Search Results
Found 1 results
510(k) Data Aggregation
(89 days)
COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000)
The Sandoz Nutrition #0888000 Gastrostomy/Jejunostomy Feeding Tube is intended for use with patients who require delivery of enteral feeding formulas directly into the small bowl (jejunum). The Sandoz Nutrition #088000 Gastrostomy/Jejunostomy Feeding Tube is intended for use with patients who require enteral feeding. Indications for such medical and post-surgical treatments may include surgical problems, prolonged artificial ventilation, central nervous system trauma, and others. The placement of the device in patients is accomplished surgically using standard surgical techniques.
The Sandoz Nutrition #0888000 Gastrostomy/Jejunostomy Feeding Tube also provides for the evacuation of gastric contents through the gastrostomy tube while simultaneously feeding directly into the small bowl with the jejunal feeding tube.
The Sandoz Nutrition Surgical Gastrostomy/Jejunostomy Feeding Tube Kit provides for the delivery of enteral formula through a surgically placed Gastrostomy/Jejunostomy feeding tube. Jejunal feeding us used when patients require feeding past the stomach directly into the jejunum. This method is used to enhance the absorption of nutrients and minimize the risks of gastric feeding including gastric reflux and aspiration.
A Surgical Gastrostomy/Jejunostomy Feeding Tube Kit.
The Sandoz #088000 Surgical Gastrostomy and Jejunostomy Feeding Tube Kit provides the same ability as the comparative substantially equivalent (SE) device for delivery of formula and medications to the small intestine (through "FEED" port) while allowing simultaneous gastric drainage (through "DRAIN" port) via the gastrostomy tube.
Initial placement of the #088000 Kit tubes may be accomplished surgically, as with the predicate SE device through a laparotomy midline incision and Stamm (gastrostomy) technique. The jejunal feeding tube can be placed in a similar fashion to that of the SE device in that the tube is led through the lumen of the gastrostomy tube into the stomach, then grasped at its tip and manipulated through the gastric pylorus into the small intestine.
This manual manipulation into the bowel is assisted by the presence of the bolus tip on the jejunal tube and by a removable stylet. In the SE device, the stylet is a twisted wire stiffener; however, in the device of this submission, the stylet is made of a plastic material with an inflatable cuff/balloon at its distal end. The inflation of the cuff provides an additional (temporary) feature for grasping and directing the jejunal tube tip.
Both the SE and modified (submission) devices contain a Y-port at the connector end of the Jejunal Feeding tube which may be pressed into the lumen of the Gastrostomy tube to complete the placement and allow for gastric drainage through the gastrostomy tube. The Gastrostomy/Jejunostomy tube combination may be immobilized using the external retainer and the abdomen may be closed in the standard fashion.
The construction of the Gastrostomy and Jejunostomy tubes is almost identical to that of the SE device for the #088000 Kit. The only difference occurs in the Jejunal feeding tube where the Y-Connector has been modified to a 3 part assembly from what was previously an 8 part assembly. This revised Y-Connector assembly was included in a previous 510(k) notification, K961664. Also, the bolus tip is shortened.
The two stylets of the SE device and the submission device differ in that:
a) The SE device stylet is a twisted wire construction with an end button.
b) The submission device stylet is a semi-rigid plastic tube with and inflatable cuff/balloon at one end and an inflation port/valve at the opposite end.
This document is a 510(k) summary for a medical device named "Nutrition COMPAT Surgical Sandoz Gastrostomy/Jejunostomy Feeding Tube Kit". It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and performance metrics for a novel device.
Therefore, many of the requested categories for a study proving device performance are not directly applicable or explicitly stated in this type of regulatory submission. The document aims to show that the modified device is as safe and effective as the existing, legally marketed predicate device, not to prove performance against predetermined acceptance criteria for a new device.
However, I can extract the relevant information that is present and indicate where information is not provided.
Acceptance Criteria and Study for Sandoz Nutrition Gastrostomy/Jejunostomy Feeding Tube Kit (Modified #088000)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance (Claimed Substantial Equivalence) |
|---|---|
| Intended Use: For delivery of enteral feeding formulas directly into the small bowel (jejunum), for patients requiring enteral feeding due to medical/post-surgical treatments (surgical problems, prolonged artificial ventilation, central nervous system trauma, etc.). Also provides for evacuation of gastric contents through gastrostomy tube while simultaneously feeding directly into the small bowel. | The modified device maintains the same intended use: "The Sandoz Nutrition #0888000 Gastrostomy/Jejunostomy Feeding Tube is intended for use with patients who require delivery of enteral feeding formulas directly into the small bowl (jejunum). The Sandoz Nutrition #088000 Gastrostomy/Jejunostomy Feeding Tube is intended for use with patients who require enteral feeding... The Sandoz Nutrition #0888000 Gastrostomy/Jejunostomy Feeding Tube also provides for the evacuation of gastric contents through the gastrostomy tube while simultaneously feeding directly into the small bowl with the jejunal feeding tube." This is implicitly achieved by maintaining similar functional characteristics to the predicate. |
| Functional Equivalence - Feeding & Drainage: Ability to deliver formula and medications to small intestine (through "FEED" port) while allowing simultaneous gastric drainage (through "DRAIN" port) via the gastrostomy tube. | "The Sandoz #088000 Surgical Gastrostomy and Jejunostomy Feeding Tube Kit provides the same ability as the comparative substantially equivalent (SE) device for delivery of formula and medications to the small intestine (through “FEED” port) while allowing simultaneous gastric drainage (through “DRAIN” port) via the gastrostomy tube." |
| Placement Techniques & Confirmation Methods: Compatible with standard surgical techniques (laparotomy midline incision and Stamm (gastrostomy) technique), manual manipulation into bowel assisted by specific features, confirmation via x-ray or fluoroscopic techniques. | "Initial placement of the #088000 Kit tubes may be accomplished surgically, as with the predicate SE device through a laparotomy midline incision and Stamm (gastrostomy) technique. The jejunal feeding tube can be placed in a similar fashion to that of the SE device in that the tube is led through the lumen of the gastrostomy tube into the stomach, then grasped at its tip and manipulated through the gastric pylorus into the small intestine. Confirmation of placement of both tubes may be accomplished using x-ray or fluoroscopic techniques." The modifications (plastic stylet with inflatable cuff) are described as providing an "additional (temporary) feature for grasping and directing the jejunal tube tip," implying maintained or improved placement assistance. |
| Tube and Stylet Construction (Safety/Effectiveness): Strength of bonding joints on internal portions, and general construction of tubes and stylets must not negatively affect safety or effectiveness. (Specific material properties or bond strength metrics are not provided in this summary). | "The construction of the Gastrostomy and Jejunostomy tubes is almost identical to that of the SE device for the #088000 Kit. The only difference occurs in the Jejunal feeding tube where the Y-Connector has been modified... This revised Y-Connector assembly was included in a previous 510(k) notification, K961664. Also, the bolus tip is shortened... The applied standard for strength of bonding joints on portions of devices which will reside internally to a patient is the same as in the SE product. Sandoz Nutrition believes that the changes described in this submission do not negatively affect the safety or effectiveness of the product. The material and bonding method for the gastrostomy and the jejunal feeding tubes are identical to those used in the SE device." The stylet differences are described, with the new one being a "semi-rigid plastic tube with an inflatable cuff/balloon." This is presented as a functional change, not a deficiency. |
| Overall Safety and Effectiveness: The modified device must be as safe and effective as the legally marketed predicate device. | "Sandoz Nutrition believes that the changes described in this submission do not negatively affect the safety or effectiveness of the product." This is the ultimate conclusion, supported by the detailed comparison of technological characteristics. |
2. Sample Size Used for the Test Set and the Data Provenance
This document describes modifications to an existing device and argues for substantial equivalence to a predicate device. It is a regulatory submission (510(k) summary) and does not report on a clinical 'test set' with a specific sample size. The "data provenance" is typically the comparison of design specifications and functional descriptions to the predicate device. The information provided is retrospective analysis of device design and manufacturing versus the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is not a study involving expert assessment of a test set; it's a comparison of device characteristics for regulatory purposes.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not a study comparing human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the predicate device (Sandoz Nutrition #088000 Surgical Gastrostomy/Jejunostomy Feeding Tube Kit marketed under K853351/A). The document argues that the modified device possesses technological characteristics that are substantially equivalent to the predicate, thus inheriting its established safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This document is not about a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Ask a specific question about this device
Page 1 of 1