Medical Devices Case Study

Medical Device Sealing: Implant-Grade Silicone for Dialysis Equipment

VMQMedicalUSP Class VIBiocompatibility

material

Platinum-cured VMQ

certification

USP Class VI + ISO 10993

tests passed

Cytotoxicity + Sensitization

outcome

FDA 510(k) cleared

Challenge

A medical device manufacturer needed implant-grade platinum-cured silicone O-rings for a peritoneal dialysis cycler that would pass USP Class VI and ISO 10993 biocompatibility testing.

Solution

We supplied USP Class VI platinum-cured VMQ O-rings with full lot traceability, biocompatibility certificates and dimensional reports.

Result

The seals passed all ISO 10993-5 cytotoxicity and ISO 10993-10 sensitization tests, and the device received FDA 510(k) clearance.

Details

The customer's peritoneal dialysis cycler used silicone O-rings in fluid pathways that contacted dialysate and, indirectly, patient tissue. The seals were required to meet USP Class VI, ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization) standards.

We supplied platinum-cured VMQ (not peroxide-cured) to eliminate peroxide byproducts that could interfere with biocompatibility testing. Each production lot was sampled for extractables testing and dimensional verification.

Documentation included a certificate of conformance to USP Class VI, raw material supplier biocompatibility data, and a lot-specific dimensional report. This package supported the customer's FDA 510(k) submission.

Third-party testing confirmed zero cytotoxicity and no sensitization reactions. The dialysis cycler received FDA 510(k) clearance, and the customer has used our VMQ seals for three subsequent product generations.