Replies to post #326212 on Bioelectronics Corp (BIEL)

[GetSeriousOK]

You say "when the antenna size is reduced from 12cm to 6cm, the power density within the treatment area increases." But BIEL states in their 510(k) documentation that changing the antenna length does not change the power density output. You are contradicting BIEL's 510(k) documentation. Who is correct? You, or the company?

Regarding the bruise example: Maybe the skin heals faster directly under the wire. Maybe the edge of bruises heal faster with or without an ActiPatch because there's less damage to the skin and body on the edge of a bruise. Regardless -- what has that got to do with BIEL's claim of "50% more power?"

Maybe it's true that changing the shape to a narrower rectangle increases healing of an incision wound, but the patient can accomplish that with the existing ActiPatch or RecoveryRx product simply by applying tape or rubber bands to the antenna, eliminating the need for (and therefore the marketability of) a new product and eliminating the need for a new 510(k).

Let's summarize. What exactly is the "50% more power" device? RecoveryRxtra or whatever it's called -- how is it different from the existing products?

In post 325408 you said it was the length of the antenna, but that is proven wrong by BIEL's 510(k) documentation.
In post 326204 you said it was the shape of the antenna, but fail to explain why that would require a new 510(k) or even a new device.
Now in 326212 it seems we're back to the length of the antenna.

I guess we'll have to wait for the company to break their silence.

[GetSeriousOK]

Let's revisit the 510(k) documentation for RecoveryRx that JNDouble1 found.

https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190251.pdf

In the table on page 2,
"Antenna size" is listed as "12cm or 6 cm diameter."
"Treatment Area" is listed as "110cm2 or 30cm2."
"Peak spatial power density" is the same for both antenna sizes and both treatment areas.

On page 3 it states

The subject RecoveryRx is identical to the primary predicate [Actiband] and differs from the secondary predicate [Ivivi] only in antenna size/pulse rate (Table 2), but does not affect the average spatial power density levels.

The Actipatch documentation is the same:

https://www.accessdata.fda.gov/cdrh_docs/pdf15/k152432.pdf

Key take-aways:
1. Changing the antenna length or treatment area does not change the peak power density (p. 2) or the average power density (p. 3)
2. BIEL already has FDA clearance for different antenna lengths and treatment areas.

Staelin specifically stated that the company expects to submit an "expedited" 510(k) for the new higher-power device. If it needs a new 510(k) it HAS to be something other than a change in antenna length or treatment area.