Vitaltec Corporation · Class II · Cleared Jun 10, 2025
| K-number | K242921 |
| Device name | 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm |
| Applicant | Vitaltec Corporation |
| Product code | BTO |
| Device class | Class II |
| Decision date | Jun 10, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 868.5800 |
The Rota-Trach Disposable Standard Tracheostomy Tube is a respiratory device inserted through a stoma into the patient's trachea to maintain airway in tracheostomized patients. It comes in cuffed and uncuffed variants, with optional fenestrations, in sizes 6.0–10.0 mm, and is intended for short-term use (up to 29 days) in critical care, acute care, and long-term care settings.
Both the proposed device and predicate are plastic-based tubes (PVC, PP, HDPE, cotton components) sterilized with ethylene oxide to SAL 10⁻⁶. The main difference is material composition details and shelf life: Rota-Trach has a 3-year shelf life versus the predicate's 5-year shelf life. Both undergo identical performance testing (ISO 5366, ISO 5356-1, ISO 18190) and biocompatibility evaluation per ISO 10993-1:2009, though Rota-Trach adds chemical characterization testing.
ISO 5366:2016, ISO 5356-1:2015, ASTM F2250-903, ISO 80369-7, IEC 62366-1:2015, ISO 11737-2:2009, ISO 11607, ISO 10993-1:2009 (biocompatibility), ISO 11135 (sterilization), and AAMI TIR28.
Substantial equivalence is supported by identical indications for use (airway maintenance), patient population (tracheostomized adults), invasiveness (surgically invasive), duration (29 days), functionality, sterilization method, and environment of use. Both devices pass the same performance and biocompatibility test standards. Although material composition details and shelf life differ, these differences do not raise safety or efficacy concerns because the materials have a well-documented history of safe use in medical devices with similar contact profiles, and the manufacturing processes introduce no novel safety risks.
View the full FDA submission: accessdata.fda.gov