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510(k) Data Aggregation
(26 days)
The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to < 30 day placement. Not intended for transpyloric placement.
The Infant Feeding Tube is a small diameter tube of various diameters, 5, 6, and 8 French, and lengths, 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.
This document describes a 510(k) premarket notification for a medical device, the "Infant Feeding Tube." The submission seeks to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new clinical claim. Therefore, many of the requested categories related to clinical study design (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) are not applicable in this context.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission based on substantial equivalence, the "acceptance criteria" are typically the characteristics and performance of the predicate device. The "reported device performance" demonstrates that the new device meets or is equivalent to these characteristics.
| Attribute | Acceptance Criteria (Predicate ProMedic Infant Feeding Tube – K020005) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Indications for Use | ||
| To be placed into the stomach to permit the introduction of fluids as directed by the physician. Nasogastric or orogastric placement. | Yes | Yes |
| Intended for single patient use for a duration of < 30 days | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population infants | Yes | Yes |
| Intended Environment of Use - Hospital or environments where placement of a Feeding tube is required. | Yes | Yes |
| Design Features | ||
| Provided in various diameters | 5,6,8 Fr | 5,6,8 Fr |
| Standard slip fit female luer connector | Yes | Yes |
| Two (2) eyelet holes near tip | Yes | Yes |
| Radiopaque line entire length of tubing | Yes | Yes |
| Markings along the length of the tubing | Yes | Yes |
| Materials | ||
| Tubing and Connector – PVC with no DEHP | Yes | Yes |
| Packaging | ||
| Sterile | Yes | Yes |
| Performance | ||
| None under Section 514 (Implies performance is similar to predicate and no specific performance standards apply to this class of device) | Yes | Yes |
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission demonstrating substantial equivalence to a predicate device, not a performance study with a test set of patient data. The "test" here involves comparing the characteristics of the new device to those of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of clinical studies and AI, is not relevant for this type of substantial equivalence submission.
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. This device is an Infant Feeding Tube, a physical medical device, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
Not applicable.
8. The sample size for the training set
Not applicable. There is no AI algorithm being trained for this device.
9. How the ground truth for the training set was established
Not applicable.
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