FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided text is an FDA 510(k) clearance letter for the FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER. This document is a regulatory approval notice and does not contain information about acceptance criteria or a study proving device performance as typically expected for imaging or AI devices. The information provided is:

Device Name: FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
Regulation Number: 21 CFR 880.5200 (Intravascular Catheter)
Regulatory Class: II
Product Code: FOS
Intended Use: For use in neonatal patients to sample blood, monitor blood pressure, or administer fluids intravenously.

Since this is a clearance letter for a physical medical catheter, the type of performance study details requested (e.g., number of experts, AI effect size, ground truth for training set) are not applicable in this context. These questions are typically relevant for AI/ML-based diagnostic devices or devices that involve expert interpretation of data.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study as described in your request using only the provided text, because this information is not present in the document. The FDA clearance letter confirms the device's substantial equivalence to a predicate device, which is a regulatory standard, not a detailed clinical performance study with specific metrics like sensitivity/specificity or expert adjudication.

Summary

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).