IVUS ENHANCER

K062985 · Indec Systems, Inc. · LLZ · Nov 22, 2006 · Radiology

Device Facts

• Record ID: K062985
• Device Name: IVUS ENHANCER
• Applicant: Indec Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

IVUS Enhancer is a software product intended to be used to review and analyze DICOM images, primarily intravascular ultrasound (IVUS) images. IVUS Enhancer is intended to help qualified medical professionals enhance DICOM images by adjusting image properties, making measurements, and adding annotations for easy export to other applications. These features aid in nostprocedure analysis regarding the placement of interventional devices.

Device Story

Software for viewing/analyzing DICOM medical images, primarily IVUS; inputs include DICOM data from various vendors and INDEC echoPlaque IMG/BMG files. Functionality includes image playback, adjustment of image properties, manual measurements, and annotation. Used by qualified medical professionals in clinical settings for post-procedure analysis of interventional device placement. Output consists of enhanced images, measurements, and annotations for export to other applications; aids clinicians in visualizing and documenting procedure outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based medical image viewing and analysis tool. Operates on DICOM standard data. Features include image property adjustment, measurement tools, and annotation capabilities. Standalone software application.

Indications for Use

Indicated for qualified medical professionals to review and analyze DICOM images, primarily IVUS images, to assist in post-procedure analysis following interventional device placement.

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

• In-Vision View with Measurements Module (K022940)
• QCU-CMS Analytical Software Package (K011582)

Submission Summary (Full Text)

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K062985

Image /page/0/Picture/1 description: The image shows the logo for INDEC SYSTEMS, INC. The logo includes the company name in bold, black letters. Below the company name is the address "2210 Martin Ave."

Santa Clara, CA 95050 TEL: [phone] FAX: [phone]

NUV 2 2 2006

## 510(k) Summarv

As required by section 807.92

Submitted by: INDEC Systems. Inc. 2210 Martin Ave. Santa Clara, CA 95050

> Tel: [phone] Fax: [phone]

Contact Person: Carol Hubler Date: Sept 27, 2006

Device Trade Name: IVUS Enhancer Common Name: Enhancer Classification: Picture Archiving and Communication System, Class II Sec. 21 CFR 807.92

#### Predicate Devices:

In-Vision View with Measurements Module (K022940) QCU-CMS Analytical Software Package (K011582)

#### Description of the Device:

IVUS Enhancer is a software product that provides capabilities for viewing and interacting with DICOM data from Intravascular Ultrasound (IVUS) studies from all vendors, other DICOM medical image data, and INDEC echoPlaque IMG/BMG IVUS files. IVUS Enhancer's main functionality includes viewing and playback of medical images and ancillary files, minor image analysis including some measurements, and the ability to resave image cross-sections and animations to be used in future presentations.

### Intended Use of the Device:

IVUS Enhancer is a software product intended to be used to review and analyze DICOM images, primarily intravascular ultrasound (IVUS) images. IVUS Enhancer is intended to help qualified medical professionals enhance DICOM images by adjusting image properties, making measurements, and adding annotations for easy export to other applications. These features aid in nostprocedure analysis regarding the placement of interventional devices.

## Substantial Equivalence to Predicate Device:

The IVUS Enhancer is substantially equivalent in intended use, design, and operation characteristics to the following currently marketed devices:

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Intelligent Images S.r.l. (MediMatic) In-Vision View with Measurements Module (K022940),

Medis Medical Imaging Systems B.V. QCU-CMS Analytical Software Package (K011582)

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Image /page/2/Picture/1 description: The image shows a black and white logo. The logo consists of a circular border with text around the top half, and a stylized graphic in the center. The graphic appears to be three curved lines that resemble a bird in flight or a stylized human figure.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Carol Hubler Vice President INDEC Systems, Inc. 2210 Martin Ave. SANTA CLARA CA 95050

NOV 2 2 2006

Re: K062985

Trade/Device Name: IVUS Enhancer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ and IYO Dated: September 26, 2006 Received: October 10, 2006

Dear Ms. Hubler:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "FDA Centennial 1906-2006" arranged in a circular pattern. The letters "FDA" are prominently displayed in a bold, stylized font at the center of the logo. Three stars are located beneath the word "Centennial".

Protecting and Promoting Public Health

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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 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) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy Chrogdon

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): Ko6 2985

Device Name:

Indications for Use:

IVUS Enhancer is a software product intended to be used to review and analyze DICOM images, primarily intravascular ultrasound (IVUS) images. IVUS Enhancer is intended to help qualified medical professionals review DICOM images by adjusting image properties, making simple measurements, and adding annotations for easy export to other applications. These features aid in postprocedure analysis after the placement of interventional devices.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon
(Division of
Division of
and Radiological Devices