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The Conquest™ 40 PTA Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

The Atlas™ Gold PTA Dilation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the illac and femoral veins, 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 Vida™ PTV Dilatation Cather is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in the following:
· A patient with isolated pulmonary valve stenosis.
· A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

The Vida™ BAV Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

The Conquest™ 40 PTA 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 ultra 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 a tapered atraumatic tip to facilitate advancement of the catheter to and through the stenosis. 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 quidewire lumen. The over-the-wire catheter is compatible with 0.035" guidewires and is available in 50cm and 75cm working lengths. 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. A stylet is placed into the tip of the catheter to aid in re-wrap/refolding of the balloon. This product is not manufactured with any latex.

The Atlas™ Gold PTA 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 a tapered atraumatic tip to facilitate advancement of the catheter to and through the stenosis. 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. The over-the-wire catheter is compatible with .035" guidewire and is available in 80 cm and 120 cm working lengths.
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 to aid in re-wrap/refolding of the balloon. This product is not manufactured with any natural rubber latex.

The Vida™ PTV 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, noncompliant, 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 valve. The over-the-wire catheter is compatible with .035" guidewire and is available in 100 cm working length. 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 Vida™ BAV Balloon Valvuloplasty 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. 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 valve. The over-the-wire catheter is compatible with .035" guidewire and is available in 100 cm working length. 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 document describes the substantial equivalence determination for several medical devices, specifically balloon dilatation and valvuloplasty catheters. It does not present acceptance criteria or performance data for an AI/ML-driven medical device. Instead, it focuses on the engineering and material characteristics of physical medical devices and their comparison to previously cleared predicate devices.

Therefore, I cannot provide a response based on the requirements of your prompt, as the document does not contain information related to:

1. AI/ML performance testing: The document details physical device performance tests (e.g., trackability, burst strength, fatigue, biocompatibility), not AI model performance metrics like sensitivity, specificity, or AUC.
2. Test/training sets for AI/ML: There is no mention of data sets, sample sizes for AI training or testing, data provenance, or ground truth establishment relevant to an AI algorithm.
3. Expert adjudication or MRMC studies: These are concepts specific to the evaluation of AI systems, typically involving human readers or experts, which are not applicable to the physical devices described in this submission.

The document states: "The subject devices...met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not specify what those "predetermined acceptance criteria" are for each test, nor does it present the reported device performance in detail (e.g., actual burst pressures achieved vs. minimum required). It lists the types of tests performed.

To fulfill your request, the input document would need to describe the development and validation of an AI/ML component, including its specific acceptance criteria and the results of studies demonstrating its performance.

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The Atlas® Gold PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the iliac arteries and iliac 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® Gold PTA 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 a tapered atraumatic tip to facilitate advancement of the catheter to and through the stenosis. 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. The over-the-wire catheter is compatible with .035" guidewire and is available in 80 cm and 120 cm working lengths. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A rewrapping tool is also provided on the catheter shaft to aid in re-wrap/refolding of the balloon. This product is not manufactured with any natural rubber latex.

This document describes the premarket notification (510(k)) for the Atlas® Gold PTA Dilatation Catheter (K181323). The information provided is sufficient to answer some but not all of the requested categories, as this is a medical device clearance document rather than a detailed clinical study report for an AI/software as a medical device (SaMD). The core of this submission is to demonstrate substantial equivalence to a predicate device, with an expanded indication for use.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance (for the expanded indication - venous system use):

The primary acceptance criterion mentioned is related to safety for the expanded indication in the venous system.

Study Proving the Device Meets Acceptance Criteria:

1. Sample Size and Data Provenance:

   • Sample Size: 61 patients for post-stent dilatation and 20 patients for pre-dilatation. (Total 81 patient procedures where the device was used).
   • Data Provenance: Retrospective, investigator-sponsored clinical study. Location of data origin (country) is not explicitly stated, but it's part of a US FDA submission. The study covered data between September 1, 2013, and May 30, 2017.

2. Number of Experts and Qualifications for Ground Truth:

   • This document describes a clinical study of a physical medical device (catheter), not an AI/SaMD. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or algorithm performance is not applicable here. The "ground truth" implicitly relies on standard clinical assessment during the procedures and follow-up, observed by the investigators.

3. Adjudication Method for the Test Set:

   • Not specified, as this is a device performance study, not an AI/SaMD study involving human reader variability in interpretation.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Not applicable. This study is for a physical medical device, not an AI/SaMD requiring assessment of human reader improvement with AI assistance.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. This study is for a physical medical device; there is no standalone algorithm to evaluate.

6. Type of Ground Truth Used:

   • The "ground truth" for this study is based on clinical outcomes and observations during the procedure. Specifically, it's defined by the occurrence (or absence) of major adverse events (acute thrombosis, perforation, device-related complications) and measurements of luminal area.

7. Sample Size for the Training Set:

   • Not applicable. This is a clinical validation study for a physical device, not an AI model that requires a training set. The device itself was developed and manufactured based on established engineering and quality system processes.

8. How Ground Truth for the Training Set Was Established:

   • Not applicable for the same reason as above. The "training" for such a device comes from engineering design, materials science, and in-vitro/in-vivo testing during the development phase, not from a "training set" of data in the AI sense.

Additional Information from the Document:

• Identicality to Predicate: The key argument for substantial equivalence is that the subject device (Atlas® Gold PTA Dilatation Catheter) is identical to its predicate device (Atlas® Gold PTA Dilatation Catheter, K122984) in manufacturing and design.
• Only Differences: The only differences are an expanded indications for use to include the venous system and the inclusion of the retrospective clinical study results in the labeling.
• Clinical Literature Review: The submission also included reviews of 46 published clinical articles involving over 4000 patients, demonstrating that PTA catheters are generally safe for use in the venous system, with known and low rates of adverse events.

In summary, this submission relies on demonstrating the safety and effectiveness of using an already cleared and identical physical device for an expanded indication based on a retrospective clinical study showing favorable outcomes against defined safety benchmarks, supplemented by existing literature. It's not a study designed to evaluate an AI/software component.

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The Atlas Gold PTA 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 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 Gold PTA Dilatation Catheter is 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" guidewire and is available in 80 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.

Here's a breakdown of the acceptance criteria and study information for the Atlas Gold PTA Dilatation Catheter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the device "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 provide a specific table detailing the acceptance criteria values for each test alongside the performance results. Instead, it lists the types of tests performed.

Therefore, a table cannot be constructed with specific numerical acceptance criteria and performance data. The reported device performance is broadly stated as follows:

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

The document does not specify a distinct "test set" in the context of clinical data for algorithmic performance. The tests described are in vitro (laboratory) tests on the device itself and biocompatibility tests. The document does not provide sample sizes for these tests, nor does it mention country of origin or whether the data is retrospective or prospective, as these are typically considerations for clinical studies involving patient data, not mechanical or biocompatibility testing.

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

This information is not applicable. The evaluations were based on engineering specifications and laboratory testing protocols, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable. There's no mention of an adjudication process as would be used for subjective assessments or expert reviews of clinical data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not conducted or mentioned. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the focus of this device's submission.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone (algorithm only) performance study was not conducted or mentioned. The device is a physical medical instrument (catheter), not a software algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the performance evaluation relies on established engineering specifications, test protocols, and recognized standards (e.g., ISO 10993-1:2009 for biocompatibility). For mechanical and performance tests, the ground truth is often defined by the design requirements and the physical properties expected of the device.

8. Sample Size for the Training Set:

This information is not applicable. There is no software algorithm or AI that requires a training set for this device. The evaluation is based on direct device testing.

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

This information is not applicable, as there is no training set mentioned for this device.

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