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Indicated for CP Stent / Covered CP Stent and G-Armor Covered Stent placement in vessels over 8mm in diameter

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This document, K213915, is a 510(k) clearance letter for the NuMED Inc. BIB Stent Placement Catheter. It is not a study report or a document that details acceptance criteria and device performance based on a study.

Therefore, I cannot provide the requested information as it is not present in the provided text. The document primarily focuses on the FDA's decision regarding the device's substantial equivalence and outlines regulatory requirements.

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Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter.

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I apologize, but the provided text does not contain information about acceptance criteria or a study proving device performance for the "BIB Stent Placement Catheter." This document is a 510(k) clearance letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices.

The letter details:

• The device name and applicant.
• The FDA regulation number, name, and product code.
• The date of the clearance.
• A brief statement about the substantial equivalence determination.
• Information regarding general controls and other FDA regulations that apply to the device.
• Contact information for FDA resources.
• The "Indications for Use" for the BIB Stent Placement Catheter, which states it is "Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter."

It does not include:

1. A table of acceptance criteria or reported device performance.
2. Details on sample sizes or data provenance for any studies.
3. Information about experts or ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size or how its ground truth was established.

Therefore, I cannot fulfill your request for this information based on the provided text.

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I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for the NuMED, Inc. BIB Stent Placement Catheter. It indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed, but does not include performance data or details of a study.

The sections you've highlighted regarding "Indications for Use" and what appears to be garbled text or non-English characters do not provide the requested information. Therefore, I cannot complete the table or answer the specific questions about acceptance criteria or a study based on the provided input.

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Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter.

The NuMED BIB® Stent Placement Catheter Model 420 is indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter. The catheter is triaxial in construction with two lumens being used to inflate the balloons while one lumen is being used for tracking over a guidewire. The purpose of the double balloon catheter is to apply an incremental inflation for the purpose of dilating a stent. The inner balloon provides initial expansion of the stent and also acts as a tool to hold the stent on the catheter prior to the outer balloon being inflated. The outer balloon is then inflated providing the remainder of the expansion. There are radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The balloon material is clear. The catheter balloon diameters are stamped onto the inflation extensions and are labeled with balloon diameter x balloon length and the catheter lot number.

The provided text describes a medical device, the NuMED BIB® Stent Placement Catheter, and its substantial equivalence to a predicate device. It includes performance data from in vitro testing and a clinical trial. However, the document does not explicitly state acceptance criteria in a quantitative format, nor does it present the study results specifically framed as meeting such criteria. Instead, it leverages prior testing and a clinical trial to demonstrate substantial equivalence.

Based on the provided text, here's an attempt to extract and infer the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with numerical targets are not stated, this table will present the key performance indicators from the leveraged studies, which implicitly served as the basis for performance evaluation for substantial equivalence.

2. Sample size used for the test set and the data provenance

• Test Set Description: The clinical study is referred to as the COAST trial.
• Sample Size: 112 patients were enrolled.
• Data Provenance: The COAST trial was a "prospective, multi-center, single arm study." While the specific country of origin is not explicitly stated, "multi-center" implies data from several locations, typically within a regulatory region (e.g., USA for FDA approval).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The provided text only refers to clinical trial data (COAST study) for safety and effectiveness. It does not mention the use of experts to establish a "ground truth" for the test set in the context of diagnostic performance or image interpretation often associated with AI/ML devices. Therefore, this question is not applicable to the submitted document. The clinical outcomes served as the definitive measure of device performance.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set, as no "ground truth" establishment by multiple experts is discussed for diagnostic purposes. Clinical trial outcomes are typically assessed by study investigators and monitored, but not through an adjudication process in the sense of resolving discrepancies between expert opinions on a data point.

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 such MRMC comparative effectiveness study is mentioned. The device is a physical medical device (stent placement catheter), not an AI-powered diagnostic or assistive tool for human readers.

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

This question is not applicable. The device is a physical medical device; it does not have a standalone algorithm or AI component.

7. The type of ground truth used

For the clinical study (COAST trial), the "ground truth" for evaluating the device's performance was:

• Clinical Outcomes/Events:
  • Rates of serious adverse events within 30 days.
  • Rates of post-procedure paradoxical hypertension.
  • Reduction in arm-leg systolic blood pressure gradient from baseline to 12 months.
  • Length of hospital stay.
• Successful implantation: The text states, "The results demonstrated that the CP Stent could be successfully mounted and implanted using the BiB Stent Placement Catheter..."

For the bench and biocompatibility testing, the "ground truth" was established based on pre-defined engineering specifications, material standards, and biological safety guidelines, which the device components were expected to meet.

8. The sample size for the training set

The document does not describe a "training set" in the context of AI/ML. The device is a physical medical device. The "leveraged" data from K050857 and P150028 could be considered as prior performance data used for development and comparison, but not a "training set" in the AI sense.

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

As there is no "training set" for an AI/ML algorithm described, this question is not applicable. The prior performance data from K050857 and P150028 were established through engineering tests, biocompatibility assessments, and clinical evaluation as per regulatory requirements for medical devices.

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This device is labeled for Percutaneous Transluminal Angioplasty (PTA) if the femoral, iliac and renal arteries. These catheters are not designed to be used in the coronary arteries.

The BIB PTA Catheter has a tri-axial shaft design which allows for inflation of two balloons, one contained inside the other, and a guidewire lumen for placement inside the vasculature. Both balloons are identical to those currently marketed by NuMed on the Tyshak PTA and Z-Med PTA catheters. The balloons are non-compliant and include radiopaque platinum marker bands on the catheter shaft to facilitate placement of the device under fluoroscopy. The BIB catheter will be available in standard diameters from 8 mm to 24 mm for the outer balloon and 4 mm to 12 mm for the inner balloon. Balloon lengths of 1.5 cm to 5.5 cm will available. The device has an overall shaft length of 110 cm.

The provided text describes a 510(k) summary for the BIB PTA Balloon Catheter. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as typically found in clinical trials for novel devices or AI algorithms.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as they relate to proving a device meets specific acceptance criteria through a study, is not present in the provided text.

The document states: "The BIB PTA Balloon Catheter have been tested and compared to the Summary of predicate devices listed herein. All data gathered demonstrate the BIB PTA Safety and Effectiveness Catheter is substantially equivalent. No new issues of safety or efficacy have been raised." This indicates that verification and validation activities were performed to support substantial equivalence, but the specifics of those tests and their acceptance criteria are not detailed.

Here's an assessment based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document does not provide a table of acceptance criteria or specific performance metrics. It generally states that the device has been "tested and compared" to predicate devices and deemed "substantially equivalent" with "no new issues of safety or efficacy."

2. Sample size used for the test set and the data provenance

Not available. The document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). It refers to "all data gathered" for demonstrating substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not available. This device is a PTA Balloon Catheter, not an AI diagnostic device. The concept of "ground truth" and "experts to establish ground truth" as typically applied to image analysis or diagnostic AI algorithms does not directly apply here. For a physical medical device, "ground truth" would be related to its physical properties, biocompatibility, and functional performance, which are evaluated through engineering tests, material analysis, and potentially animal or human clinical data (though no specific clinical study details are provided here beyond reference to predicate devices).

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

Not applicable/Not available. As explained above, an adjudication method for a test set, pertaining to expert consensus on diagnostic outcomes, is not relevant to this type of device and its regulatory submission.

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 specific type of study (MRMC for AI assistance) is not relevant for a physical medical device like a balloon catheter.

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

Not applicable. This concept pertains to AI algorithms, not a physical medical device.

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

Not available. While the document states "biocompatibility tests" were passed and the device was "tested and compared" to predicate devices, it does not specify the type of ground truth used for these tests. For a physical device, ground truth would typically refer to validated measurement techniques for physical properties (e.g., burst pressure, inflation/deflation times), material science standards, and potentially in vivo or in vitro models for biocompatibility and performance.

8. The sample size for the training set

Not applicable/Not available. The concept of a "training set" applies to machine learning algorithms, which is not the subject of this 510(k) submission.

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

Not applicable/Not available. As above, this concept pertains to machine learning algorithms.

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