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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.

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This device is intended to facilitate placing a catheter through the skin into a vein or artery.

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I am sorry, but the provided document is a 510(k) clearance letter for a medical device (Footprint Medical 1.9 Fr PICC Introducer). This type of document does not contain information related to acceptance criteria, device performance studies, or AI/software validation studies.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device already on the market. It typically involves comparing the device's technological characteristics and intended use to a legally marketed predicate device, and often includes bench testing to ensure the device meets basic safety and performance standards relevant to its design. It does not typically include clinical trials or detailed performance studies with ground truth establishment in the way that AI-powered devices would require.

Therefore, I cannot provide the requested information based on the text provided.

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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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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.

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THIS CATHETER IS FOR USE IN NEWBORN PEDIATRIC OR NEONATAL PATIENTS TO SAMPLE BLOOD, MONITOR BLOOD PRESSURE AND ADMINISTER I.V.FLUIDS THROUGH AN UMBILICAL VESSEL.

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I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a "Silicone Umbilical Catheter," confirming its substantial equivalence to a predicate device. It discusses regulatory compliance and indications for use but does not detail device performance, study methodologies, or ground truth establishment.

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THIS PRODUCT IS INTENDED FOR USE IN NEONATAL AND PEDIATRIC PATIENTS TO SAMPLE BLOOD, MONITOR BLOOD PRESSURE OR ADMINISTER FLUIDS INTRAVENOUSLY.

FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER, DUAL LUMEN.

This document is a 510(k) premarket notification approval letter from the FDA for a Silicone Umbilical Catheter, Dual Lumen. It does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.

The letter only states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act.

Therefore, I cannot provide the requested information based on the provided text.

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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.

Peripherally Inserted Central Catheter

This document is a 510(k) clearance letter from the FDA for a Peripherally Inserted Central Catheter. It is not an AI/ML device, and therefore the requested information about acceptance criteria and study details related to AI/ML performance is not present in the document.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than meeting specific performance criteria demonstrated by a clinical study in the context of AI/ML.

Therefore, I cannot provide the requested information.

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The Footprint Urinary Drainage Catheter is a flexible tube intended for drainage of urine from small pediatric or Neonatal patients. This is a prescription device intended for use for less than 30 days. It is not implanted and is not a life supporting device.

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This document is a 510(k) premarket notification from the FDA regarding a urinary drainage catheter. It does not contain information about the acceptance criteria or a study proving that the device meets acceptance criteria. The document is an approval letter for the device, stating it is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text.

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Ask a specific question about this device