(27 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 modified Route 92 Medical Delivery Catheter is a single-lumen, variable stiffness, hydrophilically coated catheter with a flexible tapered tip. The tapered tip is delineated by two radiopaque markers. On the proximal end is a luer hub for guidewire introduction and fluid or contrast injection. 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 catheter. The Delivery Catheter and compatible catheter are advanced to the targeted location under fluoroscopy using standard endovascular techniques.
The provided document is a 510(k) summary for the Route 92 Medical Delivery Catheter. It describes the device, its intended use, and the performance testing conducted to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state the quantitative acceptance criteria for each test. Instead, it generally states "All samples met the pre-determined acceptance criteria" under the "Results" column. The "Test Method" column describes how the device was tested, implying the criteria are inherent to or defined by these methods.
| Test | Test Method | Reported Device Performance |
|---|---|---|
| Package Integrity after Aging and Distribution | The test specimens were subjected to EO sterilization and environmental conditioning, mechanical transit challenges, visual inspection and bubble leak test and peel test per ASTM F2096 and ASTM F88. | PASS |
| Label Integrity after Aging and Distribution | The test specimens were subjected to EO sterilization and climatic conditioning per ASTM D4169. | PASS |
| Tensile Strength | The tensile strength of the catheter sections and bonds was tested. | PASS |
| Kink Resistance | Test specimen segments were formed into a defined bend diameter to evaluate kink resistance. | PASS |
| Torsion Resistance | The test specimens were rotated to evaluate integrity after rotation. | PASS |
| Tip Flexibility | Test specimens were tested for tip flexibility. | PASS |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | PASS |
| Liquid Leakage | Tested per ISO 10555-1:2013 Annex C. | PASS |
| Hydrophilic Coating Integrity | The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles. | PASS |
| Particulate Recovery | After multiple insertion and withdrawal cycles, the effluent water rinsed and flushed from the devices and model was tested per USP . | PASS |
| Catheter Burst Pressure (Static & Dynamic) | Tested per ISO 10555-1:2013 Annex F. | PASS |
| Catheter Flow Rate | Tested per ISO 10555-1:2013 Annex E. | PASS |
| Simulated Use Testing | Deliverability and compatibility with accessory devices was evaluated in a neurovascular model. | PASS |
| Packaging Integrity (ISO 11607-1 Part 1 & Part 2) | ISO 11607-1 Part 1 and ISO 11607-2 Part 2. (Note: The table lists "Packaging Integrity" twice, once with a detailed method and once with "ISO 11607-1 Part 1" and "ISO 11607-2 Part 2". It's likely the first entry is a summary and the latter specifies the standards used.) | All samples met the pre-determined acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any of the performance tests. It refers to "test specimens" and "samples" but no quantities.
The data provenance (country of origin, retrospective/prospective) is not mentioned. These are bench tests, so patient data provenance is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes bench performance testing of a medical device (catheter), not a diagnostic device involving expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for these tests would be the fulfillment of engineering specifications and standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for the type of bench testing described. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish a ground truth for diagnostic or interpretative tasks.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. This document describes bench testing for a physical medical device (catheter), not an AI-assisted diagnostic tool or an imaging product that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device and testing, the "ground truth" refers to engineering specifications, established industry standards (e.g., ASTM, ISO), and the performance characteristics of the predicate device. The tests demonstrate that the device meets these pre-defined physical and functional requirements. It is a comparison against established benchmarks for mechanical and material integrity.
8. The sample size for the training set
This is not applicable as the document describes a physical medical device and its bench testing, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as item 8.
§ 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).