New draft guidelines for 510 (K) with Different Technological Characteristics.

rangani_rj

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Hi all

FDA released draft guideline for determining substantial equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics. The new device having different technological than predicate must have same intended use as predicate. The manufacturer needs to generate performance data (non-clinical and clinical testing) for new device in comparison to predicate device to assess Risk and Benefit. Few examples for 510(k) which are submitted by manufacturer with new technologies are also included in guideline,

Here is the summary of examples.

1) Manual Rongeur having New Design (new shape, more pointed) that allows deeper cutting action than the identified predicate device. This device is utilized to cut spinal tissue to assess deeper portion of spinal cord. Found SE (Substantially Equivalent).

2) A self-contained level laser therapy device for the treatment of toenail fungus (onychomycosis) with different wavelength than the predicate. The benefit of the device is found to be much smaller and uncertain. NSE (Not Substantially Equivalent) decision may be given.

3) External infusion pump for ambulatory purpose compared with stand-alone external infusion pump used in hospital. Unlike the predicate device, the new device operates fully on a battery and has a smaller, simpler user interface than the predicate device. However, the device may function erratic in moving and vibrating vehicle. The manufacturer provided bench data that confirmed the durability of the device in simulated, worst-case ambulatory conditions. With appropriate labeling for drift calibration and considering higher benefit to patient during emergency, FDA may consider it SE.

4) Male condom composed of synthetic material claims substantial equivalence to a natural rubber latex condom (Synthetic vs Natural rubber). The only difference between the two devices is the material, synthetic versus natural rubber latex. FDA consider it SE when all risks are mitigated or minimized to predicate. FDA may give SE.

5) A device for obstructive sleep apnea having a different mechanism of action to achieve the same intended therapeutic outcome. The bench data provided by manufacturer reveal that new mechanism of action does not potentially close the oral cavity (common side effect in case of over pressure), restricting the user to breathing through the nose. Although effectiveness of device demonstrated by the new device is less than that of the predicate device, the new device scored significantly higher on a patient satisfaction questionnaire as compared to the predicate device. FDA may give SE.

6) The manufacturer obtains a critical reagent through recombinant DNA technology, rather than as a multicomponent extract of animal tissue for measurement of prothrombin time (PT) international normalized ratio (INR) and coagulation factor levels. With comparable analytical performance (as normalized) based on available studies, and with risk mitigation that is well-established, the new device and the predicate device are similar. Therefore, the device may be found SE.

7) Menstrual tampon composed of a new synthetic wadding material than conventional material-rayon. The new material has ability to absorb the same amount of fluid, but with less physical expansion than predicate device. However this new material may support overgrowth of S. aureus, can lead to TSS (Toxic Shock Syndrome), a potentially fatal disease as revealed from the inconsistent data of microbiological tests performed by manufacturer. Therefore, the device may be found NSE.
 
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