(76 days)
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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2375
EP - A 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 | KNT78KOC | 876.5980 | |
| > DEVICE PANEL/BRANCH: Gastroenterology-Urology (GU)Gastro-Renal (GRDB) | |||
| > OWNER/OPERATOR: | Boston Scientific CorporationOne Boston Scientific PlaceNatick, 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.
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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.
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Figure 9-1: Similarities and Differences between Balloon Gastrostomy Tube Kit, MRI ALL SILICONE GASTROSTOMY TUBE, AND CORPAK MEDSYSTEMS CORFLOTM-DUAL GT Gastrostomy Tubes
| MicrovasiveBalloon GastrostomyTube Kit | MRI All SiliconeGastrostomy Tube | Corpak MedsystemsCorfloTM-Dual GTGastrostomy Tubes | |
|---|---|---|---|
| (This 510(k)) | (K951489) | (K901501) | |
| USE | |||
| Indication | Feeding, medication,gastricdecompression | Feeding,medication, gastricdecompression | Feeding andmedication |
| 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 |
§ 876.5980 Gastrointestinal tube and accessories.
(a)
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).(b)
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.