(59 days)
The TracStar LDP Large Distal Platform is indicated for the introduction of interventional devices into the peripheral. coronary, and neuro vasculature.
The Zoom 88 Large Distal Platform and Zoom 88 Large Distal Platform Support are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Imperative Care Large Distal Platform™ (LDP) Catheters include the Zoom™ 88 Large Distal Platform™, Zoom™ 88 Large Distal Platform™ Support, and TracStar™ LDP Large Distal Platform. The LDP Catheters are 0.038" diameter or smaller guidewire compatible single lumen guide catheters that provide access to peripheral, coronary and neuro vasculature. The catheters are comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. An angled distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. The LDP Catheters have an inner diameter (ID) of 0.088" (6F compatible), and a maximum outer diameter (OD) of 0.110". The LDP guide catheters are packaged with a rotating hemostasis valve (RHV) that is attached to the proximal luer to help maintain hemostasis.
This document describes the acceptance criteria and the study conducted to demonstrate that the TracStar™ LDP Large Distal Platform, Zoom™ 88 Large Distal Platform, and Zoom™ 88 Large Distal Platform Support devices meet these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The device is a medical catheter, and the performance evaluation involved a series of bench and laboratory (in-vitro) tests to ensure its safety and effectiveness. The acceptance criteria are "Pass" for all tested attributes, meaning the device met the specified performance requirements.
| Test Attribute | Specification | Reported Device Performance |
|---|---|---|
| Delivery, Compatibility, and Retraction (Trackability) | The catheter shall be able to be delivered, deployed, and retracted per the IFU within a simulated neurological model without incurring any damage to the catheter. | Pass |
| Tip Flexibility | The catheter distal tip flexibility shall be comparable to the predicate. | Pass |
| Visual Inspection | The catheter shall meet visual inspection criteria. The printing on the strain relief must be legible. | Pass |
| Dimensional (Distal ID, Proximal ID, Distal OD, Proximal OD) | All defined catheter dimensions are within the specified tolerances. | Pass |
| Catheter Bond Strength | The catheter shall have sufficient bond strengths to remain intact throughout a procedure. | Pass |
| Freedom from Leakage - Positive Pressure | The catheter must remain leak free under specified test conditions. | Pass |
| Freedom from Leakage - Negative Pressure | The catheter must remain leak free under specified test conditions. | Pass |
| Burst Pressure | The catheter must withstand pressure testing under dynamic flow conditions. | Pass |
| Static Burst | The catheter shall meet criteria for static burst pressure testing. | Pass |
| Catheter Torque Strength | With the catheter tip constrained from movement, the proximal end was rotated until failure. The catheter shall not be damaged when rotated at least two (2) full rotations (720 degrees). | Pass |
| Kink Resistance | There shall be no kinking of the catheter shaft around respective clinically relevant minimum bend radii in distal tip, medial and proximal locations. | Pass |
| Flexibility | The catheters need to have acceptable flexure values for tracking in the vasculature. | Pass |
| Proximal Shaft Stiffness | The stiffness of the proximal shaft was evaluated to ensure comparable stiffness to the predicate. | Pass |
| Delivery Force | The catheters shall not be too stiff or require excessive force to safely navigate and track to the target neurovasculature. | Pass |
| Compatibility with other Devices (External) | The catheters shall be able to be delivered through the minimum introducer sheath or guide catheter size indicated in the product labeling. | Pass |
| Guidewire Compatibility | The catheters shall be able to be delivered over the maximum size guidewire indicated in the product labeling. | Pass |
| Interventional Device Compatibility (internal) | The catheters shall be able to accommodate other interventional devices (e.g., support catheter, diagnostic catheter) up to the maximum size indicated in the product labeling. | Pass |
| Luer Compatibility | Devices and accessories shall be compatible with standard syringe luer fittings per ISO 80369-7. | Pass |
| Accessory Compatibility | Devices shall be compatible with an RHV. | Pass |
| Coating - Particulate | The amount of particulate matter generated during simulated use testing shall be determined and compared to competitive products and techniques. | Pass |
| Coating - Lubricity, Durability and Integrity | Coating must be lubricious with a specified average pull force. There were no coating anomalies or significant wear observed post simulated use. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each test attribute. The study relies on bench and laboratory (in-vitro) testing, which typically involves testing a defined number of device units or components to statistical significance or to demonstrate compliance with a specification. The data provenance is prospective as the testing was conducted specifically for this submission to evaluate the subject devices. The country of origin of the data is not explicitly stated but is implied to be where Imperative Care, Inc. conducts its R&D and testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the study involves bench and laboratory (in-vitro) testing of physical device properties against established engineering and performance specifications, not human interpretation of medical data. Therefore, there is no "ground truth" established by medical experts in this context.
4. Adjudication Method for the Test Set
Not applicable, as this was not a human-reader study requiring adjudication of expert opinions. The adjudication for bench testing is typically based on whether the test results meet or exceed the predefined pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems where human readers interpret medical images. The current submission pertains to the substantial equivalence of a medical catheter based on physical and mechanical performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the device described. The device is a physical medical catheter, not a software algorithm. The "standalone" performance refers to the physical and mechanical performance of the catheter itself, which was evaluated through bench and laboratory testing without human "in-the-loop" performance in the context of interpretation or decision-making.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is defined by established engineering and performance specifications based on standards such as ISO 10555-1, as well as internal design requirements. These specifications act as the objective criteria against which the device's performance is measured.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical catheter, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
§ 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).