(66 days)
The SECTRA AB, WISE Image Management System device is intended for the management and displaying of x-ray images, other radiological objects, and information. It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devices using DICOM or similar interface standards.
WISE will be used for management of radiological images.
This document is a 510(k) summary for the SECTRA-Imtec WISE Image Management System, submitted in 1997. It explicitly states that the submission aims to demonstrate "substantial equivalence" of WISE to a predicate device, SECTRA-Imtec ImageServer 2000 (K963395).
The submission does not contain specific acceptance criteria, performance metrics, or study details such as sample sizes, ground truth establishment, or human reader studies typically associated with demonstrating clinical efficacy or diagnostic accuracy. Instead, it focuses on regulatory compliance and equivalence to a previously cleared device.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is an attempt to address the points based on the available information, noting where information is absent:
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A table of acceptance criteria and the reported device performance
This information is not provided in the given text. The filing is for demonstrating substantial equivalence, not for presenting performance against specific statistical acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC).
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document does not describe a test set or clinical study of this nature.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. There is no mention of a test set or ground truth establishment process.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided. The device is an "Image Management System," suggesting its primary function is handling and displaying images, not providing diagnostic AI assistance. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant or expected for this type of device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The WISE system is described as an "Image Management System" for displaying and managing images for "trained medical professionals," implying a human-in-the-loop system for image review and interpretation. It is not presented as an AI algorithm providing standalone diagnostic outputs.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.
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The sample size for the training set
This information is not provided. The document does not describe any machine learning or AI models requiring a training set.
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How the ground truth for the training set was established
This information is not provided.
Summary of available information related to acceptance criteria and study:
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (SECTRA-Imtec ImageServer 2000, K963395) rather than providing specific performance metrics from a clinical study. The basis for substantial equivalence is listed as:
- Compliance with Federal Performance Standards (21 CFR, part 1000).
- Manufacture in accordance with voluntary standards.
- Comprehensive user guides ensuring safe and effective use.
- Results of a hazard analysis.
The FDA's response letter (JUN 26 1997) confirms that they reviewed the 510(k) and "decemined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This indicates that the device met the regulatory bar for substantial equivalence at the time, which did not necessarily require the same type of clinical performance studies expected for newer AI/ML diagnostic devices.
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Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification Section
17 April 1997 K971451
SECTRA Doc. no: 3-97.434-2.0
510(k) summary of safety and effectiveness information for the SECTRA-Imtec WISE Image Management System
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
WISE will be used for management of radiological images. The typical users are trained medical professionals at a radiology department.
The undersigned certifies that the 510(k) Pre-Market Notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence to SECTRA-Imtec ImageServer 2000 (K963395). This information and data is summarised as follows:
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- WISE is subject to and in compliance with the Federal Performance Standards, defined in 21 CFR, part 1000.
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- WISE has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
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- WISE User's Guides contains comprehensive and extensive information on how to operate the system to ensure a safe and effective use.
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- The submission contains the results of an hazard analysis.
Texte And
Peter Andersson Regulatory Manager SECTRA-Imtec AB Linköping, Sweden Telephone: +46 13 23 52 00
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 26 1997
Sectra-Imtec AB c/o Herman Oosterwijki President Otech Inc. 6741 Grant Lane Plano, TX 75024
Re: K971451
Wise Image Management System … · Date: April 17, 1997 Received: April 21, 1997 Regulatory class: Unclassified Procode: 90 LMB
Dear Mr. Oosterwijk:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decemined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactions date of the Medical Device Amendances or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions and adulteration.
If your device is classified (see above) into either 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 895. A substanially equivalent decemination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your 510(k) premarket nouthcaion. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Y
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K971451
Device Name: WISE Image Management System
Indications For Usc:
The SECTRA AB, WISE Image Management System device is intended for the management and displaying of x-ray images, other radiological objects, and information.
It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devices using DICOM or similar interface standards.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
(PLEASE DO NOT WRITF. BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
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Over -The-Counter Use ________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
David A. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number.
§ 892.2010 Medical image storage device.
(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.