Description

The Avanos MIC-KEY low-profile balloon gastrostomy button is a skin-level, balloon-retained G-tube designed to provide long-term gastric access for enteral nutrition, medication delivery, and gastric decompression in pediatric and adult patients. It may be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance and is suitable for initial placement or as a replacement in a mature stoma tract.

Key design and features

• Low-profile external base with tapered, recessed distal tip at recommended fill volume
• Internal inflatable silicone retention balloon
• Feeding port with anti-reflux valve that remains closed when no extension set is attached
• SECUR-LOK patient-end connection for MIC-KEY extension sets; lock-and-key, quarter-turn engagement helps minimize leaks and accidental disconnects and protects the valve
• ENFit connectors (ISO 80369-3) on the feeding side of the extension sets
• High-clarity, medical-grade silicone for visibility and drapability
• Radiopaque (barium sulfate) stripe for visualization
• Not formulated with natural rubber latex or DEHP
• System is MR Conditional

Compatibility and ports

• Gastric feeding only (no jejunal feeding port)
• Use only MIC-KEY extension sets with the MIC-KEY feeding port
• Two ENFit extension options included: Continuous Right-Angle Y (with medication port) and Straight/Bolus for bolus feeding

Sizes and balloon fill volumes

• French sizes: 12, 14, 16, 18, 20, 24 Fr
• Stoma lengths (cm): 0.8, 1.0, 1.2, 1.5, 1.7, 2.0, 2.3, 2.5, 2.7, 3.0, 3.5, 4.0, 4.5, 5.0
• Length ranges: 12 Fr = 0.8–4.0 cm; 14–20 Fr = 0.8–5.0 cm; 24 Fr = 1.5–5.0 cm
• Balloon fill (use sterile/distilled water only): 12 Fr = 3 mL (max 5 mL); 14–24 Fr = 5 mL (max 10 mL)

Kit contents (ENFit configuration)

• MIC-KEY low-profile gastrostomy feeding tube (button)
• Two 12-inch MIC-KEY ENFit extension sets: Continuous Right-Angle Y and Straight/Bolus (each with clamp and caps)
• 35 mL ENFit enteral syringe
• 6 mL Luer Slip syringe for balloon inflation/deflation
• Four gauze pads
• Insertion stylet and water-soluble lubricant (US only)

Materials, sterility, and use

• Tube: silicone, polyether imide, polycarbonate, barium sulfate, stainless steel spring
• Extension sets: PVC with citrate softener and ABS; clamp is polypropylene
• Tube is sterile (ethylene oxide); single-use; Rx only
• Extension sets: supplied for single-patient reuse with routine cleaning; replace periodically per IFU

Indications and contraindications

• Indications: patients requiring long-term gastric access for feeding, medication delivery, and/or decompression who cannot tolerate oral intake
• Contraindications include ascites, colonic interposition, portal hypertension, peritonitis, and morbid obesity

Regulatory and storage

• Manufactured in Mexico under an ISO 13485–compliant quality system; CE marked (Class IIb; Notified Body BSI 2797)
• Sterilized with ethylene oxide; shelf life 2 years from date of manufacture
• Store in a cool, dry place away from heat and radiation

Notes

• ENFit is the ISO 80369-3 enteral connector standard intended to reduce wrong-route connections
• Details for MIC-KEY gastric-jejunal (GJ) devices do not apply to this G-tube configuration