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The GuardianCatheter-Infant Urinary Collection Kit is for urinary drainage and collection for use in the neonatal/pediatric patient population.

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The provided document is a 510(k) premarket notification letter from the FDA for the GuardianCatheter™-Infant Urinary Collection Kit. This type of document confirms that a device is substantially equivalent to a predicate device already on the market.

It is important to note that 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device, and often do not involve extensive new clinical studies with detailed acceptance criteria and performance metrics as might be seen for novel, high-risk devices or those requiring a PMA (Premarket Approval).

Based on the provided text, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications. The letter primarily confirms regulatory clearance and substantial equivalence.

Therefore, I cannot populate the table or answer the specific questions about performance metrics and study details from the text provided. The document outlines the device's indications for use and confirms its regulatory classification, but does not present the type of clinical study data you are asking for.

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The GuardianCatheter-Infant Urinary Drainage Catheter is a single lumen silicone urinary catheter intended to drain urine in the neonatal patient population. This catheter is NOT a Foley (balloon) type catheter.

The GuardianCatheter-Infant Urinary Drainage Catheter is a single lumen silicone urinary catheter.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a device called "GuardianCatheter"-Infant Urinary Drainage Catheter. It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

The letter mentions:

• Device Name: GuardianCatheter"-Infant Urinary Drainage Catheter
• Regulation Number: 21 CFR §876.5130
• Regulation Name: Urological catheter and accessories
• Regulatory Class: II
• Product Code: GBM
• Indications for Use: "The GuardianCatheter-Infant Urinary Drainage Catheter is a single lumen silicone urinary catheter intended to drain urine in the neonatal patient population. This catheter is NOT a Foley (balloon) type catheter."

However, it does not provide:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Information on MRMC comparative effectiveness studies or effect sizes.
6. Information on standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically found in the 510(k) submission summary or device-specific testing reports, not in the FDA's clearance letter itself.

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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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