(15 days)
No
The document describes a standard PACS system for image management, storage, and communication. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The "image processing" mentioned refers to standard PACS functionalities like compression and manipulation, not AI-driven analysis.
No
The device is described as software for importing, reviewing, editing, sending, storing, communicating, processing, and displaying medical images. Its intended use does not involve treating or diagnosing a disease or condition, which are characteristics of a therapeutic device.
No
The document explicitly states: "ETIAM PACS Components™ is not labeled for diagnostic use." While it handles medical images, its stated purpose is for import, review, edit, and sending, and it advises against using lossy compressed images for "primary image interpretations," which implies it is not intended for the initial diagnostic reading.
Yes
The device description explicitly states "ETIAM PACS Components™ are software applications" and the intended use and device description focus solely on the software's functions of capturing, storing, distributing, and networking medical images. While it interacts with imaging sources and workstations, the device itself is described as the software components.
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 the device is for importing, reviewing, editing, and sending medical images. It explicitly states "ETIAM PACS Components™ is not labeled for diagnostic use."
- Device Description: The description focuses on the technical aspects of capturing, storing, distributing, and networking medical images.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or treatment. This device deals with medical images, not biological specimens.
The device is a PACS (Picture Archiving and Communication System) component, which is a type of medical imaging software used for managing and displaying medical images. While these systems are crucial in the diagnostic process, they are not themselves IVD devices.
N/A
Intended Use / Indications for Use
ETIAM PACS Components™ is intended to be used by healthcare personnel to import, review, edit and send medical images.
ETIAM PACS Components™ is not labeled for diagnostic use.
ETIAM PACS Components™ is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that meets other technical specifications reviewed and accepted by FDA.
Product codes
LLZ
Device Description
ETIAM PACS Components™ are software applications that make possible the capturing, storage, distribution, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to ETIAM PACS Components™, the system can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored in an archive. Stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel
Typical users of this system are trained professionals, e.g. 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: Every specification of the ETIAM PACS ComponentsTM is validated by a test bench carried out during before release. The bench testing includes:
- The package (documentation included)
- The installation of the software
- The configuration of the software
- The management of the patient-study 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
Clinical performance: Our device only utilizes standard lossy (irreversible) compression techniques defined and supported by DICOM Standard. Only the administrator can activate the compression function of the device. So clinical studies were deemed unnecessary to evaluate the safety or effectiveness of ETIAM PACS Components TM.
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
Image /page/0/Picture/0 description: The image shows the word "etiam" in white letters with a black outline. The letters are set against a gray, textured background. There is a small, white shape above the letter "m".
K 131392 Secure Medical Networking
MAY 2 9 2013
510(k) Summary of Safety and Effectiveness
This 510(k) summary of Safety and Effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
March 22, 2013
Submitter's Information: 21 CFR 807.92(a)(1)
Eric Le Bihan President ETIAM S.A.S .U. 2 rue Pierre-Joseph Colin 35000. Rennes - France Tel: +33 299 143388 Fax: +33 299 143380 Email: eric.lebihan@etiam.com
Name, title and phone number of contact: 21 CFR 807.92(a)(1)
Géraldine Tessens Quality Manager +33 299 143386 Tel: Fax: +33 299 143380 Email: qeraldine.tessens@etiam.com
Name of the device: 21 CFR 807.92(a)(2)
- ETIAM PACS Components™ Trade name: 网
- Common name: Picture, Archive and Communications System 网
- ם Classification name: system, image processing, radiological (21 CFR 892.2050, Product Code LLZ)
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Image /page/1/Picture/0 description: The image shows the word "etiam" in white letters against a gray background. There is a small, white, abstract shape above the letter "m". The letters are bold and have a slight shadow effect, making them stand out from the background. The overall image has a textured appearance, possibly due to the printing or scanning process.
Secure Medical Networking
Predicate Devices: 21 CFR 807.92(a)(3)
| • | 510(k) number | K052358 |
|---|---|---|
| Regulation number | 892.2050 | |
| Device name | ETIAM STAR PACS COMPONENTS | |
| Applicant | ETIAM, S.A.S.U. | |
| Classification product code | LLZ | |
| Device classification name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL | |
| Class | II | |
| Panel | Radiology Device | |
| • | 510(k) number | K062488 |
| Regulation number | 892.2050 | |
| Device name | iQ-System PACS | |
| Applicant | IMAGE INFORMATION SYSTEMS, LTD. | |
| Classification product code | LLZ | |
| Device classification name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL | |
| Class | II | |
| Panel | Radiology Device | |
| • | 510(k) number | K083618 |
| Regulation number | 892.2050 | |
| Device name | PACS SCAN | |
| Applicant | PACSGEAR, INC | |
| Classification product code | LLZ | |
| Device classification name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL | |
| Class | II | |
| Panel | Radiology Device |
Device Description: 21 CFR 807.92(a)(4)
ETIAM PACS Components™ are software applications that make possible the capturing, storage, distribution, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to ETIAM PACS Components™, the system can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored in an archive. Stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation.
Intended Use: 21 CFR 807.92(a)(5)
ETIAM PACS Components™ is intended to be used by healthcare personnel to import, review, edit and send medical images.
ETIAM PACS Components™ is not labeled for diagnostic use.
2
Secure Medical Networking
ETIAM PACS Components™ is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that meets other technical specifications reviewed and accepted by FDA.
Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
Technological Characteristics: 21 CFR 807.92(a)(6)
ETIAM PACS Components 10 is a software product that handles digital medical images.
The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human interprets images and information being displayed and printed.
The design, fundamental technology, functionalities, intended use and performances of the ETIAM PACS Components™ are similar and therefore substantially equivalent to its three predicates like it is demonstrated in the table below.
| Spécification | ETIAM PACS
Components™ | ETIAM STAR
PACS
Components™ | iQ-System
PACS | PACS SCAN |
|---------------------------------------------------------------------------------------------|---------------------------|-----------------------------------|-------------------|-----------|
| Comparison of multiple studies | YES | YES | YES | YES |
| Measurements | YES | YES | YES | YES |
| Annotation of images | YES | YES | YES | YES |
| DICOM Query/Retrieve, DICOM Print
Client | YES | YES | YES | YES |
| JPEG lossy/lossless compression | YES | YES | YES | YES |
| TWAIN interface | YES | YES | YES | YES |
| Image file import | YES | YES | YES | YES |
| Patient CD/DVD import | YES | YES | YES | YES |
| Create Patient CD, DVD | YES | YES | YES | YES |
| Export to memory stick | YES | YES | YES | YES |
| Windows print | YES | YES | YES | YES |
| Image export to image file or AVI
video file | YES | YES | YES | - |
| Integration of direct interface to an
automatic publisher for patient
CD/DVD creation | YES | YES | YES | YES |
| Review report (SR formats) | YES | YES | YES | YES |
| Manipulating images | YES | YES | YES | YES |
| Interface to RIS worklist or DICOM
Archive | YES | YES | YES | YES |
| Video capture interface | YES | NO | YES | YES |
| Digitize film | YES | YES | NO | YES |
| Edit patient demographics | YES | YES | YES | YES |
3
Image /page/3/Picture/0 description: The image shows the word "etiam" in white letters against a gray background. The letters are slightly stylized with a thick outline. There is a small white shape above the letter "m", possibly a design element or a blemish on the image. The background has a textured appearance, resembling a rough or grainy surface.
Non-clinical performance
Every specification of the ETIAM PACS Components™ is validated by a test bench carried out during before release. The bench testing includes:
- o The package (documentation included)
- ם The installation of the software
- The configuration of the software
- The management of the patient-study information ם
- 그 The acquisition and integration of new data
- The manipulation of the data 0
- ם The DICOM conversion
- ם The DICOM connectivity
- 口 The export and distribution of data
Cinical performance
Our device only utilizes standard lossy (irreversible) compression techniques defined and supported by DICOM Standard. Only the administrator can activate the compression function of the device.
So clinical studies were deemed unnecessary to evaluate the safety or effectiveness of ETIAM PACS Components TM.
Conclusion: 21 CFR 807.92(b)(1)
The 510(k) Pre-Market Notification for ETIAM PACS Components™ contains adequate information and data to enable FDA-CDRH to determine substantial equivalence to the predicate device.
ETIAM PACS Components™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the `\Level of Concern'' for potential hazard has been classified as "Moderate".
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 29, 2013
Etiam S.A.S.U. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313
Re: K131392
Trade/Device Name: ETIAM PACS Components™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 10, 2013 Received: May 14, 2013
Dear Mr. Job:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, 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), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
5
Page 2 - Mr. Mark Job
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
hup://www.lda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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
6
Indications for Use
510(k) Number (if known): K131392
Device Name: ETIAM PACS Components ™
Indications for Use:
ETIAM PACS Components™ is intended to be used by healthcare personnel to import, review, edit and send medical images.
ETIAM PACS Components™ is not labeled for diagnostic use.
ETIAM PACS Components™ is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that meets other technical specifications reviewed and accepted by FDA.
Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Sm. 70.
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K131392 510(k)
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