REMOTEIMAGE SYSTEM

K994228 · Etrauma.Com Corp. · LLZ · Feb 22, 2000 · Radiology

Device Facts

• Record ID: K994228
• Device Name: REMOTEIMAGE SYSTEM
• Applicant: Etrauma.Com Corp.
• Product Code: LLZ · Radiology
• Decision Date: Feb 22, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The Remotelmage™ System is indicated to be used for remote viewing of medical image data.

Device Story

RemoteImage is a client-server software system enabling remote access to medical images. It accepts inputs from various digital imaging modalities, including DICOM radiology systems, film digitizers (e.g., Vidar), and digital cameras. The software converts images to JPEG format and transmits them via 128-bit SSL encryption to a central server. Authorized medical professionals access these images via standard internet browsers on personal computers or workstations after password authentication. The system is intended for use by clinicians to review images remotely; it does not provide a diagnosis, control medical devices, or administer drugs. It serves as a communication tool to facilitate visualization where verbal communication would otherwise be used. Benefits include improved access to medical image data for licensed professionals, potentially aiding clinical decision-making by providing visual information in remote settings.

Clinical Evidence

Bench testing only. The system was evaluated by transmitting 2,016 images over a seven-day period. All images were delivered successfully in a complete and usable format with zero percent loss. A five percent retransmission rate occurred during modem connectivity, which was resolved via the software's automatic reconnection functionality, achieving a 100 percent final delivery ratio.

Technological Characteristics

Client-server software architecture; written in C; approximately 1 MB in size. Supports JPEG image conversion and 128-bit SSL encryption for data transmission. Operates on off-the-shelf hardware and standard internet browsers. Connectivity via TCP/IP. No specific hardware materials or sterilization methods applicable as it is a software-only system.

Indications for Use

Indicated for remote viewing of medical image data by licensed medical professionals.

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

• AMICAS Web/Intranet Image Server (K970064)

Reference Devices

• Vidar film digitizer (K933632)

Submission Summary (Full Text)

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**FEB 22 2000**

K994228
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## Section 510(k) Premarket Notification

### Summary of Safety and Effectiveness Information

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

- Device Trade Name: Remotelmage™ System
Common Name: Image Communication Device

Regulation Number: 892.2020

Classification Name: System, Image Processing

> Product Code: LLZ

### Establishment Name & Registration Number:

| Name: | eTrauma, LLC |
|-------|-----------------------------------|
| | 1425 East Newport Center Drive |
| | Deerfield Beach, FL 33442 |
| | [phone] [phone] FAX |

Number: To Be Applied For

# Classification:

| Device Class: | Class II |
|--------------------------|-----------|
| Classification<br>Panel: | Radiology |

### Applicant / Contact Information:

eTrauma, LLC Dan Hodgeman, President 1425 East Newport Center Drive Deerfield Beach, Florida 33442 [phone] [phone] FAX

## Submission Correspondent:

Dan Hodgeman eTrauma, LLC 1425 East Newport Center Drive Deerfield Beach, Florida 33442 [phone] [phone] FAX

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K 774228
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# Manufacturing Facility:

eTrauma, LLC 1425 East Newport Center Drive Deerfield Beach, Florida 33442 [phone](954) 570-6368 FAX

## Equivalent / Predicate Devices:

Autocyt Group, Inc. AMICAS Web/Intranet Image Server

K970064

## Comparison to Predicate Device:

The Remotelmage™ system is substantially equivalent to the AMICAS Web/Intranet Image Server in that it is an integrated client-server software system designed to allow access to medical images by radiologists, referring physicians and other licensed professionals and is intended to allow the review of images using a personal computer or workstation configured for standard internet access. Like the AMICAS system, the Remotelmage system enables the client (medical professional) to access images through an Internet browser.

## Comparison Table:

| Feature | Remotelmage | AMICAS | S/E |
|--------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------|-----|
| Indications for Use | Similar | Similar | Yes |
| Target Population | Health Professionals | Health Professionals | Yes |
| Uses Off-The-Shelf<br>Hardware | Yes | Yes | Yes |
| Lossy²/Lossless Image<br>Compression | Yes/Yes | Yes/No | Yes |
| TCP/IP Communications | Yes | Yes | Yes |
| Acquisition of images | DICOM Radiology Systems<br>Digital Film Scanner<br>Digital Camera<br>Other Imaging Modalities | DICOM Radiology Systems | Yes |

## Device Information:

Description Remotelmage is a client-server software system designed to allow access to medical images by licensed medical professionals. This product is intended to allow the review of images from a modality of digital imaging systems (including the Vidar (k933632) film digitizer, a digital camera, a radiography system (PACS) or other modality) using a personal computer for standard Internet access. Remotelmage software is installed on a computer configured with connections to a mode of digital imaging and the internet. Once images are obtained,

All lossy compressed images are labeled as such when viewed by end user. Dona 14 of 17

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the Remotelmage™ software converts the images from their original format to JPEG format and transmits them over 128 bit SSL encryption to an Internet server where they are stored for a specified period of time. Authorized medical personnel, upon password authentication, may download the images over 128 bit SSL encryption for viewing. The software program is written in C and is approximately 1 megabyte in size.

- The Remotelmage™ System is indicated to be used for remote Indicated Use viewing of medical image data.
- The severity of injury that the device could permit or inflict (directly or Level of Concern indirectly) on a patient or operator is minimal ( Lower Level of Concern). Failure of the device to function would result in the common practice of verbal telephone communications without the aid of visualization.

#### Hazard Analysis

Incorrect display of an image is possible due to incorrect data produced by the scanning modality or from a software malfunction. The method of control is through the current regulation of these devices by the FDA and/or through the testing procedures adhered to during development and testing stages of the device software prior to release. The corrective action is the intended use of this software with properly regulated devices, and timely identification and correction of these potential software problems and the subsequent testing procedures.

- Testing Testing of the Remotelmage software included transmitting 2,016 images in an aggregate for a seven day period. During each 24 hour period. three images were sent quarterly on the hour. All images during the testing phase were delivered successfully in complete and usable format with a loss of zero percent. During testing, a five percent retransmission rate was experienced using modem connectivity. These were successfully retransmitted within 120 seconds via the Remotelmage software reconnection functionality thereby reaching the 100 percent final delivery ratio above stated.
## Standards

Performance: None Voluntary: ACRINEMA DICOM

## Hardware/Software Information:

## Off-The-Shelf (OTS) Software

The Remotelmage system utilizes OTS hardware and software.

The end user does not directly interact with the OTS software, therefore, there are no end user decisional inputs required to the OTS software. No OTS software documentation will be provided to the end user.

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The inherent graphics, automation, calculation and communications processing power in the OTS software is the optimal platform for accomplishing the system's goal of efficient delivery of image data via the Internet.

#### Expected Limitation

There are no expected design limitations of the OTS software as the use of the software is within the current limits of the OTS software intended use. Use of the OTS software does not extend beyond, or specifically modify in any way, the original specifications set by the OTS software manufacturer.

Since the Remotelmage server is central and not located at a user facility, the end user of the Remotelmage system will not be required to configure or manage any OTS software. The user will not directly interact with the OTS software, therefore, there are no end user decisional inputs required to the OTS software.

#### Testing

Testing of the OTS software included transmitting 2,016 images in an aggregate for a seven day period. During each 24 hour period, three images were sent quarterly on the hour. All images during the testing phase were delivered successfully in complete and usable format with a loss of zero percent. During testing, a five percent retransmission rate was experienced using modem connectivity. These were successfully retransmitted within 120 seconds via the Remotelmage software reconnection functionality thereby reaching the 100 percent final delivery ratio above.

#### Tracking

The end user does not directly interact with the OTS software. All OTS software is installed, manipulated, maintained, and stored on a central server by the Company's Informations System Administrator.

## Release Version Number

Remotelmage™ software current release version is 1.1.0

## Safety and Effectiveness Information

- Description Remotelmage is a client-server software system designed to allow access to medical images by licensed medical professionals. This product is intended to allow the review of images from a modality of digital imaging systems (including the Vidar (k933632) film digitizer, a digital camera, a radiography system (PACS) or other modality) using a personal computer for standard Internet access. Remotelmage software is installed on a computer configured with connections to a mode of digital imaging and the internet. Once images are obtained, the Remotelmage™ software converts the images from their original format to JPEG format and transmits them over 128 bit SSL encryption to an Internet server where they are stored for a specified period of time. Authorized medical personnel, upon password authentication, may download the images over 128 bit SSL encryption for viewing. The software program is written in C and is approximately 1 meqabyte in size.

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K99422
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| Indicated Use | The Remotelmage™ System is indicated to be used for remote viewing of medical image data. |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Level of Concern | The severity of injury that the device could permit or inflict (directly or indirectly) on a patient or operator is minimal (Lower Level of Concern). Failure of the device to function would result in the common practice of verbal telephone communications without the aid of visualization. |
| | Hazard Analysis Incorrect display of an image is possible due to incorrect data produced by the scanning modality or from a software malfunction. The method of control is through the current regulation of these devices by the FDA, and through the testing procedures adhered to during development and testing stages of the device software prior to release. The corrective action is the intended use of this software with properly regulated devices, and timely identification and correction of these potential software problems and the subsequent testing procedures. |
| Testing | Testing of the Remotelmage software included transmitting 2,016 images in an aggregate for a seven day period. During each 24 hour period, three images were sent quarterly on the hour. All images during the testing phase were delivered successfully in complete and usable format with a loss of zero percent. During the test, a five percent retransmission rate was experienced using modem connectivity. These were successfully retransmitted within 120 seconds via the Remotelmage software reconnection functionality thereby reaching the 100 percent final delivery ratio above. |
| Factors Considered | The risk or danger to the patient as a result of using the system: The Remotelmage system cannot immediately threaten a patient's life nor directly cause irreversible illness or permanent injury as it deals only with image data and is intended to be viewed by a competent medical professional. |
| | Degree of influence on therapy or diagnosis: The Remotelmage system does not control the delivery or energy, administration or parenteral drugs, or life-sustaining functions. It does not provide a diagnosis. It provides information/data only. Competent health professionals would reasonably be expected to exercise judgement in the use of the information. |

.

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FEB 2 2 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re:

K994228 RemoteImage System Dated: December 9, 1999 Received: December 15, 1999 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Hodgeman:

1425 East Newport Center Drive

Deerfield Beach, FL 33442

Dan Hodgeman

eTrauma, LLC

President

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K994228 510(k) Number: Unknown

Device Name: Remotelmage™ System

# Indications For Use:

The Remotelmage™ System is indicated to be used for remote viewing of medical image data.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Emil l. Segura
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Def

OR

510(k) Number

Prescription Use

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)