(89 days)
The Route 92 Medical Delivery Catheter is indicated for use with compatible catheters in facilitating the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.
The Delivery Catheter is a single-lumen, variable stiffness catheter with a flexible, tapered tip delineated by two radiopaque markers. The distal shaft of the Delivery Catheter has a hydrophilic coating. On the proximal end is a hypotube attached to a luer hub for guidewire introduction. This proximal hypotube includes a fluoro-saver marker indicating when the tip of the catheter is about to exit a long femoral sheath/guide. The devices are provided sterile and non-pyrogenic and are intended for single use only. During use, a standard neurovascular guidewire may be inserted through the Delivery Catheter. The Delivery Catheter is inserted through a compatible access catheter. The Delivery Catheter and access catheter are advanced to the targeted location under fluoroscopy using standard endovascular techniques.
This document describes the premarket notification (510(k)) for the Route 92 Medical Delivery Catheter. The submission aims to demonstrate substantial equivalence to a predicate device, not to perform a comparative effectiveness study or validate an AI/ML algorithm. Therefore, many of the requested elements for describing AI-related studies are not applicable.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are typically "PASS," meaning the samples met pre-determined criteria. The document states "All samples met the pre-determined acceptance criteria" for nearly all non-clinical performance tests. Specific quantitative acceptance criteria are not provided within this summary for most tests, but they would have been defined in the full test protocols.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | ||
| Cytotoxicity - ISO MEM Elution | Grade 0 | Grade 0 at 24, 48, 72 ± 4 hrs (Non-cytotoxic) |
| Sensitization - ISO Guinea Pig Maximization Sensitization Test | No sensitization response | No sensitization response |
| Irritation - ISO Intracutaneous Reactivity | Mean Test-Mean Control requirements | PASS |
| Corrosion Resistance | Meets ISO 10555-1:2013 Annex A requirements | PASS |
| Catheter Burst Pressure (Static & Dynamic) | Meets ISO 10555-1:2013 Annex F requirements | PASS |
| Catheter Flow Rate | Meets ISO 10555-1:2013 Annex E requirements | PASS |
| Simulated Use Testing | Deliverability and compatibility met pre-determined acceptance criteria | PASS |
| Packaging Integrity | Meets ISO 11607-1 Part 1 & ISO 11607-2 Part 2 requirements | PASS |
| Radiopacity | Met pre-determined acceptance criteria | PASS |
2. Sample Size for Test Set and Data Provenance
This submission is for a medical device (catheter) and relies on non-clinical (bench and biocompatibility) testing, not a clinical study involving human patient data or a "test set" in the context of an AI/ML algorithm.
- Sample Size (Test Set): The specific number of samples for each bench test is not provided in this summary. For biocompatibility, animal testing (Guinea Pig Maximization, Acute Systemic Injection, Pyrogen, Thromboresistance in animal model) was performed, but the exact number of animals per test is not detailed.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not applicable for bench and biocompatibility testing of a physical device. Biocompatibility data was leveraged from the predicate device (K180201), indicating it was previously generated.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
Not applicable. Ground truth, in the context of expert consensus, is typically used for AI/ML image analysis or diagnostic devices. This submission involves physical device performance and safety testing.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device or an AI/ML algorithm being compared to human readers. It is a delivery catheter.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is not an AI/ML algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Pre-defined technical specifications and engineering requirements.
- International standards (e.g., ISO 10993-1, ISO 80369-7, ISO 10555-1, ISO 11607-1/2, USP ).
- Laboratory measurements and observations during bench testing.
- Biological responses observed in animal models (for biocompatibility).
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a combination of Biocompatibility Testing and Performance Testing - Bench.
- Biocompatibility Testing: Evaluated the biological safety of the device materials. These tests were leveraged from the predicate device (Route 92 Medical Access System, K180201) because the subject device is identical in materials, design, and manufacturing processes. The tests included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogen, Hemocompatibility (Complement Activation, PTT, Hemolysis, Thromboresistance), and Genotoxicity (Bacterial Mutagenicity, In Vitro Mouse Lymphoma). All tests reported "PASS" or conclusions indicating the device is safe and biocompatible within accepted medical device standards.
- Performance Testing - Bench: Evaluated the physical and mechanical performance characteristics of the catheter. Most of these tests were also leveraged from the predicate device (K180201) due to identical design. Tests included Dimensional Verification, Luer Integrity, RHV Sealing, Tensile Strength, Kink Resistance, Torsion Resistance, Tip Flexibility, Air Leakage, Liquid Leakage, Hydrophilic Coating Integrity, Particulate Recovery, Corrosion Resistance, Catheter Burst Pressure, Catheter Flow Rate, Simulated Use Testing, Packaging Integrity, and Radiopacity. All tests reported "PASS," indicating that the samples met their pre-determined acceptance criteria.
The summary concludes that: "The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical Delivery Catheter is suitable for its intended use." And "based on the identical design and materials of construction between the subject and predicate devices and the completed non-clinical testing, the subject Route 92 Medical Delivery Catheter is substantially equivalent to the predicate Route 92 Medical Access System (K180201)."
§ 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).