(63 days)
Stryker Neurovascular's Excelsior XT -17 Microcatheters are 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 neuro vasculature.
Stryker Neurovascular Excelsior® XT-17™ Microcatheters are single lumen devices 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. A radiopaque tip facilitates fluoroscopic visualization. Stryker Neurovascular hydrophilically coated Excelsior XT-17 Microcatheters are coated on the outer surface with Hydrolene® Coating that reduces friction during manipulation in the vessel. The Excelsior XT-17 Microcatheter is a single use device made of polymers, stainless steel, and Hydrolene® Coating, sterilized with Ethylene Oxide (EO) gas. Patient contact duration is less than 24 hours, and patient contact materials are polymers and Hydrolene® Coating. The Excelsior XT-17 Microcatheter is used in health care facility/hospital by physicians trained in performing endovascular procedures.
This document is a 510(k) summary for the Stryker Neurovascular Excelsior XT-17 Microcatheter, indicating its substantial equivalence to a predicate device. It is not a study that proves a device meets specific acceptance criteria in the way a clinical trial or a deep learning algorithm validation study would. Instead, it describes a product and compares it to a previously cleared product to show substantial equivalence.
Therefore, many of the requested categories (like sample size for test set, data provenance, ground truth establishment for training, MRMC studies, and standalone algorithm performance) are not applicable or cannot be extracted from this type of regulatory document.
However, I can extract information related to the performance data presented, which essentially serves as the "study" demonstrating the device meets the acceptance criteria of being substantially equivalent to the predicate device.
Here's a breakdown of the information that can be extracted from the provided text:
Acceptance Criteria and Device Performance:
The "acceptance criteria" here is that the modified device, the Excelsior XT-17 Microcatheter, has a safety and effectiveness profile similar to the predicate device (Tracker-17 Microcatheter) and raises no new questions of safety or effectiveness. The device performance is demonstrated through various verification tests.
| Acceptance Criteria (Demonstrated Similarity to Predicate) | Reported Device Performance (Verification Test Results) |
|---|---|
| Functionality (Overall) | Functional Testing (T=0) performed, assessing: |
- Tip Shape Retention
- Tip steam shape shrinkage
- Flexibility of the Distal Shaft
- Softness of the Distal Tip
- Tip shape retention (only applicable to Preshaped catheters)
- Surface defects along effective length
- Surface extraneous matter along effective length
- Static Rupture / Leakage under High Static Pressure
- Dynamic Burst
- Tensile Strength
- Catheter Hub
- Compatibility with DMSO
- Compatibility with Peel-away introducer sheath
- Proximal Fluoro-saver marker visibility |
| Biological Safety | Biocompatibility testing performed according to EN ISO10993-1:2009 + AC: 2010, comprising: - Cytotoxicity
- Hemolysis
- Physiochemical Test
- FTIR
- Latex |
| Shelf Life and Packaging Integrity | Shelf life testing (Product and Packaging) conducted.
Distribution/shipping Challenge Conditioning and Testing performed.
Packaging Verification Testing performed. |
| Risk Assessment | Risk assessment conducted in accordance with EN ISO 14971:2012 (Design and Use FMEAs). Conclusion: Modifications "raise no new questions of safety or effectiveness." |
| Technological Characteristics | Product feature comparison table shows most characteristics are "Same as predicate" or variations that do not alter safety/effectiveness (e.g., smaller hub, smaller distal OD, material without colorant). |
Here's how the other requested points align with the provided document:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in this document. The "test set" here refers to the samples of the device undergoing verification testing. The exact number of microcatheters tested for each functional, biocompatibility, and shelf-life test is not detailed.
- Data Provenance: Not specified. This is an internal regulatory submission by Stryker Neurovascular (Fremont, CA, USA). The testing would typically be performed internally or by contracted labs.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable as this is a medical device performance and safety verification, not an AI or diagnostic imaging study requiring expert ground truth consensus. The "ground truth" is established by adherence to established engineering, biocompatibility, and regulatory standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for clinical outcome or diagnostic performance studies, not for physical device testing.
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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 study was not done. This is a microcatheter, not a diagnostic or AI-assisted device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is a physical medical device, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this type of submission is adherence to established, recognized standards for medical device design, manufacturing, and performance (e.g., ISO standards for biocompatibility, material properties, and functional performance) and comparison to the predicate device's established safety and effectiveness.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning 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).