(84 days)
The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit is intended for use as a surgically place gastrostomy tube intended to deliver enteral feeding formulas directly into the small bowel (jejunum). The COMPAT® Surgical 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. This method is used to enhance the absorption of nutrients and minimize the risks of gastric feeding including gastric reflux and aspiration.
The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube also provides for the evacuation of gastric contents through the gastrostomy tube while simultaneously feeding directly into the small bowel with the jejunal feeding tube. This device is for use under medical supervision only.
The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit provides for the delivery of enteral formula through a surgically placed Gastrostomy/Jejunostomy feeding tube. Jejunal feeding is 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.
The Novartis Nutrition COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube is packaged in a sterile kit. It is designed for easy intra-operative placement and facilitates immediate postoperative feeding into the jejunum. The two-tube system allows for easy placement and replacement in the event of a jejunal tube clog. The large gastrostomy tube provides access to the stomach for decompression and drainage. The system's jejunal feeding tube is easy to place intra-operatively through the gastrostomy tube into the small bowel using the innovative balloon tipped stylet provided in the kit.
The major components of the kit include:
- . 28 FR Silicone Gastrostomy Tube
- 12 FR Polyurethane Jejunal Feeding Tube with Double Lumen FEED/DRAIN . adapter and radiopaque, flow-through tip
- Preassembled disposable balloon tipped stylet
The COMPAT administration set contains or attaches to the formula reservoir/container and provides the conduit to deliver the feeding solution to the patient's feeding tube via a feeding pump. The patient's feeding tube may be a variety of tubes including, but not limited to, a nasogastic tube, a gastrostomy tube, or a jejunostomy tube. The administration set attaches to the patient's feeding tube to provide the formula or feeding solution required.
The provided document describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data to prove novel performance criteria. Therefore, the typical structure of an acceptance criteria table and a study proving those criteria is not directly applicable in this context.
Instead, the document asserts substantial equivalence based on technological characteristics and the absence of additional non-clinical or clinical testing for this specific use.
Here's an analysis of the provided information in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission primarily based on substantial equivalence, there isn't a table of new acceptance criteria that the device had to meet through a specific study. The "acceptance criteria" here are implicitly that the modified device performs similarly to the predicate device and does not raise new questions of safety or effectiveness.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Delivery of enteral feeding formula directly into the small bowel, minimization of gastric reflux and aspiration, and evacuation of gastric contents. | Met: "The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit provides the same ability as the comparative substantially equivalent device for delivery of formula and medications to the small intestine... while allowing simultaneous gastric drainage." The Statement of Intended Use and Indications for Use are identical to the predicate device. |
| Placement Techniques & Confirmation: Surgical placement, manipulation into jejunum, and confirmation via X-ray/fluoroscopy. | Met: "Initial placement... may be accomplished surgically, as with the predicate substantially equivalent device." "The jejunal feeding tube can be placed in a similar fashion to that of the substantially equivalent device." "Confirmation of placement... may be accomplished using x-ray or fluoroscopic techniques." |
| Materials of Construction: Gastrostomy and Jejunostomy tube materials. | Met: "The materials of construction of the Gastrostomy and Jejunostomy tubes are identical to that of the substantially equivalent device." |
| Radiopacity of Jejunal Tubing: Visibility under imaging. | Met/Equivalent: The only difference is the orientation of the radiopaque material (solid filled vs. stripe), but the content (20% barium sulfate) is unchanged. This change is not considered to alter performance. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. No clinical or non-clinical studies with a "test set" were conducted beyond the comparison of technological characteristics to the predicate device.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. No new ground truth was established as no new studies were conducted. The ground truth relies on the established safety and effectiveness of the predicate device.
4. Adjudication Method for the Test Set:
- Not applicable. No test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC comparative effectiveness study was not done. This device is a component for enteral feeding, not an AI-assisted diagnostic or therapeutic tool that would typically involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No. This is a medical device (feeding tube kit), not an algorithm or AI system.
7. The Type of Ground Truth Used:
- The implicit "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate device (Sandoz Nutrition COMPAT® Surgical Gastro/Jejunostomy Feeding Tube Kit, K965087). The documentation focuses on demonstrating that the modified device is substantially equivalent and does not introduce new questions of safety or effectiveness compared to this predicate.
8. The Sample Size for the Training Set:
- Not applicable. No "training set" was used as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
Summary of the Study Proving Device Meets Acceptance Criteria:
The "study" in this context is the 510(k) Premarket Notification process itself, which concluded that the modified Novartis Nutrition Corporation COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit (item number 088000) is substantially equivalent to its predicate device (Sandoz Nutrition COMPAT® Surgical Gastro/Jejunostomy Feeding Tube Kit, K965087).
The document explicitly states:
- "No additional non-clinical testing of this product for this use was conducted."
- "No additional clinical evaluations of this product for this use have been conducted."
The justification for substantial equivalence relies on comparing the technological characteristics of the modified device to the predicate device, specifically highlighting:
- Identical intended use and indications for use.
- Similar functionality (intestinal feeding, gastric drainage).
- Similar placement techniques and confirmation methods.
- Identical materials of construction for the tubes, with a minor, non-performance-altering change in the radiopaque material's orientation within the jejunal tubing.
The FDA's decision to clear the device (K071191) indicates their agreement with the manufacturer's assertion of substantial equivalence based on this comparison of technological characteristics and the absence of new safety or effectiveness concerns.
§ 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.