(250 days)
For nasogastric/oralgastric enteral feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.
The Nutrisafe 2 silicone feeding tubes are utilizing a different formulation of silicone material I he Nutrisate 2 silicone feeding tubes. The feeding tubes. The feeding tubes are available in several than the catisting Nutrioure is a unique connection does not incorporate a luer, reducing SIZCS, and the leveling system connains an IV administration set or other medical delivery the fisk of madvertenity connection reduces the risk of involuntary disconnection; voluntary systems: "The is achieved by simply unscrewing the hub connections.
The Nutrisafe 2 Feeding Tube's acceptance criteria and the study proving its performance are detailed below. It's important to note that this device is a medical device, and the provided text from a 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing, rather than a clinical study with human subjects, AI systems, or extensive statistical performance metrics typically found for diagnostic or AI-driven medical devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain material specifications after formulation change | Meets all specifications |
| Maintain intended use after material formulation change | Meets intended use |
| Reduce risk of inadvertent connection to IV administration sets or other medical delivery systems due to unique connection system | Unique connection reduces the risk of inadvertent connection |
| Reduce risk of involuntary disconnection | Voluntary disconnection achieved by simply unscrewing hub connections |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "test set" sample size in terms of the number of feeding tubes or components used for the non-clinical bench testing. It broadly states that "Non-Clinical verification... was conducted through in-vitro bench testing."
- Data Provenance: The data is from in-vitro bench testing, meaning it was conducted in a laboratory setting. The country of origin for the data is not explicitly stated, but the submission is to the US FDA, implying the tests were conducted either by the applicant (Vygon Corp. in Montgomeryville, PA, USA) or a certified laboratory for the purpose of US market approval. The testing is retrospective in the sense that it evaluates the performance of the manufactured device in a controlled environment as part of the market submission process, rather than a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This section is not applicable as the provided information describes non-clinical bench testing of a physical medical device, not a diagnostic or AI-driven system requiring expert-established ground truth from images or clinical data. The "ground truth" here is determined by engineering specifications and physical measurements, and the conformity to these is assessed by technical personnel.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers on a diagnosis or interpretation, which is not relevant to the described non-clinical bench testing.
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 section is not applicable. The provided document is for a physical medical device (feeding tube) and does not involve AI assistance, human readers, or image interpretation. Therefore, an MRMC study or effect size calculation with AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical feeding tube, not an algorithm or software. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The ground truth used for this premarket notification is based on engineering specifications and intended use requirements. The non-clinical bench testing verified that the Nutrisafe 2 Feeding Tube, despite a change in silicone material formulation, continued to meet these established specifications and its intended use, which includes safety features related to connection types.
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of this device's non-clinical verification. Training sets are relevant for machine learning algorithms, which are not part of this submission. Device manufacturers conduct design and development activities where prototypes might be tested, but this is distinct from an "AI training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for this device.
§ 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.