Level of Concern for Class II Medical Device Software 510(k) Submission

tebusse

Involved In Discussions
#1
Greetings,

I am currently writing the 510(k) submission for my company, which manufactures a class II medical device that is software (PACS).

I have utilized the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and determined that the Level of Concern is Moderate.

However, according to the FDA's "Guidance for the Submission of Premarket Notifications for Medical Image Management Devices" the Level of Concern is considered to be Minor.

I'm a bit confused regarding what constitutes the proper Level of Concern for a PACS system. Has the FDA changed it's preference regarding the level since the release of the latter guidance document in 2000?

Regards, Tonia
 
Elsmar Forum Sponsor

sagai

Quite Involved in Discussions
#2
Sorry for the dumb question, but are you sure for a PACS software you can say "certainly not" for this question?
Prior to mitigation of hazards, could a failure of the Software Device result in death or serious injury, either to a patient or to a user of the device?
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm

I am lost in your second question actually due to I have found any reference to LoC in that guidance.

Many thanks, Cheers
 
Last edited:
A

arnaudl

#3
I think that the level of concern depends of the of use of your application. If it just dealing with files and a basic viewing of images, the loc is indeed minor. But there are plenty of proofs that the FDA is expecting a moderate level if the application offers advanced imaging functions (measure or analysis).
 
Thread starter Similar threads Forum Replies Date
T FDA level of concern vs IEC 62304 safety classification - 510(k) exempt device Other US Medical Device Regulations 13
K FDA Premarket Submissions for Embedded Software - Level of Concern Other US Medical Device Regulations 4
Highground Identifying Guidance on Medical Device Software Level of Concern for the EU EU Medical Device Regulations 2
M Medical Device Software "Level of Concern" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
J Level of Concern - Ultrasound Medical Device Systems ISO 14971 - Medical Device Risk Management 2
L IEC 62304 and FDA Level of Concern IEC 62304 - Medical Device Software Life Cycle Processes 8
M Level of Concern (FDA) vs. Software Safety Classification(IEC) US Food and Drug Administration (FDA) 3
S Level of Concern only applicable to Medical Device software? IEC 62304 - Medical Device Software Life Cycle Processes 3
S Medical Device Software Level of Concern Determination 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 23
P Level of Concern anomaly - FDA Guidance Document Conflicts 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
F Level of Concern for 892.2050 - FDA Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
S Software Validation - Splitting the Level of Concern on multiple software parts 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
L Software Documents in 510(k) submission (Moderate Level Concern) Other US Medical Device Regulations 1
J FDA classifying all PACS software devices as Moderate Level of Concern? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
R Using RPN to Confirm Risk Reduced to an Acceptable Level Risk Management Principles and Generic Guidelines 12
qualprod Do sum of results of quality objectives should met a high level goal? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Maturity level and the way to obtain it Various Other Specifications, Standards, and related Requirements 2
F GM BIQS level 4 requirements Customer and Company Specific Requirements 1
K Level 1 PPAP Submission APQP and PPAP 11
H At what level (harm, hazardous situation, seq. of events, etc) is "risk" estimated? ISO 14971 - Medical Device Risk Management 12
F Site level CMRT reporting: how? Miscellaneous Environmental Standards and EMS Related Discussions 0
T NDT/NDE Level 2 Technicians Certification Oil and Gas Industry Standards and Regulations 20
T How can I determine the current level of exposure to talc in the workplace? Occupational Health & Safety Management Standards 6
M Packaging level EU Medical Device Regulations 2
B UKRP to what level should you audit Class I Technical Documentation? UK Medical Device Regulations 0
D What does a level 1 (PSW) PPAP actually promise? APQP and PPAP 19
A % of defects on the whole batch based on result from inspection under AQL Level II Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
R IATF and ASPICE level 2 Design and Development of Products and Processes 9
B ANOVA 3 level and 4 factors f and p values are not showing Using Minitab Software 0
N Level 3 PPAPs APQP and PPAP 4
J Part submission warrant for Level 1 PPAP APQP and PPAP 1
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
was named killer Onsite Level II N.D.T. Training in Florida Training - Internal, External, Online and Distance Learning 0
D High level understanding of EUDAMED EU Medical Device Regulations 3
D Supplier Quality level category help - high level ISO 13485:2016 - Medical Device Quality Management Systems 6
silentmonkey Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
Y What are different Special Inspection Level 1-4 and General spesification 1-3 ? AQL - Acceptable Quality Level 0
D Supplier Quality - How to classify a supplier level Medical Device and FDA Regulations and Standards News 10
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
J Level 3 KPI Excel Template Manufacturing and Related Processes 1
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
R Bottom up approach versus system level ISO 14971 - Medical Device Risk Management 2
C Failure nets - Same level effects FMEA and Control Plans 0
H Graphical analysis of results - Confidence level bands nomenclature Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
S Level of Clinical Evidence - MDR EU Medical Device Regulations 3
D GM BIQS level 5 requirements Customer and Company Specific Requirements 5
I Sampling processes - Who must define the AQL level? AQL - Acceptable Quality Level 9
R Identifying internal issues.. at what level? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
I What level of change in documentation requires re-training? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Level 3 PPAP submission of intentional defective parts APQP and PPAP 4

Similar threads

Top Bottom