(87 days)
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
The ReeKross family of over the wire PTA catheters are a balloon dilation catheter for angioplasty. They consist of a stainless steel guidewire shaft that extends from the proximal hub to the distal tip of the catheter. This stainless steel shaft has a spiral cut positioned at its distal end. The spiral cut is laser cut and passivated following completion. A polymer bodybond material is used to seal the spiral cut and ensure that the contrast solution remains in the inflation lumen only and does not leak into the guidewire lumen. This bodybond material is fused onto the outside diameter of the stainless steel shaft. A copolymer inflation lumen extends from the proximal hub of the catheter to the proximal shoulder of the balloon. The lumen of the shaft is used for the purpose of inflating and deflating the balloon. This outer is thermally fused to the balloon's proximal shoulder.
The balloon material is a Nylon/Pebax blend. Low Profile Platinum Radiopaque bands are used to locate the balloon under fluoroscopy. These bands are swaged onto the bodybond material sealing the spiral cut section of the guidewire lumen.
The provided document is a 510(k) Premarket Notification for the ClearStream Technologies PTA Catheters, seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a novel device or a Premarket Approval (PMA) application.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific study designs (like multi-reader multi-case studies), ground truth establishment, or sample sizes for diagnostic performance metrics that are typical for AI/ML device evaluations.
Here's a breakdown of why the requested information isn't present and what the document does provide:
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A table of acceptance criteria and the reported device performance:
- Not Applicable. This submission demonstrates substantial equivalence to a predicate device (Savvy Long, K072947) based on "intended use, design characteristics and general physical characteristics." There are no explicit quantitative acceptance criteria or reported performance metrics (e.g., sensitivity, specificity, accuracy) for the device's diagnostic or clinical performance mentioned. The document states, "Performance testing and compliance with recognized standards have established substantial equivalence with regard to safety and effectiveness," implying a battery of engineering and bench tests, but no specific clinical performance targets.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. The document describes an angioplasty catheter, which is a medical device used for intervention, not an AI/ML diagnostic algorithm. Therefore, there's no "test set" of data in the context of an AI/ML algorithm's evaluation. The "testing" referred to is likely engineering verification and validation (V&V) related to the physical and functional aspects of the catheter, not a dataset for an algorithm.
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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):
- Not Applicable. As above, there's no "test set" or "ground truth" establishment for an AI/ML algorithm's performance in this type of device submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable.
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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:
- Not Applicable. This is a physical medical device (catheter), not an AI/ML system requiring human reader assistance or evaluation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. For a physical device like a catheter, "ground truth" relating to diagnostic performance as understood for AI/ML is not relevant. Its "performance" is assessed through engineering specifications (e.g., burst pressure, tensile strength, flow rates, steerability) and potentially pre-clinical animal studies or limited human clinical data (though not detailed here) to ensure it performs its intended mechanical function safely and effectively.
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The sample size for the training set:
- Not Applicable. There is no AI/ML algorithm being "trained" for this device.
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How the ground truth for the training set was established:
- Not Applicable.
Summary of Device and Approval Process based on the document:
This 510(k) submission is for the ClearStream Technologies PTA Catheters (ReeKross™, ReeKross™14, and ReeKross™18), which are balloon dilation catheters used for angioplasty in femoral, popliteal, and infra-popliteal arteries.
The basis for clearance is substantial equivalence to a predicate device, the Savvy Long manufactured by ClearStream Technologies Ltd (K072947). The document states that the new device is equivalent in:
- Intended use
- Design characteristics
- General physical characteristics
The conclusion for approval is based on "Performance testing and compliance with recognized standards," which the FDA determined "established substantial equivalence with regard to safety and effectiveness" to the predicate device. This implies a set of standard engineering and bench tests for catheter performance (e.g., balloon inflation/deflation, burst pressure, trackability, pushability, material compatibility, radiopacity) but no clinical study data, comparative effectiveness data, or AI-specific validation is presented because it is not an AI/ML device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).