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The PolarCath Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

This submission (K051916) by CryoVascular Systems, Inc. for the PolarCath™ Peripheral Dilatation System does not include detailed acceptance criteria or a dedicated study report proving the device meets specific performance criteria in the way typically seen for a new or significantly modified device requiring extensive clinical trials.

Instead, the submission relies heavily on substantial equivalence to a predicate device. This is a common pathway for 510(k) clearances where the new device is "as safe and effective as" an already legally marketed device.

Here's an analysis based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided documents, there isn't a table of specific acceptance criteria (e.g., specific lumens, burst pressures, deployment times) and corresponding reported performance from a formal study. The primary statement regarding performance is:

Explanation: In a substantial equivalence submission like this, the "acceptance criteria" are implicitly met if the device can demonstrate it is as safe and effective as a legally marketed predicate device, often through a combination of design controls, bench testing data, and sometimes animal or clinical data if the differences are significant. This summary explicitly states that the safety and effectiveness are demonstrated with design control activities and bench testing, but the specifics of those findings are "on file" and not detailed in the provided K document.

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

• Test Set Sample Size: Not specified in the provided documents. The filing mentions "bench testing" but doesn't detail the number of units tested or specific parameters.
• Data Provenance: The data provenance is internal, originating from CryoVascular Systems, Inc. It appears to be primarily retrospective in the sense that it relies on existing design controls and bench testing, rather than a prospective clinical trial designed to collect specific performance data for this submission. The origin is the USA (California, based on the sponsor's address).

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

This information is not applicable and not provided in the context of this 510(k) summary. For a device like a angioplasty catheter primarily relying on bench testing and substantial equivalence, there isn't an "expert" review of a clinical test set to establish ground truth in the way there would be for an AI diagnostic device. The "ground truth" here relates to engineering specifications and performance against those specifications, which are typically evaluated by internal engineers and quality control personnel.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret medical images or data against a reference standard. For a device primarily cleared based on bench testing and substantial equivalence, this type of adjudication is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement:

No, a MRMC comparative effectiveness study was not done according to the provided documents. This type of study is common for AI systems that assist human readers in diagnosing or detecting conditions on medical images. This 510(k) is for a medical device (catheter), not an AI-powered diagnostic tool.

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

No, a standalone study was not done. This is not an AI algorithm. The device is a physical medical device (catheter) used by a human operator, making the concept of a "standalone" algorithm study irrelevant.

7. The Type of Ground Truth Used:

The "ground truth" for this device, as implied by the submission, would be based on:

• Engineering Specifications: The design and performance parameters the catheter is intended to meet (e.g., catheter dimensions, inflation pressure, burst pressure, material integrity).
• Bench Test Results: Direct measurements and observations from laboratory testing verifying these specifications.
• Predicate Device Performance: The known safety and effectiveness profile of the legally marketed predicate device, which the PolarCath is demonstrated to be substantially equivalent to.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. "Training set" refers to data used to train machine learning models. This 510(k) is for a physical medical device and does not involve AI or machine learning.

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

This information is not applicable and not provided, as there is no training set for an AI algorithm in this context.

Summary of the K051916 Submission Approach:

The K051916 submission primarily relies on the substantial equivalence pathway. This means the applicant demonstrated that the PolarCath™ Peripheral Dilatation System is "as safe and as effective" as a legally marketed predicate device. This demonstration is typically achieved through:

• Comparison of Device Characteristics: Showing that the design, materials, manufacturing process, and intended use are similar to the predicate.
• Bench Testing: Laboratory tests to ensure the device meets its own engineering specifications and performs comparably to the predicate for critical parameters (e.g., burst pressure, inflation/deflation times, guidewire compatibility).
• Risk Analysis and Design Controls: Ensuring that potential risks have been identified and mitigated through the design and manufacturing process.

The provided documents explicitly state: "The safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at CryoVascular Systems, Inc." This indicates that studies were conducted, but the detailed results and specific acceptance criteria used in those studies are retained by the manufacturer and summarized in this high-level document. They are not typically elaborated in the public 510(k) summary if substantial equivalence is the primary basis for clearance.

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The PolarCath™ Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (subclavian, renal, iliac, femoral, popliteal, and infrapopliteal arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for postdeployed stent expansion in self-expanding peripheral vascular stents.

The PolarCath Peripheral Balloon Catheter System consists of a Peripheral Balloon Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cylinder.

The provided text is a 510(k) summary for the PolarCath™ Peripheral Dilatation System. It states that "In vitro testing demonstrated that the PolarCath Peripheral Balloon Catheter System met all acceptance criteria." However, it does not provide specific details about the acceptance criteria or the study that proves the device meets them.

Therefore, I cannot provide the requested information in the structured format. The document only contains the following general statement about performance data:

The requested information (acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, training set size, and ground truth establishment for training set) is not available in the provided text.

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The PolarCath™ Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal and renal arteries) and for the treatment of obstructive lesions of PTFE access grafts or arteriovenous dialysis fistulae.

The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

The provided text describes a 510(k) premarket notification for the PolarCath™ Peripheral Dilatation System, which is a Percutaneous Transluminal Angioplasty Catheter. The document is a regulatory submission, not a study report, and therefore does not contain the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance.

The "Performance Data" section explicitly states: "The safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at CryoVascular Systems, Inc." This indicates traditional device testing (bench testing, design controls) was performed, not clinical studies involving AI performance metrics.

Therefore, I cannot provide the requested table and study details as they are not present in the provided document.

This document is from 2004, a period before AI/ML-driven medical devices were commonly evaluated in the same manner as described in your request. The evaluation framework for devices like this involved demonstrating substantial equivalence to a predicate device through engineering design, material specifications, manufacturing processes, and bench testing, rather than through extensive clinical performance studies with AI components.

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The PolarCath Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal and renal arteries) and for the treatment of obstructive lesions of PTFE access grafts or artcriovenous dialysis fistulae.

The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

The provided text describes the 510(k) summary for the PolarCath™ Peripheral Dilatation System. However, it does not include detailed acceptance criteria or a study proving that the device meets those criteria.

The "Performance Data" section explicitly states: "The safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at CryoVascular Systems, Inc." This indicates that the supporting data is held internally by the company and is not detailed in the provided 510(k) summary.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study that is not described in this document.

The document focuses on:

• Device Description: What the PolarCath Peripheral Dilatation System is.
• Indications for Use: What the device is intended for.
• Substantial Equivalence: How it is similar to predicate devices.
• Regulatory Information: Sponsor, contact person, product codes, classification, and the FDA's letter of clearance.

In summary, based on the provided text, the specific study details and acceptance criteria you've requested are not available.

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The CVSi™ Peripheral Balloon Catheter and the CVSi™ Catheter Inflation Unit are indicated for percutaneous, transluminal angioplasty of stenotic lesions in the superficial femoral and popliteal arteries. The CVSi™ Peripheral Balloon Catheter System is not indicated for use in other vasculature, including coronary arteries, carotid arteries, synthetic vascular grafts, and vein grafts. The CVSi™ Peripheral Balloon Catheter System is not indicated for stent delivery or stent expansion.

The CVSi™ Peripheral Balloon Catheter System consists of a CVSi™ Peripheral Balloon Catheter, CVSj™ Catheter Inflation Unit, connecting cable, and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cylinder.

The provided text describes a 510(k) premarket notification for the CVSi™ Peripheral Balloon Catheter System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for AI/ML-based devices.

Therefore, many of the requested details, such as sample sizes for test/training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for the training set, are NOT applicable to this submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria in the format typically seen for AI/ML device performance. Instead, it relies on demonstrating function and safety through a series of tests and showing substantial equivalence to predicate devices.

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