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The Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter is a reprocessed single use device. After clinical use of the Visions PV .035 Digital IVUS Catheter (Manufactured by Philips), the IVUS catheter is shipped to Vein360 per established Vein360 instructions. Upon receipt, the Visions PV .035 Digital IVUS catheter is cleaned, inspected, functionally tested, hydrophilic coated, packaged and sterilized using ethylene oxide (EO) gas.

The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter is an over-thewire intravascular imaging catheter containing an ultrasound transducer located at the distal end of the catheter. This transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels.

The catheter is introduced percutaneously or via surgical cutdown into the peripheral vasculature. The catheter is designed to track over a maximum guidewire of 0.038" (0.97mm).

The catheter is 90cm in working length with 1cm inked markers (non-radiopaque) along the proximal shaft for length assessments during pull back. There are 25 radiopaque markers spaced 1cm apart along the distal shaft for quick length measurements under angiogram imaging. A hydrophilic coating is applied externally to the distal end of the catheter. The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter maintains all mechanical and electrical properties of the predicate device after reprocessing operations.

The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter may only be used with Volcano s5 Series and CORE Series imaging systems.

The Vein360 Reprocessed Visions PV.035 Digital IVUS catheter is not supplied with any accessories.

The Visions PV .035 Digital IVUS catheter can only be reprocessed once. All Vein360 Reprocessed Visions PV .035 Digital IVUS catheters are permanently marked to indicate it has been reprocessed.

The provided text describes the 510(k) summary for the Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter. This device is a reprocessed single-use device, meaning it is an original device that has been cleaned, inspected, functionally tested, repackaged, and sterilized for re-use. The performance data presented focuses on demonstrating that the reprocessed device is substantially equivalent to the new, unused predicate device.

Here's an analysis based on your request, highlighting what is available and what is not in the provided document:

Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct table of specific numerical acceptance criteria for various performance metrics alongside the reported results. Instead, it states that "Results of performance testing demonstrate the Vein360 Reprocessed Visions PV .035 Digital IVUS catheters are substantially equivalent to the predicate devices which are safe and effective for their intended use."

The types of tests performed indicate the areas where performance was assessed, and the conclusion of substantial equivalence implies that the reprocessed device met the necessary criteria in all these areas.

Inferred Acceptance Criteria (Implied by the tests performed) and Implied Performance:

Important Note: The document confirms that "The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter is validated for one reprocessing cycle after successful completion of the above performance testing."

Study Information:

The provided document describes a bench and laboratory testing study (performance validation) to demonstrate substantial equivalence, rather than a clinical study involving human patients or a reader study typically associated with AI/CADe devices.

1. A table of acceptance criteria and the reported device performance:
   As detailed above, the document implies that acceptance criteria were met for various functional and material properties, but does not provide a specific table with numerical thresholds. The standard for a reprocessed device is typically that it performs "as well as or better than" the predicate device and that reprocessing does not adversely affect its performance, safety, or effectiveness.

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

   • Test Set Sample Size: Not explicitly stated. The document mentions that "Visions PV .035 Digital IVUS catheters were clinically used and then soiled with artificial test soil" for cleaning validation and performance validation. The exact number of catheters used for these tests is not provided.
   • Data Provenance: The studies are laboratory and bench tests on reprocessed devices, some of which were "clinically used" prior to reprocessing. The country of origin of this clinical use data (if it informs the "soiling" step) is not specified. The studies are by nature retrospective in terms of using already-used devices and then testing them.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This question is not applicable in the context of this device and study. The "ground truth" here is the performance of the predicate device (a new, unused IVUS catheter) and established engineering/performance standards for mechanical, electrical, and imaging properties. Experts would be involved in setting these standards and interpreting test results, but likely not in the typical "ground truth" establishment for image interpretation as seen in AI/CADe devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. Adjudication methods are typically used in reader studies for diagnostic devices to resolve discrepancies in expert interpretations. This submission focuses on the physical and functional properties of a reprocessed medical device.

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, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant to AI/CADe devices that assist human readers in diagnosis. The Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter is an imaging catheter itself, not an AI diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is not an algorithm or AI device. The "performance" described is the catheter's ability to mechanically and electrically function to produce images, and the quality of those images.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" is primarily based on established engineering specifications and performance benchmarks of the original predicate device (Visions PV .035 Digital IVUS Catheter) and relevant industry standards for safety and performance of reprocessed medical devices. This includes:

   • Absence of residual soil/bioburden.
   • Dimensional accuracy.
   • Mechanical strength and flexibility.
   • Electrical signal integrity.
   • Image quality metrics (though specific metrics are not detailed).
   • Sterility.
   • Biocompatibility.

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, as there is no training set for an AI model.

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