Multi4 System

The Multi4 System is an electrosurgical device used by urologists to perform transurethral resection of bladder tumors (TURBT) and other endoscopic urological procedures. It consists of a reusable Multi4 Pump that delivers radiofrequency energy to a single-use Multi4 B instrument, which performs cutting, coagulation, aspiration, irrigation, and injection functions through a cystoscope working channel.

The Multi4 System uses monopolar radiofrequency energy with water irrigation, employs a dual-action pump for irrigation and aspiration, and includes a 27-gauge needle with 716 mm working length for injection. It differs from the primary predicate (Veloxion) in using monopolar rather than bipolar energy and water rather than saline irrigation, but shares the same cut/coagulation/aspiration/injection functional capabilities and target patient population.

IEC 62304 (software verification and validation), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-6, IEC 60601-2-2, plus biocompatibility testing (cytotoxicity, irritation, sensitization, acute systemic toxicity, pyrogenicity), sterility testing, packaging validation, and shelf-life testing.

The subject device has similar design, dimensions, and materials to the predicate devices and performs the same intended urological functions. Testing demonstrates equivalent safety across biocompatibility, sterility, packaging, and electrical safety domains. Although the Multi4 uses monopolar energy and water irrigation while the primary predicate uses bipolar energy and saline, both systems achieve identical cut and coagulation functions with equivalent performance characteristics, and the secondary predicate's injection capability demonstrates the device type is established. The technical differences do not raise new safety or effectiveness questions because the functional outcomes and performance testing are equivalent.