(306 days)
The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube device is inserted into the stomach through the nasal cavity for the purpose of supplying a nutritional source for those patients who are unable to feed themselves.
The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube is an enteral feeding tube designed for continuous or intermittent use. It comprises of radio-opaque polyurethane tube with guide wire set and ENFit connector.
The guide wire set is composed of a rigid guide wire and a male threaded connector, which is inserted into the polyurethane tube. They're depth marks printed on the tube in order to provide reference about the depth of insertion to the practitioner.
The tube is to be inserted through the nasal or oral area and feed down into the alimentary canal system (i.e. stomach area, duodenum or small intestine as intended). The guide wire with male connector is removed when the insertion is done leaving the tube and ENFit connector in situ. Only a female ENFit enteral syringe can be attached to the ENFit connector when in use.
This document describes the regulatory submission for the NUTRICARE – ISOSAF™ Naso-Gastric Feeding Tube, seeking substantial equivalence to a predicate device, rather than an AI-powered diagnostic device. Therefore, the questions related to AI-specific performance criteria (accuracy metrics, ground truth establishment, training/test sets, human reader studies, etc.) are not applicable to this submission.
The document focuses on demonstrating substantial equivalence based on:
- Intended Use: Both the new device and the predicate device are for supplying nutritional sources through a naso-gastric route.
- Technological Characteristics: Comparison of materials, design, sterilization, dimensions, and other physical properties.
- Non-Clinical Performance Data: Biocompatibility testing (in accordance with ISO 10993), mechanical testing (e.g., tensile strength, leakage, resistance to separation), and flow rate testing.
There is no mention of an AI algorithm, image analysis, or diagnostic performance evaluation with acceptance criteria related to sensitivity, specificity, or AUC.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI-powered diagnostics or answer the specific questions about sample sizes for test/training sets, expert consensus, adjudication methods, or MRMC studies, as these types of studies were not conducted or required for this device's 510(k) submission.
Summary of what can be extracted from the document regarding "acceptance criteria" (non-AI related):
The acceptance criteria for this device are demonstrated by its successful performance in a series of non-clinical tests, aligning with relevant industry standards and showing comparable performance to the predicate device. These tests are physical and material property tests, not performance metrics for an AI algorithm.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (Implied: Pass) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993) | Pass | Passed |
| Sensitization (ISO 10993) | Pass | Passed | |
| Intracutaneous Reactivity (ISO 10993) | Pass | Passed | |
| Mechanical Performance | Falling drop positive pressure liquid leakage (per AAMI/CN3:2014(PS)) | Pass | Pass |
| Stress Cracking | Pass | Pass | |
| Resistance to separation from axial load | Pass | Pass | |
| Resistance to separation from unscrewing | Pass | Pass | |
| Resistance to overriding | Pass | Pass | |
| Disconnection from unscrewing | Pass | Pass | |
| Tensile testing of the catheter | Pass | Pass | |
| Tensile testing of the connectors | Pass | Pass | |
| Corrosion testing of guide wire | Pass | Pass | |
| Liquid leakage | Pass | Pass | |
| Flow Rate Testing (EN 1618:1997) | As per standard | Passed | |
| Mechanical Testing of connector (AAMI/CN3:2014(PS)) | As per standard | Passed | |
| Dimensional analysis (AAMI/CN3:2014(PS)) | As per standard | Passed | |
| Risk Management | Risk Analysis (EN ISO 14971:2012), including misconnection risk | Identified & Mitigated | Conducted and reviewed |
| General Compliance | Compliance with applicable voluntary standards for biocompatibility & sterilization | Yes | Complies / Passed all testing |
2. Sample sized used for the test set and the data provenance: Not applicable. This is a medical tubing device, not an AI diagnostic with a "test set" of images/data for AI performance evaluation. The "tests" are laboratory-based physical and material tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI performance (e.g., confirmed disease status) is not relevant here. Decisions are based on objective physical/chemical test results against ISO/EN standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. See above.
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. This is a medical device (feeding tube), not a diagnostic AI system requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for this device's acceptance is based on compliance with established international and national standards (ISO, EN, AAMI) for material properties and mechanical performance. This is not a diagnostic device where "ground truth" relates to clinical outcomes or expert labels.
8. The sample size for the training set: Not applicable. There is no AI training set.
9. How the ground truth for the training set was established: Not applicable. There is no AI training set.
§ 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.