ETIAM STAR PACS COMPONENTS

K052358 · Etiam, S.A. · LLZ · Oct 5, 2005 · Radiology

Device Facts

• Record ID: K052358
• Device Name: ETIAM STAR PACS COMPONENTS
• Applicant: Etiam, S.A.
• Product Code: LLZ · Radiology
• Decision Date: Oct 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

ETIAM STAR PACS Components™ is a software-based Picture Archiving and Communication System (PACS). It ingests medical images and data from various imaging sources, including DICOM-compliant devices and film digitizers (which convert legacy film to DICOM). The system stores, distributes, and networks these images across distributed clinical locations. It provides tools for viewing and manipulating images on workstations. Operated by trained healthcare professionals (physicians, radiologists, nurses, technicians), the system facilitates clinical workflow by enabling remote access to diagnostic images. It does not perform automated diagnostic interpretation; rather, it serves as a platform for human clinicians to review and interpret images. The device benefits patients by enabling efficient image management, storage, and timely access to diagnostic data by clinical staff.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparisons to the predicate device.

Technological Characteristics

Software-based PACS for digital medical image handling. Operates on networked workstations. Supports DICOM standard. Does not contact patients. No life-sustaining functions. Hazard analysis level of concern: Minor.

Indications for Use

Indicated for trained professionals (physicians, radiologists, nurses, technicians, assistants) to receive, store, communicate, process, and display medical images, including mammograms. Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images. Mammographic interpretation requires FDA-approved 5 Mpixel resolution monitors.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• INTEGRADWEB MPR/MIP (K042313)

Submission Summary (Full Text)

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K052352

# 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: [phone]

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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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 [phone] or [phone] 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