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The COMPAT® Enteral Delivery Pump Sets are intended to deliver liquid nutrition formulas or hydration to an enteral access device (a feeding tube).

The COMPAT Pump administration sets are designed specifically for use with the COMPAT® Enteral Pumps. The SpikeRight piercing spike with 1000 mL water bag is compatible with all SpikeRight compatible enteral feeding systems. The twist and lock feature ensures safe and effective connection and prevents inadvertent connections to IV sets. The 1000 mL formula vinyl bag with 1000 mL water bag has 50 mL graduations to make it easier for reading and better accuracy when filling. The different-colored print on the bags make it easy to identify water and formula and the nutrition orders can be written directly on the formula bag for convenience. Single Use Only.

The COMPAT Pump administration sets are designed specifically for use with the COMPAT® Enteral Pumps. The SpikeRight piercing spike is compatible with all SpikeRight compatible enteral feeding systems. The COMPAT pump set with the in-line "Y" adapter is DEHP and latex free. Easy to use "Y" adapter - simply disconnect "Y" adapter cap and insert syringe for flushing. The in-line "Y" saves time - no need to disconnect set from the feeding tube when flushing medications, water or bolus feeding. Ready to use. Single use only.

The provided text is for a 510(k) premarket notification for a modified medical device. This type of document is about regulatory clearance for a device based on its substantial equivalence to a predicate device, not about a study proving the device meets clinical acceptance criteria in terms of diagnostic performance or efficacy for AI/imaging devices.

Therefore, the information requested (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set size and ground truth establishment) is not applicable to this document.

Manufacturers use bench testing and engineering verification to demonstrate that a modified device functions as intended and meets its design specifications, and that these specifications are equivalent to the predicate device. The statement "All test results verify that the device meets or exceeds all predetermined specifications" confirms this. However, the specific details of these technical specifications and their corresponding test results are generally proprietary and not included in the public 510(k) summary.

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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.

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.

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The Novartis Nutrition COMPAT Jejunostomy Tube is a surgically placed small bowel feeding access port intended for single patient use. The device delivers enteral solutions and medications directly into the small intestine. When direct access to the small bowel lumen is necessary, the tube may be placed, and positioned within the small bowel using an appropriate technique. It may be permanently fixed to the skin of the outer abdomen using the arternal retainer provided and suture, or another appropriate fixation technique.

The Jejunostomy Tube is a surgically placed small bowel feeding access port intended for single patient use.

The provided text describes a 510(k) submission for the Novartis Nutrition COMPAT® Jejunostomy Tube Kit. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove device performance against specific acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study that proves device performance against those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

Instead, the submission focuses on comparing the new device's technological characteristics to those of the predicate device (Medical Innovations Corp. MIC Jejunostomy Tube #300-014). The key differences highlighted are:

• Length: 50cm for the new device vs. 30cm for the predicate.
• Radiopacity: Solid radiopaque silicone for the new device vs. clear with stripe for the predicate.
• Exit Ports: Side and open-end for the new device vs. open-end only for the predicate.
• Fixation: No "wings" or suture cuff for the new device vs. 2 soft "wings" and a Dacron cuff for the predicate.

The FDA's letter (K991668) confirms that the device was found substantially equivalent for the stated indications for use based on this comparison, not on performance data from a clinical study as would be described by the requested table and study details.

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The Novartis Nutrition COMPAT Mini-G Feeding Tube Kit provides for the delivery of enteral formula through an externally minimized feeding tube. This replacement tube is used when there exists an established, well healed and mature stoma tract communicating between the stomach and external body surface. Externally minimized or low profile feeding devices are used to minimize the exposure of the tube outside of the patient's body and to provide an improved body image to the patient by concealing the feeding device under the clothing.

The Novartis Nutrition COMPAT MINI-G Replacement Gastrostomy Tube kit is a Class II medical device and is intended for use as an enteral feeding tube to deliver feeding formula and/or medications to the stomach, as well as providing the ability to decompress and drain the stomach.

This document is a 510(k) summary for a medical device and does not contain information about a study with acceptance criteria and device performance data.

The provided text outlines the device name, intended use, and a comparison of its technological characteristics to a legally marketed predicate device. The purpose of this 510(k) submission is to demonstrate substantial equivalence to an existing device, which is a regulatory pathway for certain medical devices in the US.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance: This type of data is typically found in performance studies or clinical trial reports, which are not present here.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth establishment is mentioned.
4. Adjudication method for the test set: No test set or adjudication process is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No such study is described.
6. If a standalone performance (algorithm only) study was done: No such study is described.
7. The type of ground truth used: No ground truth is described.
8. The sample size for the training set: No training set is described.
9. How the ground truth for the training set was established: No training set or ground truth establishment is mentioned.

The document primarily focuses on establishing "substantial equivalence" of the new device (Novartis Nutrition COMPAT MINI-G Replacement Gastrostomy Tube Kit) to a predicate device (Novartis Nutrition (Sandoz Nutrition)/Superior Healthcare Flow-Thru Replacement Balloon Gastrostomy Tube Kits) based on technological characteristics and intended use, rather than presenting a performance study with specific acceptance criteria and results.

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