(15 days)
Not Found
No
The document describes standard image viewing and manipulation software for medical images, with no mention of AI, ML, or related concepts.
No.
The device is a software application for viewing, processing, and displaying medical images for diagnostic purposes, not for treating or rehabilitating patients.
Yes
The device description states "eFilm Workstation with Modules is a software application that provides image viewing and manipulation in a diagnostic imaging setting." This explicitly indicates its use in a diagnostic context.
Yes
The device description explicitly states that eFilm Workstation with Modules is a "software application" and a "component of a PACS". It focuses on software functions like viewing, processing, and manipulating images, and transferring data. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for viewing, processing, and displaying medical images acquired from various imaging modalities (CT, MR, US, etc.). This is a core function of medical image viewing software, not a diagnostic test performed on biological samples.
- Device Description: The description clearly states it's a software application for image viewing and manipulation within a PACS system. It handles digital images, not biological specimens or samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is centered around the visualization and manipulation of medical images, which are distinct from the activities of an IVD.
N/A
Intended Use / Indications for Use
eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in preoperative planning. eFilm Workstation with Modules can be integrated with an institution's existing HIS or RIS for a fully integrated electronic patient record.
Product codes
LLZ
Device Description
eFilm Workstation with Modules is one of the components of a PACS (Picture Archiving and Communications System). eFilm Workstation with Modules is a software application that provides image viewing and manipulation in a diagnostic imaging setting. The functions of this application image viewing and manipadian in are acquired and stored on an image server in DICOM and/or other proprietary formats. eFilm Workstation with Modules can also transfer DICOM 3.0 images over a medical imaging network, as well as export images to applications in other proprietary formats.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical professionals, including but not limited to radiologists, technologists and clinicians.
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
eFilm Workstation with Module is tested according to the specifications that are documented in a Software Test Plan. Testing is an integral part of eFilm Medical Inc.'s software development process as described in the SOP-01: Product Development Process
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KO20995
510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness is provided as part of the Premarket Notification for eFilm Workstation with Modules, in accordance with SMDA 1990.
Date Prepared:
March 15/2002
Toronto. Ontario Canada M5G 1V7
Joseph A. Thomas
(416) 204 9442
Submitted By:
eFilm Medical Inc. 500 University Ave, Suite 300,
(416) 204 9664 ext 291
Contact Name: Contact Email: Contact Telephone: Contact Fax:
Device Trade Name: Device Common Name: Regulation Number: Device Classification: Name:
Predicate Device: Predicate Device Manufacturer: Predicate Device 510(k) Number: Date Received: Decision Date: Decision: Panel Code Device Reviewed by: Panel Code Device Classified by: Product Code: Requiation Number: Device Classification:
eFilm Workstation with Modules Picture Archiving Communications System (PACS) 892.2050 Class II Image Processing System
eFilm™ Workstation™ eFilm Medical Inc. K012211 07/16/2001 07/31/2001 Substantially Equivalent Radiology Radiology LLZ 892.2050 Class II
Device Description
eFilm Workstation with Modules is one of the components of a PACS (Picture Archiving and Communications System). eFilm Workstation with Modules is a software application that provides image viewing and manipulation in a diagnostic imaging setting. The functions of this application image viewing and manipadian in are acquired and stored on an image server in DICOM and/or other proprietary formats. eFilm Workstation with Modules can also transfer DICOM 3.0 images over a medical imaging network, as well as export images to applications in other proprietary formats.
1
Indications For Use
eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in preoperative planning. eFilm Workstation with Modules can be integrated with an institution's existing HIS or RIS for a fully integrated electronic patient record.
Typical users of eFilm Workstation with Modules are trained medical professionals, including but not limited to radiologists, technologists and clinicians.
Technological Characteristics
Both the eFilm Workstation with Modules and the eFilm™ are stand-alone software packages that can be used on more than one hardware platform. As long as minimum hardware requirements are met, the user is free to choose his/her own hardware platform.
Both systems allow digital image processing and measurement capability. Both systems can transmit to remote viewing stations over a medical imaging network.
eFilm Workstation with Modules does not contact the patient, nor does it control any lifesustaining devices. A physician providing ample opportunity for competent human intervention interprets images and information being displayed and/or printed.
Testing
eFilm Workstation with Module is tested according to the specifications that are documented in a Software Test Plan. Testing is an integral part of eFilm Medical Inc.'s software development process as described in the SOP-01: Product Development Process
Conclusion
The 510(k) premarket notification for eFilm Workstation with Modules contains adequate information and data to enable FDA-CDRH to determine substantial equivalence to the predicate device.
-
- eFilm Workstation with Module has been and will continue to be manufactured according to the voluntary standards listed in the Voluntary Standards section (4.1) of this submission.
-
- This submission contains the result of a hazard analysis and all potential hazards have been classified as minor.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is simple, using black lines on a white background.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
eFilm Medical, Inc. % Mr. Neil E. Devine Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548
APR 1 2 2002
Medical, Inc.
Neil E. Devine
asible Third Party Official
Inc.
Madison Ave. SE
Re: K020995
Trade/Device Name: eFilm Workstation with Modules Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving
and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: March 19, 2002 Received: March 28, 2002
Dear Mr. Devine:
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 (PMA), it may be subject to 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use Statement
510(k) Number: _ Ko 20995
Device Name: eFilm Workstation with Modules
Indications for Use:
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Typical users of eFilm Workstation with Modules are trained medical professionals, including but not limited to radiologists, technologists and clinicians.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEE DED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109):
OR
Over the Counter Use (optional Format 1-2-96):
Jancy C nogdon
(Division Sign-Om
vision of Reproductive, Abdominal,
Radiological Devices K020995