Search Results

For nasogastric oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube.

Nutrifit is a combined system of feeding tubes and extension sets. The feeding tubes are available in several configurations: Not made with DEHP PVC and Polyurethane (PUR). The PUR versions are available without stylet. All tubes include centimeter numerical markings from 5 to 35 cm for the 40, 50 and 75 cm feeding tubes and markings from 5 to 70 cm for the 90, 125 and 160 cm feeding tubes.

The Nutrifit devices are single-use, disposable devices intention in adults and children. Nutrifit PVC feeding tubes are intended for enteral nutrition and for a short-term use, not longer than 5 days. Nutrifit PUR feeding tubes are intended for enteral nutrition and for a short-term use, not longer than 29 days.

The Nutrifit accessories for this submission sets, which enable longer connections for the feeding tubes. They allow greater freedom of movement and greater flexibility and are available with or without a pinch clamp.

Nutrift is ENFit compliant, meeting requirements for design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories as detailed in ISO 80369-3.

The provided text is a 510(k) summary for the Vygon USA Nutrifit device, a gastrointestinal tube and accessories. It asserts the device's substantial equivalence to a predicate device (Nutrisafe 2) based on non-clinical performance bench testing.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set for any of the bench tests mentioned. It states "Adequate non-clinical performance bench testing was conducted" and "The VYGON's Nutrifit device met all predetermined acceptance criteria."
The data provenance is from non-clinical performance bench testing conducted by Vygon; the country of origin is not explicitly stated but implied to be internal testing by the manufacturer. The data is prospective for this device's evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The tests performed are engineering/performance-based bench tests, not clinical evaluations requiring expert interpretation of ground truth in the traditional sense (e.g., medical image interpretation). The "ground truth" for these tests would be the established specifications and standards (e.g., ISO 80369-3).

4. Adjudication Method for the Test Set

This is not applicable as the tests are objective, performance-based bench tests against defined specifications, not subjective assessments requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states "Bench Testing was conducted in order to support this submission." There is no mention of human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. The Nutrifit is a medical device (tubing and accessories), not an AI algorithm or software. The testing focuses on its physical performance and safety characteristics.

7. The Type of Ground Truth Used

The ground truth used for the performance testing cited is based on established engineering specifications, international standards (ISO 80369-3), and FDA guidance protocols (e.g., "Gravity Flow Rate Testing in Enteral Tube"). This falls under objective technical standards rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable as the Nutrifit device is a physical medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Ask a specific question about this device