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Atlas® PTA Balloon Dilatation Catheters are indicated for use in Percutaneous Transluminal Angioplasty (PTA) of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

The Atlas® PTA Balloon Dilatation Catheter is a high performance balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The over the wire catheter is compatible with 0.035" guidewires and is available in 75 and 120 cm working lengths. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen.

Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.

The provided text describes a 510(k) submission for the Atlas® PTA Balloon Dilatation Catheter, focusing on its substantial equivalence to predicate devices. The document explicitly states that the submission is for a "modified indications for use statement" and outlines performance data used to demonstrate equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document does not provide a table of specific numerical acceptance criteria. Instead, it states:

• Puncture Resistance
• Robustness
• Balloon Removal
  (The specific results for these tests are not provided, only that they were performed and supported comparability/equivalence.) |

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

The document describes in vitro tests ("Puncture Resistance," "Robustness," "Balloon Removal") for performance data. It does not mention clinical trials or studies with human subjects that would have a "test set" in the context of diagnostic accuracy or effectiveness on patients. Therefore, information about sample size for a test set (in a clinical sense) or data provenance (country, retrospective/prospective) is not applicable here as this is an engineering performance evaluation, not a clinical study.

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)

This information is not applicable. Since the performance data is based on in vitro engineering tests, there is no mention of human experts being used to establish ground truth in the way it would be for a diagnostic tool or clinical assessment.

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

This information is not applicable. As the performance data is based on in vitro engineering tests, there is no mention of an adjudication process typically used in clinical studies involving interpretation by multiple readers.

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

This information is not applicable. The document does not describe an MRMC study or any study involving human readers or AI assistance. This is a medical device (balloon catheter) and its clearance is based on performance equivalence, not AI-assisted interpretation.

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

This information is not applicable. The device is a physical medical instrument (balloon catheter), not a software algorithm or AI.

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

For the in vitro tests, the "ground truth" would be established by the physical and mechanical properties and measurements against defined specifications and industry standards for balloon catheters. The document lists "applicable standards, quidance, test protocols and/or customer inputs" as the basis for acceptance criteria, which implies objective measurement against known benchmarks rather than subjective expert consensus or clinical outcomes data.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" in the context of device development for this type of medical instrument. The performance evaluation is based on engineering tests, not machine learning model training.

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

This information is not applicable for the same reasons as point 8.

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The Atlas™ PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

The Atlas™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.

This 510(k) summary for the Atlas™ PTA Balloon Dilatation Catheter (K052236) does not contain the specific acceptance criteria or a detailed study description to prove the device meets said criteria.

Here's an explanation of what is available and what is missing, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The summary explicitly states: "The Atlas™ PTA Balloon Dilatation Catheter met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not list what those specific acceptance criteria were or present the data from tests that demonstrate the device met them.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

Explanation: This 510(k) refers to "design verification and validation" but does not detail the specific test sets, their sizes, or the nature of experiments conducted (e.g., in vitro, in vivo, clinical trials).

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

• Number of Experts: Not applicable/Not provided.
• Qualifications of Experts: Not applicable/Not provided.

Explanation: No information is given about expert involvement in establishing ground truth for any test data, as no specific test data or ground truth methodology is discussed.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable/Not provided.

Explanation: Since no detailed test set or ground truth establishment is described, neither is an adjudication method.

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:

• MRMC Study: No.
• Effect Size: Not applicable.

Explanation: This is a 510(k) for a medical device (balloon catheter), not an AI-powered diagnostic tool. MRMC studies and AI assistance metrics are not relevant to this device type.

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

• Standalone Study: No.

Explanation: This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• Type of Ground Truth: Not applicable/Not provided.

Explanation: As no specific data or evaluation of diagnostic accuracy is discussed, the concept of "ground truth" as typically used for AI or diagnostic imaging devices is not relevant here. The "ground truth" for a physical device might relate to engineering specifications and performance, but these are not detailed.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable/Not provided.

Explanation: This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.

9. How the Ground Truth for the Training Set was Established:

• Ground Truth Establishment: Not applicable/Not provided.

Explanation: As above, this is not an AI/ML device, so no training set and its ground truth establishment are relevant.

Summary of what the document does provide:

• Device Name: Atlas™ PTA Balloon Dilatation Catheter
• Submitter: Bard Peripheral Vascular, Inc.
• Predicate Device: Atlas™ PTA Balloon Dilatation Catheter (K040243)
• Change: Additional balloon sizes.
• Intended Use: Percutaneous Transluminal Angioplasty (PTA) of the iliac arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for coronary arteries.
• Conclusion: The device met all predetermined acceptance criteria for design verification and validation, establishing substantial equivalence to the predicate device.

To get the specific acceptance criteria and detailed study data, one would typically need to refer to the full design verification and validation documentation which is referenced but not included in this 510(k) summary.

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The Bard® AtlasTM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Bard® Atlas™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.

The provided text describes a medical device, the Bard® Atlas™ PTA Balloon Dilatation Catheter, and its clearance process with the FDA. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the specific details required to complete your request about the study proving the device meets acceptance criteria.

The document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting detailed performance study results from which acceptance criteria are derived.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The text only states that:

• "A variety of tests, assessments, and comparisons demonstrate that the Bard® Atlas™ PTA Balloon Dilatation Catheter is substantially equivalent to the above-referenced predicates in terms of composition, design, intended use, and performance attributes."

This is a general statement of equivalence and does not detail the specific tests, their acceptance criteria, or the results.

To fulfill your request, specific performance study reports or clinical trial summaries would be needed.

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