PACS - interpreting MDD and Borderline Guidance


Involved In Discussions
Classification of PACS has been covered from different angles in various posts. However I haven't found specifically what will help resolve a classification issue I'm having.

We have a PACS stand-alone software device used as a non-primary diagnostic aid for dental applications. We are in the early stages of CE marking this device. Using the MDD 93-42, Borderline Classification Guidance, and several other informal resources, we're not coming to a clear consensus on classification.

When evaluating the device per MDD Annex 9 Section 3, all rules leave the device as Class I (ie Rule 10 mentions "direct diagnosis of vital physiological processes.." where our device isn't a direct means to diagnosis nor are physiological conditions considered vital).

Going up to Annex 9 Section 2 (Implementing Rules), 2.3 states "Software, which drives a device or influences the use of a device, falls automatically in the same class." Our software connects to class iia and iib scanners, but does it "drive or influence" them?

This is where I get confused on the intention of the rule. Our software 1) displays the status of the scanner during acquisition, with all status information going from scanner -> software. 2) Upon starting acquisition, our software gives the "green light" to the scanner to initiate it's own acquisition protocol/parameters to complete the exam. Our device does not set any scanner parameters or directly turn it on or off; scanner must be prepared independently prior to acquisition. Where does this put us with "drive" or "influence"?

Now, looking at Borderline Classification Guidance, 8.4 (PACS) c(iii) states, "Standalone software, e.g. software which is used for image enhancement is regarded as driving or influencing the use of a device and so falls automatically into the same class. Other standalone software, which is not regarded as driving or influencing the use of a device, is classified in its own right". Our software DOES allow for the enhancement of images in a post-process fashion; again not setting scanner parameters such as exposure (risk associated with duration of radiation). I don't see where the added risk (bump in classification) is in this manner of image enhancement, as all raw images are displayed in the software as well. So, I'm not sure we meet the intention of this rule.

The Competent Authority we've just started speaking with claims that the "green light" we give to a 3rd party scanner "indicates that this software can control Extraoral X-ray units"

I would appreciate any input on this, as interpretation of these points has a huge impact on a small, low-risk device manufacturer. Thanks!
Elsmar Forum Sponsor


Involved In Discussions
We also manufacture software that falls under the PACS portion of the Borderline Manual. What kind of post-processing functions does your product allow? Also, is the "green light" required for the other unit to proceed with acquisition?


Involved In Discussions
Our device can sharpen, contrast, perio and endo filters, rotate, flip, invert, colorize, grayscale and emboss, and various combinations of basic adjustments - all while having the original image from the scanner available to easily switch back to.
On all extra oral 2b scanners, our "green light" isn't needed. Also, any images can be imported into the software free of 3rd party device pairing. The "green light" is needed for intraoral (2a) sensors in some cases.


Involved In Discussions
You mention a couple filtering functions, though I am unfamiliar with those specific types. Take a look at 8.4(b)'s language and see if that seems applicable:
(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
If so, in related the Outcome section you may find your answer (emphasis mine):
(ii) Those types of PACS (b) which drive a device or influence the use of a source device fall automatically in the same class in accordance with implementing rule 2.3, which classifies them as Class IIa or IIb. If this type of PACS does not drive or influence the use of the source device, this type of PACS can be classified under rule 10 if such PACS are intended to allow direct diagnosis, classifying them as Class IIa.


Involved In Discussions
Thanks for your response.
I think the bottom line is determining the drive/influence applicability.
With our enhancement tools, we do meet the description you provide from the Borderline Guidance 8.4(b). I'm not sure what this guidance is concluding from meeting this definition of PACS type. It's unclear if you're directed to Outcome (ii) from this? If so, we're back to drive/influence interpretation.
I can make the argument for Rule 10 not applying, as our device is not intended for "direct diagnosis of vital physiological processes". It IS indicated as a diagnostic device, but explained further in the IFU to what end.


Involved In Discussions
Help me understand what you mean by 'The "green light" is needed for intraoral (2a) sensors in some cases.' In what way are the sensors dependent on it?
Thread starter Similar threads Forum Replies Date
S Regulatory strategy for Third party plugin in a PACS EU Medical Device Regulations 1
E Accessory to a PACS (Picture Archiving and Communication System) system? EU Medical Device Regulations 4
F MDD, Technical File, Clinical Evaluation for PACS/DICOM Viewer ISO 13485:2016 - Medical Device Quality Management Systems 2
T Importing Non-Electromedical Device (PACS Software) into South Africa Other Medical Device Regulations World-Wide 2
T Selecting which MDD 93/42/EEC Annex to follow - PACS software system CE Marking (Conformité Européene) / CB Scheme 2
X EtO Steriliser Software (PACS) Update Validation Requirements Qualification and Validation (including 21 CFR Part 11) 5
T Medical Device PACS (Picture Archiving and Communication) - Class I or Class IIa? EU Medical Device Regulations 2
C Image Viewer Classification in Australia (Software Image Processing similar to PACS) Other Medical Device Regulations World-Wide 2
A In what class - A, B or C - should PACS workstation be? IEC 62304 - Medical Device Software Life Cycle Processes 6
J FDA classifying all PACS software devices as Moderate Level of Concern? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
Q Interpreting China Medical Device regulations/standards China Medical Device Regulations 1
P ISO 80369-7 standard - Interpreting which Parts should be in scope Other Medical Device Related Standards 7
M List of Packaging Contents - Medical Devices - Interpreting EU Directive 93/42/EEC CE Marking (Conformité Européene) / CB Scheme 3
D Interpreting Normal vs Weibull Capabilities Capability, Accuracy and Stability - Processes, Machines, etc. 4
P Interpreting Span Measurement - P95-P5 Six Sigma 1
B Interpreting Deviations 5 & 6 in Annex ZA in ISO 14971:2012 ISO 14971 - Medical Device Risk Management 1
B Interpreting "misuse" when assessing Hazardous Situations ISO 14971 - Medical Device Risk Management 2
SteveK Interpreting clause 4.1.5 in ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 9
M Interpreting Process Controls - 21 CFR Part 820.70(a) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Help interpreting 21 CFR Part 806 (corrections and removals) Other US Medical Device Regulations 1
G Interpreting Type 1 MSA (Measurement Systems Analysis) Results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
M Help interpreting MIL-STD-105E Single Sampling Plans Tables Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
M Biocompatibility in Respiratory Products - Help interpreting whitepaper IEC 60601 - Medical Electrical Equipment Safety Standards Series 22
I Interpreting Product Realization (Clause 7) in ISO 9001:2008 for Service Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V GD&T Interpreting Datums in Two Single Segmented Position Tolerances Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
M Interpreting X bar and R Control Charts Statistical Analysis Tools, Techniques and SPC 2
B Help with interpreting stock market terminologies Coffee Break and Water Cooler Discussions 4
V Interpreting Zinc Plating Specification GMW 3044 - 6K96/48 APQP and PPAP 2
K Interpreting and Applying 7.3.2 Design and Development Inputs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Interpreting the Calibration Report for my Dial Indicator General Measurement Device and Calibration Topics 3
J Interpreting Process Capability results and ratios Capability, Accuracy and Stability - Processes, Machines, etc. 1
B Length Measure - Interpreting Calibration Results and Measurement Uncertainty (MU) Measurement Uncertainty (MU) 3
S Interpreting Level of Confidence - Round Robin for Tensile Testing - Help needed Statistical Analysis Tools, Techniques and SPC 4
M Interpreting AS9100 Clause 8.2.2 Internal Audit Requirements Internal Auditing 28
T Interpreting my t test in Minitab Using Minitab Software 2
S Interpreting Linear Regression Results from Minitab Using Minitab Software 15
optomist1 Interpreting LMC for Pattern of Slots (GD&T) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
optomist1 Interpreting Minitab Test For Equal Variances Using Minitab Software 3
V Interpreting Minitab Gauge R&R Results Using Minitab Software 6
A ISO 2081 - Interpreting Coating Thickness Other ISO and International Standards and European Regulations 3
L Interpreting Injection Molding Tooling Documents - Cavities Manufacturing and Related Processes 3
C Interpreting Gage R&R Results - 3 operators, 3 iterations and 10 parts Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
M Interpreting Measurement Uncertainty for Temperature PRT probes Measurement Uncertainty (MU) 2
N Interpreting Hygrometer Calibration Uncertainty - Temperature Coefficient Measurement Uncertainty (MU) 1
mr500 Interpreting Decimals in the mm state - Off Wall Question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 14
J Interpreting clause (validation of software used in production & service) ISO 13485:2016 - Medical Device Quality Management Systems 2
E Interpreting Partial Least Square Results Using Minitab Software 1
C Interpreting Outside Laboratory Calibration Certificate Measurement Uncertainty (MU) 3
M Interpreting MIL-PRF-19500 (Performance Spec, Semicon Dev) - What is LTPD of 20 - ??? Manufacturing and Related Processes 4
T Rules for interpreting control charts Statistical Analysis Tools, Techniques and SPC 2

Similar threads

Top Bottom