MICROVASIVE BALLOON GASTROSTOMY TUBE KIT

K962375 · Boston Scientific Corp · KNT · Sep 4, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962375
• Device Name: MICROVASIVE BALLOON GASTROSTOMY TUBE KIT
• Applicant: Boston Scientific Corp
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Sep 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Balloon Gastrostomy Tube Kit facilitates enteral feeding, medication delivery, and gastric decompression. Device consists of a silicone gastrostomy tube and associated kit components (guidewire, syringe, gauze, lubricant, etc.). Used in clinical settings for percutaneous placement via established tract or Stamm procedure. Operates as a mechanical conduit for gastric access. Benefits include reliable enteral nutrition and decompression for patients unable to ingest food orally. No electronic or software components.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Material: Silicone. Dimensions: 10-28 Fr diameter, 7-18 inch length. Sterilization: Ethylene oxide gas per AAMI protocol. Non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring percutaneous gastrostomy tube placement for feeding, medication administration, or gastric decompression. Contraindicated in patients with granulation tissue, infection, or stoma irritation at the site. Must not be used in the vasculature.

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

• MRI All Silicone Gastrostomy Tube (K951489)
• Corpak Medsystems CorfloTM-Dual GT Gastrostomy Tubes (K901501)

Submission Summary (Full Text)

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K96 2375

SEP - 4 1996

SECTION 9

510(K) SUMMARY

# FOI RELEASABLE

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification “...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person.” Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.

- COMMON/USUAL NAMES: Tube, Gastro-Enterostomy
- TRADE/PROPRIETARY NAME: Microvasive Balloon Gastrostomy Tube Kit
- CLASSIFICATION NAME & DEVICE CLASSIFICATION: Class II

| Name | Number | 21 CFR Ref. |
| --- | --- | --- |
| Tube, Gastro-Enterostomy | 78KGC | 876.5980 |

- DEVICE PANEL/BRANCH: Gastroenterology-Urology (GU)<br/>Gastro-Renal (GRDB)
- OWNER/OPERATOR: Boston Scientific Corporation<br/>One Boston Scientific Place<br/>Natick, MA 01760
- CONTACT PERSON: Lisa M. Quaglia, Regulatory Affairs Specialist

# INDICATIONS FOR USE

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

# CONTRAINDICATIONS

Contraindications for this device are those specific to patients where evidence of granulation tissue, infection or stoma irritation are present. The product must NEVER be used in the vasculature.

Premarket Notification, Balloon Gastrostomy Tube Kit, June 19, 1996

Proprietary and Confidential Information of Boston Scientific Corporation

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K962375

## POTENTIAL COMPLICATIONS

Complications may include, but are not limited to minor wound infections at stoma site; leakage of gastric contents; gastrocolic fistula; and sepsis.

## DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

Boston Scientific Corporation believes that the Balloon Gastrostomy Tube Kit is substantially equivalent to the currently-marketed MRI All Silicone Gastrostomy Tube and Corpak Medsystems CorfloTM-Dual GT Gastrostomy Tubes. Figure 9-1 compares the descriptive characteristics of these products.

## PERFORMANCE CHARACTERISTICS

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.

## PACKAGING, STERILIZATION, AND PYROGENICITY

The Balloon Gastrostomy Tube Kit will be packaged in a tray and sealed with a Tyvek lid. The Balloon Gastrostomy Tube Kit will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization. Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels.

## CONCLUSION

Boston Scientific Corporation believes that the Balloon Gastrostomy Tube Kit is substantially equivalent to the currently-marketed devices. Figure 9-1 compares the descriptive characteristics of these products. As demonstrated in Figure 9-1, the Balloon Gastrostomy Tube Kit is equivalent in its indications for use, design, and materials.

Premarket Notification, Balloon Gastrostomy Tube Kit, June 19, 1996
Proprietary and Confidential Information of Boston Scientific Corporation

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K 962375

FIGURE 9-1: SIMILARITIES AND DIFFERENCES BETWEEN BALLOON GASTROSTOMY TUBE KIT, MRI ALL SILICONE GASTROSTOMY TUBE, AND CORPAK MEDSYSTEMS CORFLOTM-DUAL GT GASTROSTOMY TUBES

| | Microvasive Balloon Gastrostomy Tube Kit (This 510(k)) | MRI All Silicone Gastrostomy Tube (K951489) | Corpak Medsystems CorfloTM-Dual GT Gastrostomy Tubes (K901501) |
| --- | --- | --- | --- |
| USE | | | |
| Indication | Feeding, medication, gastric decompression | Feeding, medication, gastric decompression | Feeding and medication |
| Route of Administration | Percutaneous | Percutaneous | Percutaneous |
| GASTROSTOMY TUBE | | | |
| Material | Silicone | Silicone | Silicone |
| Length | 7-18" | 7.5" | 9" |
| Diameter | 10 - 28 Fr. | 12 - 28 Fr. | 12 - 24 Fr. |
| KIT COMPONENTS | | | |
| Gastrostomy Tube | Yes | Yes | Yes |
| Pre-Filled Syringe | Yes | No | Yes |
| Guidewire | Yes | No | No |
| Gauze | Yes | No | Yes |
| Drainage Sponge | Yes | No | No |
| Swabsticks | Yes | No | No |
| Lubricating Jelly | Yes | No | Yes |
| Antibiotic Ointment | Yes | No | Yes |
| Enteral Y Extension | No | No | Yes |

Premarket Notification, Balloon Gastrostomy Tube Kit, June 19, 1996

Proprietary and Confidential Information of Boston Scientific Corporation