| K-number | K242336 |
| Device name | hygh-tec Drainage II |
| Applicant | Amb Medtec |
| Product code | KNT |
| Device class | Class II |
| Decision date | Jan 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.5980 |
The hygh-tec drainage II is a fecal management system for continuous trans-anal drainage and collection of liquid or semi-liquid stools in adult patients. It also provides access for medication administration. The system comprises a stool drainage tool, collection bag, and inflating syringe, used by healthcare professionals in clinical settings.
The device uses a three-layer extruded drainage tube made of TPU-EVOH-TPU material, whereas the predicate device (hygh-tec drainage) uses a PVC drainage tube. The design and principle of operation remain identical between the two devices.
ISO 10993-5:2009 (cytotoxicity testing), ISO 10993-10:2021 (sensitization and irritation), ISO 10993-23:2021 (temporary implantation), and tensile strength testing.
Substantial equivalence is established through identical indications for use and identical design/principle of operation as the predicate. The only material change—from PVC to TPU-EVOH-TPU for the drainage tube—was evaluated and demonstrated to be acceptable through biocompatibility testing (ISO 10993 standards) and mechanical testing (tensile strength), confirming the new material poses no additional safety or effectiveness concerns compared to the predicate.
View the full FDA submission: accessdata.fda.gov