Tembo Embolic System

The Tembo Embolic System is a sterile, single-use medical device consisting of biocompatible, dry resorbable porcine gelatin particles in a 10 mL syringe. It is intended for embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature. The dry particles (85–255 µm) are hydrated with contrast media or saline and injected through a microcatheter to block target blood vessels.

The subject device differs from the predicate device only in packaging design, which has been redesigned to protect the device through sterilization, distribution, handling, and storage. The embolic material composition, particle size specifications, principle of operation, indications for use, and technological characteristics remain identical to the predicate device.

ISO 10993-1 (biocompatibility evaluation), ISO 22442-1 (animal tissues in medical devices), ISO 11137-1 and 11137-2 (gamma radiation sterilization), ISO 11607-1 (packaging for sterilized devices), ISTA 3A (simulated distribution challenge testing), and ISO 14971 (risk management, implicit in design approach).

Substantial equivalence is supported because the embolic material and all fundamental technological characteristics remain unchanged from the predicate device K240873. The only modification is to non-patient-contacting packaging; biocompatibility and animal testing data from the predicate are representative of the subject device. All performance testing met predetermined specifications with no new safety or effectiveness issues identified.