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510(k) Data Aggregation
(30 days)
The Stingray LP Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the coronary vasculature.
When used as part of the system consisting of the CrossBoss™ Catheter, and Stingray Guidewire, the Stingray LP Catheter is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention.
The Stingray LP Catheter facilitates the placement, support and steering of a guidewire into discrete regions of the coronary vasculature through the central guidewire lumen or through one of two side-ports. These side-ports are on opposite sides of the balloon and are identified by radiopaque markers. The side-ports communicate with the central guidewire lumen and facilitate guidewire steering (at an angle to the central lumen) by allowing the quidewire to exit the Stingray LP Catheter. The Stingray LP Catheter contains a small balloon used for fluoroscopic orientation on the distal tip of a flexible shaft. The distal end of the catheter is hydrophilic coated. The Stingray LP Catheter is compatible with 6F guide catheters with minimum inner diameter of 0.070 in (1.7 mm), and may be used with guidewires ≤0.014 in (0.36 mm).
This document describes a 510(k) premarket notification for the Stingray LP Catheter. It is a submission for a medical device and, as such, does not contain information related to AI/ML or software performance evaluation studies. Therefore, I cannot provide information on acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as the provided text does not contain any of these details in the context of an AI/ML device study.
The document focuses on explaining that the device is substantially equivalent to a previously cleared predicate device based on its indications for use, technological characteristics, and non-clinical performance data (bench and biocompatibility testing).
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(101 days)
The Stingray LP Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the coronary and peripheral vasculature.
When used as part of the system consisting of the CrossBoss™ Catheter, Stingray LP Catheter, and Stingray Guidewire, the Stingray LP Catheter is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention.
The Stingray LP Catheter facilitates the placement, support and steering of a guidewire into discrete regions of the coronary and peripheral vasculature through the central guidewire lumen or through one of two side-ports. These side-ports are on opposite sides of the balloon and are identified by radiopaque markers. The side-ports communicate with the central guidewire lumen and facilitate guidewire steering (at an angle to the central lumen) by allowing the guidewire to exit the Stingray LP Catheter. The Stingray LP Catheter contains a small balloon used for fluoroscopic orientation on the distal tip of a flexible shaft. The distal end of the catheter is hydrophilic coated. The Stingray LP Catheter is compatible with 6F guide catheters with minimum inner diameter of 0.070 in (1.7 mm), and may be used with guidewires ≤0.014 in (0.36 mm).
This document describes the 510(k) premarket notification for the Stingray LP Catheter. The submission aims to demonstrate substantial equivalence to a predicate device.
The document does not describe an AI/ML device or a study involving human readers and AI. The acceptance criteria and testing detailed relate to the physical and biological performance of a medical catheter, not an algorithm.
Therefore, many of the requested categories in your prompt are not applicable to the provided text.
Here's the relevant information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the device was subjected to testing according to the requirements of the "Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters." It then lists the types of tests performed. The specific numerical acceptance criteria and detailed performance results are not provided in this summary document. It only states that "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
The categories of tests performed include:
| Test Type | Specific Tests Mentioned (where applicable) |
|---|---|
| Biocompatibility & Chemical | Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, Hemolysis (Direct Contact), Hemolysis (Extract Method), Partial Thromboplastin Time, In Vitro Hemocompatibility, Complement Activation, In Vivo Thromboresistance, USP Physicochemical Properties (though not listed under this section, it's a general category that might cover some material characterization) |
| In-vitro Performance | Effective Length, Shaft Outer Diameter, Crossing Profile, Delivery, Catheter Torque / Guidewire Movement, Guidewire Movement at Rated Burst Pressure, Withdrawal into a Guide, Two Catheters in a 7F Guide, Rated Burst Pressure (RPB), Balloon Burst Mode, Repeat Inflation, Balloon Dimensional, Inflation and Deflation Time, Full Unit Tensile, Distal Reflow Bond Yield Strength, Kink – Proximal End, Kink – Distal End of Gradient Outer, Kink – Distal End, Catheter Torque (listed again), Marker Visibility, System Radiopacity, Coating Integrity (Balloon and Shaft), Particulates (Sim Use), Corrosion Resistance |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers generally to "bench testing and biocompatibility testing" without specifying sample sizes for each test or data provenance.
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 is not applicable. The device is a physical catheter, and the testing involves engineering and biocompatibility evaluations, not interpretive tasks requiring expert ground truth in the context of AI/ML.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. See point 3.
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 is not applicable. This document is for a physical medical device (catheter), not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility tests, the "ground truth" would be established by standardized biological assays and chemical characterization methods. For the in-vitro performance tests, the "ground truth" would be the engineering specifications and performance limits defined for the device based on design requirements and relevant standards. These are concrete, measurable physical and chemical properties, not expert consensus or pathology in the clinical sense.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" as this is not an AI/ML device.
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