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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI
CCSI 29.77+3.7%Nov 5 3:59 PM EST
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To: invest04 who wrote (2820)6/11/1998 10:11:00 AM
From: JanyBlueEyes  Read Replies (1) of 5736
 
SUBSTANTIAL EQUIVALENCE

"The basic concept behind obtaining 510(k) clearance is that the device being reviewed is very much like others already being sold in the United States....". This statement says it all.

In order to obtain 510K clearance from the FDA, Chromatics was required to prove it was equivalent to other devices currently marketed. If they could not do that they would have had to file for a PMA clearance from the FDA - a much longer process. It is as simple as that. (see below for further explanation, if needed)

As far as the FDA is concerned. They based their approval on the fact that the device had "excellent correlation" to serum (blood based) bilirubin readings:

From The Actual 510K From the FDA
techstocks.com :

"In conclusion, the Colormate III performance was superior to visual examination in estimating the true level of serum bilirubin, in addition to an excellent correlation to serum bilirubin throughout a clinically useful range."

-----------------
From techstocks.com originally posted 8/97:

Understanding the 510(k) Summary

For their submission to the FDA Chromatics had to prove "Substantial Equivalence" by comparing the Colormate III with at least two legally marketed predicate devices. Notice they compared the Colormate III to

1) a device that is invasive (Unistat Bilirubinometer) and
2) a visual aid - graded yellow stripes on a device to compare to the skin of the infant.

Both of these devices used color & light (like the Colormate III).

The following was taken from an article from Medical Device & Diagnostic Industry Magazine dated January 1996. devicelink.com

"Substantial Equivalence. The basic concept behind obtaining 510(k) clearance is that the device being reviewed is very much like others already being sold in the United States. Two important terms enter into arriving at such a conclusion--substantial equivalence and predicate device. The 510(k) notification must show that the device is substantially equivalent to one or more predicate devices legally marketed in the United States.3 A predicate device is often one that was legally marketed on or before passage of the Medical Device Amendments to the FD&C Act on May 28, 1976. However, a number of predicate devices were first marketed after that date. They have been declared by the agency to be substantially equivalent after submission of a 510(k) application.

As defined in the FD&C Act, a finding of substantial equivalence requires either of two major conditions to be met.4 Substantial equivalence is likely to be determined if the device being reviewed is found to have the same intended use and the same technological characteristics as the predicate device. The device can have different technological characteristics. For example, it may be made up of different materials, have a different design, use a different energy source, or even rely on different principles of operation and still be substantially equivalent to a predicate device--but only if it has the same intended use and the submitter can demonstrate that it is as safe and effective as the predicate device. Additionally, the device being reviewed must not raise any different issues regarding safety and effectiveness when compared to the predicate device."
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