(43 days)
The Proxis System is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) (3.0 mm - 5.0 mm) during percutaneous transluminal coronary angioplasty and/or stenting procedures.
The Proxis System is also indicated to control the flow of fluids and aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature.
The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction. The device is not intended to be used as a thrombectomy system.
The Proxis System (Proxis Embolic Protection System) is a proximal embolic protection system used in conjunction with other interventional devices. The Proxis System protects the patient from distal embolization by preventing antegrade flow of emboli release during an interventional procedure and then removing it from the vessel. The Proxis System consists of an Evacuation Sheath Catheter (Proxis Catheter), Inflation device, Aspiration syringe, Lip Seal and Strainer basket.
In addition, an optional accessory called the Proxis Infusion Catheter (packaged separately) may be used with Proxis System.
In the stagnant flow, the guide wire is advanced across the lesion site and the interventional device is tracked over the guide wire. Upon completion of the interventional device procedure, fluid and particles from the procedure may be aspirated using the aspiration syringe. If there is insufficient venous or collateral flow, the Proxis Infusion Catheter (optional accessory) may be used to deliver saline distal to the treatment site while simultaneously applying vacuum to aspirate fluid and particles from the treatment site.
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the structure you requested:
Acceptance Criteria and Device Performance
This 510(k) submission for the Proxis System is for a minor modification (material change in the occluding balloon) to an already cleared device. Therefore, the "acceptance criteria" are not reported as specific performance metrics in this summary, but rather as meeting all previously established verification specifications. The device did not undergo a new clinical trial for this specific submission because the changes were deemed non-significant.
| Acceptance Criteria (Verification Specifications) | Reported Device Performance (for K073563) |
|---|---|
| Dimensional | Passed all verification specification criteria (as per K060651) |
| Strength | Passed all verification specification criteria (as per K060651) |
| Functional | Passed all verification specification criteria (as per K060651) |
| Packaging | Passed all verification specification criteria (as per K060651) |
| Sterilization | Passed all verification specification criteria (as per K060651) |
| Biocompatibility | Passed all verification specification criteria (as per K060651) |
| Shelf Life | Passed all verification specification criteria (as per K060651) |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is actually based on the previous clearances of the Proxis System (K060651 and K052523), not a new study for this specific submission (K073563).
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Sample size used for the test set and the data provenance: No new clinical test set was used for this 510(k) submission. The decision was made that "no additional animal or clinical data was deemed necessary" due to the non-significant nature of the modification. The original test data would have come from the studies supporting K060651 and K052523, but details like sample size, country of origin, or retrospective/prospective nature are not provided in this document.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this submission as no new clinical test data was generated. For the predicate device clearances, this information is not available in the provided text.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this submission.
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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 device is a medical instrument (an embolic protection system), not an AI-based diagnostic or imaging device used by human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for this submission. For the predicate device clearances, this information is not available in the provided text, but it would presumably involve a combination of in-vitro testing, animal studies, and potentially clinical trial outcomes demonstrating safety and effectiveness in preventing embolization.
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The sample size for the training set: Not applicable. This is not an AI/ML-based device that relies on a "training set."
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How the ground truth for the training set was established: Not applicable.
§ 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).