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If you are developing a new orthopaedic implant or medical device, you need to be able to show equivalence to an existing product to be able to register through the 510(k) route. 510(k) in itself is not a specific test method, but it does require that tests and supporting data demonstrate the medical device is as safe and effective as its predicate device.
When is 510(k) Applicable?
When your new device is made from the same materials and is similar to the design and function of the predicate medical device, then 510(k) will usually be the preferred, and fastest, route to market.
What if a Medical Device is Significantly Different?
If the design, function or materials used in a medical device are not similar to an approved medical device, then you might need to get Pre-Market Approval, PMA. If you are unsure whether 510(k) is the best route for you, contact us to discuss your requirements.
Why Choose Lucideon as a Testing Partner?
At Lucideon, we provide a one-stop-shop for all of your needs. We perform testing and analytical services to USP, ISO, ASTM, and other required standards, as well as in accordance with various regulatory and testing guidance documents (e.g. FDA, AAMI, etc.). In addition to testing, we provide consultancy services to assist in preparing your 510(k) file and product registration.
The tests carried out to prove equivalence need to be relevant, thorough and supported by rationale, ready for your submission. Our experts work with Class II, Class III and Combination Products that incorporate a pharmaceutical component. We develop the testing strategy, perform all relevant analysis and provide the data, complete with full interpretation and justification, for why it demonstrates equivalence.
Our core team of medical device experts are based in the United States and, along with our extensive network of global partners, we support 510(k) submissions and help navigate the FDA pathway for clients all over the world. We also operate in many other markets around the world and can test to other regulatory body requirements.
We team with strategic scientific partners who have specific, industry leading expertise in areas including: toxicology, fatigue testing and regulatory evaluation support. This network means that we can take you from the very start, right to the finish.
What Analytical Services Does Lucideon Offer?
The list below provides examples of the related analytical services we provide, and supporting services for medical devices:
- Wear and Fatigue Testing of Orthopaedic Implants
- Mechanical Testing
- Vascular Device Testing
- Chemical Characterization
- Extractables and Leachables
- Cleaning and Sterilization Validations
- Method Development and Validation
- Failure Analysis and Troubleshooting
Materials science is at the heart of what we do and we can provide services for all medical device materials.
FDA inspected and ISO 17025 accredited laboratories with global support.
FDA Links for 510(k) Reporting
» How to Prepare a Traditional 510(k)