FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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. The Silk Road Access Catheter is a limited duration (

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device called the Silk Road Access Catheter. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel performance against acceptance criteria for a new type of device.

Therefore, the specific information requested in the prompt about acceptance criteria, detailed study results, sample sizes for test and training sets, expert qualifications, adjudication methods, and standalone/MRMC studies is not directly applicable or available in this document.

This document describes a regulatory submission where the goal is to show the new device (Subject Device) is as safe and effective as an existing, legally marketed device (Predicate Device), not to establish new performance benchmarks.

However, I can extract information regarding the performance testing conducted to support the substantial equivalence claim.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with explicit acceptance criteria and corresponding numerical performance results for the Subject Device. Instead, it lists the types of tests performed and states that these tests demonstrate "substantial equivalence." For biocompatibility, it states "The battery of tests included the following tests," and for animal studies, it mentions "the safety acceptance criteria for the studies were met." This implies the tests were successfully passed, but specific quantitative criteria and results are not detailed.

2. Sample size used for the test set and the data provenance:

Biocompatibility Tests: The document lists various biocompatibility tests (e.g., Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility, Genotoxicity, Pyrogenicity). However, it does not specify the sample sizes used for these tests.
Bench Testing: A comprehensive list of bench tests is provided (e.g., Visual Inspection, Coating Particulate, Leakage, Kink Resistance, Burst, Radiopacity, Shelf Life). Again, no sample sizes for these tests are mentioned.
Animal Studies: A "GLP animal study was previously performed to evaluate the safety, performance and handling of the Predicate Device in the canine model." The sample size for this animal study is not specified.
Data Provenance: The studies were internal testing, likely conducted by the manufacturer or contracted labs, as part of the regulatory submission process. The document does not specify country of origin for the data or whether the data was retrospective or prospective, though regulatory testing like this is typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The document refers to "acceptance criteria" being met for the animal study, but does not detail how ground truth for any of the non-clinical tests was established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided in the document.

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 is a non-clinical device that does not involve "human readers" or "AI assistance" in the context of diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not an AI/algorithm-based device. Therefore, this type of standalone performance study is not applicable and was not performed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For Biocompatibility, ground truth is typically assessed against established ISO standards and biological responses (e.g., cell viability, immune reaction indicators, blood compatibility parameters).
For Bench Testing, ground truth is based on engineering specifications and performance limits defined by relevant standards (e.g., ISO 10555-1) and internal design requirements.
For Animal Studies, ground truth for safety and performance was based on "pathology and histopathology results" and "performance and handling observations" by a clinician in the canine model.

8. The sample size for the training set:

This information is not applicable as this is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable as this is not an AI/machine learning device that requires a training set.

Summary of Device and Performance Testing:

The Silk Road Access Catheter is a sterile, single-use percutaneous catheter. The regulatory submission (K143459) aims to demonstrate its substantial equivalence to a previously cleared predicate device (K130649).

The performance data to support this claim includes:

Biocompatibility Testing: Conducted according to FDA Blue Book Memorandum #G-95-1 and ISO 10993-1, covering Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility, Genotoxicity, and Pyrogenicity. The document states that the device is considered an externally communicating medical device with circulating blood contact for less than 24 hours. No specific quantitative results or sample sizes are provided for these tests, only that an evaluation was conducted.
Bench Testing: A comprehensive set of engineering tests were performed, including Visual Inspection, Dimensional Verification, Coating Particulate, Coating Integrity, Liquid Leakage, Air Leakage, Kink Resistance, Torsion, Guidewire Advancement and Withdrawal Force, Burst, Bending Stiffness, Aspiration Rate, Flush Rate, Tensile Test, Corrosion, Radiopacity, Simulated Preparation and Use, and Shelf Life. These tests aim to verify the physical and mechanical properties of the device. No specific quantitative results or sample sizes are provided.
Animal Studies: A GLP animal study was "previously performed to evaluate the safety, performance and handling of the Predicate Device in the canine model." The document states that based on pathology and histopathology results, "the safety acceptance criteria for the studies were met," and "No untoward observations were found by the clinician." The rationale is that since the subject device has the same basic design and fundamental technology as the predicate, the predicate's animal study results are applicable. No specific sample size for the animal study is mentioned.
Clinical Performance Testing: The document explicitly states, "The Predicate Device was cleared based on the results of only non-clinical testing, therefore, only non-clinical testing was required to support substantial equivalence." No clinical performance testing was conducted or required for this 510(k) submission.

In conclusion, this regulatory document focuses on establishing substantial equivalence through non-clinical testing (biocompatibility, bench testing, and reliance on previous animal studies for the predicate device). It does not provide the detailed acceptance criteria and performance data in a format suitable for the requested table, nor does it involve the types of studies (MRMC, standalone AI) or expert-based ground truth establishment typically associated with diagnostic AI/software devices.

Summary

Regulation Number and Section

§ 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).