(235 days)
The Silk Road™ Access Catheter is indicated for the introduction of interventional devices into the peripheral vasculature.
The Silk Road Access Catheter is a sterile, non-pyrogenic, single-use access catheter indicated for introduction of interventional devices into the peripheral vasculature. The Silk Road Access Catheter is a single-lumen, coil-reinforced shaft, variable stiffness catheter in a range of diameters and working lengths to accommodate target anatomy. All sizes contain a radiopaque marker on the distal end and a catheter hub on the proximal end. The catheter shaft has a hydrophilic coating on its distal portion to reduce friction during use. The catheter is offered with a dilator in all but the smallest size (SR-045-AC). The Silk Road Access Catheter is a limited duration (
The Silk Road™ Access Catheter underwent a series of non-clinical tests to demonstrate its safety and effectiveness. The acceptance criteria and reported device performance are summarized below:
1. Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection and Dimensional Verification | All samples must pass visual and dimensional inspection specifications. | Pass |
| Simulated Prep and Use | All samples must be able to be prepped and used per the IFU. | Pass |
| Coating Particulate | All samples must track through the track fixture and meet USP 788 microscopy method. | Pass |
| Coating Integrity | All samples must easily track through the track fixture. | Pass |
| Guidewire-Microcatheter Advance/Withdrawal Force | All samples must pass advancement and withdrawal force. | Pass |
| Bonding Stiffness | Characterize Bend Stiffness. | All samples are acceptable. |
| Aspiration Rate | Characterize Aspiration Rate. | All samples are acceptable. |
| Flush Rate | Characterization Flush Rate. | All samples are acceptable. |
| Tensile Test | All bonds must withstand a set force dictated by the device outer diameter for all samples. | Pass |
| Shaft Kink Resistance | The distal and proximal shaft must not kink around the bend for all samples. | Pass |
| Torsion Test | All samples shall show no evidence of damage (kinking, flattening, separation) to any joints or bonds. | Pass |
| Liquid Leakage | All samples shall show no water leaks large enough to form a falling drop over the entire device. | Pass |
| Air Leakage | All samples shall show no bubbles are present. | Pass |
| Luer Functional Testing | All samples shall meet the requirements of ISO 594-2 (gauging, separation force). | Pass |
| Biocompatibility | ||
| Cytotoxicity (MEM Elution L-929) | The test article passes if the mouse fibroblast cells do not display signs of toxicity after examination at 24, 48, and 72 hours. | The test article scored '0' at 24, 48, and 72 ± 4 hours, considered non-cytotoxic. |
| Sensitization (Maximum Sensitization, Guinea Pig) | The test article passes if the animals do not have signs of a delayed allergic response after being exposed to the test extract when compared to a control group. | No sensitization response greater than '0' was observed in animals challenged with test article extracts, considered non-sensitizing. |
| Irritation (ISO Intracutaneous Reactivity Test) | The test article passes if the difference between the mean scores for the test article extract and control are less than or equal to 1.0. | Differences in mean test and control scores of dermal observations were less than 1.0, meeting test requirements. |
| Systemic Toxicity (ISO Acute Systemic Injection) | The test article passes if the animals exposed to the test article extract do not show signs of toxicity greater than the concurrent control groups over a 72 hour period. | No clinical signs of toxicity were observed in treated animals, and body weight changes were acceptable. |
| Systemic Toxicity (Material Mediated Pyrogen) | The test article passes if the animals exposed to the test article extract do not show a significant increase in body temperature over a 3 hour period. | No temperature rise of 0.5 °C at required observation times, determined to be non-pyrogenic. |
| Hemocompatibility (Four Hour Thromboresistance Evaluation in Dogs) | 1) Test animals survive general anesthesia and study observation interval without test article complications; and 2) blood test results, pre/post weight differences, and patency and thrombus scores are not subjectively different between the test and control articles. | Implantation in two canines resulted in no adverse effects or significant thrombus formation; blood tests and clinical observations indicated no compromise in clotting abilities. Similar thromboresistance characteristics to control devices. |
| Hemocompatibility (Complement Activation C3a and SC5b-9) | The test article passes if complement activation in human plasma (C3a Assay and SC5b-9) is not induced significantly when compared with the comparison article. | All biomaterials have the potential to affect complement components; no established acceptable ranges. Test article and comparison article showed similar activation levels. |
| Hemocompatibility (Platelet and Leukocyte Count) | The test article passes if the counts are not statistically and adversely significant compared to the reference material and comparison article. | Test article groups and comparison article showed platelet and leukocyte counts within a reasonable percentage of reference material. All biomaterials have the potential to affect blood components; no established acceptable ranges. |
| Hemocompatibility (Partial Thromboplastin Time (PTT)) | The test article passes if the PTT is not significantly shortened following contact with a material under standardized conditions. | Both test article groups and the comparison article had an average clotting time of 300.0 seconds (100% of negative control), indicating non-activation of the intrinsic coagulation pathway. |
| Hemocompatibility (Hemolysis - Direct Contact and Extract (ASTM F 756)) | The test samples are rated per the hemolytic index above the negative control. If 0 – 2%, classified as non-hemolytic, if 2.1-5%, classified as slightly hemolytic, and if ≥5.1%, classified as hemolytic. | Test article returned hemolytic index values equal to or lower than the negative control, falling within the non-hemolytic range for both direct contact and extract tests. |
| Genotoxicity | ||
| Bacterial Mutagenicity Test (Ames Assay) | The test article passes if the criteria for positive mutagen are not met. | The test article did not induce substantial increases in reversion rates associated with mutagenesis; no substantial toxicity noted. Considered non-mutagenic. |
| In Vitro Mouse Lymphoma Assay | The test article passes if the mutant frequency is less than 1.8 fold higher than that of the concurrent negative control groups. | Mutant frequencies and cloning efficiencies were within limits for a negative response. Considered non-mutagenic (non-genotoxic and non-clastogenic). |
| In Vivo Mouse Micronucleus Assay | The test article passes if it does not show a significant increase in the number of micronucleated polychromatic erythrocytes. | No apparent gross manifestations of toxicity nor biologically significant erythropoietic disturbances. No biologically significant increases in mPCE production. Considered non-mutagenic. |
| Packaging Validation | Packaging must maintain product sterility and protect the product during shipment and storage. | Pass |
| Sterilization Validation | Silk Road Access Catheter must be validated ISO 11135-1:2007. | Pass |
| Shelf Life | Silk Road Access Catheter must perform to specification and the package must maintain a sterile barrier during the shelf-life period as labeled on the product label. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each non-clinical test beyond phrases like "all samples" or mentioning "replicates" for certain biocompatibility tests. For the animal study, it mentions "two canines" for the Hemocompatibility (Four Hour Thromboresistance Evaluation) test.
The data provenance is not explicitly stated. These appear to be laboratory test results conducted by the manufacturer or contracted labs for the purpose of regulatory submission. The studies are non-clinical, meaning they were performed in a lab or animal setting, not on human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the studies are non-clinical (laboratory and animal studies) and do not involve human interpretation of medical images or data requiring expert consensus or clinical evaluation of ground truth. The "ground truth" for these tests is based on established scientific and regulatory standards in material science, engineering, and toxicology.
4. Adjudication Method for the Test Set
This is not applicable as the studies performed are non-clinical and do not involve human diagnostic decisions or require adjudication for consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (access catheter) and focuses on non-clinical performance, safety, and biocompatibility, not on diagnostic accuracy or reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical medical instrument (an access catheter), not a software algorithm, so "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for these non-clinical tests is based on:
- Established specifications and standards: e.g., "All samples must pass visual and dimensional inspection specifications," "meet USP 788 microscopy method," "meet the requirements of ISO 594-2," "validated ISO 11135-1:2007."
- Biological responses as defined by assays and protocols: e.g., "mouse fibroblast cells do not display signs of toxicity," "animals do not have signs of a delayed allergic response," "no significant increase in body temperature."
- Physical and mechanical measurements: e.g., "advancement and withdrawal force," "bend stiffness," "aspiration rate."
- Pathology and histopathology results: from the GLP animal study.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical instrument, not an AI or machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
§ 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).