(120 days)
The Excelsior XT-27 Microcatheter is intended to assist in the delivery of diagnostic agents (such as contrast media), therapeutic agents, and non- liquid interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.
The Excelsior® XT-27™ Microcatheter is a sterile, single lumen 0.027 in ID device with one tip marker designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the microcatheter hub is used for the attachment of accessories. One radiopaque tip marker is positioned at the distal tip of the device to facilitate fluoroscopic visualization. The Excelsior XT-27 Microcatheter is coated on the outer surface with Hydrolene™ coating which reduces friction during manipulation in the vessel.
The Excelsior XT-27 Microcatheters are available in effective lengths of both 135cm (53.1 inch) and 150 cm (59.1 inch), with two distal shaft configurations achieved through distal shaft lengths of 6 cm (XT-27 model) and 18 cm (XT-27 Flex model). Both straight tip and Pre-Shaped versions are available.
This document describes the Stryker Neurovascular Excelsior® XT-27™ Microcatheter and its 510(k) submission for market clearance. The submission relies on demonstrating substantial equivalence to predicate devices through a series of bench tests.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Excelsior XT-27 Microcatheter are largely based on demonstrating equivalence to the predicate devices (K000177, Renegade™ Hi-Flo™ Microcatheter and K042568, Excelsior® SL-10 Pre-Shaped Microcatheter). The "Result" column explicitly states "Met same criteria as predicate," indicating that the performance of the Excelsior XT-27 Microcatheter was found to be comparable to or better than the predicate devices for these specific tests.
| Test / Performance Metric | Acceptance Criteria (Implicitly based on Predicate) | Reported Device Performance |
|---|---|---|
| Visual Inspection | ||
| Durable Hydrophilic Coating | Performance comparable to predicate device | Met same criteria as predicate |
| Surface Defects | Performance comparable to predicate device | Met same criteria as predicate |
| Surface-Extraneous matter | Performance comparable to predicate device | Met same criteria as predicate |
| Dimensional Measurement | ||
| Kink Radius of Curvature / Proximal Shaft Kink | Performance comparable to predicate device | Met same criteria as predicate |
| Distal OD Reduction | Performance comparable to predicate device | Met same criteria as predicate |
| Tip Configuration | Performance comparable to predicate device | Met same criteria as predicate |
| Catheter Hub | Performance comparable to predicate device | Met same criteria as predicate |
| Corrosion Resistance | Performance comparable to predicate device | Met same criteria as predicate |
| Simulated Use: | ||
| Introduction | Performance comparable to predicate device in simulated use | Met same criteria as predicate |
| Tracking | Performance comparable to predicate device in simulated use | Met same criteria as predicate |
| Reposition / Deployment | Performance comparable to predicate device in simulated use | Met same criteria as predicate |
| Detachment | Performance comparable to predicate device in simulated use | Met same criteria as predicate |
| Overall Performance | Performance comparable to predicate device in simulated use | Met same criteria as predicate |
| Advancement / Retraction Force | Performance comparable to predicate device | Met same criteria as predicate |
| Biocompatibility Testing: | ||
| In-vitro Cytotoxicity, MEM Elution | Non-cytotoxic | Non-cytotoxic |
| Intracutaneous reactivity | Non-irritating | Non-irritating |
| Acute systemic toxicity, Injection | Non-toxic | Non-toxic |
| Sensitization, Guinea Pig Maximization | Non-sensitizing | Non-sensitizing |
| Hemocompatibility (Direct Contact; Complement Activation C3a and SC5b-9; PTT; blood cell counts and hemoglobin / hematocrit levels) | Non-hemolytic | Non-hemolytic |
| Materials Mediated Pyrogen levels, Rabbit test | Non-pyrogenic | Non-pyrogenic |
| USP impurities, | No significant impurities / Comparable to predicate | None |
| Latex test, ELISA Inhibition | No latex present / Comparable to predicate | None |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each of the bench tests. It also does not provide information about data provenance in terms of country of origin or whether the tests were retrospective or prospective. Given the nature of bench testing for a medical device, it is typically prospective, with samples of the device being manufactured and then tested in controlled laboratory environments.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. For bench testing, "ground truth" is typically established through adherence to test methodologies and specifications, often informed by engineering standards and regulatory guidance, rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
This information is not provided. As mentioned above, bench testing relies on objective measurements and predefined acceptance criteria rather than expert adjudication in the way clinical studies might.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This information is not applicable and not provided. The Excelsior XT-27 Microcatheter is a physical medical device (microcatheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance would not be relevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. As it is a physical medical device, there is no "algorithm only" performance to be evaluated in a standalone manner.
7. The Type of Ground Truth Used
The ground truth for most of these tests is established by:
- Engineering Specifications and Design Requirements: For dimensional measurements, kink radius, advancement/retraction force.
- Established Biomedical Test Standards: For biocompatibility tests (cytotoxicity, irritation, systemic toxicity, sensitization, hemocompatibility, pyrogenicity, USP impurities, latex). These standards define the methods and acceptance criteria for classifying a material as non-toxic, non-irritating, etc.
- Comparison to Predicate Device Performance: For many performance characteristics (e.g., visual inspection, simulated use), the "ground truth" for the new device is that its performance must be equivalent or superior to the already legally marketed predicate devices.
8. The Sample Size for the Training Set
This information is not applicable and not provided. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering iterations, but this is distinct from an algorithmic training process.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as point 8.
In Summary:
The document focuses on demonstrating substantial equivalence of the Excelsior® XT-27™ Microcatheter to its predicate devices through comprehensive bench testing. The acceptance criteria for most tests are implicitly or explicitly that the new device must perform comparably to (or better than) the predicate devices, or meet established safety and performance standards (especially for biocompatibility). The study design is largely a series of controlled laboratory tests performed on samples of the device. Aspects related to AI, human readers, or large-scale data training sets are not relevant to this type of device submission and therefore not included.
§ 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).