Rusch SoftSimplastic Foley Catheters

The Rüsch SoftSimplastic Foley Catheters are sterile, single-use, short-term indwelling balloon catheters designed for transurethral bladder drainage in adult male and female patients. They are available in 2-way and 3-way lumen configurations, with sizes ranging from 14 to 24 French gauge, and are indicated for routine bladder drainage postoperatively or for patients with conditions requiring transurethral urine drainage, with 3-way catheters also supporting bladder irrigation.

Both subject and predicate devices feature a flexible PVC shaft, a distal latex balloon for retention, proximal funnel and inflation valve, radiopaque stripe for X-ray visibility, ethylene oxide sterilization, and paper-film peel-back packaging for single-use. The primary difference is that the subject device has been evaluated for MR safety and is labeled MR Conditional per ASTM standards, whereas the predicate device was not previously evaluated for MR safety.

ASTM F2052-21 (magnetically induced displacement force), ASTM F2213-17 (magnetically induced torque), ASTM F2182-19e2 (RF-induced heating), ASTM F2119-07 (MR image artifacts), ASTM F2503-23 (MR safety marking), and ISO 10993-1 (biocompatibility).

The subject device is substantially equivalent to the predicate device (K212077) because both share identical intended use, materials (PVC shaft, latex balloon), design features, lumen configurations, size ranges, sterilization methods, and performance characteristics. The only difference is the addition of MR Conditional labeling based on comprehensive MR safety testing, which enhances rather than changes the device's fundamental technological principles and intended use.