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This device is intended to infuse therapeutic agents into the extra-cardiac vasculature.

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Here's an analysis of the provided text regarding the Uresil® VASCU-FLO® Infusion Catheter.

It's important to note that the provided documents are a 510(k) summary letter and an Indications for Use statement for a medical device. These types of documents do not typically contain detailed information about specific acceptance criteria, study designs, or performance metrics in the way a clinical study report or a pre-market approval (PMA) submission would.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving efficacy and safety through extensive clinical trials for new device types. Therefore, many of the requested details about acceptance criteria, study data, and ground truth establishment are not present in these documents.

Based on the provided text, here's what can be extracted and what cannot:

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

• Not explicitly available in the provided documents. The 510(k) letter states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce..." This indicates that the device met the criteria for substantial equivalence, which is the core "acceptance criteria" for a 510(k) submission. However, the specific performance metrics used to demonstrate this equivalence are not detailed.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not explicitly available in the provided documents. The letter mentions a "510(k) notification of intent to market," which refers to a submission with performance data, but does not provide details of any test set sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable/Not available. For a 510(k) submission, the "ground truth" is typically established by comparing the new device's performance to the predicate device's established performance, often through bench testing and sometimes limited clinical data. There is no mention of expert consensus for ground truth establishment in these documents as one might find in an AI/imaging device submission for diagnostics.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable/Not available. Adjudication methods are typically relevant for studies involving human interpretation (e.g., clinical trials or radiology reading studies). This information is not present in the provided 510(k) letter.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable/Not available. The Uresil® VASCU-FLO® Infusion Catheter is a physical infusion catheter, not an AI or imaging diagnostic device. Therefore, MRMC studies and AI assistance comparisons are not relevant to this device type.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable/Not available. As above, this device is a physical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Implicitly established by comparison to a predicate device. For a 510(k) submission, the "ground truth" for demonstrating substantial equivalence often relies on:
  • Bench testing data: Comparing physical properties, material compatibility, flow rates, and other engineering specifications to the predicate device.
  • Biocompatibility data: Showing the device materials are safe.
  • Sterilization validation: Ensuring the device can be sterilized.
  • Performance data: Showing the device performs as intended for its stated Indications for Use, often by demonstrating similar functional characteristics to the predicate.
• The documents do not specify the exact nature of this comparative data.

8. The sample size for the training set

• Not applicable/Not available. "Training set" is a concept primarily used in machine learning and AI development. This is a physical medical device, not an AI algorithm.

9. How the ground truth for the training set was established

• Not applicable/Not available. As above, this is not an AI algorithm.

Summary of available information from the provided documents:

• Device Name: Uresil® VASCU-FLO® Infusion Catheter
• Regulatory Class: II
• Product Code: DQY
• Indications For Use: "This device is intended to infuse therapeutic agents into the extra-cardiac vasculature."
• Regulatory Outcome: Substantial equivalence determined by the FDA to legally marketed predicate devices available prior to May 28, 1976. This determination allows the device to be marketed.
• Implicit Acceptance Criteria Met: The device demonstrated sufficient equivalence to a predicate device as required for a 510(k) clearance, covering aspects like safety, fundamental technology, and performance for its indications. Specific numeric criteria are not detailed in these overview documents.

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For percutaneous drainage of abscess, nephrostomy and other fluids.

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I am sorry, but the provided text from the FDA 510(k) K981344 approval letter and "ATTACHMENT D" does not contain information about the acceptance criteria or a study proving that the device meets such criteria.

The documents primarily focus on the regulatory approval process for the Uresil Percutaneous Drainage Catheters with Hydrophilic Coating, stating that the device is substantially equivalent to legally marketed predicate devices. They outline the general controls provisions of the Federal Food, Drug, and Cosmetic Act, regulatory responsibilities, and the indications for use.

There is no mention of specific performance metrics, clinical or non-clinical study design, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

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This device is intended to help create a tract for catheter insertion.

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This is a 510(k) summary and not a study. It does not provide the information requested to describe acceptance criteria and study proving device meets the criteria.

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This catheter/stent is intended for use when the physician selects a patient suitable for percutaneous drainage from the ureterpelvic junction to the bladder while maintaining external access.

Modified Uresil® Nephro-Ureteral Stent

This document is a 510(k) clearance letter from the FDA for a medical device called the "Uresil® Nephro-Ureteral Stent" (K980889). It declares the device substantially equivalent to pre-amendment devices or reclassified devices.

This type of document (510(k) clearance) does not include information about specific acceptance criteria or studies proving device performance in the way a clinical trial report or a performance study summary for an AI/ML powered device would.

The FDA 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on proving novel performance metrics or conducting extensive new clinical studies unless the device represents a significant technological change.

Therefore, I cannot provide the requested information from this document. The document primarily discusses regulatory classification and marketing authorization based on substantial equivalence.

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This device is intended for use in percutaneous nephrostomy, biliary und abscess drainage and other gastrointestinal and genitourinary procedures.

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The provided document is a 510(k) clearance letter from the FDA for a medical device: the Uresil® Guidewire. This type of document is generally a regulatory approval based on demonstrating "substantial equivalence" to a predicate device already on the market, rather than a de novo approval based on extensive clinical trials proving safety and effectiveness through well-defined acceptance criteria and study results.

Therefore, the information requested regarding acceptance criteria and study details (such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is typically not found or relevant in a 510(k) clearance letter dated 1997 for a guidewire.

The 510(k) process focuses on comparing a new device to an existing predicate device, primarily to show that it is as safe and effective and raises no new questions of safety or effectiveness. It does not generally require the detailed performance studies or statistical analysis with specific acceptance criteria that would be expected for novel devices or AI/software as a medical device (SaMD) where such information would be central to demonstrating efficacy and safety.

However, I can extract the following information that is present:

• Device Name: Uresil® Guidewire
• Intended Use Statement: "This device is intended for use in percutaneous nephrostomy, biliary und abscess drainage and other gastrointestinal and genitourinary procedures."
• Regulatory Class: Class II
• Product Codes: 78 FGE, 78 EZB
• Date of Clearance: November 21, 1997

Therefore, I cannot provide the requested table and study details as they are not part of a standard 510(k) clearance documentation for a guidewire from 1997. The document explicitly states that the device is determined to be "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This implies that its performance is expected to be similar to those existing devices, and detailed evidence of meeting specific numerical acceptance criteria (as for an AI algorithm) is not presented here.

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For percutaneous drainage of abscess, nephrostomy and other fluids.

Uresil General Purpose Drainage Catheters

This is a 510(k) premarket notification for a medical device (Uresil Percutaneous Drainage Catheters), which typically relies on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, the provided text does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, as one would expect for a novel AI/software device.

The document is an FDA clearance letter based on substantial equivalence to pre-amendment devices, indicating that the device is a well-established type of medical product.

To answer your specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document is a 510(k) clearance letter based on substantial equivalence, not a performance study against specific acceptance criteria for a new device.
2. Sample sized used for the test set and the data provenance: Not applicable. No test set or clinical study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment is described.
4. Adjudication method: Not applicable. No test set or ground truth establishment is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical catheter, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical catheter.
7. The type of ground truth used: Not applicable. No ground truth is described.
8. The sample size for the training set: Not applicable. This is a physical medical catheter, not an AI/software device requiring a training set.
9. How the ground truth for the training set was established: Not applicable. This is a physical medical catheter.

In summary, the provided document is a regulatory approval for a physical medical device (catheter) under the 510(k) pathway, which focuses on substantial equivalence. It does not involve the type of performance study and acceptance criteria evaluation typically associated with novel diagnostic devices, especially AI/software-based ones.

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