(66 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 is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Imperative Care Large Distal Platform (LDP) Catheters include the TracStar™ LDP Large Distal Platform and Zoom™ 88 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. LDP Catheters have an inner diameter of 0.088" (6F compatible), and a maximum outer diameter 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 premarket notification for the Imperative Care TracStar LDP Large Distal Platform and Zoom 88 Large Distal Platform, which are guide catheters. The submission is based on substantial equivalence to predicate devices, meaning extensive new studies were not required. The provided text details the acceptance criteria and study findings for this medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Attribute | Acceptance Criteria | Reported 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 |
| Flexibility and Kink Resistance | There shall be no kinking of shaft (permanent deformation) after simulated use. | 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 |
| Catheter Bond Strength | The catheter shall have sufficient bond strengths to remain intact throughout a procedure. | Pass |
| Freedom from Leakage – positive pressure | No liquid leakage from the hub or catheter shaft at 46psi for 30 seconds. | Pass |
| Freedom from leakage - negative pressure | No air leakage into a 20cc syringe when vacuum pulled for 15 seconds. | Pass |
| Dynamic Burst Pressure | Catheter does not burst under pressures that could be seen when performing contrast injections with a standard 10cc syringe. | Pass |
| Static Burst Pressure | Catheter does not burst under pressures that could be seen when performing contrast injections with a standard 10cc syringe. | Pass |
| Catheter Torque Strength | With the catheter tip held in a static position, there shall be no separation of any portion of the catheter when rotated at the hub at least two (2) full rotations (720 degrees). | Pass |
| Kink Resistance | There shall be no kinking of the catheter shaft (permanent deformation) after wrapping around anatomically relevant bend radii. | Pass |
| Pushability | The proximal shaft of the catheters shall have sufficient stiffness that the user can easily push the catheter to the target anatomy without buckling. | Pass |
| Access Force | Catheters shall not require excessive force to safely navigate and track to the target anatomy. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (number of units tested) for each individual bench and laboratory test. It generally refers to "bench and laboratory (in-vitro) testing." The data provenance is in-vitro, conducted in a laboratory setting. There is no information regarding country of origin of the data or if it was retrospective or prospective, as these terms typically apply to clinical studies with human participants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. For performance testing of a medical device like a catheter, "ground truth" is typically established by physical measurements, engineering specifications, and adherence to recognized standards (like ISO 10555-1), rather than expert consensus on interpretive data.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data (e.g., imaging) by multiple readers to resolve discrepancies. The performance tests described here are objective, pass/fail engineering tests.
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. The submission is for a medical device (catheter) and relies on bench and laboratory testing for substantial equivalence, not comparative clinical effectiveness with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to the device described. The TracStar LDP Large Distal Platform and Zoom 88 Large Distal Platform are physical guide catheters, not algorithms or AI software. Therefore, there is no "algorithm only" or "human-in-the-loop" performance to report.
7. The Type of Ground Truth Used
For the bench and laboratory tests, the "ground truth" is based on pre-defined engineering specifications and performance standards, particularly ISO 10555-1 for catheters. The results are objective measurements against these established criteria, leading to a "Pass" or "Fail" outcome.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical catheter, not an AI/ML algorithm that requires a training set. The substantial equivalence pathway relies on demonstrating that the new device performs similarly to a predicate device through bench testing, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a physical medical 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).