July 1, 2008

substantially equivalent

From the FDA site re: Animas ezManager Max

Device Description:
The Animas ezManager MAX Diabetes Management Software, installed onto a patient's or healthcare professional's personal computer, allows downloading and uploading of information to and from Animas insulin pumps and specified commercially available blood glucose meters. The software displays downloaded historical data stored in the pump and blood glucose meter such as basal/bolus deliveries and blood glucose measurements. The data can be displayed in reports and logs to facilitate trending and diabetes management.

Indications for Use:
The Animas ezManager MAX Diabetes Management Software is indicated for use as an accessory to Animas insulin pumps and specified commercially available blood glucose meters. The software supports diabetes management by the patient and/or healthcare professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information.

Predicate Device:
K063674 - Animas ezManager® Plus Diabetes Management Software (Animas Corporation)
Substantial Equivalence:
The Animas ezManager MAX is substantially equivalent to the legally marketed predicate, Animas ezManager Plus. Both devices have the same intended use and fundamental scientific technology.

http://www.fda.gov/cdrh/pdf8/K080587.pdf
http://www.fda.gov/cdrh/pdf6/K063674.pdf



I understand it is legal double speak to get an FDA blessing to market the product, but substantially equivalent isn't exactly what I want to hear. Substantially rewritten from the ground up and only similar only in name would be much better.