DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE

K961345 · Applied Medical Technologies · KNT · Sep 17, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961345
• Device Name: DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE
• Applicant: Applied Medical Technologies
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Sep 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Domed Percutaneous Endoscopic Gastrostomy (P.E.G.) Feeding Tube is a percutaneously placed gastrostomy feeding device used to administer nutrition directly into the stomach.

Device Story

Percutaneous endoscopic gastrostomy (P.E.G.) feeding tube; used for direct gastric nutritional administration. Device features domed internal bolster; clear medical-grade silicone tubing with graduated markings for position verification. Internal bolster pigmented with barium sulfate for radiopacity; shape facilitates placement and allows passage of jejunostomy tube for jejunal feeding. Available in guidewire or pullwire configurations. Sold sterile for single-use; includes all necessary procedural supplies. Used by clinicians in clinical settings for patients requiring enteral nutrition.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: medical-grade silicone, barium sulfate (radiopaque). Form factor: domed internal bolster, graduated tubing. Energy source: none (mechanical). Sterilization: sterile, single-use.

Indications for Use

Indicated for patients requiring percutaneous gastrostomy feeding for nutritional administration directly into the stomach.

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

• U.S. Endoscopy P.E.G. Systems
• AMT P.R.G. Feeding Tubes

Submission Summary (Full Text)

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K 961345

SEP 17 1996

EXHIBIT IX

510(k) SUMMARY

Kathy Feltrin
Regulatory Affairs

April 5, 1996

Common Name: Percutaneous Endoscopic Gastrostomy (P.E.G.)
Feeding Tube

Classification name: Gastroenterology Tube (78 KGC)

Trade Name: None Established

The Domed Percutaneous Endoscopic Gastrostomy (P.E.G.) Feeding Tube is a percutaneously placed gastrostomy feeding device used to administer nutrition directly into the stomach. This device has been designed to be substantially equivalent to the U.S. Endoscopy P.E.G. Systems and the AMT P.R.G. Feeding Tubes.

The device is available in either the guidewire or pullwire method. The domed shaped internal bolster is injection molded onto clear medical grade silicone tubing. The tubing has graduated markings which allows for verification of tube positioning. The internal bolster is also composed of medical grade silicone but which has been pigmented with barium sulfate which provides radiopacity. The internal bolsters' shape allows for ease of passage during placement and is advantages because it permits passage of a jeujenostomy tube if jeujenal feeding is required.

The Domed P.E.G. Feeding Tube has been developed incorporating all of the safety and effectiveness features of the U.S. Endoscopy P.E.G. Systems and the AMT P.R.G. Feeding Tubes. The device is sold sterile for single use with all the supplies required to perform the procedure.

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