Search Results

The Route 92 Medical 088 Access System, 143 cm, 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 088 Access System, 143 cm, is comprised of a Support Catheter and a Delivery Catheter. The distal portion of the Support Catheter is a single-lumen, variable stiffness catheter. Like the predicate device, the proximal portion is a stainless-steel control wire. The Delivery Catheter is a hubbed, single-lumen variable stiffness catheter. Both catheters are hydrophilically coated. The Route 92 Medical Access System, 143 cm, is intended for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. The devices are provided sterile and non-pyrogenic and are intended for single use only.

This document describes the premarket notification for a medical device, the Route 92 Medical 088 Access System, 143 cm, a percutaneous catheter designed to facilitate the insertion and guidance of microcatheters in the neurovascular system.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document categorizes performance testing into Biocompatibility Testing and Engineering Performance Testing. The acceptance criteria for all tests are implicitly stated as "met the pre-determined acceptance criteria," and the results are uniformly "PASS."

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

The document consistently states "All samples met the pre-determined acceptance criteria" for the performance tests, implying that the sample size for each specific test was sufficient to demonstrate compliance. However, the exact numerical sample size for each performance test is not explicitly provided.

• Data Provenance:
  • Biocompatibility: In-vitro and in-vivo tests aligned with ISO 10993-1 standards.
  • Performance Testing: In-vitro bench testing, and in-vivo animal model testing (acute swine model). No specific country of origin is mentioned for the data, but the testing standards (ISO, USP, ASTM) are international.
  • Retrospective/Prospective: The testing described is prospective, specifically designed to evaluate the new device against established standards and a predicate device.

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

This document is for a medical device (catheter), not an AI/imaging device requiring expert interpretation of results. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or clinical diagnosis is not directly applicable.

The ground truth for the device's performance is established by:

• Engineering specifications and validated test methods (e.g., ISO, ASTM, USP standards).
• Performance in animal models, assessed by researchers and potentially, but not explicitly stated, veterinary or interventional specialists.

4. Adjudication Method for the Test Set:

Not applicable in the typical sense of a human-in-the-loop AI study. The "adjudication" is inherent in the quantitative and qualitative PASS/FAIL results generated by the standardized test methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC study was not conducted. This type of study is primarily relevant for diagnostic imaging AI devices where human readers interpret medical images. This document describes a physical medical device (catheter) and its mechanical/biocompatibility performance.

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

This question is not applicable. This is not an AI algorithm. The device's "standalone" performance is evaluated through the detailed bench testing, biocompatibility testing, and animal studies, which assess the device's intrinsic properties and function without human intervention during the measurement of performance metrics.

7. The Type of Ground Truth Used:

The ground truth for this device's performance is based on:

• Validated Standard Test Methods: International standards (ISO, ASTM, USP) for medical device performance and biocompatibility.
• Predicate Device Comparison: The new device is compared to a legally marketed predicate device (Route 92 Medical 088 Access System, 110 cm, K200121) to demonstrate substantial equivalence, implying the predicate's performance serves as a comparative "ground truth."
• Pre-determined Acceptance Criteria: Internal specifications and performance limits set by the manufacturer based on regulatory requirements and engineering principles.
• Animal Model Observations: Direct observation of device safety and performance in an acute swine model, including angiographic and histological assessments.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model that requires a "training set."

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

Not applicable, as there is no training set for a physical medical device.

Ask a specific question about this device

The Route 92 Medical 088 Access System, 110 cm, 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 088 Access System, 110 cm, is comprised of a Support Catheter and a Delivery Catheter. The distal portion of the Support Catheter is a single-lumen, variable stiffness catheter. Like the predicate device, the proximal portion is a stainless-steel control wire. The Delivery Catheter is a hubbed, single-lumen variable stiffness catheter. Both catheters are hydrophilically coated. The Route 92 Medical Access System, 110 cm, is intended for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. The devices are provided sterile and non-pyrogenic and are intended for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Route 92 Medical 088 Access System, 110 cm:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance criteria in two main sections: Biocompatibility Testing and Performance Testing. For both, the acceptance criterion is implicitly "PASS" meaning the device met pre-determined criteria for each test. Specific quantitative acceptance criteria are not detailed in this summary.

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

The document states "All samples met the pre-determined acceptance criteria" for various performance tests, but does not specify the exact sample size for any of the individual tests. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not provided. Many tests mention adherence to ISO standards, implying controlled laboratory conditions, but details about the test setting are not available. The Biocompatibility and Performance tests are "Non-Clinical Testing."

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

This information is not provided as the tests conducted are primarily non-clinical, mechanical, and material-based, not involving human interpretation of medical images or patient outcomes that would typically require expert ground truth establishment in that manner. For the "Simulated Use Testing," "Radiopacity," and "Contrast Delivery," and "In Vivo Thromboresistance" which involve models and animals, the experts involved in conducting and evaluating these tests are not specified.

4. Adjudication Method for the Test Set:

An adjudication method is not applicable and therefore not mentioned, as the tests are primarily objective physical and chemical characterizations, rather than assessments requiring human judgment or consensus from multiple reviewers for a "ground truth" determination.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not conducted. This document describes a 510(k) submission for a medical device (catheter system), not an AI or imaging diagnostic tool. Therefore, human reader performance with or without AI assistance is not relevant to this submission.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm or software.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by the specifications and acceptable ranges established by industry standards (e.g., ISO) and the manufacturer's pre-determined acceptance criteria. For "Simulated Use Testing," "Radiopacity," "Contrast Delivery," and "In Vivo Thromboresistance," the ground truth would be based on direct observation and measurement within the respective models (neurovascular model, animal model), demonstrating the device's functional integrity and performance as intended. No human pathology, outcomes data, or expert consensus in the medical diagnostic sense is mentioned as ground truth.

8. The Sample Size for the Training Set:

This information is not applicable as this is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable as this is a physical medical device, not an AI model requiring a training set and associated ground truth.

Ask a specific question about this device