(15 days)
Not Found
No
The document describes a standard medical image viewing and processing workstation with functions like window/level adjustment, annotation, and image manipulation. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance study summaries.
No
The device is a software application for viewing medical images for diagnostic purposes, not for treating conditions.
Yes
Explanation: The device is used for "viewing medical images," and its users, "trained medical professionals, including but not limited to radiologists, clinicians, technologists," perform tasks like "adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images" on these images. These functions are typical for software used in interpreting medical images for diagnostic purposes. The use of a "Workstation" by "radiologists" also strongly suggests a diagnostic context.
Yes
The device description explicitly states that eFilm™ Workstation is a "software application" and a "component of a PACS". The functions described are all software-based image processing and viewing tasks. There is no mention of any accompanying hardware that is 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 clearly states that eFilm™ Workstation is for "viewing medical images." It describes tasks related to manipulating and displaying these images for trained medical professionals. This is consistent with a medical image viewer or PACS component, not a device used for testing samples from the human body.
- Device Description: The description reinforces that it's a software application for image viewing and communication within a PACS. It handles medical images acquired from various imaging modalities.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on such analysis. IVDs are typically used to detect, measure, or identify substances or characteristics in samples from the human body to provide information for diagnosis, monitoring, or treatment.
The device's function is centered around the display and manipulation of medical images acquired through imaging modalities like CT, MR, etc., which are not considered in vitro diagnostic procedures.
N/A
Intended Use / Indications for Use
eFilm™ Workstation is a software application that is used for viewing medical images. eFilm™ Workstation 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). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm™ Workstation can be integrated with an institution's existing HIS or RIS for a fully integrated electronic patient record.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
eFilm™ Workstation is one of the components of a PACS (Picture Archiving and Communications System). eFilm™ Workstation is a software application that provides image viewing and System). Chim - Wonotion 10 a setting. The functions of this application are applied to medical images that are acquired and stored on an image server in DICOM and/or other modioal integor that an 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
Typical users of eFilm™ Workstation are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
eFilm™ Workstation is tested according to the specifications that are documented in a Software of mr. Testing is an integral part of eFilm Medical Inc.'s software development process as described in the SOP-01: Product Development Process
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
JUL 3 1 2001
510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness is provided as part of the Premarket Notification for eFilm™ Workstation, in accordance with SMDA 1990.
| Date Prepared: | July 4, 2001 |
|---|---|
| Submitted By: | eFilm™ Medical Inc. |
| 500 University Ave, Suite 300, | |
| Toronto, Ontario | |
| Canada M5G 1V7 | |
| Contact Name: | Kathy Chin |
| Contact Email: | kathy.chin@efilm.ca |
| Contact Telephone: | (416) 204 9664 ext 222 |
| Contact Fax: | (416) 204 9442 |
| Device Trade Name: | eFilm™ Workstation |
| Device Common Name: | Picture Archiving Communications System (PACS) |
| Device Classification: | 892.2050 (Class II) |
| Name: | Image Processing System |
| Predicate Device: | RadWorks™ Medical Imaging Software with Quality |
| Control Module | |
| Predicate Device Manufacturer: | Applicare Medical Imaging B.V. |
| Predicate Device 510(k) Number: | K982862 |
| Date Received: | 08/13/1998 |
| Decision Date: | 10/21/1998 |
| Decision: | Substantially Equivalent |
| Panel Code Device Reviewed by: | Radiology |
| Panel Code Device Classified by: | Radiology |
| Product Code: | LLZ |
| Classification: | 892.2050 (Class II) |
Device Description
eFilm™ Workstation is one of the components of a PACS (Picture Archiving and Communications System). eFilm™ Workstation is a software application that provides image viewing and System). Chim - Wonotion 10 a setting. The functions of this application are applied to medical images that are acquired and stored on an image server in DICOM and/or other modioal integor that an also transfer DICOM 3.0 images over a medical imaging network, as well as export images to applications in other proprietary formats.
Indications For Use
eFilm™ Workstation is a software application that is used for viewing medical images. eFilm™ Workstation 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). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of
1
interest; and inversion, rotation, and flips of images. In addition, eFilm™ Workstation can be interest, and litverolori, forcation, this or RIS for a fully integrated electronic patient record.
Typical users of eFilm™ Workstation are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
Technological Characteristics
Both the eFilm™ Workstation and the Radworks™ Medical Imaging Software with Quality Control Bon the on intentioners packages which can be used on more than one hardware Moduc are other alone benefits before 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 does not contact the patient, nor does it control any life-sustaining devices. e int" wontetation associety for competent human intervention interprets images and information being displayed and/or printed.
Testing
eFilm™ Workstation is tested according to the specifications that are documented in a Software of mr. 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 contains adequate information and data to enable FDA-CDRH to determine substantial equivalence to the predicate device.
-
- eFilm™ Workstation 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2001
eFilm Medical, Inc. % Mr. N.E. Devine, Jr. Responsible Third Party Offical Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548
Re: K012211
eFILMTM Workstation (PACS) Dated: July 4, 2001 Received: July 16, 2001 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Devine:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We meversions your booking of or the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror 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). You may, that neve room recentise in about 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 (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, to such additions of the minute the equivalent determination assumes compliance with the Current Good Manufacturing The 21, 1 at 5 oo to 093. I Fouromation (QS) for Medical Devices: General regulation (QS) for Medical Devices (21 CFR Part I have 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 regulatory action. In addition, FDA may publish further announcements to comply frial also are the Federal Register. Please note: this response to your premarket notification submission does not ection 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) 594-4639. 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" (21CFR 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
Nancy C. Bogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
3
Indications For Use Statement
510(k) Number: K012211
Device Name: eFilm™ Workstation
Indications for Use:
eFilm™ Workstation is a software application that is used for viewing medical images. eFilm™ Workstation 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). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm™ Workstation can be integrated with an institution's existing HIS or RIS for a fully integrated electronic patient record.
Typical users of eFilm™ Workstation are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
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): __
Ohrid L. Ingram
(Division Sign-Division of Reproductive, Abdomin and Radiological Devices 510(k) Number