(22 days)
The Excelsior SL-10 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.
The Excelsior SL-10 Microcatheter is a single lumen device designed to aid the physician in accessing distal vasculature when used with a guide catheter and guidewire. The device shaft is comprised of graded materials of varying durometers, from a flexible tip to a semirigid proximal end. Stainless steel wire reinforcement provides for strength during torque transmission while the inner liner provides for lubricity. The hub / strain reliefs provide for kink resistance from the proximal end. A luer fitting on the catheter hub is used for the attachment of accessories. The radiopaque tip with one or two markers allows for visualization under fluoroscopy. The outer surface is coated with a hydrophilic coating which reduces friction during navigation in the vasculature. A steam shaping mandrel accessory is packaged with the catheter.
This submission describes the Excelsior™ SL-10 Microcatheter. The manufacturer is seeking substantial equivalence to existing predicate devices based on in vitro performance testing.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly provide a table of acceptance criteria with specific thresholds. Instead, it states that "All testing indicates that the device is safe and performs according to its intended use." This is common for predicate device comparisons where the performance is expected to be at least equivalent to the predicate, rather than meeting a specific numerical benchmark.
However, based on the testing mentioned, we can infer the performance aspects evaluated:
| Performance Aspect | Reported Device Performance |
|---|---|
| Dimensional Inspection | Performed, implied to meet specifications |
| Tensile Strength | Performed, implied to meet safety and function |
| Burst Pressure | Performed, implied to meet safety and function |
| Flow Rate | Performed, implied to meet efficacy requirements |
| Withdrawal Force Testing | Performed, implied to meet safety and function |
| Biocompatibility | Confirmed according to ISO-10993 |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample sizes used for the in vitro performance tests. The data provenance is not explicitly stated as retrospective or prospective, nor are countries of origin mentioned. However, since these are in vitro performance tests, they are typically conducted in a laboratory setting by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth for this device is established through objective in vitro measurements and comparison to predicate devices, rather than expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" is based on objective measurements and established standards (like ISO-10993) and comparison to predicate devices, not subjective expert reviews requiring adjudication.
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
Not applicable. This is a medical device (microcatheter), not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims is based on:
- Objective Measurements: Results of the in vitro performance tests (dimensional, tensile, burst, flow rate, withdrawal force).
- Established Standards: Biocompatibility verified according to ISO-10993.
- Predicate Device Equivalence: The primary "ground truth" for regulatory clearance is substantial equivalence to the legally marketed predicate devices (Tracker-10 Microcatheter and Excelsior 1018 Microcatheter) in terms of functionality, intended use, design, materials, and method of operation.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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).