SBS - The best value in QMS software

Three final products in one biocompatibility test?



We're a young start-up medical device company and our products are bTCP bone graft, bTCP-Hap bone graft and bTCP-calcium sulfate injection type bone graft.
We are now planning the biocompatibility test for 510(k) submission.

According to my regulatory and 10993 knowledge, three final products should conduct their own 10993 test separately.

However, RD department insist that since they can prove these products do not have any interacted effect, so three final products can be extract in one extract solution (used the extraction of bTCP to extract bTCP-Hap and then extract bTCP-calcium sulfate, so it would not have any dilute problem) and conduct one full biocompatibility test. The cost is only 1/3 compare to the three individual product testing.

I am really confusing, :confused:
it's sound quite logistic, although i concerned about the thought of one solution extract three sample would be the same situation for single product extraction (based on those solvent/solution chemistry things), and for me, according to the regulatory, it seems not right.

Any experience?or has anyone been facing this problem too?
please help and thousand thanks!
Elsmar Forum Sponsor


Trusted Information Resource
Re: Help~ three final products in one biocompatibility test?


I would recommend as a first step, you do a thorough material characterization (both literature and your own leachables/extractables studies) and at least a cytotoxicity test on each individual final product before you consider pooling independent product for any further biocompatibility test.

If you can demonstrate that your 3 products have an equivalent leachable/extractable and cytotoxicity profile, whereby equivalency is supported by the material data you unearthed in your literature search, you might be able to present enough objective evidence justifying pooling you three products for any further studies.

But be aware that you might get challenged on your "equivalence" rationale and you would have really convincing data at hand why you would not introduce any masking /suppressing or other artificial effect into your extracts and why you could reliably predict the absence of those effects for any further biocompatibility test you plan to do.

Personally, I would be conservative and not pool the 3 final products, but focus on gathering enough objective data justifying minimizing the (in-vivo) test array for each bone graft, respectively, rather than focusing on pooling extracts and explicitely testing for all biological risks that you have identified for your products, which should be considered according to the "test-to-consider" matrix in ISO 10993-1:2009.




Re: Help~ three final products in one biocompatibility test?

THANKS!!! it's helpful :)
Thread starter Similar threads Forum Replies Date
B Toyota PPAP Process - Three Questions APQP and PPAP 3
R Problem solving activity - Three hours to fix the issue Manufacturing and Related Processes 15
E Three basic questions about ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Beginner in ISO 45001 here! Three questions Occupational Health & Safety Management Standards 6
L Templates for three ISO 13485:2016 SOPs ISO 13485:2016 - Medical Device Quality Management Systems 8
S How to number and control translated SOPs - Three languages Document Control Systems, Procedures, Forms and Templates 4
I Flatness - Rectangular part using the three jack method Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
B Variable Gage R&R - Two operators instead of three Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
D How to fill a Process FMEA - Three columns - Severity, occurrence and Detection FMEA and Control Plans 16
Marc Hackers unleash smart Twitter phishing tool that snags two in three users IEC 27001 - Information Security Management Systems (ISMS) 7
R FDA released three guidance documents for Medical Devices - August 2014 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Is it mandatory to revise MSDS every three years? ISO 14001:2015 Specific Discussions 3
E ANOVA for Taguchi method - Four factors and three levels and nine runs (Minitab) Using Minitab Software 6
Ajit Basrur India marks three years since last polio case Hospitals, Clinics & other Health Care Providers 2
S Three Questions on Finished Medical Device Traceability, Labeling and Packaging US Food and Drug Administration (FDA) 3
C Optimize One Response with Three Variables Using Minitab Software 8
E How can I measure three true positions? GD&T basic question General Measurement Device and Calibration Topics 5
B Three Sub-Companies - Is One Quality Manual Enough? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Three Best Practices and Lessons Learned in APQP APQP and PPAP 1
H Do we need all three AS9102 forms if we manufacture only Piece Parts? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
I Analysing the data from three different cavities of one mould Quality Tools, Improvement and Analysis 4
P Monitoring Production Defects - Three simple questions Six Sigma 3
L I have four groups to compare, and each group has three samples Using Minitab Software 4
N What are three kinds of flow in Lean or Six Sigma? Lean in Manufacturing and Service Industries 4
B What is the psychology behind three rings? Customer Complaints 8
Marc Customer Service - Three Stories About Improving Customer Service Funny Stuff - Jokes and Humour 3
J Calibration of Micrometer Reading up to Three Decimals General Measurement Device and Calibration Topics 3
D One-Two-Three Sigma Control Limits - Calculating Control Limits for X-bar Charts Statistical Analysis Tools, Techniques and SPC 3
T Constant for a M3x.35 Set Plug using the "Three-Wire Method" Calibration and Metrology Software and Hardware 2
AnaMariaVR2 FDA has issued three Warning Letters... US Food and Drug Administration (FDA) 13
F Differences among three locations with respect to mean selling price - Minitab help Using Minitab Software 2
R How to determine the reference voltage for three-phase transformer? IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
Marc Three Email Topics Funny Stuff - Jokes and Humour 3
S Best wire size for 'three wire method' to measure pitch dia. of asymmetrical thread General Measurement Device and Calibration Topics 2
L Proposal to Senior Management - Three options for our new CAPA process Quality Manager and Management Related Issues 2
N DFM, DFA and POKA YOKE - Are these three related? Manufacturing and Related Processes 4
Marc Three-Inch Device Detects 3,000 Types of Viruses and Bacteria World News 0
P Panic time! Audit in three days! ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Top Three Reasons why TPM (Total Productive Maintenance) Initiatives Fail Manufacturing and Related Processes 39
Hershal Only THREE foods - Informal sharing of tastes Coffee Break and Water Cooler Discussions 17
isolisa Three ISO 17025 Questions ISO 17025 related Discussions 8
P Determining Sample Size - Filling a bag with three different types of candy Inspection, Prints (Drawings), Testing, Sampling and Related Topics 31
T Gage R & R Study "Best Practices" - More than three operators? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
S The Three Jars! Brain Teasers and Puzzles 4
M Chi Square Help - One of my variables has three possible results Using Minitab Software 15
Proud Liberal Using Three (3) Gage Pins to Check Hole Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
O Difference between Six and Three Sigma? Statistical Analysis Tools, Techniques and SPC 11
D Gap Analysis - Three months until our ISO/TS 16949 3rd party surveillance audit IATF 16949 - Automotive Quality Systems Standard 4
Sidney Vianna Tough talk on Detroit Three doesn't consider suppliers World News 0
B MTBF calculations - Three student homework problems Reliability Analysis - Predictions, Testing and Standards 10

Similar threads

Top Bottom