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The Balloon Gastrostomy Tube Kit is indicated for use in percutaneous placement of a gastrostomy tube for feeding and/or medication in conjunction with an established gastrostomy tract, or using a Stamm Procedure. The gastrostomy tube may also be used for gastric decompression

The Balloon Gastrostomy Tube Kit includes a gastrostomy tube, pre-filled syringe, guidewire, gauze, drainage sponge, swabsticks, lubricating jelly, and antibiotic ointment. The gastrostomy tube is made of silicone and is available in lengths from 7-18" and diameters from 10-28 Fr.

The provided document does not contain information about acceptance criteria or a study demonstrating that the device meets specific performance criteria. Instead, it is a 510(k) summary for a medical device, the Microvasive Balloon Gastrostomy Tube Kit, and primarily focuses on establishing "substantial equivalence" to predicate devices.

The document discusses:

• Indications for Use, Contraindications, and Potential Complications: These describe the intended use and potential risks of the device, but not measurable performance criteria.
• Descriptive and Technological Characteristics: A comparison is made between the proposed device and two predicate devices (MRI All Silicone Gastrostomy Tube and Corpak Medsystems CorfloTM-Dual GT Gastrostomy Tubes) in Figure 9-1. This comparison highlights similarities and differences in materials, dimensions, and kit components.
• Performance Characteristics (stated absence of change): The document explicitly states: "The components of the Balloon Gastrostomy Tube Kit have the same characteristics as those devices that are currently marketed. There is no change in the performance characteristics or intended use." This indicates that no new performance study was undertaken to establish specific acceptance criteria for this device, as its performance is asserted to be equivalent to existing, already marketed devices.
• Packaging, Sterilization, and Pyrogenicity: These are standard manufacturing and quality control aspects, with pyrogenicity testing performed periodically, but not as part of a performance study with defined acceptance criteria for the device's functional use.

Therefore, I cannot provide the requested table or details about a study proving the device meets acceptance criteria because such information is not present in the provided text. The submission relies on establishing substantial equivalence rather than presenting new performance data against specific acceptance metrics.

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