Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)

The Streamline Temporary Pacing Leads and Wires are temporary cardiac pacing devices used during or after cardiac surgery to treat irregular heartbeats by electrically stimulating the heart. The product line includes five models with variations for pediatric, atrial, ventricular, and myocardial applications, each with a lead body, distal electrode, polypropylene fixation coil (except one model), and proximal chest needle for placement.

All Streamline models share the same finished device operating principle, packaging materials, and EtO sterilization method as predicate devices K190716 and K171253. The key change in this submission is the addition of MRI safety labeling; all models were tested and determined to be MR Conditional at 1.5T and 3.0T magnetic field strengths with specified RF and scan parameters.

ASTM F2192-19e2 (RF heating at 64 MHz for 1.5T and 123 MHz for 3.0T), ASTM F2052-15w (force and torque assessment in 3.0T MR systems). Imaging artifact assessment was not performed based on determination that only head and lower extremity imaging is permitted.

The Streamline devices maintain identical intended use, indications, and operating principles as their predicates (K190716 and K171253). The submission involves only the addition of MRI safety information based on nonclinical testing demonstrating MR Conditional status; there are no changes to device design, materials, sterilization, or fundamental function. Substantial equivalence is supported by this preclinical MRI data showing safe operation under specified conditions, combined with continuity of all other device characteristics.