MOLECULAR BREAST IMAGING SOFTWARE

K111731 · Gamma Medica-Ideas Incorporated · LLZ · Sep 15, 2011 · Radiology

Device Facts

• Record ID: K111731
• Device Name: MOLECULAR BREAST IMAGING SOFTWARE
• Applicant: Gamma Medica-Ideas Incorporated
• Product Code: LLZ · Radiology
• Decision Date: Sep 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Molecular Breast Imaging Software is designed to acquire nuclear medicine image data from the Gamma Medica-Ideas LumaGEM™ gamma camera systems. The Molecular Breast Imaging Software allows images and data to be stored, communicated, processed, analyzed, and displayed on a compatible workstation.

Device Story

Software tool for nuclear medicine breast imaging; inputs raw image data from LumaGEM gamma camera systems; performs pixel-by-pixel analysis and algorithmic filtering; outputs processed images for clinical review; features include study display, window/level adjustment, measurement tools, and image summation; used in clinical settings by healthcare professionals; supports DICOM standards; facilitates visualization of breast tissue for diagnostic assessment.

Clinical Evidence

Bench testing only. Evidence includes software verification and validation testing and direct comparison testing against the original application to confirm performance as intended.

Technological Characteristics

Software-based PACS for nuclear medicine; supports DICOM and other formats; pixel-by-pixel analysis; algorithmic filters; compatible with LumaGEM gamma camera systems.

Indications for Use

Indicated for the acquisition, storage, communication, processing, analysis, and display of nuclear medicine image data from LumaGEM gamma camera systems for breast imaging.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• HERMES HDAQ Acquisition Station and HERMES Workstation (K002782)
• Segami Mirage (Release 5.0) (K010726)
• Philips Medical Systems (Cleveland) NM Application Suite (K080961)

Submission Summary (Full Text)

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GAMMA MEDICA-IDEAS, INC.

## SECTION 5 510(k) SUMMARY

| 510(k) Notification K | / / / 173 / |
|-----------------------|-------------|
|-----------------------|-------------|

#### GENERAL INFORMATION

## Applicant:

Gamma Medica-Ideas, Inc. 19355 Business Center Drive, Suite #8 Northridge, CA, 91324 U.S.A. Phone: [phone] Fax: [phone]

## Contact Person:

Albert Boniske Regulatory Consultant for Gamma Medica-Ideas, Inc. 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: [phone] ext. 113 Fax: [phone]

Date Prepared: June 17, 2011

#### DEVICE INFORMATION

#### Trade Name:

Molecular Breast Imaging Software

## Generic/Common Name:

Picture Archiving and Communications System

#### Classification:

21 CFR8892.2050

#### Product Code:

LLZ

#### PREDICATE DEVICE(S)

- HERMES HDAQ Acquisition Station and HERMES Workstation (K002782) .
- Segami Mirage (Release 5.0) (K010726) .
- Philips Medical Systems (Cleveland) NM Application Suite (K080961) .

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GAMMA MEDICA-IDEAS, INC.

## SECTION 5 510(k) SUMMARY (CONT.)

#### INTENDED USE

The Molecular Breast Imaging Software is designed to acquire nuclear medicine image data from the Gamma Medica-Ideas LumaGEM™ gamma camera systems. The Molecular Breast Imaging Software allows images and data to be stored, communicated, processed, analyzed, and displayed on a compatible workstation.

## PRODUCT DESCRIPTION

The Gamma Medica-Ideas Molecular Breast Imaging Software ("MBI Software") is a software tool intended to display and process breast images captured with the Gamma Medica-Ideas LumaGEM" gamma camera systems. The MBI Software contains functions of study display, Gray and Inverse Gray Images, Window/Level changes, Measuring Tool, image processing, and Save, Sum, and Reload (both raw and processed). Image processing is based on pixel-by-pixel analysis and algorithmic filters applications. The MBI Software application supports simultaneous display of multiple images, allowing the user to visualize several angles of the imaged breast tissue at once. The MBI Software is compatible with DICOM and other formats.

## SUBSTANTIAL EQUIVALENCE

The proposed indications for use for the Molecular Breast Imaging Software are substantially equivalent to the indications for use for the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Molecular Breast Imaging Software is substantially equivalent to the predicate devices.

## TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary performance bench testing was conducted on the MBI Software to support a determination of substantial equivalence to the predicate devices. The MBI Software is based on a clinically validated software application, which was designed for breast tissue screening using gamma cameras. All necessary verification and validation testing was conducted to ensure that the MBI Software performs as intended. This testing included:

- . Software verification and validation
- Direct comparison testing between the subject device and the original application .

## SUMMARY

The results of the software verification and validation testing and the direct comparison testing has demonstrated that the Molecular Breast Imaging Software performs as intended. As such, the Molecular Breast Imaging Software is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Gamma Medica-Ideas Incorporated % Mr. Albert Boniske Senior Manager of Regulatory Affairs Experien Group LLC 755 N. Mathilda Avenue, Suite 100 SUNNYVALE CA 94085

15 2011

Re: K111731

Trade/Device Name: Molecular Breast Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 17, 2011 Received: June 20, 2011

Dear Mr. Boniske:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR \$03); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at [phone]. 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/MedicallDevices/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/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K111731

Device Name: Molecular Breast Imaging Software

#### Indications for Use:

The Molecular Breast Imaging Software is designed to acquire nuclear medicine image data from the Gamma Medica-Ideas LumaGEM™ gamma camera systems. The Molecular Breast Imaging Software allows images and data to be stored, communicated, processed, analyzed and displayed on a compatible workstation.

Prescription Use _ X (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

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Mary Statt

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(Division Sign Off)

(Dwision Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K111731