MODIFICATION TO: SECTRA IDS5 WORKSTATION

K051315 · Sectra Imtec AB · LLZ · Jun 15, 2005 · Radiology

Device Facts

• Record ID: K051315
• Device Name: MODIFICATION TO: SECTRA IDS5 WORKSTATION
• Applicant: Sectra Imtec AB
• Product Code: LLZ · Radiology
• Decision Date: Jun 15, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Sectra IDS5 device is intended for the manipulation and displaying 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. Device options make possible mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

Device Story

Sectra IDS5 Workstation is a software-based PACS client running on Windows PCs; processes and displays digital medical images from various modalities. Operates in clinical environments (hospitals, remote clinics, home) by radiologists, clinicians, and technicians. Inputs include DICOM-compliant medical images; outputs are visualized images on high-resolution monitors. Features include mammography reading, 3D reconstruction, angiography, and prosthesis CAD. Healthcare providers use the workstation to review images and reports to support clinical decision-making. System requires server-side connectivity; supports telecommunications and teleconferencing. Patient benefit derived from efficient image access and diagnostic review by trained professionals.

Clinical Evidence

No clinical data provided. Bench testing only; device complies with ISO 9001:2000 and ACR/NEMA DICOM 3.0 standards.

Technological Characteristics

Software-based PACS workstation; runs on Windows 2000/XP PCs. Supports multi-monitor configurations (up to four). Connectivity via DICOM 3.0. No patient-contacting components. Software-based image processing and visualization.

Indications for Use

Indicated for trained professionals (physicians, radiologists, nurses, technicians) to manipulate and display medical images, including mammograms, from various modalities for diagnostic review and clinical assessment.

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

• Sectra IDS5 Workstation (K050196)

Submission Summary (Full Text)

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K051315

JUN 1 5 2005

# 510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

Date Prepared:

May 12, 2005

# Submitter's Information:

Sectra Imtec AB Teknikringen 20 SE-583 30 Linköping Sweden Phone: [phone] Fax: [phone]

#### Trade Name, Common Name, Classification:

| Trade Name: | Sectra IDS5 Workstation |
|----------------------|---------------------------------------------------|
| Software version: | 10.2 |
| Common Name: | Picture Archiving and Communications System |
| Classification Name: | Image Processing System (LLZ) (21 CFR § 892.2050) |

### Predicate Device:

| Applicant: | Sectra Imtec AB |
|----------------|-------------------------|
| 510(k) Number: | K050196 |
| Device: | Sectra IDS5 Workstation |

## Device Description:

The Sectra IDS5 Workstation is mainly a software product. It is used for visualization and processing of digital medical images. The IDS5 is used as a client together with a Sectra provided server (Class I Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used.

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The Sectra IDS5 Workstation is in fact a family of devices, including several workstations or types of workstations, e.g. the following:

- Primary diagnostics workstation and the most powerful version of IDS5 -. IDS5/dx.net. It contains tools for assisting advanced users, e.g. the radiologists, in making a diagnosis.
- Dedicated workstation for mammography IDS5/mx.net. It has all functionality as an . IDS5/dx.net but with an additional mammography package. Reading of mammographic images shall only be conducted with IDS5/mx.net.
- Quality assurance workstation, mainly used by the technologists to prepare the images . for the reviewing radiologist.
- Clinicians workstation used by the clinicians within the hospital to view the medical . images and to read the report.
- . "Web" workstation that can be used by remote clinics to view images and reports.
- "At-home" workstation that can be used by users, e.g. radiologists, over a low . bandwidth connection.

### Indications for Use:

The Sectra IDSS device is intended for the manipulation and displaying 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.

Device options make possible mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

# Technological Characteristics:

The IDS5 Workstation runs under the Window 2000 and Windows XP operating system for PCs (as a minimum and depending upon system configuration)'. The requirements on hardware are quite ordinary for a system used for displaying images. Most notably up to four monitors can be used.

# Performance Data:

The subject device is developed according to ISO 9001:2000 and complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.

^| Windows NT is supported for IDS5/web and IDS5/cl.net only.

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#### Conclusion:

Similar to the predicate device, the IDS5 Workstation does not contact the patient, nor does it control any life sustaining devices. Images and information being reviewed, processed, relayed, and or transmitted are interpreted by a physician or trained medical personnel, providing ample opportunity for competent human intervention. The device and the predicate device share the same certification or conformance to performance standards and both function as Image Processing System (LLZ). Device failures, which might result in partial or failed transmissions, images, or data, may be recovered from storage or re-transmission after correcting the problem(s). Passwords are required for operation and to protect against unauthorized use.

Based on the information supplied in this Special 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device.

Pat And

Peter Andersson Regulatory Affairs Officer Sectra Imtec AB Linköping, Sweden

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 5 2005

Sectra Imtec AB % Mr. Carl Alletto Official Correspondent OTech, Inc. 1600 Manchester Way CORINTH TX 76210

Re: K051315

Trade/Device Name: Sectra IDS5 Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 17, 2005 Received: May 23, 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 (0S) 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 \$10(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 contact the Office of Compliance 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 Division 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. Brogdon

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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Kostsiz 510(k) Number:

Device Name: IDS5 Workstation by Sectra Imtec AB

Indications For Use:

The Sectra IDS5 device is intended for the manipulation and displaying 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.

Device options make possible mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc.; and teleconferencing.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

Typical users of this system are trained professionals, including but not limited to 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)

V Prescription Use (Per 21 CFR 801.109)

OR

Over -The-Counter Use ________________________________________________________________________________________________________________________________________________________

Daniel h. Syzmm

Division Sign-C sion of Reproduct