(76 days)
No
The summary describes a standard medical device kit for gastrostomy tube placement and does not mention any AI or ML components or functionalities.
No.
The device is used for feeding, medication, and gastric decompression, which are supportive functions rather than treating a disease or condition itself.
No
Explanation: The device is a Balloon Gastrostomy Tube Kit, used for placing a gastrostomy tube for feeding, medication, or gastric decompression. Its function is to provide access to the stomach for therapeutic purposes, not to diagnose a condition.
No
The device description clearly lists multiple hardware components (gastrostomy tube, syringe, guidewire, gauze, etc.) and does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside of the body (in vitro).
- Device Function: The Balloon Gastrostomy Tube Kit is a medical device used for direct intervention within the body. It's a tube inserted into the stomach for feeding, medication, or decompression. It does not perform any testing on specimens.
The description clearly indicates a device for therapeutic and supportive purposes within the patient's body, not for diagnostic testing of samples.
N/A
Intended Use / 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
Product codes
78KOC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrostomy tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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. Boston Scientific Corporation believes that the Balloon Gastrostomy Tube Kit is substantially equivalent to the currently-marketed devices. As demonstrated in Figure 9-1, the Balloon Gastrostomy Tube Kit is equivalent in its indications for use, design, and materials.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 | KNT | ||
| 78KOC | 876.5980 | ||
| > DEVICE PANEL/BRANCH: Gastroenterology-Urology (GU) | |||
| Gastro-Renal (GRDB) | |||
| > OWNER/OPERATOR: | Boston Scientific Corporation | ||
| One Boston Scientific Place | |||
| 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.
1
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.
2
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 | MRI All Silicone
Gastrostomy Tube | Corpak Medsystems
CorfloTM-Dual GT
Gastrostomy Tubes |
|-------------------------|--------------------------------------------------|--------------------------------------------------|------------------------------------------------------------|
| | (This 510(k)) | (K951489) | (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 |