(37 days)
ETIAM STAR 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 offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
ETIAM STAR 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 STAR 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.
ETIAM STAR PACS Components™ 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 provided text describes the ETIAM STAR PACS Components™, a Picture Archiving Communications System. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, or ground truth establishment.
The document is a 510(k) summary of safety and effectiveness information, which primarily focuses on demonstrating substantial equivalence to a predicate device. It describes the device's function and indications for use, but not the detailed performance evaluation studies typically associated with acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
The following information is NOT available in the provided document:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs without AI assistance
- If a standalone (algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
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OCT 5 - 2005
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:
August 22, 2005
Submitter's Information: 21 CFR 807.92(a)(1)
Mr. Didier Lemoine, Technical Director ETIAM s.a. 20 Rue Professeur Jean Pecker 3500, Rennes France Fax: 33-299-43380
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | ETIAM STAR PACS Components™ |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 System, Image Processing |
| Product Code: | LLZ |
Predicate Device: 21 CFR 807. 92(a)(3)
| 510(k) Number | K042313 |
|---|---|
| Regulation Number | 892.2050 |
| Device Name | INTEGRADWEB MPR/MIP |
| Applicant | DYNAMIC IMAGING INC. |
Classification Product Code LLZ
SYSTEM, IMAGE PROCESSING. Device Classification Name RADIOLOGICAL
Device Description: 21 CFR 807 92(a)(4)
ETIAM STAR 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 STAR 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.
Indications for Use: 21 CFR 807 92(a)(5)
ETIAM STAR 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.
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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 offers at least 5 Mpixel resolution and 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 STAR PACS Components™ 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.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for ETIAM STAR PACS Components™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
ETIAM STAR 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 hazards has been classified as "Minor".
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle, with three stylized lines representing the bird's body and wings.
Public Health Service
OCT 5 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ETIAM s.a. % Mr. Carl Alletto 1600 Manchester Way CORINTH TX 76210 Re: K052358 Trade/Device Name: ETIAM STAR PACS Components™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 7, 2005 Received: August 31, 2005
Dear Mr. Alletto:
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 (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, 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.
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This letter will allow you to begin marketing your device as described in your Section 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 if you desire specific darres at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 001:57): " Colling 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/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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(Indications for Use Form)
510(k) Number: Kosz3558
Device Name: ETIAM STAR PACS Components™
Indications for Use:
ETIAM STAR 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 offers at least 5 Mpixel resolution and 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ANDYOR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
Daniel h. Lessem
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number
§ 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).