INSTRUCTIONS FOR REINVENTION OF 510(k) REGULATORY FRAMEWORK





Update and enhancement of the current 510(k) regulatory framework for the currently marketed surgical stapling

products to be able to provide an improved level of assurance in safety and effectiveness of the surgical stapling

products by properly incorporating in the design of the framework the advancements, over several decades, of

surgical stapling technologies/sciences and surgical techniques, and diversification of application of the surgical

stapling products in clinical practices.








A LETTER URGING FDA TO TAKE STEPS TO REFINE AND REINFORCE A FOUNDATIONAL ASPECT OF 510(K)

REGULATION OF SURGICAL STAPLING PRODUCTS*





Introduction



The 510(k) program for surgical stapling products is a science driven regulatory framework of the FDA for obtaining

marketing clearance for a subject stapling device and based on the principle of substantial equivalence (SE). The

administration of 510(k) regulation involves a scientific review of scientific information regarding the subject device

provided by the manufacturer necessary for determination of SE. Naturally, the subject device must be firmly rooted

in a scientific foundation from the very beginning, i.e., conceptualization, throughout engineering development and

analysis of and development of corrective measures for adverse events in clinical uses of the subject device, and to the

end of its commercial life.




Oversight in Administration of 510(k) Regulation



The majority of currently marketed surgical stapling products from leading manufacturers fail to meet perhaps the

most basic and critical test of eligibility for regulatory clearance under 510(k) program, that is, the subject device

must be founded on a scientific foundation. These products, particularly, the claimed novel features employed in

those products, e.g., steps and bumps on the deck of staple cartridge and offset legs of formed staples, had never even

been conceived and much less developed based on any science or derived from the old generation of surgical stapling

products enjoying the status of historically accepted, de facto, standard of safety and effectiveness. The bases

presented for these products and technological features presented by the manufacturers are more of speculation and

wishful thinking than logical scientific argument. Any purported scientific facts produced and submitted by the

manufacturers in support of 510(k) application cannot be scientifically linked with the subject devices. There cannot

and should not be any room for medical device conceived, developed and cleared for marketing on a heuristic ground

in the science driven regulatory program of the FDA.




Scientific Foundation of Surgical Stapling & 510(k)



The scientific foundation for the surgical stapling (products) should consist of:


(1) a first (academic) knowledge base pertaining to the technological characteristics of surgical stapling instruments

and the clinical, anatomical and physiological, characteristics of target organ, and mechanical interactions between

instruments and organ tissue, and obtained through in depth analysis performed solidly based on or in a manner

traceable to the principle(s) of mechanics, where needed and


(2) a second (real world) knowledge base obtained through analysis, based on the first knowledge base, of the known

clinical problems of legacy surgical stapling (products) identified by the FDA and recorded in the MAUDE database.


It is to be understood that there can be certain degree of variations among the languages, but not the underlying

principles, describing the models and parameterization of the models adopted by each manufacturer for development

of surgical stapling products submitted for marketing clearance through 510(k) program. The manufacturer sponsor of

a stapling product would need to be required to submit only the description of models including parameterization

pertinent to the subject stapling product. The manufacturer sponsor of a stapling product should also be required to

consistently rely on the adopted model(s) for the subject stapling product as frame of reference in preparing portions

of component of 510(k) submission including the technical specification, the substantial equivalence comparison and

the design and analysis of results of performance tests. Additionally, the model(s) of the subject stapling product

should also be considered a sole guiding principle when the FDA evaluates scientific merit of various tests and data

analysis performed to support 510(k) submission and determines relevance of tests with respect to the subject stapling

product and its intended use. Beyond the prime importance in 510(k) regulatory program the model(s) of the subject

stapling product should once again play a pivot role in analyzing and developing remedial solutions for adverse events

in clinical uses of the subject stapling products developed and cleared based on the model(s).






Please contact us for assistance and/or collaboration in reinventing the 510(k) regulatory framework strategy for your

surgical stapling product portfolio in part or entirety.