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510(k) Data Aggregation
(252 days)
Nasogastric Feeding Tubes - ENFit Port - PVC
The Nasogastric Feeding Tubes – ENFit Port - PVC are intended for hydration, feeding and administration of oral medications for patients who require enteral feeding. This product is single use for no longer than 24 hours.
The Nasogastric Feeding Tubes – ENFit Port - PVC are sterile, single use devices. The feeding tubes consist of a graduated polyvinyl chloride tube, with radiopaque edge. The tubes have a closed tip and two lateral eyes for Fr sizes 5 to 10 and three lateral eyes for Fr sizes 12 to 16. The tubes have at the other end an ENFit male connector in ABS with its Polypropylene cap. A tether in thermoplastic polyurethane connects the ENFit connector to its cap. The ENFit connector allows the device to be connected to female enteral devices that have an ISO 80369-3 compliant connector. The feeding tubes are available in 50cm and 90cm lengths and in French sizes from 5 to 16.
The provided text describes the regulatory clearance of a medical device, the "Nasogastric Feeding Tubes - ENFit Port - PVC," through a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's de novo clinical efficacy through comparative studies. As such, the information you've requested regarding AI device performance metrics, expert adjudication, and training/test set specifics for an AI algorithm is largely not applicable to this document.
The document discusses non-clinical performance testing to demonstrate that the new device meets established standards and performs comparably to the predicate device.
Here's an analysis based on the provided text, where applicable:
1. A table of acceptance criteria and the reported device performance
The document refers to a "Substantial Equivalence Discussion" (Table 5-2) comparing the new device to a predicate. The "acceptance criteria" are effectively the performance characteristics and safety profiles of the predicate device, and the "reported device performance" is the new device's compliance with these or relevant standards.
| Acceptance Criteria (Based on Predicate Device & Standards) | Reported Device Performance (New Device) |
|---|---|
| Indications for Use: Enteral feeding to deliver nutrition, fluids, medications from ENFit compatible syringe/set. | Equivalent: Intended for enteral feeding to deliver nutrition, fluids, and medications from an ENFit compatible syringe or feeding set. Single use for no longer than 24 hours. |
| Intended Use: For pediatric patients requiring enteral feeding. (Predicate warning: not beyond 3-5 days) | Similar: Intended for hydration, feeding, and administration of oral medications for pediatric and adult patients requiring enteral feeding. Single use for no longer than 24 hours. |
| Environment of Use: Unspecified - Prescription Only | Equivalent: Hospital or medical home environment - Prescription Only |
| Intended Users: Trained professional clinicians or trained pediatric caregivers. | Equivalent: Physicians, nurses, and trained clinicians. |
| Patient Population: Pediatric patients | Similar: Pediatric and Adult patients. |
| Single Use: Yes | Yes |
| Sterility Condition: Sterile | Sterile |
| ENFit Connector: Yes; compliant with ISO 80369-3 | Yes; compliant with ISO 80369-3 |
| Radiopacity Verification: Yes | Yes; compliant with ISO 20695:2020 |
| Tube Markings: Yes | Yes; compliant with ISO 20695:2020 |
| French Sizes: 3.5, 5, 6.5, 8, 10 | Similar: 5, 6, 8, 10, 12, 14, 16 |
| Lengths: 41cm, 91cm, 107cm | Similar: 50cm, 90cm |
| Biocompatibility: Compliant with ISO 10993-1 | Compliant with ISO 10993-1. Specific tests: Cytotoxicity (ISO 10993-5:2009), Guinea Pig Maximization Sensitization (ISO 10993-10:2010), Irritation (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2017), Material-Mediated Pyrogenicity (ISO 10993-11:2017). |
| Liquid Leakage Testing: Completed (e.g. EN 1615:2000) | Tested and met updated standard ISO 20695:2020 |
| Tensile Testing: Completed (e.g. EN 1615:2000) | Tested and met updated standard ISO 20695:2020 |
| Flow Rate Testing: Completed per substantial equivalence | Tested per ISO 20695:2020 |
| Fluid Leakage (Connector): Tested per ISO 80369-20 and met 80369-3 standards. | Tested per ISO 80369-20 and met 80369-3 standards. |
| Stress Cracking (Connector): Tested per ISO 80369-20 and met 80369-3 standards. | Tested per ISO 80369-20 and met 80369-3 standards. |
| Resistance to separation from axial load (Connector): Tested per ISO 80369-20 and met 80369-3 standards. | Tested per ISO 80369-20 and met 80369-3 standards. |
| Resistance to separation from unscrewing (Connector): Tested per ISO 80369-20 and met 80369-3 standards. | Tested per ISO 80369-20 and met 80369-3 standards. |
| Resistance to overriding (Connector): Tested per ISO 80369-20 and met 80369-3 standards. | Tested per ISO 80369-20 and met 80369-3 standards. |
| Disconnection by unscrewing (Connector): Tested per ISO 80369-20 and met 80369-3 standards. | Tested per ISO 80369-20 and met 80369-3 standards. |
| ENFit Dimensional Verification: Evaluated per ISO 80369-3. | Evaluated per ISO 80369-3. |
| Risk Analysis: Not specified for predicate, but generally expected. | Performed: ISO 14971:2019 (DFMEA) |
| Usability Analysis: Not specified for predicate, but generally expected. | Performed: ISO 62366-1:2015 |
2. Sample size used for the test set and the data provenance
The document does not detail specific sample sizes for each non-clinical test. The tests were conducted according to various ISO standards (e.g., ISO 10993 series for biocompatibility, ISO 20695:2020 for enteral device performance, ISO 80369-20:2019 linked to ISO 80369-3:2016 for connector performance). These standards typically specify sample sizes or methods for determining them. No information on data provenance (country of origin, retrospective/prospective) is provided, as these are physical product tests, not data-driven AI evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical tube, not an AI device that produces diagnostic interpretations requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI diagnostic device. The "tests" here are physical and chemical evaluations against predefined criteria in international standards.
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 not an AI-powered device or an imaging device requiring human reader interpretation. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by the criteria defined in the referenced international standards (e.g., ISO 10993, ISO 20695, ISO 80369 series). For example, passing biocompatibility tests means the materials meet the safety requirements outlined in ISO 10993.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. No training set was used.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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