ECHOPLAQUE

K092842 · Indec Systems, Inc. · LLZ · Mar 1, 2010 · Radiology

Device Facts

• Record ID: K092842
• Device Name: ECHOPLAQUE
• Applicant: Indec Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Mar 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

echoPlaque is a software product intended to be used to visualize, analyze, and save DICOM and IMG/BMG (INDEC proprietary format) Intravascular Ultrasound (IVUS) images. echoPlaque is intended to allow qualified medical professionals to view, measure, and save new IVUS images. Images can be loaded into the echoPlaque software via removable media (CD/DVD) or hard disk or new images can be acquired from an analog or digital video signal. echoPlaque supports linear, area, and volumetric measurements. Measurements can be exported and images can be saved using echoPlaque. Images can be saved in either a compressed or uncompressed format. These features aid in post-procedure analysis regarding the placement of interventional devices.

Device Story

echoPlaque is a software-based IVUS analysis tool. Inputs: vendor-neutral multi-frame DICOM data, proprietary INDEC IMG/BMG IVUS files, and Microsoft Video 1 codec compressed AVI files; also acquires live analog/digital video signals. Operation: software loads, displays, and analyzes IVUS datasets. Features: 2D and volumetric measurements; image playback; saving/exporting images in compressed or uncompressed formats. Context: used by medical professionals in clinical settings for post-procedure analysis of interventional device placement. Output: quantitative measurements of vessel/stent dimensions and processed image files. Benefit: assists clinicians in evaluating vessel/stent status post-intervention.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based IVUS analysis tool. Operates on standard PC hardware. Supports DICOM, proprietary IMG/BMG, and AVI file formats. Connectivity via removable media (CD/DVD) or hard disk; analog/digital video signal acquisition. Performs linear, area, and volumetric measurements.

Indications for Use

Indicated for qualified medical professionals to visualize, analyze, and measure intravascular ultrasound (IVUS) images to quantify vessel and stent dimensions for post-procedure analysis.

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

• QIVA Intra Vascular Ultrasound Analysis software (K021495)
• QCU-CMS Analytical Software Package (K011582)

Submission Summary (Full Text)

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# 510(k) Summary

1092842

Submitted by:

MAR - 1 2010

Tel: [phone] Fax: [phone]

Contact Person: Carol Hubler Date: September 14, 2009

INDEC Systems, Inc.

Santa Clara, CA 95050

2210 Martin Ave.

Device Trade Name: echoPlaque

Common Name: Classification:

echoPlaque Intra Vascular Analysis Software Picture Archiving and Communication System, Class II Sec. 21 CFR 807.92

## Predicate Devices:

QIVA Intra Vascular Ultrasound Analysis software (K021495) QCU-CMS Analytical Software Package (K011582)

## Description of the Device:

echoPlaque is a software product that provides capabilities for loading, acquiring, viewing, analyzing and saving vendor-neutral, multi-frame DICOM data from Intravascular Ultrasound (IVUS) studies, INDEC echoPlaque IMG/BMG IVUS files, and medical datasets saved as Microsoft Video 1 codec compressed AVI files. echoPlaque's main functionality includes viewing and playback of medical images and ancillary files, acquiring new images from analog and digital signals, image analysis including 2D and volumetric measurements, and the ability to resave multi-frame images in either a compressed or uncompressed format for future visualization and analysis.

## Intended Use of the Device:

.

echoPlaque is a software product intended to be used to review, analyze, and measure intravascular ultrasound (IVUS) images. echoPlaque is intended to help qualified medical professionals examine intravascular ultrasound (IVUS) images and make measurements to quantify vessel and stent dimensions. These features aid in post-procedure analysis regarding the placement of interventional devices.

## Substantial Equivalence to Predicate Device:

echoPlaque 3.0 is substantially equivalent in intended use, design, and operation characteristics to the following currently marketed devices:

- QIVA Intra Vascular Ultrasound Analysis software (K021495)
- Medis Medical Imaging Systems B.V. QCU-CMS Analytical Software Package (K011582)

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal on the left and a stylized symbol on the right. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. The symbol on the right is a stylized representation of three overlapping figures.

## 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

MAR - 1 2010

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

Re: K092842

Trade/Device Name: echoPlaque Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 22, 2010 Received: January 26, 2010

#### 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 adultcration.

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 803); 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 Vitro 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/MedicalDevices/Safety/ReportalProblem/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/cdrlv/industry/support/index.html.

Sincerely yours.

Donald J. Trump

Donald J. St.Pierre Acting 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):

Device Name: _ _ _ _ _ echoPlaque

Indications for Use:

echoPlaque is a software product intended to be used to visualize, analyze, and save DICOM and IMG/BMG (INDEC proprietary format) Intravascular Ultrasound (IVUS) images. echoPlaque is intended to allow qualified medical professionals to view, measure, and save new IVUS images. Images can be loaded into the echoPlaque software via removable media (CD/DVD) or hard disk or new images can be acquired from an analog or digital video signal. echoPlaque supports linear, area, and volumetric measurements. Measurements can be exported and images can be saved using echoPlaque. Images can be saved in either a compressed or uncompressed format. These features aid in post-procedure analysis regarding the placement of interventional devices.

Prescription Use × Prescription Use _____________________________________________________________________________________________________________________________________________________________

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)

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

510(k) Number K092842

(Posted November 13, 2003)

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