(27 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. 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 FDA 510(k) Summary describes a device (TracStar LDP Large Distal Platform, Zoom 88 Large Distal Platform, Zoom 88 Large Distal Platform Support) intended for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The submission is for a line extension and manufacturing process improvements, referencing a predicate device (K212224). Therefore, the study details provided are focused on demonstrating substantial equivalence to the predicate device, rather than a de novo clinical trial for a new product with absolute performance metrics against a disease state.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are based on the performance of the device against a set of predefined specifications derived from an existing standard (ISO 10555-1 for catheter performance) and internal engineering requirements. The reported device performance is simply "Pass" for all tested attributes, indicating that the subject device met these specifications.
| Test Attribute | Acceptance Criteria | 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 |
| 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 |
| Dimensional (Distal ID, Proximal ID, Distal OD, Proximal OD) | All defined catheter dimensions are within the specified tolerances. | 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 |
| Coating - Particulate and Integrity | The amount of particulate matter generated during simulated use testing shall be determined and compared to competitive products and techniques. There were no coating anomalies or significant wear observed post simulated use. | Pass |
| Coating – Lubricity and Durability | Coating must be lubricious with a specified average pull force. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each bench and laboratory test. It states that "Bench and laboratory (in-vitro) testing was completed" and references "simulated neurological model" and "simulated use testing," indicating an in-vitro experimental setting.
Data Provenance: The data is generated from in-vitro bench and laboratory testing conducted by the manufacturer, Imperative Care, Inc. The country of origin of this data is not explicitly stated, but it is implied to be internal testing. The data is retrospective in the sense that it evaluates the performance of the manufactured devices against pre-established specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. "Ground truth" established by experts (e.g., radiologists) is typically relevant for studies validating diagnostic or AI-driven devices against clinical outcomes or expert interpretation, such as in an MRMC study. This submission focuses on the physical and mechanical performance of a medical device (catheter) through bench testing.
4. Adjudication Method for the Test Set
Since the evaluation is based on objective measurements and predefined specifications in bench testing (e.g., absence of kinking, passage through a simulated model), there is no adjudication method as typically understood in clinical or expert-reviewed studies. The "Pass/Fail" results are determined by whether the device meets the quantitative and qualitative requirements of the test specifications.
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
No, an MRMC comparative effectiveness study was not done. This submission is for a percutaneous catheter, not an AI-driven or diagnostic device that involves human reader interpretation. Consequently, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. This device is a physical medical instrument (catheter), not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the pre-established physical and mechanical performance specifications laid out in the test attributes and derived from standards like ISO 10555-1 and internal engineering requirements. It is a benchmark of expected functional performance, rather than a clinical or pathological diagnosis.
8. The Sample Size for the Training Set
This question is not applicable as this is not a machine learning or AI-driven device. There is no concept of a "training set" for physical device performance testing.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as this is not a machine learning or AI-driven 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).