PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid

The PUREVUE™ Quick Connect Cannula System Tray and Lid are reusable, perforated aluminum containers designed to store, organize, and transport surgical instruments during steam sterilization and clinical use. The tray and lid are not intended to maintain sterility independently; they must be used with an FDA-cleared sterile barrier wrap. The system is validated for a maximum load of 22.1 lb and two pre-vacuum steam sterilization cycles (132°C/4 minutes or 134°C/3 minutes exposure).

Both subject and predicate devices feature basic lid/base design, general-use trays, perforations for steam sterilization, handles, and stainless steel latches. Materials are identical: anodized aluminum bases with silicone, aluminum, and stainless steel inserts. The subject devices are slightly smaller (21.23–21.50 × 9.71–10.01 × 0.63–2.86 inches; 22.1 lb maximum) than the predicate (6.34–20 × 9.25–9.7 × 1.77–6.6 inches; 25 lb maximum), reflecting their specific use with PUREVUE™ Quick Connect Cannula instruments rather than broader orthopedic devices. The subject devices include an additional sterilization cycle at 134°C/3 minutes.

Not stated in this summary. The document references ISO 13485 clauses 7.3, 8.3, and 8.5 in regulatory context but does not cite specific consensus standards (ISO, ASTM, IEC) for performance testing.

The subject devices are substantially equivalent to the Synthes Graphic Case & Tray System (K241927) because they share identical principles of operation, design features, materials, and sterilization methods. Both are non-sterile, reusable containers with perforations for steam penetration used to organize instruments for sterilization and transport. Dimensional and weight differences are negligible and driven by different compatible instruments. Non-clinical testing (steam sterilization efficacy, dry time, cleaning, durability over 500 cycles, and biocompatibility) demonstrates the subject devices perform as well as or better than the predicate. No new questions of safety or effectiveness arise from the minor differences.