Search Results

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 Proxis Embolic Protection System is used in conjunction with other percutaneous transluminal coronary angioplasty devices (PTCA). It is compatible with 8F guide catheters. The Proxis System protects the patient from distal embolization by preventing antegrade flow of emboli released during a PTCA and then removing it from the vessel. The Proxis System consists of an Evacuation Sheath Catheter, Accessory Pack (contains an inflation system, evacuation syringe and double y-adaptor) and an optional additional accessory called the Proxis Infusion Catheter (packaged separately).

The Evacuation Sheath Catheter is loaded into the hemostasis valve and tracked down to the distal portion of the guide catheter. The Evacuation Sheath lines the inner lumen of the distal end of the guide catheter. When the sealing balloons are inflated, the proximal balloon seals against the guide catheter wall and the distal balloon seals against the blood vessel wall and the antegrade flow of the fluid in the target vessel is stopped. The stagnation of flow is accomplished before any devices touch or cross the lesion(s). This minimizes the distal release of embolic material.

Interventional devices are passed through the evacuation sheath to the treatment site and the procedure is performed in stagnant fluid. After the procedure, fluid and particles from the procedure are evacuated using the Evacuation Syringe. The Proxis Infusion Catheter may be used to augment the retrograde flow during the evacuation by infusing saline distal to the treatment site while simultaneously applying vacuum to evacuate fluid and particles from the treatment site.

This document describes the Proxis System, an embolic protection device, and the study supporting its expanded indications. Here's an analysis of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the "Proximal Trial" which assessed the safety and effectiveness of the Proxis System for embolic protection. The primary acceptance criterion appears to be non-inferiority in the 30-day Major Adverse Cardiac Event (MACE) rate compared to existing distal protection devices.

Interpretation: The reported performance of the Proxis System (9.2% MACE in the test arm) and the control arm (10.0% MACE) demonstrates a difference of -0.8% (Proxis

Ask a specific question about this device

The Premere™ Delivery Sheath is indicated for use in intravascular introduction of therapeutic devices into the left atrium of the heart through the septal wall.

The Premere™ Delivery Sheath consists of a non-tapered catheter introducer and an obturator. The distal portion is tapered to facilitate positioning and crossing the atrial septum. The Premere™ Delivery Sheath is intended to provide a pathway for introduction of therapeutic devices into the right and left atrium.

The delivery sheath is fitted with a hemostasis valve at the proximal end to allow insertion of devices while minimizing blood loss and a side port with a three-way stopcock for infusion, blood sampling and pressure monitoring. The sheath is provided with a stainless steel braid and a radiopaque material on outer jacket with a high-contrast radiopaque marker at the tip.

The obturator is radiopaque with a tapered tip and is compatible with a 0.038" guiding wire.

The provided text does not contain information about acceptance criteria and a study proving a device meets them. The document is a 510(k) summary for the Premere™ Delivery Sheath, which describes the device, its indication for use, and claims substantial equivalence to predicate devices. It also lists performance data that was provided in the 510(k) submission, including various ISO standards and specific tests (dimensional verification, tensile strength, leak/burst), and in-vivo testing in a swine model. The FDA's letter states that the device is substantially equivalent based on the provided information.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information. This type of detailed study information is typically found in the full performance data sections of a 510(k) submission, which are often not publicly available in this summarized format.

Ask a specific question about this device

The Proxis System controls the flow of fluids in the coronary and periphery vasculature. This is achieved by the temporary occlusion of vessels and holding the column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control device is not indicated for use for embolic protection.

The Proxis System has four major components: The Evacuation Sheath Catheter, the Inflation System, Infusion Catheter, and an Evacuation syringe.

The Evacuation Sheath Catheter has two low-pressure compliant sealing balloons that are inflated simultaneously. The proximal balloon stays within the guide catheter while the distal balloon resides in the arterial vessel. Radiopaque markers at the two balloon sites facilitate visualization and intravascular placement of the catheter prior to inflation. The Evacuation Sheath has sufficiently large inner diameter to accommodate standard therapeutic devices within its size range. The balloons are inflated using the Inflation Svstem.

Devices can be deployed through the Evacuation sheath to the target site before, during or after the sealing balloons are inflated to occlude the vessel. Infusing ~0.5cc of contrast dye through the guide catheter will produce a continuous "roadmap" of the lesion as an aid for the physician in guiding the therapeutic device to the lesion site.

Alternatively, while the vessel is occluded, therapeutic solutions like anticoagulant, cardioplegia and thrombolytics may be infused through the guide catheter and stagnated in the target vessel/lesion during the delivery of the therapeutic device or after the deployment of the therapeutic device.

The Evacuation syringe is provided for the removal of the fluid and the emboli/thrombi during aspiration. The infusion catheter may be used to infuse saline to augment the retrograde flow of fluid and the removal the emboli/thrombi.

This document describes a 510(k) premarket notification for the Velocimed Proxis System, a percutaneous catheter. The submission primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain a study demonstrating device performance against specific acceptance criteria for diagnostic or clinical effectiveness. Instead, it describes compliance with various performance requirements and standards for medical devices.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document does not present specific acceptance criteria in a quantitative table format for clinical performance or diagnostic accuracy. Instead, it lists broader performance requirements and compliance with international standards for medical devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes performance testing of the device, primarily focusing on physical and mechanical properties, and biological safety. It does not describe a clinical study with a "test set" in the context of diagnostic accuracy or clinical effectiveness on patients. Therefore, information on sample size, data provenance, and study design for such a "test set" (e.g., patient data) is not applicable or provided in this submission for this type of device. The testing described would typically involve laboratory-based testing of device units.

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 information is not applicable as the document does not describe a study involving expert-established ground truth on patient data for diagnostic or clinical performance. The "ground truth" for the performance tests described (dimensional, tensile, etc.) would be established by engineering specifications and objective measurements against those specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there is no mention of a "test set" requiring expert adjudication for clinical or diagnostic outcomes.

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 information is not applicable. The Proxis System is a medical device (a catheter) for controlling fluid flow and temporary occlusion, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The Proxis System is a physical medical device, not an algorithm, and therefore does not have a "standalone" algorithmic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Given the nature of the device and the performance data described, the "ground truth" would be based on:

• Engineering specifications and objective physical measurements for dimensional verification, balloon compliance, tensile strength, torque, flexibility, and trackability.
• Established biological testing protocols for ISO 10993 (biological evaluation).
• Standardized testing procedures for packaging integrity and sterilization validation.

8. The sample size for the training set

This information is not applicable. The Proxis System is a physical medical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This information is not applicable for the reasons stated in point 8.

Ask a specific question about this device

The Venture™ Wire Control Catheter is indicated for directing, steering, controlling, and supporting a guide wire to access discreet regions of the coronary and peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.

The Venture Wire Control Catheter is a single use, over-the-wire support catheter with a radiopaque deflectable tip. A rotating knob at the handle controls the tip deflection angle. The tip can be deflected continuously up to about 90° from the catheter axis. The device is compatible with all 0.014" guidewires. It is torqueable and can be use to instantaneously shape, and control the curvature of the guidewire while in use as well as provide support to the guidewire when needed. A luer attachment is also provided to allow for the manual injection of dye through the guidewire lumen of the catheter

The provided text describes a 510(k) premarket notification for a medical device, the Venture Wire Control Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specified acceptance criteria and detailed performance metrics as one might find for novel device applications.

Therefore, the requested information elements related to detailed acceptance criteria, specific performance metrics, and studies proving these criteria are largely not present in the provided document. The submission primarily relies on demonstrating that the new device has "the same indication for use, principles of operation, and technological characteristics" as a previously cleared predicate device (Venture Wire Control Catheter K040922) and that any differences "do not raise new questions of safety or efficacy."

However, I can extract the available information and indicate where details are missing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document mentions "performance test data" and "test results" but does not detail the number of units tested.
• Data Provenance: Not specified. The performance tests are likely laboratory bench tests and material tests conducted by the manufacturer (Velocimed Inc.) in Minneapolis, MN, where the company is located. There is no indication of clinical studies, human subject data, or country of origin for such data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable. The ground truth for the engineering and material tests would be established by the specifications of the referenced ISO and ASTM standards, not by clinical expert consensus.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. The "test set" here refers to engineering and material tests, which are objective and do not require expert adjudication for ground truth.

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

• MRMC Study: No. This is a medical catheter and not an AI-powered diagnostic device, so an MRMC study is not relevant or described.
• Effect Size of AI: Not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: The ground truth for the performance data mentioned (biocompatibility, sterilization, packaging, catheter performance) is based on international and national standards (ISO 10555, ISO 10993-1, ASTM D-4169, ISO 11607, ISO 11135). The "truth" is whether the device meets the objective requirements and specifications outlined in these standards.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This submission is for a physical medical device, not a machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set mentioned or implied.

Ask a specific question about this device

The Venture™ Wire Control Catheter is indicated for directing, steering, controlling, and supporting a guide wire to access discreet regions of the coronary and peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.

The Venture Wire Control Catheter is a single use, over-the-wire support catheter with a radiopaque tip that can be deflected continuously up to about 90° from the catheter axis. The device is compatible with all 0.014" guidewires. It is torqueable and can be use to guide the guidewire while in use as well as instantaneously shape, and control the curvature of the guidewire when needed. A luer attachment is also provided to allow for manual delivery of saline solution or diagnostic contrast agents through the guidewire lumen of the catheter.

This request is outside the scope of my current capabilities. I am a language model and cannot interpret images or process visual information from the provided text. I lack the ability to process the image/page/2/Picture/11 description to extract information.

Ask a specific question about this device