SECTRA IDS5 WORKSTATION

K050196 · Sectra Imtec AB · LLZ · Feb 24, 2005 · Radiology

Device Facts

• Record ID: K050196
• Device Name: SECTRA IDS5 WORKSTATION
• Applicant: Sectra Imtec AB
• Product Code: LLZ · Radiology
• Decision Date: Feb 24, 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 for visualization and processing of digital medical images. Operates on Windows PCs with multi-monitor configurations. Used by radiologists, clinicians, and technologists in hospitals, clinics, or remote settings. Inputs include medical images from various modalities via DICOM or similar standards. Provides tools for mammography reading, 3D visualization, angiography, and prosthesis CAD. Output is displayed on FDA-approved monitors for clinical review. Healthcare providers use the output to assist in diagnosis and clinical decision-making. System supports telecommunications and teleconferencing. Access is protected by passwords.

Clinical Evidence

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

Technological Characteristics

Software-based PACS workstation; runs on Windows 2000/XP PCs; supports up to four monitors; DICOM 3.0 compliant; password-protected access; non-patient contacting.

Indications for Use

Indicated for trained professionals (physicians, radiologists, nurses, technicians) for manipulation and display of medical images, including mammograms, across various modalities. Contraindicated for diagnostic review using lossy compressed mammographic images.

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 (K040376)

Submission Summary (Full Text)

{0}------------------------------------------------

K050196

Sectra Document Number: DOC-PANN-68UE65-2.0

FEB 2 4 2005

# 510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

### Date Prepared:

January 24, 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: | 10.1 |
| 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: | K040376 |
| 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.

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.

{1}------------------------------------------------

- 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 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.

## 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.

## 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 (LZ). 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.

⁴ Windows NT is supported for IDS5/web and IDS5/cl.net only.

{2}------------------------------------------------

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.

Peter And

Peter Andersson Regulatory Affairs Officer Sectra Imtec AB Linköping, Sweden

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.

FEB 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050196 Trade/Device Name: Sectra IDS5 Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: 90 LLZ Dated: January 25, 2005 Received: February 9, 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 redy 20, 1770, 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 I addition of 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 . oct s requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CIFR 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.

{4}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with and in your of substantial equivalence of your device to a legally premaince notification: - rrosults 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 at nov 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 Anot process nother general information on your responsibilities under the Act from the 00 : 77). I va may overnment 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

{5}------------------------------------------------

510(k) Number: Koso196

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)

| Prescription Use | <div style="display:flex; align-items:center;"> <span style="font-size: 20px;">✓</span> </div> | OR | Over-The-Counter Use | |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------|----|----------------------|--|
| (Per 21 CFR 801.109) | | | | |
| (Division Sign-Off) | | | | |
| Division of Reproductive, Abdominal, and Radiological Devices | | | | |
| 510(k) Number | KD50196 | | | |