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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

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.

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The Sandoz Nutrition #082302 NFG Tube is intended for use with patients who require both enteral feeding and gastric suction simultaneously. The Sandoz Nutrition #082304 NF Tube is intended for use with patients who require only 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 can be accomplished intraoperatively at laparotomy using standard surgical techniques.

A Nasojejunal Feeding Tube with or without Gastric Drainage.

This document, K961664, is a 510(k) premarket notification for a medical device: a nasojejunal feeding tube. The purpose of a 510(k) submission is to demonstrate that the device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through extensive clinical trials as might be required for a PMA (Premarket Approval).

Therefore, the submission does not contain the typical "acceptance criteria" and a detailed "study" as you might expect for a new diagnostic or AI-powered device. Instead, it focuses on demonstrating equivalence to a predicate device.

Here's an analysis based on the provided text, addressing your points where applicable:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Logic)

Since this is a substantial equivalence submission, the "acceptance criteria" are implied to be at least equivalent performance regarding safety and effectiveness as the predicate device. The "reported device performance" is essentially the claim that the modified device performs similarly to the predicate.

Addressing Your Specific Points:

1. A table of acceptance criteria and the reported device performance
   See table above. The "acceptance criteria" are not explicitly stated in a quantitative manner as this is a medical device and not a diagnostic/AI product. The criteria are implicitly tied to the safety and performance of the predicate device.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
   Not applicable / Not provided. This submission does not describe a test set or clinical study in the traditional sense for evaluating performance. The argument for substantial equivalence relies on material equivalence, design similarity, and the existing safety record of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
   Not applicable / Not provided. No ground truth establishment is described as there is no specific performance test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
   Not applicable / Not provided. No test set or expert adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
   Not applicable. This is a physical medical device (feeding tube), not a diagnostic or AI product. Therefore, an MRMC study is not relevant or described.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
   Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   Not applicable. No specific "ground truth" or clinical outcomes data is presented to prove performance of this specific modification. The "ground truth" for the predicate device's safety and effectiveness is assumed to be established through its 5 years of marketing without complaints regarding materials.

8. The sample size for the training set
   Not applicable / Not provided. There is no training set mentioned, as this is not an AI or machine learning device.

9. How the ground truth for the training set was established
   Not applicable / Not provided. No training set is mentioned.

In summary: This 510(k) submission for a nasojejunal feeding tube demonstrates substantial equivalence to a predicate device by highlighting:

• Identical intended use (delivering enteral formula post-pylorically, and gastric drainage for one model).
• Identical materials for new and existing components.
• Identical lengths, diameters, and connectors to the predicate.
• The minor changes (grasping rings, bolus tip) are designed to "assist in surgical palpation on manipulation of the tube tip during placement" and don't negatively affect safety or effectiveness, especially since their materials and bonding are the same as the predicate device which has a 5-year complaint-free history regarding materials.
• Placement confirmation can still be achieved via radiography due to radiopaque features.

The "study" in this context is the comparison between the proposed device and the predicate device, emphasizing their similarities and arguing that the minor differences do not introduce new risks or alter fundamental performance, thus meeting the criteria for substantial equivalence. No clinical trials or performance studies are detailed in this summary.

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