(268 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image display, manipulation, and management, not AI-driven analysis.
No
The device is described as software for selection, display, manipulation, and media interchange of medical images for diagnostic purposes, not for direct therapeutic intervention.
Yes
The device description states that the software offers solutions for "reviewing them for diagnostic purposes" and is "used by radiologists for all functions".
Yes
The device description explicitly states "The MEDWS software range offers solutions..." and describes it as being "installed on a computer connected to the imaging network." The validation is described as "bench testing" of the software's functions. There is no mention of hardware components being part of the device itself, only that it interfaces with existing imaging modalities and computers.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the MEDWS Software is for the "selection, display, manipulation and media interchange of medical images." It processes and displays images acquired from various imaging modalities (MG, MR, US, CT, etc.).
- No Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on materials taken from the human body. Its function is centered around the management and viewing of medical images.
Therefore, the MEDWS Software falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MEDWS Software (MEDVIEWS, MEDMAMMO) is intended for selection, display, manipulation and media interchange of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing device using DICOM or similar interface standards.
Lossy compressed mammographic image are not intended for diagnostic images should only be viewed with a monitor cleared by FDA for viewing mammographic images. For primary diagnosis, post process DICOM for presentation images must be used.
The MEDWS Software (MEDVIEWS, MEDDIAG, MEDMAMMO) is typically used by trained professionals including but not limited to physicians, radiologists, nurses, medical technicians and assistants.
Product codes
LLZ
Device Description
The MEDWS software range offers solutions for managing radiology images and reviewing them for diagnostic purposes. They are used in hospital or clinic radiology departments and in private medical imaging practices. They are used by radiologists for all functions and by technicians for functions not involving diagnoses (formatting for printing, CD burning, etc. ). A solution from the MEDWS software range is installed on a computer connected to the imaging network. The radiology table (modality) manages image acquisition and sends images over the local network to a console from the MEDWS range.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MG, MR, US, CT, SC, CR, PET, DR, ES, NM, PX, RF, XA
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
used in hospital or clinic radiology departments and in private medical imaging practices. They are used by radiologists for all functions and by technicians for functions not involving diagnoses (formatting for printing, CD burning, etc. ).
The MEDWS Software (MEDVIEWS, MEDDIAG, MEDMAMMO) is typically used by trained professionals including but not limited to physicians, radiologists, nurses, medical technicians and assistants.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance: The subject device is designed in conformance with ACR/NEMA Digital Imaging Communication in Medicine (DICOM) . Version 3.1, ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements, ISO 14971:2007 Medical devices Application of risk management to medical devices, IEC 62304:2006 Medical device software Software life-cycle . processes, IEC 62366:2007 Medical devices Application of usability . engineering to medical devices. Every specification of the MEDWS software is validated by a bench test before release. Bench testing includes: The installation of the software, The configuration of the software, The management of the patient information, The acquisition and integration of new data, The manipulation of the data, The DICOM conversion, The DICOM connectivity, The export and distribution of data.
Results: The MEDWS software has successfully undergone every bench testing designed to simulate clinical use. Based on the information supplied in this 510(k), MEDECOM SARL concludes that MEDWS is substantially equivalent to the predicate device and is safe and effective.
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
CAD
K132684
MAY 23 2014
510(k) Summary of Safety and Effectiveness
MEDWS
Product Name: MEDWS (variants MEDVIEW, MEDDIAG, MEDMAMMO)
Product Classification Name: Picture, Archive and Communications System
Product Code: LLZ
CFR Section: 892.2050
Classification Panel: Radiology device
Class: II
Date prepared: May 21st, 2014
Submitter's information (21 CFR 807.92(a)(1)):
MEDECOM SARL 9 bis rue de Kerbrat 29 470 PLOUGASTEL DAOULAS FRANCE Phone: +33 298 465 248 Fax: +33 298 247 193 Email: mathieu.reinaud@medecom.fr
Name, title and phone number of contact (21 CFR 807.92(a)(1)):
Mrs Cynthia Cottereau, Consultant. TWOKSA SAS 2 bis rue des Vauzelles 16 100 CHATEAUBERNARD FRANCE Phone: +33 545 321 884 Fax: +33 963 294 139 Email: cynthia.cottereau@twoksa.com
Predicate Device (21 CFR 807.92(a)(3)):
510k number: K103385 Regulation number: 892.2050 Device name: SecurView DX Applicant: Hologic, Inc, 35 Crosby Drive, Bedford, MA 01730, USA Classification product code: LLZ
1
Image /page/1/Picture/0 description: The image shows the logo for Medecom, a company that specializes in communicating imaging. The logo features a stylized handwritten font for the word "Medecom", with the tagline "Communicating Imaging" printed in a simple, bold font below. The logo also includes a geometric design element to the left of the company name.
Device classification name: System, image processing, radiological Class: II Panel: Radiology Device
Device Description (21 CFR 807.92(a)(4)):
The MEDWS software range offers solutions for managing radiology images and reviewing them for diagnostic purposes. They are used in hospital or clinic radiology departments and in private medical imaging practices. They are used by radiologists for all functions and by technicians for functions not involving diagnoses (formatting for printing, CD burning, etc. ). A solution from the MEDWS software range is installed on a computer connected to the imaging network. The radiology table (modality) manages image acquisition and sends images over the local network to a console from the MEDWS range.
Intended Use (21 CFR 807.92(a)(5)):
The MEDWS Software (MEDVIEW, MEDDIAG, MEDMAMMO) is intended for selection, display, manipulation and media interchange of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
Lossy compressed mammographic image are not intended for diagnostic review. Mammographic images should only be viewed with a monitor cleared by FDA for viewing mammographic images. For primary diagnosis, post process DICOM for presentation images must be used.
The MEDWS Software (MEDVIEW, MEDDIAG, MEDMAMMO) is typically used by trained professionals including but not limited to physicians, radiologists, nurses, medical technicians and assistants.
Technological Characteristics (21 CFR 807.92(a)(6)):
MEDWS is a software product used to manipulated digital medical images for diagnosis purpose. The device does not contact the patient, nor does it control any life sustaining devices.
MEDWS software runs under Windows XP Professional SP3 or Windows 7 operating systems for Pcs (as minimum and depending upon system configuration). The requirements on hardware are quite ordinary for a system for displaying images.
MEDWS has the same main technological characteristics as its predicate device.
2
Image /page/2/Picture/0 description: The image shows a logo with the word "Medecom" in a stylized font. The "M" is a handwritten-style letter, and the rest of the letters are in a sans-serif font. There is a geometric shape to the left of the word "Medecom". The word "om" is at the end of the word.
Non-clinical performance
The subject device is designed in conformance with:
- ACR/NEMA Digital Imaging Communication in Medicine (DICOM) . Version 3.1
- ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
- ISO 14971:2007 Medical devices Application of risk management to medical devices
- IEC 62304:2006 Medical device software Software life-cycle . processes
- IEC 62366:2007 Medical devices Application of usability . engineering to medical devices
Every specification of the MEDWS software is validated by a bench test before release. Bench testing includes:
- The installation of the software .
- The configuration of the software
- The management of the patient information
- The acquisition and integration of new data .
- The manipulation of the data .
- The DICOM conversion .
- The DICOM connectivity .
- The export and distribution of data .
Substantial Equivalence
The design, fundamental technology, functionalities ,intended use and performances of the MEDWS software are similar and therefore substantially equivalent to its predicate like it is demonstrated in the table below.
| | Predicate
Device | Subject Device | | If different, |
|---------------------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| | | MEDVIEW
MEDDIAG | MED-MAMMO | impact on safety
or efficacy |
| | Hardware requirements | | | |
| Operating system | Windows XP,
Windows 7 | Windows XP Professional SP3 or
Windows 7 | | No difference |
| Memory | 2.0 GB RAM | 1.0 GB RAM | 4.0 GB RAM | No impact : RAM
needed is different
in order to insure
same efficacy |
| Processor | Dual | Pentium Core 2 | Xeon Quad Core | No impact : |
| | Predicate
Device | Subject Device | | If different,
impact on safety
or efficacy |
| | | MEDVIEW
MEDDIAG | MED-MAMMO | |
| | Processor Intel
CPU with
clock rate of
2.0 GHz or
higher | | 3 GHz | Processor needed
is different in
order to insure
same efficacy |
| Free disc space | Unknown | 150 Mb for the software | | No impact |
| Graphic Card | Unknown | OpenGL 2.0
compatible
graphic
controller
(Chipset or
graphic card) | 256 Mo, OpenGL
3.0 compatible
graphic card | No impact |
| Networking | Network
Interface Card
(NIC) 10/100
Base-T | 100 Mbps
TCP/IP network
card | 1 Gbps TCP/IP
network card | No impact |
| Support
conventional
screen for
multimodality
image review | Yes | Yes | Yes | No difference |
| Support specific
screen for
mammography
image review
cleared by FDA | Yes | No | Yes | No difference |
| Support Tactile
screen | Unknown | No | Yes | Tactile screen
does not add any
safety risks
because it permits
better control by
the user.
There is no impact
on efficacy. |
| Support Several
screens at the
same time | Yes | MEDVIEW : No
MEDDIAG : Yes | Yes | No difference
If needed, support
of several screens
is available in
MEDDIAG or
MEDMAMMO
variants |
3
Image /page/3/Picture/0 description: The image shows a logo with the word "Medecom" written in a stylized font. The "M" is a large, cursive letter, while the rest of the word is in a sans-serif font with a slightly rounded appearance. There are also some geometric shapes to the left of the word, including a rectangle and a square.
Communicating Imaging
4
Image /page/4/Picture/0 description: The image shows the logo for "Medecom". The logo consists of a stylized letter "M" followed by the letters "edecom" in a unique font. There are also some geometric shapes to the left of the "M".
| | Predicate
Device | Subject Device | | If different,
impact on safety
or efficacy |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------|--------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | MEDVIEW
MEDDIAG | MED-MAMMO | |
| Support
conventional
Keyboard | | Yes | Yes | |
| Support specific
keyboard for
mammography
image review | Yes | No | Yes | No difference |
| Printing on
DICOM printer | Yes | Yes | Yes | No difference |
| Printing on
standard printer | Unknown | | Yes | This functionality
does not add risks
and permit to user
to keep some
images in the
paper patient file.
There is no impact
on safety. |
| Administration Setting | | | | |
| Account user
administration | Yes | | Yes | No difference |
| Patients list
administration | Yes | | Yes | No difference |
| User preference
setting | Yes | | Yes | No difference |
| User workflow
setting | Yes | | Yes | No difference |
| DICOM Features | | | | |
| Modalities
supported | MG, MR, US,
CT, SC, CR,
PET, DR and
multiframe
mammography
images | | MG, MR, US, CT, SC, CR, PET,
DR, ES, NM, PX, RF, XA and
multiframe mammography images | The subject device
support more
modalities than
the predicate
device (ES, NM,
PX, RF, XA).
This has no
impact on the
safety of the
device and
permits to the
device to be used
for more patients. |
5
Image /page/5/Picture/0 description: The image shows the word "Medecom" in a stylized font. The word is written in black ink on a white background. There are some abstract shapes to the left of the word. The shapes are also in black ink.
Communicating Imaging
| | Predicate
Device | Subject Device | | If different, impact on safety or efficacy |
|---------------------------------------------------|---------------------|--------------------|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | MEDVIEW
MEDDIAG | MED-MAMMO | |
| DICOM Objects transfer & communication | Yes | Yes | Yes | No difference |
| Query / retrieve DICOM Operation | Yes | Yes | Yes | No difference |
| Viewing DICOM Images | Yes | Yes | Yes | No difference |
| Viewing DICOM Reports | Yes | Yes | Yes | No difference |
| Send GSPS[1] or SC[2] images to other DICOM nodes | Yes | No, only SC images | | GSPC is a file which contains parameters to apply to an image. The subject device could send the SC image, that is to say the image with the parameters applied. This difference has no impact on safety or efficacy of the device. |
| Exporting DICOM image | Yes | Yes | Yes | No difference |
| Exporting anonymised DICOM image | Yes | Yes | Yes | No difference |
| Exporting anonymised TIFF image | Yes | Yes | Yes | No difference |
| Application Synchronization and Data Exchange | Yes | Yes | Yes | No difference |
| Windows / Level | Yes | Yes | Yes | No difference |
| Magnification Window | Yes | Yes | Yes | No difference |
6
Image /page/6/Picture/0 description: The image shows a logo with the word "Medecom" in a stylized font. The word is written in lowercase letters, with the "M" having a unique, flowing design. To the left of the word is a geometric shape composed of two rectangles stacked vertically, with the top rectangle being smaller than the bottom one. The logo appears to be simple and modern.
| | Predicate
Device | Subject Device | If different,
impact on safety
or efficacy |
|--------------------------------------------------------------------------------------|---------------------|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | MEDVIEW
MEDDIAG
MED-MAMMO | |
| Display at
variable
resolution | Yes | Yes | No difference |
| Rotation | Yes | Yes | No difference |
| Mirroring | Yes | Yes | No difference |
| Image inversion | Yes | Yes | No difference |
| Display of CAD
results | Yes | No | Medical
users are
informed
about this
fact, and
not all users
use CAD, so
this point
does not
add new
risk. |
| Display of patient
demographic
information | Yes | Yes | No difference |
| Multiframe
images breast
MR CAD analysis
And breast MR
motion correction | Yes | No | The fact that
MEDWS cannot
perform MR CAD
analysis and
breast MR motion
correction does
not add new risks.
Medical users are
informed about
this fact. Not all
users use CAD
nor display MR
images. |
| Free hand
drawing | Yes | Yes | No difference |
| Ellipse drawing | Yes | Yes | No difference |
| Ability to add
textual
annotation | Yes | Yes | No difference |
| Ability to | Yes | Yes | No difference |
7
Image /page/7/Picture/0 description: The image shows a logo with the word "Medecom" in a stylized font. The "M" is a large, cursive letter with a textured fill, while the rest of the letters are in a simpler, sans-serif font. To the left of the word is a geometric design consisting of two rectangles, one larger than the other, connected by a vertical line.
| | Predicate
Device | Subject Device | | If different,
impact on safety
or efficacy |
|----------------------------------------------------------------------------------------------------|---------------------|--------------------|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | MEDVIEW
MEDDIAG | MED-MAMMO | |
| measure features | | | | |
| Other functions | | | | |
| Image storage for
short duration | Yes | Yes | Yes | No difference |
| Full conformance
to IHE
Mammography
image profile | Yes | No | | The transactions
from IHE
Mammography
image profile not
supported by
MEDWS concern
Evidence
Documents, i.e.
CAD results.
Medical users are
informed about
this fact, and not
all users use CAD,
so this point does
not add new risk. |
| Standardized
display of
mammography
images for all
FFDM vendors | Yes | No | Yes | No difference |
| Intelligent
roaming | Yes | Yes | | No difference |
| Can display
tomosynthesis
images | Yes | Yes | Yes | No difference |
| Usability | | | | |
| Single click
navigation | Yes | Yes | | No difference |
| Allow instant
access to images
and shared
patient data
across multiple
workstations | Yes | Yes | Yes | No difference |
Conclusion
8
Image /page/8/Picture/0 description: The image shows a logo with a stylized design. The logo includes a geometric shape on the left side, consisting of two rectangles connected by a vertical line. To the right of the geometric shape is the text "Medecom" in a stylized font, with the "M" appearing as a flowing, cursive letter.
The MEDWS Software is substantially equivalent to the predicate software in terms or intended use, indications for use and conformance to the DICOM standard.
The MEDWS software has successfully undergone every bench testing designed to simulate clinical use.
Based on the information supplied in this 510(k), MEDECOM SARL concludes that MEDWS is substantially equivalent to the predicate device and is safe and effective.
9
Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2014
MEDECOM SARL % Ms. Cynthia Cottereau Consultant TWOKSA 2 rue Quenot JARNAC, 16 200 FRANCE
Re: K132684
Trade/Device Name: MEDWS Software (Variants MEDVIEW, MEDDIAG, MEDMAMMO) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Il Product Code: LLZ Dated: April 22, 2014 Received: April 30, 2014
Dear Ms. Cottereau:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your cover mined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the 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). and Cosmetic Act (71cc) that as not request to the general controls provisions of the Act. The 1 ou may, mercrore, manel of the Act include requirements for annual registration, listing of general controls provisions or actice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Theast note: ODNY Book however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is elassified tools and 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 I lease oc advised that 1 Dris issuance evour device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I edital statutes and regalations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
10
Page 2-Ms. Cottereau
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
11
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K 132684
Device Name
MEDWS software (variants MEDVIEW, MEDDIAG, MEDMAMMO)
Indications for Use (Describe)
The MEDWS Software (MEDVIEWS, MEDMAMMO) is intended for selection, display, manipulation and media interchange of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing device using DICOM or similar interface standards.
Lossy compressed mammographic image are not intended for diagnostic images should only be viewed with a monitor cleared by FDA for viewing mammographic images. For primary diagnosis, post process DICOM for presentation images must be used.
The MEDWS Software (MEDVIEWS, MEDDIAG, MEDMAMMO) is typically used by trained professionals including but not limited to physicians, radiologists, nurses, medical technicians and assistants.
Type of Use (Select one or both, as applicable)
[図] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
12
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