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.

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.

AI/ML Overview

This document describes the MEDWS software, an image management, review, and display system for radiology images. It provides a substantial equivalence comparison to a predicate device, but it does not contain any information about specific acceptance criteria or a study proving the device meets those criteria, especially not regarding "diagnosing" or "reporting device performance" in the context of CAD.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) or quantitative performance metrics for the MEDWS software.

The acceptance criteria discussed relate to general software and medical device standards (e.g., DICOM conformance, ISO standards, IEC standards) and internal bench testing for functionalities like installation, configuration, data management, DICOM conversion/connectivity, and export. There are no performance metrics related to diagnostic accuracy or efficacy.

2. Sample Size for Test Set and Data Provenance:

No information is provided about a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The document states that "Every specification of the MEDWS software is validated by a bench test before release," but these are described as internal functional software tests, not clinical evaluations.

3. Number of Experts and Qualifications for Ground Truth:

No information is provided about experts used to establish ground truth. Since no diagnostic performance study is described, the concept of clinical ground truth as defined by experts is not applicable in this document's context.

4. Adjudication Method:

No information is provided about an adjudication method. This is relevant for studies involving human readers and ground truth, which are not present in this document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study is mentioned. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use, not on comparing performance with and without AI assistance or evaluating human reader improvement. The device itself (MEDWS) is described as an image management and viewing system, not an AI-powered diagnostic tool. Furthermore, the document explicitly states that the "Display of CAD results" and "Multiframe images breast MR CAD analysis And breast MR motion correction" capabilities of the predicate device are not present in MEDWS (specifically MEDVIEW/MEDDIAG).

6. Standalone (Algorithm Only) Performance Study:

No standalone performance study for an algorithm is mentioned. MEDWS is a software platform for image display and management, not a diagnostic algorithm itself.

7. Type of Ground Truth Used:

The document refers to "bench testing" to validate software specifications. The "ground truth" for these tests would be the expected functional outcome of the software (e.g., "does it install correctly?", "does it transfer DICOM objects successfully?"). This is distinct from clinical ground truth (e.g., pathology, outcomes data, expert consensus) used to evaluate diagnostic accuracy.

8. Sample Size for Training Set:

No information is provided about a training set since the device is not described as an AI/ML algorithm that requires training data for diagnostic tasks.

9. How Ground Truth for Training Set was Established:

As no training set is mentioned (see point 8), this information is not applicable.

Summary of what the document does provide regarding "performance":

The document focuses on:

Non-clinical performance (bench testing): This involves validating software specifications against defined requirements (e.g., installation, configuration, data management, DICOM operations). This is a functional and technical assessment, not a clinical performance study.
Substantial Equivalence: The primary "performance" argument is that the device's design, technology, functionalities, intended use, and performances (in a functional sense, e.g., how much RAM is needed, what modalities are supported) are similar to a legally marketed predicate device. Any differences are argued to have no impact on safety or efficacy.

Conclusion:

The provided text details the regulatory submission (510(k)) for the MEDWS software, emphasizing its substantial equivalence to a predicate device for managing and displaying medical images. It describes the software's functional capabilities and adherence to relevant standards. However, it does not include information about clinical acceptance criteria or a study demonstrating diagnostic performance, as the device's role is not a diagnostic algorithm but rather an image viewing and management system. The document explicitly notes the absence of CAD result display and CAD analysis capabilities in MEDWS compared to the predicate device, further indicating it's not a CAD system requiring diagnostic performance metrics.

Summary

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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

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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)):

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.

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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.

	PredicateDevice	Subject Device		If different,
		MEDVIEWMEDDIAG	MED-MAMMO	impact on safetyor efficacy
	Hardware requirements
Operating system	Windows XP,Windows 7	Windows XP Professional SP3 orWindows 7		No difference
Memory	2.0 GB RAM	1.0 GB RAM	4.0 GB RAM	No impact : RAMneeded is differentin order to insuresame efficacy
Processor	Dual	Pentium Core 2	Xeon Quad Core	No impact :
	PredicateDevice	Subject Device		If different,impact on safetyor efficacy
		MEDVIEWMEDDIAG	MED-MAMMO
	Processor IntelCPU withclock rate of2.0 GHz orhigher		3 GHz	Processor neededis different inorder to insuresame efficacy
Free disc space	Unknown	150 Mb for the software		No impact
Graphic Card	Unknown	OpenGL 2.0compatiblegraphiccontroller(Chipset orgraphic card)	256 Mo, OpenGL3.0 compatiblegraphic card	No impact
Networking	NetworkInterface Card(NIC) 10/100Base-T	100 MbpsTCP/IP networkcard	1 Gbps TCP/IPnetwork card	No impact
Supportconventionalscreen formultimodalityimage review	Yes	Yes	Yes	No difference
Support specificscreen formammographyimage reviewcleared by FDA	Yes	No	Yes	No difference
Support Tactilescreen	Unknown	No	Yes	Tactile screendoes not add anysafety risksbecause it permitsbetter control bythe user.There is no impacton efficacy.
Support Severalscreens at thesame time	Yes	MEDVIEW : NoMEDDIAG : Yes	Yes	No differenceIf needed, supportof several screensis available inMEDDIAG orMEDMAMMOvariants

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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

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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".

	PredicateDevice	Subject Device		If different,impact on safetyor efficacy
		MEDVIEWMEDDIAG	MED-MAMMO
SupportconventionalKeyboard		Yes	Yes
Support specifickeyboard formammographyimage review	Yes	No	Yes	No difference
Printing onDICOM printer	Yes	Yes	Yes	No difference
Printing onstandard printer	Unknown		Yes	This functionalitydoes not add risksand permit to userto keep someimages in thepaper patient file.There is no impacton safety.
Administration Setting
Account useradministration	Yes		Yes	No difference
Patients listadministration	Yes		Yes	No difference
User preferencesetting	Yes		Yes	No difference
User workflowsetting	Yes		Yes	No difference
DICOM Features
Modalitiessupported	MG, MR, US,CT, SC, CR,PET, DR andmultiframemammographyimages		MG, MR, US, CT, SC, CR, PET,DR, ES, NM, PX, RF, XA andmultiframe mammography images	The subject devicesupport moremodalities thanthe predicatedevice (ES, NM,PX, RF, XA).This has noimpact on thesafety of thedevice andpermits to thedevice to be usedfor more patients.

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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

	PredicateDevice	Subject Device		If different, impact on safety or efficacy
		MEDVIEWMEDDIAG	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

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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.

	PredicateDevice	Subject Device	If different,impact on safetyor efficacy
		MEDVIEWMEDDIAGMED-MAMMO
Display atvariableresolution	Yes	Yes	No difference
Rotation	Yes	Yes	No difference
Mirroring	Yes	Yes	No difference
Image inversion	Yes	Yes	No difference
Display of CADresults	Yes	No	Medicalusers areinformedabout thisfact, andnot all usersuse CAD, sothis pointdoes notadd newrisk.
Display of patientdemographicinformation	Yes	Yes	No difference
Multiframeimages breastMR CAD analysisAnd breast MRmotion correction	Yes	No	The fact thatMEDWS cannotperform MR CADanalysis andbreast MR motioncorrection doesnot add new risks.Medical users areinformed aboutthis fact. Not allusers use CADnor display MRimages.
Free handdrawing	Yes	Yes	No difference
Ellipse drawing	Yes	Yes	No difference
Ability to addtextualannotation	Yes	Yes	No difference
Ability to	Yes	Yes	No difference

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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.

	PredicateDevice	Subject Device		If different,impact on safetyor efficacy
		MEDVIEWMEDDIAG	MED-MAMMO
measure features
Other functions
Image storage forshort duration	Yes	Yes	Yes	No difference
Full conformanceto IHEMammographyimage profile	Yes	No		The transactionsfrom IHEMammographyimage profile notsupported byMEDWS concernEvidenceDocuments, i.e.CAD results.Medical users areinformed aboutthis fact, and notall users use CAD,so this point doesnot add new risk.
Standardizeddisplay ofmammographyimages for allFFDM vendors	Yes	No	Yes	No difference
Intelligentroaming	Yes	Yes		No difference
Can displaytomosynthesisimages	Yes	Yes	Yes	No difference
Usability
Single clicknavigation	Yes	Yes		No difference
Allow instantaccess to imagesand sharedpatient dataacross multipleworkstations	Yes	Yes	Yes	No difference

Conclusion

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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.

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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

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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

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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, 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)

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Regulation Number and Section

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