(155 days)
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.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance |
|---|---|---|
| Product Specification | Meets performance requirements of the product specification. | "The Proxis System has been shown to meet the performance requirements of the product specification." |
| International Standards | ISO 10555 (Sterile, single-use intravascular catheter Part 1 & 4) | Complies |
| ISO 10993 (Biological evaluation of medical devices) | Complies | |
| ASTM D-4169 (Packaging Integrity Testing) | Complies | |
| ISO 11607 (Packaging for terminally sterilized medical devices) | Complies | |
| ISO 11135: 1994(E) (Validation and routine control of ETO sterilization) | Complies | |
| Physical/Mechanical Tests | Dimensional verification | Test results demonstrate device meets or exceeds requirements. |
| Balloon compliance and integrity | Test results demonstrate device meets or exceeds requirements. | |
| Catheter tensile strength | Test results demonstrate device meets or exceeds requirements. | |
| Torque strength | Test results demonstrate device meets or exceeds requirements. | |
| Flexibility and trackability | Test results demonstrate device meets or exceeds requirements. | |
| Substantial Equivalence | To the predicate device without hydrophilic coating (K023548), except for the addition of hydrophilic coating. | "The Proxis System with hydrophilic coating, ...is substantially equivalent to the Proxis System without hydrophilic coating (predicate device)..." |
| Intended Use | The addition of hydrophilic coating does not alter the intended use. | "The addition of the hydrophilic coating does not alter the intended use the Proxis System." |
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.
§ 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).