KANGAROO FEEDING TUBE PLACMENT STYLET

K960632 · Sherwood Medical Co. · KNT · May 9, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960632
• Device Name: KANGAROO FEEDING TUBE PLACMENT STYLET
• Applicant: Sherwood Medical Co.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: May 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Indications for Use

The function of the stylet is to provide the necessary stiffness to aid the clinician in the placement of a nasointestinal feeding tube. The stylet is inserted in the feeding tube prior to insertion of the feeding tube in the patient. Once it has been verified that the feeding tube is appropriately placed, the stylet is removed.

Device Story

Stainless steel wire stylet with distal stainless steel spring tip; proximal end attached to flow-through male polypropylene luer hub. Used by clinicians in clinical settings to stiffen nasointestinal feeding tubes during insertion. Stylet inserted into feeding tube prior to patient placement; removed after verification of tube position. Facilitates accurate tube placement; reduces risk of malposition.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Stainless steel wire; stainless steel spring tip; polypropylene luer hub. Manual insertion device. Sold sterile or non-sterile.

Indications for Use

Indicated for use by clinicians to provide stiffness for the placement of nasointestinal feeding tubes in patients requiring enteral nutrition.

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

• Biosearch Medical Products’ Feeding Tube Placement Stylet (K831840A)
• Pedi-Tube Stylet (K894857)

Reference Devices

• Pedi-Tube Pediatric Feeding Tube (K822875)
• Dobbhoff Feeding Tube w/Hydromer Lubricant (K831868)
• Entriflex Feeding Tube (K833621)
• Non-Weighted Polyurethane Enteral Feeding Tube (K914375)

Submission Summary (Full Text)

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K960632
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MAY - 9 1996

510(k) Summary of Safety & Efficacy: Kangaroo® Pedi-Tube Flow Through Stylet & Kangaroo® Flow-Through Stylet

Submitted by: Sherwood Medical Co., 1915 Olive St., St. Louis, MO 63103, [phone]
Contact: Dennis Pozzo, Regulatory Affairs Manager
Date Prepared: January 30, 1996

The Kangaroo® Pedi-Tube Flow Through Stylet & Kangaroo® Flow-Through Stylet are Class II devices per 21 CFR 876.5980.

The Kangaroo® Stylets are comprised of a stainless steel wire that terminates at its distal end welded to an atraumatic stainless steel spring. The proximal end of the stainless stylet wire is mechanically attached to a flow-through male polypropylene luer hub.

The function of the stylet is to provide the necessary stiffness to aid the clinician in the placement of a nasointestinal feeding tube. The stylet is inserted in the feeding tube prior to insertion of the feeding tube in the patient. Once it has been verified that the feeding tube is appropriately placed, the stylet is removed.

The stylets will be sold both sterile & non-sterile and individually & with the following nasointestinal feeding tubes:

- Pedi-Tube Pediatric Feeding Tube - K822875,
- Dobbhoff Feeding Tube w/Hydromer Lubricant- K831868,
- Entriflex Feeding Tube - K833621 &
- Non-Weighted Polyurethane Enteral Feeding Tube - K914375.

The Kangaroo® Stylets are substantially equivalent to Biosearch Medical Products’ Feeding Tube Placement Stylet cleared via the 510(k) process, #K831840A in that both share the same design, components and intended use.

The Kangaroo® Stylets are also substantially equivalent to the Pedi-Tube Stylet cleared via the 510(k) process, #K894857 in that both share the same basic design, components and intended use.

The major difference between the stylets is the currently marketed Pedi-Tube Stylet does not contain a flow-through hub or a stainless steel spring tip.

The materials that comprise the Sherwood Stylets will be the same as those that comprise Biosearch’s currently marketed Feeding Tube Placement Stylet.