(88 days)
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.
| Test Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity – ISO MEM Elution | Non-cytotoxic | Non-cytotoxic |
| Sensitization – ISO Guinea Pig Maximization | No sensitization response | No sensitization response | |
| Irritation – ISO Intracutaneous Reactivity | Requirements met | Requirements met | |
| Acute Systemic Toxicity – ISO Acute Systemic Injection | Requirements met | Requirements met | |
| Pyrogen – Material Mediated Pyrogen | Non-pyrogenic | Non-pyrogenic | |
| Hemocompatibility – Complement Activation | No adverse effects expected | No adverse effects expected | |
| Hemocompatibility – Partial Thromboplastin Time | Non-activator | Non-activator | |
| Hemocompatibility – ASTM Hemolysis | Non-hemolytic | Non-hemolytic | |
| Hemocompatibility – Thromboresistance | Similar to control devices | Similar to control devices | |
| Performance Testing | Dimensional Verification | Conformance to specifications | PASS |
| Luer Integrity | Met pre-determined criteria | PASS | |
| RHV Sealing | Met pre-determined criteria | PASS | |
| Tensile Strength | Met pre-determined criteria | PASS | |
| Kink Resistance | Met pre-determined criteria | PASS | |
| Torsion Resistance | Met pre-determined criteria | PASS | |
| Tip Flexibility | Met pre-determined criteria | PASS | |
| Air Leakage | Met pre-determined criteria | PASS | |
| Liquid Leakage / Static Burst | Met pre-determined criteria | PASS | |
| Dynamic Burst | Maintained mechanical integrity | PASS | |
| Hydrophilic Coating Integrity | Met pre-determined criteria | PASS | |
| Particulate Recovery | Met pre-determined criteria | PASS | |
| Simulated Use Testing | Met pre-determined criteria | PASS | |
| Radiopacity | Met pre-determined criteria | PASS | |
| Contrast Delivery | Met pre-determined criteria | PASS | |
| In Vivo Thromboresistance | Met pre-determined criteria | PASS | |
| Packaging Integrity | Met pre-determined criteria | PASS |
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.
§ 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).