(162 days)
For nasogastric/oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube.
The Nutrisafe 2 is a complete system of feeding tubes and accessories. The feeding tubes are available in several configurations and in three materials: DEHP-free PVC, Polyurethane, and Silicone. One of the benefits of the Nutrisafe 2 is that the connection does not incorporate a luer, and thus eliminating the risk of inadvertently connecting the system to an IV system. The Nutrisafe 2 feeding tube features a locking connection which eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections.
The provided 510(k) summary for the Nutrisafe 2 describes a medical device, not a software algorithm or AI device. Therefore, many of the requested categories related to acceptance criteria, ground truth, and studies for AI/algorithm performance are not applicable.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Non-irritant and non-toxic | "Biocompatibility testing of the material demonstrates that it is non-irritant and non-toxic." |
| Performance: No adverse effect on safety/efficacy due to changes | "Performance testing demonstrates that the changes do not affect safety or efficacy." |
| Risk Assessment (ISO 14971 compliance) | "Risk Assessment was conducted in compliance with ISO 14971." |
| Elimination of risk of IV administration through feeding tube | The device's design "does not incorporate a luer, and thus eliminating the risk of inadvertently connecting the system to an IV system." This is a fundamental design characteristic and the basis for its intended use and a key benefit over predicate devices. |
| Elimination of risk of involuntary disconnection | The device features "a locking connection which eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections." This is a fundamental design characteristic. |
| No change in end-user technique; no special training required | "Another benefit of the Nutrisafe 2 is that it does not change the technique of the end-user, and therefore it does not require any special training." This is a claim made about user interaction with the device. |
| Meets manufacturers specifications | "Biocompatibility testing, performance testing and risk assessment demonstrate that the Nutrisafe 2 meets manufacturers specifications." While this is a general statement, it implies various internal specifications were met. This is a common umbrella acceptance criterion for medical devices. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as the device is a physical feeding tube system, not an algorithm or AI device that relies on a test set of data. The studies conducted were physical materials and performance tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable for a physical medical device. "Ground truth" in the context of AI refers to verified labels on data. For the Nutrisafe 2, evaluations would involve standard engineering and biological testing methods.
4. Adjudication Method for the Test Set
This information is not applicable for a physical medical device. Adjudication methods like 2+1 or 3+1 are used in studies involving expert review of data, typically for AI performance evaluation.
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
This information is not applicable as the device is a physical feeding tube system, not an AI-assisted diagnostic or therapeutic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This information is not applicable as the device is a physical feeding tube system, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the Nutrisafe 2 is derived from physical and biological testing standards and requirements, interpreted as meeting manufacturer specifications and safety/efficacy goals. This includes:
- Biocompatibility standards: Demonstrating non-irritant and non-toxic properties.
- Performance standards: Verifying the functional aspects like the locking connection and prevention of incorrect luer connections.
- Risk assessment standards: Compliance with ISO 14971.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical feeding tube system, not an AI algorithm that requires a training set. Material and design choices are based on engineering principles and existing medical knowledge, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above.
§ 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.