evo820 Collaboration:

Achieving Success in your medical device 510(k) Clearance.

It is required that you have a clearance to sell and market your device in the US. This is not a device FDA Approval but demonstrating that your device is substantially equivalent to another device.

If you are a medical device manufacture and want to have access to the US market, evo820 will collaborate with you to obtain the 510(k) Clearance required to enter and sell your products in the US.

We are a full-service consulting firm to successfully collaborate with your manufacturing company to bring you, not only Regulatory Affairs complaint, but also FDA Quality Assurance compliant.  We customize your documentation to suit your company needs and train your team on the management of the record keeping.

510(k) Submission Information required (all or some)

  1. evo820 will need detailed information regarding the device(s) being submitted for a 510(k) This information should provide sufficient detail for FDA to be able to determine that the device is substantially equivalent to another similar legally marketed device(s).
  2. If testing is required for the 510(k), a description of the tests and the results required are essential. Reasonable and sufficient details of all test procedures and results should be submitted to FDA.
  3. Client will need to provide the following information to assure that your 510(k) is complete. evo820 may need additional information for other 510(k) submissions.
    1. Classification of your device (if you have)
    2. Predicate device(s)
    3. Final draft labeling
    4. Specifications including engineering drawings, photos, etc.
    5. Performance data such as bench, animal, or clinical testing (if applicable)
    6. Sterilization information (if applicable)
    7. evo820 will need a Statement of Indications for Use as a separate page.
    8. All 510(k) submitters must include a statement certifying that all information submitted in the 510(k) is truthful and accurate and that no material fact has been omitted.
    9. narrative description of the “new” device will be required and should include the indications for use, principles of operation, power source, composition and other information necessary to understand the device.
    10. A required physical description of the “new” device may include labeled diagrams, photographs or pictures, engineering drawings, schematics, etc. These may include all internal and external, assembled and unassembled, interchangeable, etc., parts of the device and should address their name and function. In addition, the description should include the length, width, height, diameter, weight, etc., of the device and identify any parts which are intended for single use.
    11. A substantial equivalence comparison is required. The device specifications are the basis for the comparison of features between the new and the legally marketed device to which compared (predicate device). Substantial equivalence is to be established with respect, but not limited to, intended use, design, energy used/delivered, materials, performance, safety, effectiveness, labeling and other applicable characteristics, such as sterility. You should include a comparison table AND discussion of the similarities and differences of your device compared to one or more predicate devices to which you are claiming equivalency.
    12. Device performance may be required Most 510(k)s will include some type of performance data. The extent of performance data will depend on the complexity of the device and its intended use and indications. Performance data should be provided to help demonstrate SE of your device to one or more legally marketed devices (predicate device)

With the US FDA required information listed above for your 510(k) submission, evo820 will develop the proper documents to present to the FDA and achieve a 510(k) Clearence for your company.

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