(57 days)
The NutriGlide™ Nasal Feeding Tube is indicated for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
The Nutriglide™ Nasal Feeding Tube is a nasal feeding tube available in both sterile and non-sterile ENFit® and legacy configurations featuring a y-port, widening lumen diameter, dissolvable tube tip, and optional stylet with water activated lubricous coating. The device is identical between the ENFit® and legacy configurations but for the y-port which will feature either ENFit® adapters or the legacy ports. Both configurations feature tubing with a unique taper design where the lumen gradually increases from the proximal end (external) to the distal opening (indwelling). This design creates a tube that is smaller near the external y-port and gradually increases to its largest diameter at the distal tip opening where the nutrition/medication exists into the patient's stomach or small intestine. The lubricious dissolvable tip offers increased comfort during placement on the various configurations of both the ENFit® and legacy devices, and then once dissolved it reveals the entire rounded distal opening of the tube, allowing for maximum flow during feeding.
The provided text is a 510(k) Premarket Notification for the Nutriglide™ Nasal Feeding Tube. It describes the device's characteristics, intended use, and comparison to predicate devices, along with performance data. However, this document does NOT contain information about a study proving the device meets acceptance criteria related to an AI/ML algorithm or a multi-reader, multi-case study.
The performance data section (Section VII) focuses on biocompatibility, sterilization, shelf life, and bench testing for the physical device itself. It explicitly states:
- C. Animal Study: Animal testing was NOT performed.
- D. Clinical Study: Clinical testing was NOT performed.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets these criteria in the context of an AI/ML algorithm, as no such study is described in this document.
The document covers the following for the physical medical device:
1. A table of acceptance criteria and the reported device performance:
The document references that the device met "all the acceptance criteria" for various bench tests. However, it does not provide a specific table detailing these acceptance criteria alongside the quantitative reported performance for each. It mentions conformance to recognized standards and "reliable design and performance under the specified testing parameters according to predetermined criteria."
- Bench Testing Acceptance Criteria (General Statement): The subject device met all the acceptance criteria and does not raise new questions of safety or effectiveness when compared to the predicates.
- Bench Testing Categories Performed (without specific numeric criteria or results):
- Testing per ASTM F2528 (Enteral Feeding Devices with a Retention Balloon)
- Testing per EN 1618:1997 (Catheters other than intravascular catheters - Test methods for common properties)
- Testing per EN1615:2000 (Enteral Feeding catheters and Enteral Giving Sets for Single Use and their Connectors - Design and Testing)
- Testing per ISO 80369-3 (Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications)
- Bench testing according to AMT specifications for:
- Kink Distance
- Clog Formation
- Clog Removal
- Tip Dissolution
- Lubricious Coating
- Component Attachment strength
- Component integrity testing
Regarding the other requested information (which would typically be relevant for an AI/ML device approval but are not present here):
- 2. Sample sized used for the test set and the data provenance: Not applicable, no AI/ML test set described.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no AI/ML ground truth establishment described.
- 4. Adjudication method for the test set: Not applicable.
- 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, no MRMC study described.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no AI/ML algorithm described.
- 7. The type of ground truth used: Not applicable.
- 8. The sample size for the training set: Not applicable, no training set described.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.