SUMMARY

A in vitro biocompatibility test, based on the International Organization for Standartization (ISO 10993-5) guidelance, was conducted on the test article, AES Capsule, Identification No. P-6551-KL, in order to determine the potential for in vitro citotoxity. Triplicate extracts of the test article were prepared using Minimum Essential Medium (MEM). Each test extract was placed onto separate confluent monolayers of L-929 Mouse Fibroblast cells. Seperate triplicate flasks were prepared for a negative control, reagent control, and for a positive control. The monolayer in the test, negative, and reagent control flasks was examined microscopicallly at 48 hours to determine any change in cell morphology. The changes were graded on a 0-4 basis. The monolayer in the positive control flasks (end-point titration procedure) was examined at 24 hours and the result was compared to the NAmSA historical value.

The MEM test extracts showed no evidence of causing cell lysis or toxity. The negative controls, reagent controls, and the positive controls performed as anticipated. Under the conditions of this study, the MEM test extracts were not cytotoxic.

Study and Supervisory Personnel:	John Broad, B.S. Tina Chang Christina Pham, B.S. Nancy Fernandez, B.S. Parviz Ronaghi, B.S.
Approved by
	John Broad, B.S. Manager, Microbiology	Report Date
Approved by		10-9-96
	Darvin L. Cheney, Ph.D. General Manager	Date Completed

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