BI-RADS COMPANION

K072258 · Almen Laboratories, Inc. · LLZ · May 16, 2008 · Radiology

Device Facts

• Record ID: K072258
• Device Name: BI-RADS COMPANION
• Applicant: Almen Laboratories, Inc.
• Product Code: LLZ · Radiology
• Decision Date: May 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

BI-RADS Companion™ ("BRC") is a computer-aided image viewing and report generating tool designed to assist radiologists in the analysis of ultrasound images of breast masses by making the ACR "BI-RADS Classification Form and Lexicon®" ("ABCFL") available in electronic format. The user can view any selected image from a case and segment the lesion from the background by applying a user selected threshold or outlining the lesion manually with a cursor. The user can annotate, tag, measure, and record selected views. Under user control and review, the software electronically assembles reports from inputs selected by the user from the ultrasound ABCFL during the image interpretation process. The assembled report complies with the ABCFL for ultrasound. The output may be viewed and sent to electronic storage media, or standard film or paper printers or other document manipulation programs such as Adobe or Microsoft. When used by a skilled radiologist, this device provides information that may be useful in image interpretation. Patient management decisions should not be based solely on forms generated by BRC. The ultrasound images displayed by BRC must not be used for primary diagnostic interpretation.

Device Story

Computer-aided image viewing and report generation tool; assists radiologists in analyzing ultrasound images of breast masses. Inputs: ultrasound images. Operation: user views images; segments lesions via manual cursor outlining or user-selected thresholding; annotates, tags, and measures findings. Software assembles reports based on ACR BI-RADS Classification Form and Lexicon (ABCFL) inputs selected by the radiologist. Output: electronic reports, printable or exportable to standard document formats. Used in clinical settings by radiologists. Benefits: standardizes reporting according to ACR guidelines; facilitates efficient documentation and record-keeping during image interpretation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Windows 2000/XP-based software; DICOM File Set Reader (FSR) compatible; HL7 compliant. Operates on PC, notebook, or workstation. Features include manual and threshold-based image segmentation, annotation, measurement, and automated report generation based on ACR ABCFL standards.

Indications for Use

Indicated for use by radiologists to assist in the analysis of ultrasound images of breast masses in female patients. Not for primary diagnostic interpretation; patient management decisions should not be based solely on generated reports.

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

• B-CAD System, Version 1.0 (K050846)

Submission Summary (Full Text)

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K072258

MAY 1 6 2008

## 510(k) Summary of Safety and Effectiveness As required by 807.92 for BI-RADS Companion Prepared on August 7, 2007 Revised October 31, 2007, January 29, 2008, April 18, 2008, May 16, 2008

Submitted by: Almen Laboratories, Inc. 1672 Gil Way Vista, CA 92084

> Fax: [phone] Tel. [phone]

Contact Person: Roger H. Schneider 6319 Massachusetts Avenue Bethesda, MD 20816-1139

> Fax: [phone] Tel. [phone]

Device Trade Name: BI-RADS Companion

Common Name: Medical Image Processing System

Classification: Class II, 21 CFR 892.2050 PACS

B-CAD System, Version 1.0 (K050846) Predicate Device:

MEDIPATTERN CORPORATION Manufactured by: 2300 Sheppard Avenue West Suite 204. Toronto, Ontario M9M 3 A4

#### Indications for Use

BI-RADS Companion™ ("BRC") is a computer-aided image viewing and report generating tool designed to assist radiologists in the analysis of ultrasound images of breast masses by making the ACR "BI-RADS Classification Form and Lexicon® ("ABCFL") available in electronic format. The user can view any selected image from a case and segment the background by applying a user selected threshold or outlining the lesion manually with a cursor.

The user can annotate, tag, measure, and record selected views. Under user control and review, the software electronically assembles reports from inputs selected by the user from the ultrasound ABCFL during the image interpretation process. The assembled report complies with the ABCFL for ultrasound. The output may be viewed and sent to electronic storage media, or standard film or paper printers or other document manipulation programs such as Adobe or Microsoft.

When used by a skilled radiologist, this device provides information that may be useful in image interpretation. Paticnt management decisions should not be based solely on forms generated by BRC.

The ultrasound images displayed by BRC must not be used for primary diagnostic interpretation.

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#### Description of the Device:

BI-RADS Companion™ ("BRC") is a computer-aided image viewing and report generating tool designed to assist radiologists in the analysis of ultrasound images of breast masses by making the ACR "BI-RADS Classification Form and Lexicon® ("ABCFL") available in electronic format. The user can view any selected image from a case and segment the background by applying a user selected threshold or outlining the lesion manually with a cursor.

The user can annotate, tag, measure, and record selected views. Under user control and review, the software electronically assembles reports from inputs selected by the ultrasound ABCFL during the image interpretation process. The assembled report complies with the ABCFL for ultrasound. The output may be viewed and sent to electronic storage media, or standard film or paper printers or other document manipulation programs such as Adobe or Microsoft.

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Substantial Equivalence to Predicate Device: BI-RADS Companion is substantially equivalent to: B-CAD System, Version 1.0. (K050846)

The following table is a comparison of the functions of the device.

| | Function | BI-RADS<br>Companion,<br>Version 1.0<br>(K072258) | B-CAD<br>System,<br>Version<br>1.0.<br>(K050846) |
|----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|--------------------------------------------------|
| 1 | Intended as aide to radiologists' reviewing of images of<br>masses in the human female breast | yes | yes |
| 3 | Windows 2000/XP based DICOM File Set Reader (FSR)<br>compatible platform may be installed on a PC, Notebook or<br>Workstation with HL7 compatibility | yes | yes |
| 4 | User interface designed to follow typical clinical workflow<br>patterns to process, review and analyze digital images | yes | yes |
| 5 | User may annotate, tag, calibrate, measure and<br>automatically record selected views | yes | yes |
| 6 | Automatically generates reports with user annotations<br>during image analysis process. Allows saving custom<br>annotations of images of confirmed cases to be used for<br>future reference and education | yes | yes |
| 7 | Annotations is based on ACR ABCFL Breast Imaging Atlas | yes | yes |
| 8 | Report format supports compliance with ACR ABCFL | yes | yes |
| 9 | Outputs may be viewed and sent to standard film or paper<br>printers or sent electronically to intranet web server or<br>other HL7 compliant media format | yes | yes |
| 10 | Display multiple and full study views | yes | yes |
| 11 | Radiologist's BI-RADS assessment based on visual<br>impressions of the user ABCFL | yes | yes |

The intended use, design, function, and performance characteristics for BRC are substantially equivalent to the predicate device listed above. It is the opinion of Almen Laboratories, Inc., that BRC raises no new issues of safety and effectiveness compared to these predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized representation of the body and legs.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ALMEN LABORATORIES, Inc. % Mr. Roger Schneider Consultant Medical & Radiation Technology 6319 Massachusetts Avenue BETHESDA MD 20816

MAY 1 6 2008

Re: K072258

Trade/Device Name: BI-RADS Companion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 20, 2008 Received: March 21, 2008

Dear Mr. Schneider:

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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### Page 2

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); 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.

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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): K072258

Device Name: BI-RADS Companion

Indications For Use:

BI-RADS Companion™ ("BRC") is a computer-aided image viewing and report generating tool designed to assist radiologists in the analysis of ultrasound images of breast masses by making the ACR "BI-RADS Classification Form and Lexicon®" ("ABCFL") available in electronic format. The user can view any selected image from a case and segment the lesion from the background by applying a user selected threshold or outlining the lesion manually with a cursor.

The user can annotate, tag, measure, and record selected views. Under user control and review, the software electronically assembles reports from inputs selected by the user from the ultrasound ABCFL during the image interpretation process. The assembled report complies with the ABCFL for ultrasound. The output may be viewed and sent to electronic storage media, or standard film or paper printers or other document manipulation programs such as Adobe or Microsoft.

When used by a skilled radiologist, this device provides information that may be useful in image interpretation. Patient management decisions should not be based solely on forms generated by BRC.

The ultrasound images displayed by BRC must not be used for primary diagnostic interpretation.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Nancy C Brogdon

ctive. A Radiological De 510(k) Number