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The GuardianPICC™ is a sterile, disposable, single lumen catheter intended for I.V. administration. The catheter may be used for delivery of TPN nutritional solutions, antibiotics, pain medications, chemotherapy and hurritional concernis inserted peripherally and provides a mechanism for the administration of IV medications to the large central veins of the body.

The GuardianPICC™ is a sterile, disposable, single lumen catheter intended for I.V. administration.

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called GuardianPICC™ Percutaneous Central Venous Catheter. This type of document does not contain information about acceptance criteria, study details, or performance metrics of the device.

The 510(k) pathway is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than on proving new safety and effectiveness through extensive clinical trials with detailed performance metrics like those requested in your prompt.

Therefore, I cannot provide the requested information based on the given text. The document is a clearance letter, not a study report.

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The GuardingCatheter - Infant Feeding Tube is a sterile, disposable silicone catheter intended to deliver nutritional media. The catheter is inserted into the stomach or intestine-small bowel through the nares or mouth for delivery of liquid nutritional diets to patients with a functional GI tract.

The GuardingCatheter - Infant Feeding Tube is a sterile, disposable silicone catheter intended to deliver nutritional media.

I am sorry, but the provided text from the FDA 510(k) K042112 document is a clearance letter for the "Marian Infant Feeding Tube (GuardianCatheter™-Infant Feeding Tube)." This letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory information.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies related to any AI/algorithm-based device.

The request asks for specific details about studies proving a device meets acceptance criteria, which is not present in this regulatory clearance letter for a physical medical device. Therefore, I cannot fulfill your request based on the provided input.

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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 less than 30 day placement. Not intended for transpyloric placement.

The Infant Feeding Tube is a small diameter tube of various sizes - 5,6, and 8 French, and lengths of 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.

The provided document is a 510(k) premarket notification for a medical device called "Infant Feeding Tube." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling specific acceptance criteria through a clinical study. Therefore, the information requested in the prompt, which is typically found in clinical study reports for devices proving new claims or safety/effectiveness, is largely not applicable or present in this document.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance

The document does not specify formal "acceptance criteria" in terms of performance metrics with thresholds (e.g., sensitivity, specificity, accuracy percentages) that would be met by a study. Instead, the "device performance" is demonstrated through a comparison of key attributes to predicate devices, showing that the proposed device shares the same intended use, design features, materials, and sterile packaging.

Ask a specific question about this device

Ask a specific question about this device