indications for use as the predicate Mammomat Inspiration VB10. The imaging properties (TFT with pixel size and number and image processing algorithms) have not been modified. It is Siemens opinion; that the Mammomat Inspiration VB30 is substantially equivalent to the Mammomat Inspiration VB10.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 22, 2013

Patricia D. Jones Siemens Medical Solutions. Inc. 51 Valley Stream Parkway MALVERN PA 19355

Re: K122286

Trade/Device Name: Mammomat Inspiration Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: February 11, 2013 Received: February 12, 2013

Dear Ms. Jones:

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

FDA

for

Janine M. Morris 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: K122286

Device Name: Mammomat Inspiration

Indications for Use:

The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under supervision of medical professionals.

Mammographic images can be interpreted by either hardcopy film or softcopy workstation.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Image /page/5/Picture/13 description: The image shows a logo or signature that appears to be stylized and abstract. The text is illegible, but it seems to be a combination of letters and symbols. The overall design is intricate and complex, with a mix of curved and straight lines.

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostic and Radiological Health

K122286 510(k)

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