Re: "Do you think all 12 of these apps will be covered by simple 510k filings or will they require clinical trials before FDA approval?"
That's a good albeit broad question. In brief, it depends on whether the medical device in question can be shown to be a predicate device, i.e., "substantially equivalent" to a device on the market prior to 28 May 1976 "in terms of design, material, chemical composition, energy source, manufacturing process, or intended use."
Electrosurgical devices have been around for decades, and the market is replete with their generational successors. FDA 510(k) clearance for LTC's VAD 400 generator and two handsets pursuant to duct-and-vessel sealing was obtained because the devices were shown to be "substantially equivalent" to other cleared and well-represented devices.
The ill-fated PR of 26 March 2010 mentions that LTC's approved device could be used for such varied procedures as "stripping veins or arteries from a patient for use in open heart surgery, cutting the connecting vessel for gall bladder surgery, and hemorrhoid surgeries." Of course, these aforementioned are just non-excluding examples, but they do illustrate a varied range of approved surgical procedures for that 510(k) device.
My guess is that a healthy majority of the devices appertaining to the "12 applications" will require 510(k) (i.e., Pre Market Notfication or PMN) but not PMA (Pre Market Approval) which latter could subject them to clinical trial. The immediate exception would be the lung resection application. Presently, to my knowledge, FDA forbids electrosurgery as applied to the lungs. Therefore, a PMA is a given. Colon resection requiring PMA? That's an interesting question.
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