AIE REGION OF INTEREST IMAGE ENHANCEMENT

K062059 · Advanced Image Enhancement · LLZ · Sep 6, 2006 · Radiology

Device Facts

• Record ID: K062059
• Device Name: AIE REGION OF INTEREST IMAGE ENHANCEMENT
• Applicant: Advanced Image Enhancement
• Product Code: LLZ · Radiology
• Decision Date: Sep 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The Advance Image Enhancement, Inc.'s Region of Interest Image Enhancement software is intended to improve the sharpness and clarity of subtle image features. The device used with FDA cleared monitors may be used by a trained physician or healthcare professional for display, manipulation and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image. The AIE software is intended as an added tool residing on any DICOM image workstation for improving the radiologist's perception of image features on any lossless compressed or noncompressed multi-modality DICOM "for-presentation" image. This software would be used while the radiologist is reviewing magnification window image segments on FDA cleared monitors and is intended to complement existing DICOM image workstation functionality. Warning: Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Story

ROILE-DM software enhances sharpness/clarity of subtle image features in DICOM mammographic and multi-modality images. Operates as add-on tool on existing DICOM workstations; used by radiologists during review of magnification window segments on FDA-cleared 5Mpixel monitors. Transforms input image data to improve visual perception of features; assists clinicians in resolving abnormalities with greater confidence. Intended for radiology reading rooms; complements existing workstation functionality. Benefits patient through improved diagnostic accuracy and feature detection.

Clinical Evidence

Reader study conducted with 6 MQSA-certified radiologists comparing AIE software to predicate device. Study utilized 50 mammography cases to perform feature analysis. Results supported substantial equivalence.

Technological Characteristics

Software-based image enhancement tool for DICOM workstations. Operates on standard DICOM multi-modality images. Requires FDA-cleared monitors with minimum 5 Mpixel resolution for mammography. Designed for integration with existing DICOM workstation environments.

Indications for Use

Indicated for trained physicians or healthcare professionals to display, manipulate, and interpret lossless compressed or non-compressed mammographic images for screening and diagnostic purposes, and other DICOM multi-modality images. Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images.

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

• Hologic, Inc.'s SecureView DX Softcopy Workstation (K041555)

Submission Summary (Full Text)

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K06205'9

AIE

### Advanced Image Enhancement, Inc. Region of Interest Image Enhancement for Digital Mammography Traditional 510(k) Submission

#### Section 5: 510(k) Summary

Submitter: Advanced Image Enhancement 306 Valentine Street Fall River, MA 02720 Contact Person: Jillian M. Reed Consultant Reed Technical Associates, LLC Date Prepared: July 19, 2006 Classification Name: Picture Archiving and Communications System Proprietary Name: Advance Image Enhancement, Inc.'s Region of Interest Image Enhancement Software Predicate Devices: Hologic, Inc.'s SecureView DX Softcopy Workstation (#K041555)

#### Device Description:

The Region of Interest Image Enhancement for Digital Mammography (ROILE-DM) software created by Advanced Image Enhancement, Inc. is intended to improve the overall ability of an image reader to resolve abnormalities with greater confidence in their findings. The AIE software is intended to improve the sharpness and clarity of subtle image features. The device used with FDA cleared monitors may be used by a trained physician for display, manipulation and interpretation of lossless compressed or noncompressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image. The intended operational environment is the radiology reading room or any other FDA approved environment.

## Intended Use:

The Advance Image Enhancement, Inc.'s Region of Interest Image Enhancement software is intended to improve the sharpness and clarity of subtle image features. The device used with FDA cleared monitors may be used by a trained physician or healthcare professional for display, manipulation and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image.

The AIE software is intended as an added tool residing on any DICOM image workstation for improving the radiologist's perception of image features on any lossless compressed multi-modality DICOM "for-presentation" image. This software would be used while the radiologist is reviewing magnification window image segments on FDA cleared monitors and is intended to complement existing DICOM image workstation functionality.

Warning: Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

SEP - 6 2006

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Image /page/1/Picture/0 description: The image shows the letters AIE in a bold, sans-serif font. The letters are arranged horizontally, with 'A' on the left, 'I' in the middle, and 'E' on the right. The letters are all capitalized and appear to be printed in black ink on a white background. The letters are closely spaced together.

#### Advanced Image Enhancement, Inc. Region of Interest Image Enhancement for Digital Mammography Traditional 510(k) Submission

#### Substantial Equivalence:

Testing performed has shown that Advanced Image Enhancement, Inc.'s Region of Interest Image Enhancement Software is substantially equivalent to the Hologic, Inc. 's SecureView DX Softcopy Workstation for its intended use.

#### Discussion of Non-Clinical Testing Performed:

Thorough system verification and validation testing was performed to ensure the safe and effective use of the AIE Region of Interest Enhancement Software.

#### Discussion of Clinical Testing Performed:

A reader study, comprised of 6 MQSA certified Radiologists, was conducted where they performed a features analysis comparing the AIE Region of Interest Enhancement Software to the predicate device on 50 mammography cases.

#### Conclusions:

The information provided in this premarket notification submission has shown that the AIE Region of Interest Image Enhancement Software is substantially equivalent to the predicate device and is safe and effective for its intended use.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP - 6 2006

Advanced Image Enhancement, Inc. c/o Ms. Jillian Reed Regulatory and Clinical Affairs Consultant Reed Technical Associates, LLC 25 Walnut Street MONROE CT 06468

Re: K062059

Trade/Device Name: Advance Image Enhancement, Inc.'s Region of Interest Image Enhancement Software Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 19, 2006 Received: July 20, 2006

Dear Ms. Reed:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encreases to the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic have been roctablines 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 controls provibitions of a labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket IT your device is olassified (500 a00 (1) ifitional controls. Existing major regulations affecting your Apploval), it may of subject to aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA device build be round announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a circular logo for the FDA Centennial, celebrating 100 years from 1906-2006. The logo features the FDA acronym prominently in the center. Below the acronym, the word "Centennial" is written in cursive. Three stars are arranged below the word "Centennial".

ting and Promoting Public Hoalth

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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-011. |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-011. |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C Hodgdon

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

Enclosure

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#### Indications for Use

#### 510(k) Number (if known): K062059

Advance Image Enhancement, Inc.'s Region of Interest Image Enhancement Software Device Name:

Indications for Use:

The Advance Image Enhancement, Inc.'s Region of Interest Image Enhancement software is intended to improve the sharpness and clarity of subtle image features. The device used with FDA cleared monitors may be used by a trained physician or healthcare professional for display. manipulation and interpretation of lossless compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image.

The AIE software is intended as an added tool residing on any DICOM image workstation for improving the radiologist's perception of image features on any lossless compressed or noncompressed multi-modality DICOM "for-presentation" image. This software would be used while the radiologist is reviewing magnification window image segments on FDA cleared monitors and is intended to complement existing DICOM image workstation functionality.

Warning: Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Prescription Use XXX (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

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