ECHOINSIGHT

K110447 · Ultrasound Medical Devices, Inc. · LLZ · May 27, 2011 · Radiology

Device Facts

• Record ID: K110447
• Device Name: ECHOINSIGHT
• Applicant: Ultrasound Medical Devices, Inc.
• Product Code: LLZ · Radiology
• Decision Date: May 27, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

EchoInsight™ is intended for use by or on the order of a qualified physician for analysis of ultrasound imaging of the human heart. Cardiac (adult and pediatric) applications using B-mode (including harmonic) imaging are supported. The system provides image data analysis applications that supply information on cardiac structure and motion.

Device Story

EchoInsight™ is a software system for cardiac ultrasound image analysis. It ingests B-mode (including harmonic) ultrasound imagery stored in DICOM, JPEG, or JPEG 2000 formats. The device uses speckle tracking techniques to measure tissue motion, strain, and strain rate, and to derive cardiac structural measurements. Operated by or on the order of a qualified physician, the software processes imagery captured by commercial ultrasound systems. Output consists of visualized tissue motion and structural data, which assists the physician in evaluating cardiac function. The device is intended for clinical use to support diagnostic decision-making regarding cardiac structure and motion.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based image processing system. Inputs: B-mode ultrasound imagery (DICOM, JPEG, JPEG 2000). Processing: Speckle tracking algorithm for tissue motion, strain, and strain rate analysis. Connectivity: Compatible with standard DICOM imagery from commercial ultrasound systems. Standards: NEMA PS3 (DICOM), ISO/IEC 10918-1 (JPEG), ISO/IEC 15444-1 (JPEG 2000).

Indications for Use

Indicated for analysis of ultrasound imaging of the human heart in adult and pediatric patients using B-mode (including harmonic) imaging to provide information on cardiac structure and motion.

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

• syngo US Workplace, K091286 (VVI component of Clinical Application Package[CAP])

Submission Summary (Full Text)

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K110447

# FDA /ODE/ CDRH February 14, 2011

Page 13

### 510(k) Summary

MAY 2 7 2011

# Echolnsight™

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.

# Submitted By:

Ultrasound Medical Devices, Inc., dba Epsilon Imaging, Inc. 3917 Research Park Drive, Suite B7 Ann Arbor, Michigan 48108

### Contact Person:

Paul Kortesoja Director of Operations Phone: [phone] Fax: [phone]

#### Date Prepared:

February 14, 2011

# Proprietary Name:

EchoInsight™

#### Common/ Usual Name:

Image Processing System

#### Classification Name:

21 CFR §892.2050 Picture archiving and communications system Product Code LLZ-Image Processing System

#### Predicate Device:

syngo US Workplace, K091286 (VVI component of Clinical Application Package[CAP])

# Device Description:

The Echolnsight™ software system enables the production and visualization of 2D tissue motion measurements (including tissue velocities, strain rates) and cardiac «tructural measurement information derived from tracking speckle in tissue regions visualized in any Bmode (including harmonic) imagery loops as captured by most commercial ultrasound systems.

The Echolnsight™ software system has been designed to ingest and process ultrasound imagery stored in files with content organized and encoded in conformance to the following the following standards:

- NEMA PS3 (3.3, 3.5, 3.6, 3.10): Digital Imaging and Communications in Medicine . (DICOM), 2008.
- ISO/IEC 10918-1:1994-02: Information technology Digital compression and coding of . continuous-tone still images – Requirements and guidelines (JPEG standard), 1994.
- ISO/IEC 15444-1:2004: Information technology JPEG 2000 image coding system: . Core coding system, 2004.

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# Intended Uses:

EchoInsight™ is intended for use by or on the order of a qualified physician for analysis of ultrasound imaging of the human heart. Cardiac (adult and pediatric) applications using B-mode (including harmonic) imaging are supported. The system provides image data analysis applications that supply information on cardiac structure and motion.

# Technological Comparison to Predicate Devices:

EchoInsight™ is substantially equivalent to the Siemens VVI product already cleared for introduction into interstate commerce as part of K091286, syngo US Workplace. The new and predicate devices both provide methods for determination of tissue motion, strain, and strain rate for cardiac structures based on speckle tracking techniques. The new and predicate devices provide similar image and information visualization capabilities. Both utilize B-mode ultrasound imagery from other vendor as well as same vendor ultrasound scanning devices as input.

### End of 510(k) Summary

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized graphic of what appears to be a caduceus, a symbol often associated with healthcare. The caduceus is composed of three curved lines that resemble snakes intertwined around a staff.

# 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

Ultrasound Medical Devices, Inc. c/o Paul Kortesoja Director of Operations 3917 Research Park Drive, Suite B7 ANN ARBOR MI 48108

MAY 2 7 2011

Re: K110447

> Trade Name: EchoInsight Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 3, 2011 Received: May 4, 2011

Dear Mr. Kortesoja:

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 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/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 Pastel

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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### FDA /ODE/ CDRH February 14, 2011

#### Indications for Use

510(k) Number (if known):

EchoInsight™ Device Name:

Indications for Use:

Intended for use by or on the order of a qualified physician for analysis of ultrasound imaging of the human heart. Cardiac (adult and pediatric) applications using B-mode (including harmonic) imaging are supported. The system provides image data analysis applications that supply information on cardiac structure and motion.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mane Slatte
(Division Sign-On)

Office of In antinatic De

K110447
§10K

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