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Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

The system consists of an introducer, a mini-guidewire, and a vessel dilator. The introducer consists of a cannula of co-extruded polyethylene with barium sulfate, a high density polyethylene body, and polyurethane sideport extension. The radiopaque tip is made of a blend of tungsten, polyethylene, and zinc stearate.
• 4 - 11 French
• 3 - 120 cm length
• .035" - .038' mini guidewire

This document is a 510(k) summary for the Cordis Brite Tip Catheter Sheath Introducer, not a study report. Therefore, it does not contain the detailed information about acceptance criteria, device performance, study design, or ground truth establishment that would typically be found in a clinical study report.

The document states that the Brite Tip CSI's are substantially equivalent to previously cleared Brite Tip CSI's. This implies that the device meets the same performance criteria as its predicate device, but it does not specify what those criteria are or how they were tested in this particular submission.

Here's an attempt to address your questions based on the limited information provided in this 510(k) summary, with many answers indicating that the information is not provided in this document:

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

   This document does not provide a table of acceptance criteria or reported device performance in the context of a clinical study. The "Summary of Safety and Effectiveness" section focuses on establishing substantial equivalence to a predicate device.

   Acceptance Criteria	Reported Device Performance
   Not provided	Not provided

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

   Not provided. This document describes a 510(k) submission based on substantial equivalence, not a clinical study involving a test set of data.

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. No test set requiring expert ground truth establishment is described in this 510(k) summary.

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

   Not applicable. No formal test set or adjudication method 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 is not an AI/imaging device, nor is an MRMC study described.

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

   Not applicable. This is not an algorithm-based device requiring standalone performance testing in that context.

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

   Not applicable. The concept of "ground truth" as it relates to clinical data analysis for performance metrics is not relevant to this 510(k) submission, which relies on the concept of substantial equivalence based on device characteristics and intended use.

8. The sample size for the training set

   Not applicable. This document does not describe the development of an algorithm or model that would require a training set.

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

   Not applicable. As there is no training set described, the method for establishing its ground truth is also not applicable.

In summary: The provided document is a 510(k) summary for a medical device (a catheter sheath introducer) seeking market clearance based on substantial equivalence to existing devices, not a study report detailing clinical performance or algorithm validation. Therefore, most of the requested information regarding acceptance criteria derived from clinical studies, test sets, ground truth, and reader studies is not present. The primary "acceptance criterion" for this submission is that the device is substantially equivalent to predicates concerning its design, materials, and intended use.

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Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

The system consists of an introducer, a mini-guidewire, and a vessel dilator. The introducer consists of a cannula of co-extruded polyethylene with barium sulfate, a high density polyethylene body, and polyurethane sideport extension. The radiopaque tip is made of a blend of tungsten, polyethylene, and zinc stearate.
• 4 - 9 French
• 3 - 120 cm length
• .035" - 038′ mini guidewire

This document is a 510(k) premarket notification for the Cordis Brite Tip Catheter Sheath Introducer and does not contain information about acceptance criteria or a study proving the device meets them.

The document primarily focuses on demonstrating "substantial equivalence" to a predicate device, which is a regulatory pathway used when a new device is as safe and effective as an already legally marketed device. This pathway typically relies on demonstrating similar technological characteristics and intended use, rather than presenting a full study with acceptance criteria and performance metrics.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

The line extensions for Brite Tip® Catheter Sheath Introducer System is indicated for use in arterial and venous procedures requiring percutaneous introduction of catheters and other intravascular devices. As with other currently marketed Cordis CSIs mentioned in this submission, these devices provide vascular access for various intravascular devices through the valve while simultaneously maintaining hemostasis. Infusion of fluids into the vasculature and withdrawal of blood from the vasculature are possible using the sheath sideport.

This appears to be a 510(k) premarket notification for a medical device (Cordis Brite Tip® Catheter Sheath Introducer System), and the provided text primarily focuses on regulatory information, intended use, and substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-based devices or studies requiring performance data.

The document states:

• "Performance standards have not been established by the FDA under section 514 of the Food, Drug and and Cosmetic Act." This indicates there are no pre-defined FDA performance standards this device needs to meet.
• The re-submission (K974448) is a "Modification" (K971608) and a "line extension." This suggests that the substantial equivalence is based on the previously cleared device, and the modifications are likely minor enough not to require new significant performance studies.
• "All materials used in the line extensions for Cordis Brite Tip® Catheter Sheath Introducer System had been successfully tested on previously concurred devices. Since all appropriate biocompatibility tests were previously performed on these materials, testing was not repeated." This further emphasizes reliance on previous testing.
• "The modified Cordis Brite Tip® Catheter Sheath Introducer System is similar in design, constructions, indication for use, and performance characteristics to other commercially available sheath introducers." This is the core argument for substantial equivalence, implying that its performance is implicitly accepted because it's similar to already cleared devices.

Therefore, many of the requested fields cannot be filled from the provided text as they relate to performance studies, which are not detailed here.

Here's the breakdown based on the provided text, indicating where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study proving the device meets acceptance criteria:

The provided document does not describe a specific study designed to prove the device meets acceptance criteria in the way one would for a novel AI/ML device or a device requiring new clinical performance data. Instead, the substantial equivalence relies on:

• Similarity to a predicate device: The modified device is stated to be similar in design, construction, indication for use, and performance characteristics to the already cleared predicate device (K971608).
• Prior testing of materials: Biocompatibility tests were previously performed on the materials used in the line extensions and successfully cleared, so no new biocompatibility testing was repeated for this submission.

Therefore, the following points address what can be inferred or what is explicitly not present in the provided text:

• 2. Sample size used for the test set and the data provenance: Not applicable/Not provided. No new test set is described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No new test set requiring expert-established ground truth is described.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided. No new test set requiring adjudication 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: No. This is not an AI/ML device, and no MRMC study is mentioned.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an AI/ML device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. No new ground truth establishment is described. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate device and its materials.
• 8. The sample size for the training set: Not applicable/Not provided. This is not an AI/ML device; no training set described.
• 9. How the ground truth for the training set was established: Not applicable/Not provided. This is not an AI/ML device; no training set described.

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The modified Brite Tip® Catheter Sheath Introducer is indicated for use in arterial and venous procedures requiring percutaneous introduction of catheters and other intravascular devices.
Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

These devices provide vascular access for various intravascular devices through the valve while simultaneously maintaining hemostasis. Infusion of fluids into the vasculature and withdrawal of blood from the vasculature are possible using the sheath sideport.

This 510(k) submission describes a device modification for the Cordis Brite Tip® Catheter Sheath Introducer, not a clinical study to establish new performance criteria. Therefore, the information requested regarding acceptance criteria, study design, and ground truth for a new device's performance is not directly available in this document.

Here's a breakdown of what can be extracted and why certain requested information is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. This document is a 510(k) for a modified device. The determination of "substantial equivalence" is based on similarity to a predicate device (Brite Tip® Catheter Sheath Introducer, K954595). The acceptance criteria are implicit in showing that the modifications do not alter the fundamental safety and effectiveness of the device compared to the predicate. There are no new performance metrics or acceptance criteria explicitly defined for the modified device in this document, nor is there a study reporting new performance numbers. The FDA's letter states, "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent...". This means the acceptance criterion was "substantial equivalence" to the predicate, which implies the modified device performs comparably in its intended use.

2. Sample Size Used for the Test Set and Data Provenance:

• Not Applicable. This submission is not a clinical study with a "test set" in the context of AI/diagnostic device performance. It's a regulatory submission for a device modification. The basis for substantial equivalence typically involves engineering analyses, bench testing (e.g., sterilization, material compatibility, functional testing), and comparison to the predicate device's design and materials. No patient data or test set in the traditional sense is described.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

• Not Applicable. See point 2. There's no test set in the typical AI/diagnostic study sense, and therefore, no experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This document is not for an AI device. It describes a conventional medical device (catheter sheath introducer). Therefore, an MRMC study related to AI performance is not relevant or included.

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

• Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• Not Applicable. For a device modification submission, the "ground truth" is typically established through engineering design specifications, biocompatibility testing (as mentioned in the document), and functional testing to ensure the modified device continues to meet its intended purpose and safety profile, consistent with the predicate device. It's not about establishing diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

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

• Not Applicable. See point 8.

Summary of what the document does convey regarding device acceptance and study (or lack thereof):

The "study" in this context is the 510(k) premarket notification process itself, where the manufacturer (Cordis Corporation) presented evidence to the FDA to demonstrate substantial equivalence to a previously cleared predicate device.

• Acceptance Criteria (Implicit): The primary acceptance criterion was Substantial Equivalence to the predicate device (Cordis Brite Tip® Catheter Sheath Introducer, K954595, cleared October 02, 1995). This implies that the modified device must demonstrate:
  • Same intended use.
  • Similar technological characteristics (design, construction, materials).
  • No new questions of safety or effectiveness.
  • Performance characteristics comparable to the predicate.
• "Study" That Proves Acceptance (The 510(k) Submission):
  • The submission outlines that the modified device is "similar in design, construction, indication for use, and performance characteristics to other commercially available sheath introducers," specifically referencing their own predicate.
  • Biocompatibility: "All appropriate biocompatibility tests were performed on the materials used in the modified Brite Tip® Catheter Sheath Introducer." This implicitly serves as evidence that the new materials (if any) or modified device components meet safety standards.
  • The FDA then reviewed this information and determined that the modified device is substantially equivalent.

In essence, for this type of device modification, the "proof" is a regulatory assessment based on comparison to an already approved device, rather than a de novo clinical trial with new performance metrics.

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