Description

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button is a skin-level, balloon-retained device that provides enteral access to the stomach for long-term nutritional support, medication delivery, and gastric decompression in pediatric and adult patients. It is suitable for initial placement under clinical guidance or replacement in a mature stoma tract. The feeding port is accessed using MIC-KEY ENFit extension sets to open the integrated anti-reflux valve. Prescription use where applicable.

Intended Use and Indications

• For patients who cannot tolerate oral intake and require long-term enteral feeding.
• May be used for gastric decompression and/or medication administration into the stomach.
• Contraindications include, for example: ascites, colonic interposition, portal hypertension, peritonitis, and morbid obesity. Refer to the IFU for the complete list and clinical guidance.

Key Design Features

• Low-profile external base designed to sit at skin level.
• Internal silicone inflatable retention balloon.
• Feeding port with proximal anti-reflux valve (closed unless an extension set is attached).
• SECUR-LOK patient-end connectors on extension sets (right-angle for continuous feeds; straight for bolus) to help minimize leaks and unintended disconnects.
• ENFit connectivity on the feeding line/syringe side.
• Tapered distal tip; recessed when balloon is filled to recommended volume.
• Radiopaque stripe for x-ray visualization.
• Sterile tube; not made with natural rubber latex; not formulated with DEHP.

Materials and Composition

• Tube/body: medical-grade silicone with radiopaque barium sulfate stripe.
• Port/valve: components include polyetherimide (PEI), polycarbonate (PC), and stainless steel spring.
• ENFit extension sets: PVC with citrate plasticizer and ABS; polypropylene clamp; latex-free and DEHP-free.

Sizes and Balloon Volumes

• French sizes: 12, 14, 16, 18, 20, 24 Fr.
• Stoma lengths: 0.8–5.0 cm (24 Fr typically ~1.5–5.0 cm).
• Balloon fill (sterile/distilled water only): 12 Fr—3 mL recommended (max 5 mL); 14–24 Fr—5 mL recommended (max 10 mL). Do not use air, saline, or contrast.

Connectors and Compatibility

• Use only MIC-KEY extension sets to access the feeding port and open the anti-reflux valve.
• Extension sets: Continuous Feed (right-angle/Y with medication port) and Bolus (straight); typical lengths ~30 cm and ~60 cm; non-sterile; reusable for a single patient per IFU.

Kit Contents (ENFit)

• MIC-KEY Low-Profile G-tube (sterile), Continuous Feed ENFit Extension Set 12 in, Bolus ENFit Extension Set 12 in, 6 mL luer-slip syringe (balloon), 35 mL ENFit syringe, and gauze pads. Regional variations may include an insertion stylet and lubricant. Stoma measuring device not included.

Placement and Replacement

• May be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance, or exchanged through a mature tract. Measure stoma length to select shaft size; external base should rest ~1–2 mm above the skin. Follow IFU for connection, flushing, care, and balloon management.

MRI Safety

• MR Conditional at 1.5T and 3T; maximum spatial field gradient 19.06 mT/cm; whole-body SAR < 2 W/kg (Normal Operating Mode). Expected max temperature rise < 1.3 °C after 15 minutes; image artifact may extend < 45 mm at 3T (gradient echo). See IFU for full MR conditions.

Sterilization and Packaging

• Tube sterilized by ethylene oxide (ETO). Extension sets are non-sterile. Supplied in a single sterile hard tray within a carton.

Storage and Shelf Life

• Store in a cool, dry place away from heat and radiation; keep in dispenser box when possible. Shelf life: 2 years from date of manufacture (unopened, intact packaging).

Manufacturing and Regulatory

• Manufactured in Mexico at an ISO 13485-compliant site. CE marked under 93/42/EEC; Class IIb; Notified Body BSI (2797).

Important Cautions

• Single-use device (tube): do not reuse, reprocess, or resterilize. Verify package integrity before use. Inflate balloon with sterile/distilled water only. Use only MIC-KEY extension sets to access the feeding port. Refer to the IFU for complete warnings, precautions, and maintenance guidance.