(77 days)
Not Found
No
The summary describes image manipulation and display software with various workstation configurations, but it does not mention any AI or ML capabilities. The "tools for assisting the radiologist in making a diagnosis" are not explicitly described as AI/ML-powered.
No.
The device is described as an image manipulation and display system for X-ray images, intended for diagnosis and viewing by trained professionals, rather than for direct therapeutic intervention on a patient.
Yes
The device is intended for the manipulation and displaying of x-ray images, including mammograms, and is used by trained professionals such as physicians and radiologists to make a diagnosis, which falls under the definition of a diagnostic device. The "Primary diagnostics workstation" also explicitly states it "contains tools for assisting the radiologist in making a diagnosis."
No
While the device is described as "mainly a software product" and runs on PCs, it explicitly states it is used as a client with a Sectra provided server (Class 1 Exempt) and requires two or more monitors. This indicates a system that includes hardware components beyond just the software itself.
Based on the provided information, the Sectra IDS5 device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Sectra IDS5 Function: The Sectra IDS5 device is described as a system for the manipulation and displaying of x-ray images. It processes and visualizes medical images acquired from imaging modalities like X-ray and mammography. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro testing.
- Intended Use: The intended use clearly states it's for displaying and manipulating x-ray images for diagnostic purposes by trained professionals. This aligns with medical imaging interpretation, not laboratory testing of biological samples.
Therefore, the Sectra IDS5 falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Sectra IDS5 device is intended for the manipulation and displaying of x-ray 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.
Product codes
90 LLZ
Device Description
The Sectra IDS5 Radiology Workstation with Sectra 3D and MPR Packages is mainly a software product. It is used for visualization and processing of digital radiology images. The IDS5 is used as a client together with a Sectra provided server (Class 1 Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used.
The Sectra IDS5 Radiology 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. It contains . tools for assisting the radiologist in making a diagnosis.
- . Dedicated workstation for mammography. It has all functionality as an IDS5/dx.net but with an additional mammography package.
- . 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 radiology . images and to read the radiology report.
- "Web" workstation that can be used by remote clinics to view images and radiology . reports.
- . "At-home" workstation that can be used by the radiologist over a low bandwidth connection.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray images, mammograms
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this system are trained professionals, including but not limited to 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)
The subject device is developed according to ISO 9001:2000 and complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.
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
MAY = 4 2004
Koyo376
510(k) Summary of Safety & Effectiveness
(as required by 21 CFR 807.92c)
Date Prepared:
February 13, 2004
Submitter's Information:
Sectra Imtec AB Teknikringen 20 SE-583 30 Linköping Sweden Phone: +1 46 13 23 52 00 Fax: +1 46 13 21 21 85
Trade Name, Common Name, Classification:
| Trade Name: | Sectra IDS5 Radiology Workstation
Sectra MPR Package
Sectra 3D Package |
|----------------------|------------------------------------------------------------------------------|
| 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: | K033712 |
| Device: | Sectra IDS5 Radiology Workstation |
Device Description:
The Sectra IDS5 Radiology Workstation with Sectra 3D and MPR Packages is mainly a software product. It is used for visualization and processing of digital radiology images. The IDS5 is used as a client together with a Sectra provided server (Class 1 Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used.
The Sectra IDS5 Radiology 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. It contains . tools for assisting the radiologist in making a diagnosis.
1
- . Dedicated workstation for mammography. It has all functionality as an IDS5/dx.net but with an additional mammography package.
- . 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 radiology . images and to read the radiology report.
- "Web" workstation that can be used by remote clinics to view images and radiology . reports.
- . "At-home" workstation that can be used by the radiologist over a low bandwidth connection.
Indications for Use:
The Sectra IDS5 device is intended for the manipulation and displaying of x-ray 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.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
Technological Characteristics:
The system The IDS5 Radiology Workstation with Sectra 3D and MPR Packages will 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 Radiology Workstation with Sectra 3D and MPR Packages 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.
1 Windows NT is supported for IDS5/wch and IDS5/c1.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 Andre
Peter Andersson Regulatory Affairs Officer Sectra Imtec AB Linköping, Sweden
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2004
Sectra Imtec AB % Mr. Carl Alletto US Agent OTech, Inc. 1600 Manchester Way CORNITH TX 76210 Re: K040376
Received: April 5, 2004
Trade/Device Name: Sectra IDS5 Radiology Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: April 2, 2004
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 (PMA), 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.
4
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter 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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogden
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: K040376
Device Name: IDS5 Radiology Workstation by Sectra Imtec AB
Indications For Use:
1
The Sectra IDSS device is intended for the manipulation and displaying of medical, 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
| (Per 21 CFR 801.109) | OR Over-The-Counter Use ________ |
|---|---|
| ------------------------------------------ | ---------------------------------- |
| | (Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K040376 |