The Traditional 510k is one of the three types of the 510k in the US FDA. This type of 510k can be used for any circumstances and any kind of medical device for which the premarket notification is applicable for marketing in the USA. Traditional 510k should contain explanations on the intended use, technological characteristics, reports on the performance tests, and demonstration of the substantial equivalence with the predicate device.
The contents of the Traditional 510k contain some common sections. These sections include some forms from the FDA such as FDA 3601, FDA 3514, FDA 3881. Apart from these the contents include the indication of use, 510 k summary, Declaration of Conformity, Device description, Executive summary, Substantial equivalence, Labelling, Biocompatibility testing protocol and reports, sterilization details, Electric Safety reports, Performance Testing protocol and reports.
Are all the above sections to be on the sequence and what if one of the sections is not applicable?
What is a 510k summary generally contain?
4 thoughts on “Traditional 510k”
The traditional 510(k) is used to obtain permission to legally market medical devices under any circumstances in the USA by submitting information required under 21 CFR 807.87. The submission of 510(k) in any format requires establishing subsequent equivalence of the proposed device to a device that has already obtained the 510(k) clearance. This is used to demonstrate the safety and effectiveness of the device undergoing evaluation by comparing its indications of use and technological characteristics with the predicate device.
FDA recommends the inclusion of section headings in the sequence provided in the guidance to conserve the FDA and industry resources and to facilitate timely review.
If any section is not applicable, it is suggested by FDA, to include the section with the statement “This section is not applicable” or “N/A” under that heading.
Please find more details regarding the format for 510(k) submission in the link below
Refer the link below for the contents of 510(k)
Information seems not correct, both will not coexist.
Apart from the above comments the below can be considered for traditional 510k summary
In traditional 510k submission the submitter or company should clearly explain the basis for the same i,e the device is new, if any modification of a legally marketed device that is not qualifying for a Special 510(k), any new indication for use or new design of the device , a submission for a reprocessed, single use, disposable device and an exempt device which exceeds the limitations for exemption
As per the above mentioned contents of the Traditional 510 k performance testing protocol and reports for clinical is applicable and submitter describes the clinical studies then they need to provide clinical protocol that identifies the objective of the test, test methods and procedure, study end points (both for safety and effectiveness) and statistical methodology used. And also the need to discuss the study results, analyses performed and conclusions. Conclusions should discuss comparison testing with predicate device in terms of substantial equivalence.
Irrespective of Traditional or Abbreviated 510(k), FDA recommends that you include the section headings listed in the sequence. Even if the information in a particular section is not applicable to a device, the FDA recommends keeping the section for facilitate their review.
510(K) summary is a separate section in the main submission. The summary contains on the first page, preferably on letterhead paper, the 510(k) owner’s name, address, phone and fax numbers, name of the contact person, and date the summary was prepared. The summary includes the name of the device, including the trade or proprietary name, if applicable, the common or usual name, and the classification name, intended use, device description, the demonstration of substantial equivalence, assessment of non-clinical performance, technological characteristics, clinical studies, and conclusions drawn from the nonclinical and clinical tests.