Transcript sanco-sw-012015-05

Dutch
Dental software as
medical device
Alf Öhman, investigator, Läkemedelsverket/ MPA Sweden
Stefan Visscher, senior inspector
Software Working Group, Brussels, February 6 2015
PACS (borderline & classification manual)
8.4. Picture Archiving and Communication Systems (PACS)
Type/ functionality
Risk class
(a) PACS used for viewing, archiving and transmitting images.
Rule 12: class I
(b) Where the post-processing of the image for diagnostic purposes
is such as:
- image processing functions which alter the image data (e.g.
filtering, multiplanar reconstruction, 3D reconstruction)
- complex quantitative functions (e.g. arterial stenosis evaluation,
ventricular volume calculation, calcium scoring, automatic indication
(detection) of potential lesions) .
Rule 10: class IIa
(if it does not directly
influence the source device,
though allows for direct
diagnosis
(c) With image enhancing by controlling image acquisition .
Rule 10 or 11: class IIa or IIb
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MEDDEV 2.1/6
c.1) Electronic Patient Record Systems
Electronic patient record systems are intended to store and transfer electronic
patient records. They archive all kinds of documents and data related to a
specific patient. The electronic patient records themselves are not computer
programs, therefore, they should not be qualified as a medical device i.e. an
electronic patient record that simply replaces a patient’s paper file does not meet
the definition of a medical device. The modules used with electronic patient
record system modules that might be qualified in their own right as medical
devices are for example:
- an image viewer with functionality for diagnosis based on
digital images;
- a medication module.
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Intended use
Example 1 helps you to acquire, view, compare and measure all your images (x-ray,
intra oral, color, and documents), from digital x-ray systems, or scanners for
classical x-rays. The software is automatically activated from your patient
administration program when you want to view images stored with the current
patient. All patients' files can be opened from anywhere in a network. It contains
several image enhancement functions as well as measurement tools to
assist you in your daily work:
For projections' errors, you can use the software's Endo-file measurements.
To easier locate cavities between teeth, use digital subtraction.
Example 2 is a very powerful, flexible, and easy-to-use PC/Windows software
program for orthodontics and maxillofacial surgery. It can be used for visual
diagnostic imaging and cephalometric analysis, as well as for treatment
simulation with surgery prediction. It enables a quick and easy method to
interactively plot the points required by the actual analysis, chosen among
standard or custom-made cephalometric analyze methods. The points, or
markers, are plotted directly on the X-ray image admitting immediate graphical
feedback. Ready-made graphics for incisors, canines, premolars, and molars, as
well as user-defined bone segments are interactively drawn and placed on the
Xray. It automatically calculates accurate values for the measurements
(distances and angles) defined by the chosen analysis. Further measurements
can interactively be made directly on the on-screen radiograph, correctly
calibrated.
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