Green Card Bowie-Dick Test (BD115)

The Green Card Bowie-Dick Test is a sterilization process indicator card designed to detect residual air in pre-vacuum steam sterilizers operating at 270°F (132°C) and 273°F (134°C) for 3.5 minutes. The card changes color uniformly from purple to green when proper sterilization conditions are met with no air present; a non-uniform color change (purple remaining in center) indicates the presence of residual air.

The subject device is a 3.5" × 1.91" card (versus 3.5" × 1.85" for predicate) with indicator ink printed on one side and laminated with polyester film on both sides. The key modification is expansion of the intended use to include monitoring at 134°C for 3.5 minutes in addition to the predicate's 132°C cycle. The design, color change mechanism, interpretation criteria, shelf life (2 years), and holder assembly remain identical to the predicate device.

ANSI/AAMI/ISO 11140-5 Sterilization of health care products — Chemical indicators Part 5: Class 2 indicators for Bowie and Dick-type air removal tests. Testing included Annex B (uniform color change), Annex F (non-uniform color change), Annex C (dry heat testing), and Annex A (color density).

The subject device performs identically to the predicate in all functional aspects except for the addition of a single exposure condition (134°C for 3.5 minutes). Performance testing on three manufactured lots demonstrates the device meets all applicable ANSI/AAMI/ISO 11140-5 acceptance criteria for both pass and fail scenarios, with identical color change mechanisms, interpretation, and stability characteristics. The minor card dimension change (0.06 inches) and product name change do not affect functionality. Expansion to the higher temperature cycle does not introduce new safety or effectiveness concerns since the device uses the same indicator chemistry and operates on the same physical principles.