WILSON-COOK BALLOON INFLATION DEVICE

K960415 · Wilson-Cook Medical, Inc. · KNT · Apr 26, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960415
• Device Name: WILSON-COOK BALLOON INFLATION DEVICE
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Apr 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is a disposable device to be used to inflate, deflate and monitor pressure for gastrointestinal dilation balloons.

Device Story

Hand-held mechanical device; 20cc syringe; plunger mechanism; lever; extension line; stopcock; analog pressure gauge (300 psi/20atm). Used by clinicians during GI procedures to inflate/deflate dilation balloons; monitors pressure via analog gauge. Disposable; sterile or non-sterile. Benefits: provides controlled inflation/deflation and real-time pressure monitoring for GI dilation.

Clinical Evidence

Bench testing only. In-house functional testing demonstrated device integrity and adherence to specifications.

Technological Characteristics

Mechanical hand-held device; 20cc syringe; analog pressure gauge (300 psi/20atm); plunger/lever mechanism; extension line; stopcock. Sterilization: Validated EO cycle per AAMI Overkill Method (SAL 10⁻⁶).

Indications for Use

Indicated for inflation, deflation, and pressure monitoring of gastrointestinal dilation balloons in patients requiring GI dilation procedures.

Regulatory Classification

Identification

A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Special Controls

*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• Microvasive Digiflator (K860589)
• Wilson-Cook Balloon Inflation Device (K936168)

Submission Summary (Full Text)

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K960415
APR 26 1996

RE: PREMARKET NOTIFICATION FOR THE WILSON-COOK BALLOON INFLATION DEVICE

I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitted By:
Wilson-Cook Medical Inc.
4900 Bethania Station Road
Winston-Salem, NC 27105

Device Description:
The Wilson-Cook Balloon Inflation Device is a hand-held mechanical device consisting of a 20cc capacity syringe, a 300 psi/20atm pressure gauge, a plunger mechanism, lever, extension line, and stopcock. This device is to be used to inflate, deflate and monitor pressure for gastrointestinal dilation balloons.

Classification Name: Syringe, Balloon Inflation, 74 MAV
Classification: FDA has classified similar devices as Class II. This device falls within the purview of the Gastroenterology and Urology Devices Panel.
Trade/Proprietary Name: Wilson-Cook Dilation Balloon Inflation Device.
Common/Usual Name: Balloon Inflation Device
Performance Standards: To the best of our knowledge, performance standard for this device do not exist.
Sterility: Validated EO cycle following AAMI Overkill Method to SAL 10⁻⁶.
Intended Use: This device is a disposable device to be used to inflate, deflate and monitor pressure for gastrointestinal dilation balloons.
Predicate Devices: This device is similar with respect to technological characteristics and intended use to predicate balloon inflation devices, including the Microvasive Digiflator™ (K860589) and the Wilson-Cook Balloon Inflation Device (K936168).

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# RE: PREMARKET NOTIFICATION FOR THE WILSON-COOK BALLOON INFLATION DEVICE

## 1. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| CHARACTERISTIC | Wilson-Cook Balloon Inflation Device [Subject of 510(K)] | Microvasive Digiflator™ (K860589) | Wilson-Cook Quantum Inflation Device (K936168) |
| --- | --- | --- | --- |
| Intended Use | Used to inflate, deflate and monitor pressure of the Wilson-Cook line of balloon dilators for GI use. | Used to inflate, deflate and monitor pressure of balloon dilators for GI use. | Used to inflate, deflate and monitor pressure of the Wilson-Cook line of balloon dilators for GI use. |
| Construction | Plunger mechanism to control pressure. | Plunger mechanism to control pressure. | Plunger mechanism to control pressure. |
| | 20 cc syringe | 60 cc syringe | 60 cc syringe |
| | Hand held design. | Hand held design. | Hand held design. |
| | Extension line with stopcock for connection to balloon. | Extension line for connection to balloon. | Extension line for connection to balloon. |
| | Analog pressure gauge | Digital pressure gauge | Analog pressure gauge |
| Sterility | Sterile and non-sterile. | Available sterile and non-sterile. | Non-sterile. |
| | Disposable | Disposable | Disposable |

Testing: The Wilson-Cook Balloon Inflation device has been subjected to in-house functional testing to demonstrate device integrity. All samples tested were deemed acceptable in that testing specifications were met.