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The Route 92 Medical Full Length 070 Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.

The Route 92 Medical Full Length 070 Access System is comprised of a Support Catheter and a Delivery Catheter. The Support Catheter is a single-lumen, variable stiffness catheter. The Delivery Catheter is a hubbed, single-lumen variable stiffness catheter. Both catheters are hydrophilically coated. The devices are provided sterile and non-pyrogenic and are intended for single use only.

The Route 92 Medical Full Length 070 Access System is a medical device that facilitates the insertion and guidance of microcatheters in the neurovascular system. The provided document focuses on demonstrating the substantial equivalence of the device to a predicate device (Route 92 Medical Full Length 088 Access System, K210635) through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes various performance tests conducted, with the general acceptance criterion being that "All samples met the pre-determined acceptance criteria." While specific numerical acceptance criteria are not detailed in this summary, the results consistently indicate "PASS" for all tests.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the numerical sample size used for each test. Instead, it generally refers to "All samples." The provenance of the data is not specified regarding country of origin or whether it was retrospective or prospective. Given that it's non-clinical performance testing for a 510(k) submission, it's highly probable these were controlled laboratory tests conducted prospectively by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This section is not applicable to this document. The study described is non-clinical performance testing of a physical medical device, not a study involving human interpretation of medical data where expert ground truth would be required. The "ground truth" for these tests are the established engineering specifications and international standards (e.g., ISO standards).

4. Adjudication Method for the Test Set:

This section is not applicable for the same reasons as point 3. Testing involves objective measurements against pre-defined engineering and performance criteria, not expert adjudication of subjective findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing of the device itself, not on evaluating the performance of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This section is not applicable. The device is a physical catheter system, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical performance tests conducted for the Route 92 Medical Full Length 070 Access System is based on pre-determined acceptance criteria derived from established engineering specifications and relevant international standards (e.g., ISO standards). For example, Luer integrity was tested per ISO 80369-7:2016, and air/liquid leakage and static burst per ISO 10555-1:2013. Simulated use testing evaluated deliverability and compatibility against expected performance in a neurovascular model.

8. The Sample Size for the Training Set:

This section is not applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established:

This section is not applicable for the same reasons as point 8.

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