Guest guest Posted January 4, 2001 Report Share Posted January 4, 2001 Interesting. Thanks for the information. Connie & Reaghan > Hi Connie, > > As strange as this may sound, that is pretty much all Orthomerica (STAR > Band, was OPI Band) and Gillette Children's (Craniocap) had to do to get FDA > approval. For example, on bottom of page 2 for the Craniocap pdf file > http://www.fda.gov/cdrh/pdf/k000861.pdf and page 4 of the Orthomerica pdf > file http://www.fda.gov/cdrh/pdf/k001167.pdf, the FDA approval letter states > " The FDA finding of substantial equivalence for your device to the legally > marketed predicate device results in a classification of your device and > thus, permits your device to proceed to market. " The predicate device is the > DOC band (see below). That means that Orthomerica and Gillette Children's > could simply cite research conducted by Cranial Technologies. Take a look > for yourself: > > Cranial Tech > Summary/Approval > http://www.fda.gov/cdrh/pdf/k964992.pdf > > Orthomerica (STAR Band, was OPI Band) > http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm? ID=915 > Note " Decision: SUBSTANTIALLY EQUIVALENT " > Summary/Approval > http://www.fda.gov/cdrh/pdf/k001167.pdf > Note page 1 section B, the " Predicate Device is the Doc Band " > > Gillette Children's (Craniocap) > http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm? ID=676 > Note " Decision: SUBSTANTIALLY EQUIVALENT " > Summary/Approval > http://www.fda.gov/cdrh/pdf/k000861.pdf > Note page 1, the " Predicate Device is the Doc Band " > > The " intend uses " for Orthomerica (STAR Band, was OPI Band) and Gillette > Children's (Craniocap) are taken almost verbatim from the DOC band. And > believe it or not, the research described in the Orthomerica document, is > research conducted by Cranial Technologies. The " Researchers studying the > effects of treatment... with 12, 18 and 24 month follow-ups... " (page 2 of > http://www.fda.gov/cdrh/pdf/k001167.pdf) are Littlefield, and others > (articles available at http://www.plagiocephaly.org/resources/default.htm > and http://www.cranialtech.com/infocenter/infocent.htm). > > LET ME BE VERY CLEAR ON THIS, I'm not saying there's anything wrong with > predicate approval of these devices. However, let's give credit where > credit is due. These devices are available because of Cranial Tech's > investment in a system of monitoring and quality assurance. > > Quote Link to comment Share on other sites More sharing options...
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