(69 days)
No
The description focuses on image transmission, conversion, and secure access, with no mention of AI/ML algorithms for image analysis or interpretation. The performance studies are related to data transmission reliability, not diagnostic performance based on image content.
No
The device is described as a software system for remote viewing and transmission of medical image data; it does not directly treat or diagnose a medical condition.
No
The device is for remote viewing and transmission of medical image data, not for interpreting or analyzing the images to diagnose medical conditions. It serves as a tool for image access, not for diagnostic evaluation itself.
Yes
The device is described as a "client-server software system" and the description focuses solely on the software's functions (converting, transmitting, storing, and viewing images) and its implementation on a personal computer. While it interacts with hardware (personal computer, imaging modalities), the device itself is the software component.
Based on the provided information, the Remotelmage™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "remote viewing of medical image data." This is related to the display and transmission of medical images, not the analysis of biological samples or substances from the human body.
- Device Description: The description focuses on software for transmitting and viewing medical images from various imaging modalities. It describes image conversion (to JPEG) and secure transmission, which are related to image handling and display, not diagnostic testing of biological materials.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely related to the handling and display of medical images.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Remotelmage™ System does not perform such tests.
N/A
Intended Use / Indications for Use
The Remotelmage™ System is indicated to be used for remote viewing of medical image data.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device 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 megabyte in size.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM Radiology Systems, Digital Film Scanner, Digital Camera, Other Imaging Modalities
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed medical professionals / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
loss of zero percent, 100 percent final delivery ratio
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
FEB 22 2000
K994228
page 1 of 5
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 | |
| (954) 421-5623 (954) 570-6368 FAX |
Number: To Be Applied For
Classification:
| Device Class: | Class II |
|---|---|
| Classification | |
| Panel: | Radiology |
Applicant / Contact Information:
eTrauma, LLC Dan Hodgeman, President 1425 East Newport Center Drive Deerfield Beach, Florida 33442 (954) 421-5623 (954) 570-6368 FAX
Submission Correspondent:
Dan Hodgeman eTrauma, LLC 1425 East Newport Center Drive Deerfield Beach, Florida 33442 (954) 421-5623 (954) 570-6368 FAX
1
K 774228
Page 2 of 5
Manufacturing Facility:
eTrauma, LLC 1425 East Newport Center Drive Deerfield Beach, Florida 33442 (954) 421-5623(954) 570-6368 FAX
Equivalent / Predicate Devices:
Autocyt Group, Inc. AMICAS Web/Intranet Image Server
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 | |||
| Hardware | Yes | Yes | Yes |
| Lossy²/Lossless Image | |||
| Compression | Yes/Yes | Yes/No | Yes |
| TCP/IP Communications | Yes | Yes | Yes |
| Acquisition of images | DICOM Radiology Systems | ||
| Digital Film Scanner | |||
| Digital Camera | |||
| 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
2
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.
3
K414228
Page 4 of 5
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.
4
K99422
Page 5 of 5
| 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. |
.
5
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
6
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)