Search Results
Found 1 results
510(k) Data Aggregation
(101 days)
The Highlander™ 014 PTA Balloon Dilatation Catheted for use in percutaneous transluminal angioplasty (PTA) of the peripheral vasculature, including femoral, popliteal and renal arteries. This device is also indicated for post-dilatation of balloon expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.
The Highlander™ 014 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. The proprietary non-compliant, low-profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. For all balloon lengths, radiopaque markers delineate the working length of the balloon and aid in balloon placement. For balloon lengths of 100mm and greater, two radiopague markers are positioned on the distal portion of the balloon and one radiopaque marker is positioned on the proximal portion of the balloon to differentiate between the distal and proximal ends of the balloon. The catheters include an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. A silicone-based, hydrophobic coating is present on the distal segment of the shaft and balloon. Highlander™ 014 is compatible with 0.014" guidewires. The proximal portion of the catheters include 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. These products are not made with natural rubber 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 text is a 510(k) summary for the Highlander™ 014 PTA Balloon Dilatation Catheter. This document details the device's characteristics, indications for use, and a comparison to a predicate device to demonstrate substantial equivalence. It is important to note that this document does not contain information about studies related to AI/ML device performance, ground truth establishment, or expert reviews as it is for a physical medical device (balloon catheter).
Therefore, this response will focus on the acceptance criteria and performance data for the physical device as described in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various in vitro tests performed to demonstrate substantial equivalence. It does not provide specific numerical acceptance criteria or detailed quantitative performance results for each test. Instead, it states a general conclusion for each category: "The results from these tests demonstrate that the technological characteristics and performance criteria of the Highlander™ 014 PTA Balloon Dilatation Catheter are substantially equivalent to the predicate device, and that it can perform in a manner equivalent to devices currently on the market for the same intended use." and "met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."
However, based on the categories of tests listed, a general representation of acceptance criteria and reported performance is as follows:
| Test Category | Acceptance Criteria (Implicit from "met all predetermined acceptance criteria") | Reported Device Performance |
|---|---|---|
| Physical Dimensions | Conformity to specified dimensions (Catheter Length, Tip Length, Balloon Working Length, Balloon OD at OP, Shaft Outer Diameter, Coating Length) | Met all predetermined acceptance criteria for design verification and validation, demonstrating substantial equivalence to the predicate device. |
| Mechanical Performance | Acceptable limits for Marker Band Alignment, Balloon Rated Burst Pressure, Leak, & Burst Mode, Burst in Stent, Crossing Profile, Distensibility, Luer Lock Compatibility, Fatigue, Fatigue in Stent, Hub to Shaft Tensile, Shaft Inner Diameter/Guidewire Compatibility, Inflation, Deflation, Balloon to Shaft Tensile, Tip Tensile, Catheter Elongation, Trackability, Reinsertion, Kink Resistance, Torque Response, Flushability | Met all predetermined acceptance criteria for design verification and validation, demonstrating substantial equivalence to the predicate device. |
| Material Characteristics | Acceptable limits for Particulate matter, Coating Integrity, Visual Inspection (e.g., absence of defects) | Met all predetermined acceptance criteria for design verification and validation, demonstrating substantial equivalence to the predicate device. |
| Labeling/Marking | Accuracy and durability of GeoAlign™ Marking Position, GeoAlign™ Marking Durability, GeoAlign™ Marking Legibility | Met all predetermined acceptance criteria for design verification and validation, demonstrating substantial equivalence to the predicate device. |
| Packaging Integrity | Acceptable performance for Packaging Integrity Visual Inspection, Bubble Emission Leak, Pouch Seal Strength, Heat Seal Visual Inspection | Met all predetermined acceptance criteria for design verification and validation, demonstrating substantial equivalence to the predicate device. |
| Biocompatibility | Conformance to biocompatibility standards (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility) | Met all predetermined acceptance criteria for design verification and validation, demonstrating substantial equivalence to the predicate device. The device is not made with natural rubber latex. |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the sample sizes used for each in vitro test. The tests are "in vitro" (performed in a lab setting, not on human or animal subjects). Therefore, there is no data provenance in terms of country of origin or retrospective/prospective nature as would be relevant for clinical studies.
3. Number of Experts and Qualifications
This information is not applicable. The evaluations described are in vitro engineering and materials tests, not clinical studies requiring expert interpretation of diagnostic images or patient outcomes.
4. Adjudication Method
This information is not applicable as there is no mention of a ground truth needing adjudication by human experts in the context of this device's testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is typically performed for AI-driven diagnostic imaging devices to assess the impact of AI assistance on human reader performance. The Highlander™ 014 PTA Balloon Dilatation Catheter is a physical medical device, not an AI/ML diagnostic tool.
6. Standalone Performance Study
Yes, the in vitro tests conducted on the Highlander™ 014 PTA Balloon Dilatation Catheter can be considered a standalone performance study. These tests evaluated the device's physical and mechanical properties and biocompatibility independent of human use in a clinical setting. The conclusion states that "The subject device, the Highlander™ 014 PTA Balloon Dilatation Catheter, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." This indicates a standalone assessment of its performance against established benchmarks.
7. Type of Ground Truth Used
The "ground truth" for the in vitro tests would be defined by the technical specifications, industry standards, relevant FDA guidance documents, and internal risk assessment procedures. For example, for physical dimensions, the ground truth is the specified design dimension; for burst pressure, it's the minimum acceptable pressure according to device-specific or industry standards. For biocompatibility tests, the ground truth is the pass/fail criteria established by recognized international standards (e.g., ISO 10993 series).
8. Sample Size for the Training Set
This information is not applicable. The described tests are for a physical medical device and do not involve AI/ML algorithms that require training data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated in point 8.
Ask a specific question about this device
Page 1 of 1