(67 days)
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."
| Test Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity - ISO MEM Elution | Non-cytotoxic | The test article is non-cytotoxic. |
| Sensitization – ISO Guinea Pig Maximization | No sensitization response | The test article did not elicit a sensitization response. | |
| Irritation - ISO Intracutaneous Reactivity | Requirements of the ISO intracutaneous reactivity test met | Requirements of the ISO intracutaneous reactivity test have been met for the test article. | |
| Acute Systemic Toxicity – ISO Acute Systemic Injection | Requirements of the ISO acute systemic injection test met | Requirements of the ISO acute systemic injection test have been met for the test article. | |
| Pyrogen - Material Mediated Pyrogen | Non-pyrogenic | The test article is non-pyrogenic. | |
| Hemocompatibility – Complement Activation | No expected adverse effects in vivo | The test article would not be expected to result in adverse effects in vivo. | |
| Hemocompatibility – Partial Thromboplastin Time | Non-activator of intrinsic coagulation pathway | The test article is considered to be a non-activator of the intrinsic coagulation pathway. | |
| Hemocompatibility – ASTM Hemolysis | Non-hemolytic | The test article is considered non-hemolytic. | |
| Hemocompatibility – Thromboresistance | Similar thromboresistance characteristics as control devices | The test articles have similar thromboresistance characteristics as the control devices. | |
| Performance | Dimensional Verification | Conformance to specifications | PASS - All samples met the pre-determined acceptance criteria |
| Luer Integrity | Per ISO 80369-7:2016 | PASS - All samples met the pre-determined acceptance criteria | |
| RHV Sealing | Sealing around catheter shafts maintained | PASS - All samples met the pre-determined acceptance criteria | |
| Tensile Strength | Catheter sections and bonds maintain tensile strength | PASS - All samples met the pre-determined acceptance criteria | |
| Kink Resistance | No kinking when formed into defined bend diameter | PASS - All samples met the pre-determined acceptance criteria | |
| Torsion Resistance | Integrity maintained after rotation | PASS - All samples met the pre-determined acceptance criteria | |
| Tip Flexibility | Appropriate tip flexibility | PASS - All samples met the pre-determined acceptance criteria | |
| Air Leakage | Per ISO 10555-1:2013 Annex D | PASS - All samples met the pre-determined acceptance criteria | |
| Liquid Leakage / Static Burst | Per ISO 10555-1:2013 Annex C | PASS - All samples met the pre-determined acceptance criteria | |
| Dynamic Burst | Mechanical integrity maintained up to specified pressures | PASS - All samples met the pre-determined acceptance criteria | |
| Hydrophilic Coating Integrity | Integrity maintained after multiple insertion/withdrawal cycles | PASS - All samples met the pre-determined acceptance criteria | |
| Particulate Recovery | Particulates within acceptable limits per USP | PASS - All samples met the pre-determined acceptance criteria | |
| Simulated Use Testing | Deliverability and compatibility in neurovascular model | PASS - All samples met the pre-determined acceptance criteria | |
| Radiopacity | Visible under fluoroscopy in animal model | PASS - All samples met the pre-determined acceptance criteria | |
| Contrast Delivery | Successful contrast delivery in animal model | PASS - All samples met the pre-determined acceptance criteria | |
| Animal Study | Safety and performance comparable to predicate in acute swine model (angiographic and histological assessments) | PASS - All samples met the pre-determined acceptance criteria | |
| Packaging Integrity | Per ISO 11607-1 Part 1 & ISO 11607-2 Part 2 | PASS - All samples met the pre-determined acceptance criteria |
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.
§ 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).