ECHOSYSTEM

K051745 · Medstrat, Inc. · LLZ · Jul 14, 2005 · Radiology

Device Facts

• Record ID: K051745
• Device Name: ECHOSYSTEM
• Applicant: Medstrat, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jul 14, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The Medstrat echoeSYSTEM™ is intended to enable the communication, storage, viewing and manipulation of diagnostic medical images and data. The echoeSYSTEM™ can show images on workstations locally and/or across computer networks at widely distributed locations. The echoeSYSTEM™ software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical echoeSYSTEM™ users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and other authorized medical professionals. It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.

Device Story

echoeSYSTEM™ is a client-server software system for viewing, storing, and manipulating diagnostic medical images. It ingests DICOM 3.0 data from imaging modalities. Operated by orthopedic surgeons and healthcare professionals on off-the-shelf PCs, it provides tools for image measurement and overlaying prosthesis templates onto radiological images to assist in surgical planning and evaluation. The system supports secure remote access via web interfaces and enables collaboration through saved states of annotations and measurements. By facilitating precise template positioning and preoperative assessment, the device aims to improve surgical planning accuracy and clinical workflow efficiency.

Clinical Evidence

No clinical data provided; bench testing only. Substantial equivalence is based on descriptive comparisons of technological features and intended use.

Technological Characteristics

Client-server software system; runs on off-the-shelf hardware; utilizes DICOM 3.0 protocol for image acquisition; supports JPEG image compression; TCP/IP communication; includes measurement and digital templating tools; web-based authentication and secure protocols.

Indications for Use

Indicated for healthcare professionals, including orthopedic surgeons and referring physicians, for preoperative planning and postoperative evaluation of orthopedic surgery using radiological 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

• eFILM Workstation with Modules (K020995)
• Amicas Web/Intranet Image Server (K970064)

Submission Summary (Full Text)

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5/20/2005

# B. ADMINISTRATIVE INFORMATION

JUL 1 4 2005

#### 510(k) Summary of safety and effectiveness 1.

#### Manufacturer:

| Address: | Medstrat, Inc.<br>1901 Butterfield Road<br>Suite 600<br>Downers Grove, IL 60515<br>Phone: [phone]<br>Fax: [phone] |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Robert J. Bishop |
| Summary Date: | April 25, 2005 |
| Device Name: | |
| Trade name: | echoeSYSTEM™ |
| Common name: | Medstrat ECHOESTM PACS |

Classification name: Picture archiving and communication system

#### Predicate Device:

eFILM Workstation with Modules, K020995, eFilm Medical Inc.

Amicas Web/Intranet Image Server, K970064, Autocyt Group, Inc.

#### Device Description:

ECHOES™ is a client-server software system designed to allow viewing access to medical images on a personal computer by authorized medical professionals. This product is designed to function with off-the-shelf hardware and software products including standard communications products. It does not require specialized, or nonstandard, devices of any type.

Image acquisition is via the industry standard DICOM 3.0 protocol allowing the images to be produced from the digital data originated by the imaging modality.

The software will run on standard off-the-shelf hardware and system configurations,

#### Intended Use:

The Medstrat echoeSYSTEM™ is intended to enable the communication, storage, viewing and manipulation of diagnostic medical images and data. The echoeSYSTEM™ can show images on workstations locally and/or across computer networks at widely

#### Medstrat. Inc.

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distributed locations. The echoeSYSTEM™ software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical echoeSYSTEM™ users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and other authorized medical professionals.

It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.

| Feature | Efilm<br>Workstation<br>with Modules | Amicas<br>Web/Intranet<br>Server | EchoeSYSTEM |
|--------------------------------|--------------------------------------|----------------------------------|-------------------------|
| Indications for Use | Similar | Similar | Similar |
| Target Population | Health<br>Professionals | Health<br>Professionals | Health<br>Professionals |
| Uses Off-the-Shelf<br>Monitors | yes | yes | yes |
| Lossy Image Compression | yes | yes | yes |
| TCP/IP Communications | yes | yes | yes |
| Software Only | yes | yes | yes |
| Image Measurements | yes | yes | yes |
| DICOM image data | yes | yes | yes |
| Pixel-for-Pixel Zoom | yes | yes | yes |
| User Login/Authentication | NA | yes | yes |
| Digital templates | yes | no | yes |
| Editable state saves | no | no | yes |

#### Substantial equivalence:

ECHOES™ has Indications for Use similar to other medical image devices such as to eFILM Workstation with Modules [K020995], eFilm Medical Inc. 510(k) Holder and Amicas Web/Intranet Image Server [K970064], Autocyt Group, Inc. 510(k) Holder. ECHOESTM also shares with these devices a Target Population that is competent health professionals. Also equivalent to these devices, the ECHOES™ design will operate with off-the-shelf hardware and systems.

Like the Amicas Web/Intranet Image Server [K970064], Autocyt Group, Inc. 510(k) Holder, ECHOES™ employs Image Compression to remove redundant or unimportant information in the original image data. The compression methods are believed to conform to the voluntary recognized consensus JPEG standard as declared in Section A.8 herein.

Like the eFILM Workstation with Modules [K020995], eFilm Medical Inc. 510(k) Holder, ECHOESTM provides image viewing and manipulation in a diagnostic setting affording users access to various image processing and measurement tools to assist them in viewing images. Users can overlay templates on medical images to aid in operative and non-operative treatment planning.

Medstrat, Inc.

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ECHOES™ provides secure Internet and extranet interfaces through authentication mechanisms, web accessible authentication servers and access for authorized users through secure protocols to web image servers. ECHOES™ provides functions for communicating, storing and editing state save data of annotations, measurements and image manipulation states intended to be used for supporting collaboration, clinical data collection and education among health professionals.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2005

Dated: June 21, 2005 Received: June 29, 2005

4 2005

Medstrat, Inc. % Ms. Silvia Ankova Project Manager Underwriters Laboratories, Inc. 333 Pfingsten Rd. NORTHBROOK IL 60062

Re: K051745 Trade/Device Name: echoeSYSTEM™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ

Dear Ms. Ankova:

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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This leter will anow you'to organ matters of substantial equivalence of your device to a legally prematice notification: "The PDF macinsing 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 If you desire specific active for a 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" (21 CFR Also, prease note the regulation on your responsibilities under the Act from the 807.77). I ou may oouall ourers, 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. Hogdon

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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## 2. FDA Indication for Use Form

## Indications for Use

K651745 510(k) Number (if known): __

・.

. .

Device Name: echoeSYSTEM™

| Indications for Use: | The Medstrat echoeSYSTEM™ is intended to enable the communication, storage, viewing and manipulation of diagnostic medical images and data. The echoeSYSTEM™ can show images on workstations locally and/or across computer networks at widely distributed locations. The echoeSYSTEM™ software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical echoeSYSTEM™ users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and other authorized medical professionals. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications. |

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div> <img alt="Signature" src="signature.png"/> </div> |
|---------------------------------------------------------------|---------------------------------------------------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K051745 |

Medstrat, Inc.

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