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The indication for use for the stand-alone Export Catheter is:

The Export Aspiration Catheter is indicated for use with the GuardWire Temporary Occlusion and Aspiration System in coronary saphenous vein bypass grafts to:

• · Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
• · To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
• · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

When the Export Catheter is packaged with a GuardWire Temporary Occlusion and Aspiration System, the device will be marketed under the indications for use of that system.

When the Export Catheter is included in the GuardWire 2.5-5 Temporary Occlusion and Aspiration System this system will be labeled as shown below:

The PercuSurge GuardWire Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts (2.5-5.0mm) to:

• · Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
• To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
• · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
• · The safety and effectiveness of the device as an embolic protection system has not been established in treating patients with acute myocardial infarction.
• · The safety and effectiveness of the device as an embolic protection system has not been established in treating native coronaries.

When the Export Catheter is included in the GuardWire 3-6 Temporary Occlusion and Aspiration System the indications for that system will be labeled as shown below:

The PercuSurge GuardWire Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to:

• · Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
• · To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
• · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

The Export Catheter is a single lumen catheter that has guidewire access holes on the distal end of the catheter that mimic a single operator guidewire rail. This design, called the "Dual-Trak single lumen" is best described as a single lumen catheter that has wire entry and exit holes on the distal segment of the catheter. This allows a single lumen catheter to be advanced over a wire without the need for a separate wire lumen. The result is a single lumen catheter that has a smaller outer diameter compared to a dual lumen catheter yet can be advanced over a wire like a dual lumen catheter. To accomplish this feature the distal segment of the catheter is distorted so that the catheter in this portion is no longer round.

The access holes are carefully formed in the tip section. This allows the GuardWire to be placed in the distal tip and exit the catheter a short distance down the shaft, thus forming a small rail for the catheter to track over. An aspiration syringe is provided, as is an aspiration line. These are attached to the proximal end of the Export to facilitate blood and debris being evacuated from the site into the syringe.

This document describes a 510(k) premarket notification for the "Export Aspiration Catheter." It is a submission for a medical device seeking clearance based on substantial equivalence to existing legally marketed predicate devices, rather than a study demonstrating performance against specific acceptance criteria for a new AI/software-based device.

Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, MRMC study, standalone performance, etc.) is not applicable to this type of regulatory submission.

This document focuses on:

• Identifying Information: Submitters, contact person, classification, proprietary name.
• Predicate Devices: Listing previously cleared devices to which the current device is compared for substantial equivalence.
• Description: Explaining the mechanical design of the catheter, particularly its "Dual-Trak single lumen" feature.
• Intended Use: Specifying the medical procedures and anatomical locations for which the catheter is indicated, both as a standalone device and as part of the GuardWire Temporary Occlusion and Aspiration System. It also explicitly states limitations (e.g., not established for cerebral, carotid, peripheral vasculature, acute myocardial infarction, or native coronaries).
• Technology: Stating that the device uses similar manufacturing, processes, and materials as predicates and that its intended use has not changed.
• Bench Testing: Mentioning "in vitro bench testing" to determine substantial equivalence but without providing specific criteria or results.

In summary, there is no discussion of acceptance criteria, device performance metrics, or a study design to prove the device meets such criteria in the context of AI or software performance in this document. The document is a standard 510(k) filing asserting equivalence to existing devices for a physical medical catheter.

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The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts (2.5-5.0mm) to:

• Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
• To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
• The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
• The safety and effectiveness of the device as an embolic protection system has not been established in treating patients with acute myocardial infarction.
• The safety and effectiveness of the device as an embolic protection system has not been established in treating native coronaries.

The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System provides temporary vascular occlusion during diagnostic and interventional procedures in the coronary vasculature, specifically-diseased coronary bypass grafts. It is comprised of four principal components: the GuardWire Temporary Occlusion Catheter, the MicroSeal Adapter, the EZ Flator Inflation Device and the Export Aspiration Catheter. The GuardWire Plus System is a sterile, single-use disposable device.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the PercuSurge GuardWire Plus Temporary Occlusion and Aspiration System primarily establishes substantial equivalence to a predicate device rather than defining new, specific acceptance criteria for performance metrics in a standalone study. Therefore, the "acceptance criteria" are implicitly met by demonstrating comparable safety and efficacy to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Description: The "clinical performance data" presented is a summary of results from a sub-group analysis of the SAFER study (IDE G980209, cleared under 510(k) K003992). This study was conducted on the predicate device, the GuardWire 3-6 Temporary Occlusion and Aspiration System, and the data is used to support the equivalence of the new device (GuardWire Plus 2.5-5.0mm) for smaller vessel sizes.
• Sample Size:
  • Total GuardWire patients in SAFER study: N=406
  • Total vessels treated: N=417
  • Total lesions treated: N=442
  • Lesions sized at 3.0mm or less: 113 lesions
  • Patients with Reference Vessel Diameter (RVD) < 3mm: N = 111 patients (used for the efficacy analysis presented in Table 2)
• Data Provenance: The document does not explicitly state the country of origin. However, IDE studies approved by the FDA are typically multi-center clinical trials conducted primarily within the United States. The data is retrospective in the sense that this 510(k) is using previously collected data from an already-cleared device's clinical trial (SAFER study) to support the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The 510(k) summary does not provide information on the number of experts used to establish the ground truth for the SAFER study data, nor does it specify their qualifications. Clinical trial endpoints like MACE (Major Adverse Cardiac Events) are typically adjudicated by clinical Event Adjudication Committees composed of qualified medical professionals, but this detail is not present in the provided text.

4. Adjudication Method for the Test Set

The 510(k) summary does not specify the adjudication method (e.g., 2+1, 3+1, none) used for the SAFER study's clinical endpoints.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (catheter system), not an AI algorithm or a diagnostic imaging device that would typically involve MRMC studies. The "effectiveness" is shown through clinical outcomes of the device itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone study (in the context of an algorithm's performance) was not done. This device is a physical medical instrument (catheter system) and its performance is inherently linked to human use in a medical procedure.

7. The Type of Ground Truth Used

The "ground truth" for the SAFER study data (used to support this 510(k)) is based on clinical outcomes data related to patients undergoing the cardiac procedures, specifically:

• Major Adverse Cardiac Events (MACE): Death, Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), Target Lesion Revascularization (TLR), and Target Vessel Revascularization (TVR). These are hard clinical endpoints observed in patients.
• Quantitative Coronary Angiography (QCA): Used to determine Reference Vessel Diameter (RVD). QCA measurements are typically performed by trained experts, though it's not explicitly stated if consensus methods were used.

8. The Sample Size for the Training Set

The concept of a "training set" is not directly applicable here. This 510(k) is for a device, not an AI algorithm. The closest equivalent would be the development and testing phases of the device, which would involve bench testing and in-vitro simulated use, but not a "training set" in the machine learning sense. The clinical data presented is for the predicate device's performance, not for training this specific device, but rather for demonstrating its equivalence.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI algorithm, this question is not applicable. The device's design and manufacturing are based on established engineering principles and internal testing (bench testing, in-vitro simulated use) to ensure performance specifications are met.

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