Baylis Connector Cable

The Baylis Connector Cable is a sterile, single-use device designed to connect Baylis-approved Radiofrequency (RF) generators (including the PrecisePath RF Puncture Generator and RFP-100A Generator) to separately cleared compatible RF devices such as RF guidewires. The cable is 10 feet long with a multi-pin positive locking generator connector at one end and a spring-loaded wire connection connector at the other end, with a single insulated conductor cable between them, enabling RF power transfer from generator to puncture device.

The subject device shares the same fundamental design and principle of operation as the predicate (RFP-100A Connector Cable). Minor differences include: a design change to connector ends, minor changes to insulation and connector material, and an updated list of compatible generators to include the PrecisePath Radiofrequency Puncture Generator (PRG-1). Both are sterile, single-use cables with identical classification, product code, packaging, and 4-year shelf-life.

IEC 60601-1 and IEC 60601-2-2 for electrical safety, EMC, and generator compatibility. Testing also included mechanical integrity (connector strength, cable durability), sterilization and packaging validation (EO sterilization, shelf-life testing).

The Baylis Connector Cable is substantially equivalent to the predicate RFP-100A Connector Cable because both devices share the same intended use, principles of operation, and fundamental technology. Verification and validation testing confirms the subject device meets the same requirements as the predicate and does not introduce new risks. Design and material changes are minor and do not affect safety or effectiveness.