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Ultraverse® 014 and Ultraverse® 018 PTA Balloon Dilatation Catheters are recommended for use in percutaneous trasluminal angioplasty (PTA) of the renal, popliteal, tibial, femoral, and peroneal arteries. These catheters are not for use in coronary arteries.

The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheter is a small vessel balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. For all balloon lengths, radiopaque markers delineate the working length of the balloon and aid in balloon placement. For balloon lengths of 100 mm and greater, two radiopaque markers are positioned on the distal portion of the balloon and one radiopague marker is positioned on the proximal portion of the balloon to differentiate between the distal and proximal ends of the balloon. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis as well as a hydrophilic coating. The coaxial lumen, over the wire catheter is compatible with an 0.014" guidewire for the 014 platform, and compatible with an 0.014" or 0.018″ guidewire on the 018 platform, and is available in 75, 90, 100, 150 and 200 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 stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. This product is not manufactured with any latex.

The GeoAlign® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GeoAlign® markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GeoAlign® Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GeoAlign® Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GeoAlign® Marking System.

The provided document is a 510(k) summary for the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study for novel performance claims.

Therefore, much of the requested information regarding acceptance criteria for device performance in clinical settings and studies proving said performance in a context of a novel claim (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) is not applicable or not explicitly detailed within this type of regulatory submission. This submission primarily relies on non-clinical (bench) testing to show that the new device's modifications do not alter its safety or efficacy compared to the predicate.

Here's an analysis of what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists numerous in vitro tests performed (Page 6) and states that "The results from these tests demonstrate that the technological characteristics and performance criteria of the Ultraverse® 014 & 018 PTA Balloon Dilatation Catheters are substantially equivalent to the predicate device." It also states, "The subject device...met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

However, the specific acceptance criteria values (e.g., minimum tensile strength, maximum burst pressure deviation) and the numerical results for each test are not provided in this 510(k) summary. The document only confirms that the device met these criteria.

List of in vitro tests performed (serving as performance aspects tested):

• Catheter Shaft Length
• Balloon Working Length
• Marker Band Alignment
• Balloon OD at OP
• Balloon Rated Burst Pressure, Leak, & Burst Mode
• Crossing Profile
• Sheath Compatibility
• Shaft Outer Diameter
• Balloon Compliance / Distensibility
• Fatigue
• Hub to Shaft Tensile
• Guidewire Compatibility
• Inflation
• Deflation
• Balloon to Shaft Tensile
• Catheter Elongation
• Flushability
• GeoAlign® Marking Positions
• GeoAlign® Marking Durability
• GeoAlign® Marking Legibility
• Trackability
• Reinsertion
• Kink

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

• Sample Size: Not specified for any of the in vitro tests. This document doesn't involve human clinical test sets in the way that AI/diagnostic devices often do.
• Data Provenance: Not applicable in the context of clinical data for performance assessment. The tests are in vitro (bench tests).

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

• Not applicable. The "ground truth" here is derived from engineering specifications, industry standards, and the performance of the predicate device, not expert interpretation of clinical data.

4. Adjudication method for the test set:

• Not applicable. This is not a clinical study involving human readers or adjudicators.

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 a medical device for angioplasty, not an AI or diagnostic imaging device.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For the in vitro tests, the "ground truth" or reference for comparison would be engineering specifications, design requirements, and performance data from the predicate device (K121856). The goal is to show the new device performs equivalently or acceptably within these established parameters.
• For biocompatibility, the ground truth is established by recognized international standards (ISO 10993-1).

8. The sample size for the training set:

• Not applicable. This device is not an AI algorithm that requires a training set.

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

• Not applicable.

In summary:

This 510(k) submission is for a modified version of an existing PTA balloon dilatation catheter. The primary method of demonstrating "acceptance criteria" is through a comprehensive series of non-clinical (bench) tests to show that the new device remains substantially equivalent to its predicate. The document states that these tests were "performed on the subject device" and "met all predetermined acceptance criteria," but it does not provide the specific numerical acceptance criteria or the raw results of these tests. It leverages previously established predicate device data and existing standards for certain tests and biocompatibility.

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The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters Line Extension are recommended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popiteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.

The subject device, the Ultraverse® 014 & 018 PTA Balloon Dilatation Catheters Line Extension, are small vessel balloon catheters consisting of an over the wire catheter with a balloon fixed at the distal tip. The semi-compliant, low profile balloon has two radiopaque marker bands to delineate the working length of the balloon and aid in balloon placement. The coaxial, over the wire catheter is compatible with 0.014" and 0.018" guidewires, as labeled.

The provided text describes a 510(k) premarket notification for a medical device, specifically a line extension of the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to determine specific performance metrics against acceptance criteria in the same way a diagnostic AI device would.

Therefore, many of the requested categories for AI/diagnostic device studies (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this SDO (Software as a Medical Device) type of submission.

However, I can extract the relevant information regarding acceptance criteria and the studies performed to demonstrate equivalence.

Acceptance Criteria and Device Performance Study for Ultraverse® 014 and 018 PTA Balloon Dilatation Catheter Line Extension

This submission is a 510(k) for a "line extension" of an existing device (Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters). The core of a 510(k) is to demonstrate substantial equivalence to a previously cleared predicate device, rather than proving performance against novel clinical acceptance criteria. The modifications were to "add balloon and catheter lengths."

The "acceptance criteria" in this context refer to engineering and performance specifications evaluated through in vitro tests to ensure the new lengths perform comparably to the predicate and meet established safety and functional requirements.

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Performance: The document states: "The results from these tests demonstrate that the technological characteristics and performance criteria of the subject Ultraverse® 014 & 018 PTA Balloon Dilatation Catheter Line Extension is comparable to the predicate device and that it can perform in a manner equivalent to devices currently on the market for the same intended use."

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

• Sample Size: Not specified in the provided text for each individual test. These are typically in vitro bench tests, and sample sizes are determined by engineering and statistical requirements for device testing rather than patient case numbers.
• Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective patient data. The data is from in vitro laboratory testing conducted by the manufacturer, Bard Peripheral Vascular, Inc.

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

• Not Applicable. This is an in vitro device performance study, not a clinical diagnostic performance study requiring expert ground truth for patient data.

4. Adjudication Method for the Test Set

• Not Applicable. As this is an in vitro device performance study, there is no "adjudication method" in the sense of reconciling disagreements among human readers or experts on patient data. Test results are typically objective measurements against engineering specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size

• Not Applicable. This type of study is for evaluating diagnostic performance of an AI system, not for a physical medical device's line extension.

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

• Not Applicable. This is not an AI/algorithm-based device. "Standalone performance" here would refer to the device's functional and mechanical performance, which was evaluated through the in vitro tests listed.

7. The type of ground truth used

• Engineering Specifications / Predicate Device Performance: The "ground truth" or reference for comparison in this 510(k) submission is the performance of the legally marketed predicate device and established engineering specifications and standards for balloon dilatation catheters. The tests are designed to confirm the new device lines perform within acceptable ranges relative to these benchmarks.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. No training set exists for this type of device.

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