Characterization Testing - NO acceptance criteria, no minimum performance requirement

#1
Hello,
I have an established product. We are trying to get a new 510k for this medical device (a filter), and in so doing, have been advised by the Agency to perform a certain test. However, I have NO acceptance criteria, no minimum performance requirement for this test. We are just trying to establish the performance level for our product for this given solute. Our medical team has the opinion that the results from this test are low risk. In other words, the primary function of the filter, and the high risk solutes are taken care of by other tests. I'm not looking for lot acceptance. I'm trying to figure out how many to test to establish a mean value of performance that we can publish. Also, we have the ability to make 'verification' samples at the lower and upper end of our manufacturing process. So, I have typical manufactured samples, as well as upper and lower limit samples that I can test. The occurrence of these upper/lower limit samples in actual manufacturing is in the PPM range. I should also note that the test is expensive and time consuming to run.
Thanks in advance.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
You need statistical validity. As a rule of thumb you need at least N=6 for mean validity and N=10 for STD validity and starting to talk about characterising the distribution.
Also look at Bootsrap to minimise actual testing.
Caveat: I'm not a specialist statistician (there are some around here that will hopefully chime in).
 
Thread starter Similar threads Forum Replies Date
M Informational US FDA final guidance Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices Medical Device and FDA Regulations and Standards News 0
C MSA for Non Manufacturing - Design Validation, Characterization and Qualification Lab Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
V Image Analysis - Particle Measurement (Characterization) - Validation - Calibration Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
G Characterization Studies: Analyzing Data to Establish Conclusions Statistical Analysis Tools, Techniques and SPC 1
Q Product Characterization Audit - What is "Characterization" IATF 16949 - Automotive Quality Systems Standard 7
W Characterization and Measurement of Surface Wear Manufacturing and Related Processes 2
Q "Characterization to the Corners" of the Process - Translation needed IATF 16949 - Automotive Quality Systems Standard 1
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 1
J Conflict of Interest Registrar/Notified Body/Testing House Quality Manager and Management Related Issues 4
M Inter-operator Variability Testing - Requirements for EU Medical Device Regulations 5
S High voltage testing - ISO 17025 - 7.2.2 Validation of methods and 7.3 Sampling ISO 17025 related Discussions 3
M Production approval testing - Alternative ideas for Validation Reliability Analysis - Predictions, Testing and Standards 4
JoCam MDL in Canada without Canadian Electrical Testing Canada Medical Device Regulations 0
T HF testing / Summative evaluation for MDDS class I necessary? Human Factors and Ergonomics in Engineering 2
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 5
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Sequence of testing in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Workplace Drug Testing in 2020 Misc. Quality Assurance and Business Systems Related Topics 9
W ASTM F1929 dye penetration test - validation for in-house testing ISO 13485:2016 - Medical Device Quality Management Systems 2
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 7
S Internal calibrations - Part of an ISO 17025 accredited testing laboratory (Automotive) ISO 17025 related Discussions 3
T Qualification testing of Lead acid batteries Reliability Analysis - Predictions, Testing and Standards 0
D Sterility and BioBurden Testing for Plastics ISO 13485:2016 - Medical Device Quality Management Systems 5
DitchDigger IEC 60601-1 subclause 5.1 - Adequate evaluation in lieu of testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Correct way to certify hydrostatic testing when it is not 100% (and Sample Size) Various Other Specifications, Standards, and related Requirements 6
MrTetris Are GLP required for testing cytotoxicity and soil remaining after sterilization of MD? Other Medical Device Related Standards 8
D Design Verification - Is testing required? Design and Development of Products and Processes 5
M Specific Absorption Rate (SAR) Testing - What Standard to Use? Other ISO and International Standards and European Regulations 1
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 1
T Spirometer - Pulmonary Function Testing - ATS/ERS:2005 EU Medical Device Regulations 5
M 510(k) 10993 Biocompability Testing Other US Medical Device Regulations 15
C Sterility and Bioburden Testing - LAL passed under 0.5EU/mL Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
A ISO 17025 Requirement 6.2 - Department Manager Testing Qualifications ISO 17025 related Discussions 1
P IEC 62304 - evaluation of integration and system testing IEC 62304 - Medical Device Software Life Cycle Processes 4
H EO Sterilization Validation - Sterility Testing and Load Configuration Other Medical Device Related Standards 1
M What to do in SOP Phase of Head unit testing? IATF 16949 - Automotive Quality Systems Standard 0
W SOP examples wanted - Soil, Concrete and Asphalt testing ISO 17025 related Discussions 3
M Informational TGA Consultation: Review of the regulation of certain self-testing IVDs in Australia Medical Device and FDA Regulations and Standards News 0
F Proficiency Testing for ISO 17025: AC Current Ranges ISO 17025 related Discussions 1
K Mammography Machine Bench Testing - FDA 510(K) US Food and Drug Administration (FDA) 5
D Is Human Factors testing mandatory for a 510(k) submission? Human Factors and Ergonomics in Engineering 16
W My company is looking to start a materials testing lab that conforms to ISO17025:2017 ISO 17025 related Discussions 3
P Testing lab in India IEC 60601-2-25 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Testing to failure for design verification Reliability Analysis - Predictions, Testing and Standards 11
M Microbiological Testing Lab - Layout & Standards Other Medical Device Regulations World-Wide 0
B Evaluation of Basic Safety during EMC Immunity or Climate Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0
Manix Supplied Steel Material Testing Norms and Requirements Supplier Quality Assurance and other Supplier Issues 1
Similar threads


















































Top Bottom