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This product is intended for use in the neonatal and small pediatric patient. PICC Catheters are indicated when: Medications, TPN nutritional solutions, and Intravenous infusion of fluids are needed.

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I am sorry, but based on the provided document, there is no information about a study proving the device meets acceptance criteria, nor any details regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, or ground truth establishment.

The document is a letter from the FDA to Footprint Medical, Incorporated, confirming that the "Footprint Medical Polyurethane PICC Catheter" (K130507) has been found substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and general information about marketing the device. The "Indications for Use" section specifies the intended patient population (neonatal and small pediatric) and applications (medications, TPN, IV fluids).

Therefore, I cannot provide the requested table or details about a study and its methodology.

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This product is intended for use in neonatal patients to sample blood, monitor blood pressure, or administer fluids intravenously.

FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER

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.

Ask a specific question about this device

Ask a specific question about this device

This product is intended for use in the neonatal and small pediatric patient. PICC Catheters are indicated when: medications, TPN nutritional solutions, and intravenous infusion of fluids are needed.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a Peripherally Inserted Central Catheter (PICC). It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring the submission of new clinical studies with defined acceptance criteria for novel performance metrics unless specifically requested by the FDA or if the device introduces new technology or indications that raise new questions of safety and effectiveness.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided document.

Ask a specific question about this device