(146 days)
The Route 92 Medical Full Length 088 Access System 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 Full Length 088 Access System is comprised of a Support Catheter and a Delivery Catheter. The Support Catheter is a single-lumen, variable stiffness catheter. The Delivery Catheter is a hubbed, single-lumen variable stiffness catheters are hydrophilically coated. The Route 92 Medical Full Length 088 Access System 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.
The provided text describes a 510(k) premarket notification for a medical device, the Route 92 Medical Full Length 088 Access System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies. Therefore, the information requested about acceptance criteria and studies proving the device meets those criteria in the context of efficacy for a new therapeutic claim, a multi-reader multi-case study, or standalone algorithm performance, is not directly applicable in the same way it would be for a de novo submission or a PMA.
Instead, the document details non-clinical (biocompatibility and performance) testing to show the new device performs similarly safely and effectively to its predicate.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, numerical format for each performance test, but rather implies them via "All samples met the pre-determined acceptance criteria" or similar statements. The "Reported device performance" is summarized as "PASS" for all tests, indicating that they met these unquantified criteria.
| Test | Test Method | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Dimensional Verification | Device dimensions were measured to confirm conformance to the specifications | Conformance to specifications | PASS |
| Luer Integrity | Tested per ISO 80369-7:2016 | Met ISO 80369-7:2016 requirements | PASS |
| Tensile Strength | The tensile strength of the catheter sections and bonds was tested | Met pre-determined acceptance criteria for tensile strength | PASS |
| Kink Resistance | Test specimen segments were formed into a defined bend diameter to evaluate kink resistance | Met pre-determined acceptance criteria for kink resistance | PASS |
| Torsion Resistance | The test specimens were rotated to evaluate integrity after rotation | Maintained integrity after rotation, met pre-determined acceptance criteria | PASS |
| Tip Flexibility | Test specimens were tested for tip flexibility | Met pre-determined acceptance criteria for tip flexibility | PASS |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | Met ISO 10555-1:2013 Annex D requirements | PASS |
| Liquid Leakage | Tested per ISO 10555-1:2013 Annex C. | Met ISO 10555-1:2013 Annex C requirements | PASS |
| Static Burst | Tested per ISO 10555-1:2013 Annex F. | Met ISO 10555-1:2013 Annex F requirements | PASS |
| Dynamic Burst | Mechanical integrity was maintained up to the specified pressures | Maintained mechanical integrity up to specified pressures, met acceptance criteria | PASS |
| Hydrophilic Coating Integrity | The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles. | Maintained integrity after multiple cycles, met acceptance criteria | PASS |
| Particulate Recovery | After multiple insertion and withdrawal cycles, the effluent water rinsed and flushed from the devices and model was tested per USP . Particulates were characterized for size ranges ≥10 µm, ≥25 µm, ≥50 µm, ≥100 µm, ≥200 µm, ≥500 µm and ≥1000 µm | Met USP requirements for particulate matter, met acceptance criteria | PASS |
| Simulated Use Testing | Deliverability and compatibility with accessory devices were evaluated in a neurovascular model | Demonstrated deliverability and compatibility in a neurovascular model, met acceptance criteria | PASS |
| Packaging Integrity | ISO 11607-1 Part 1 | ||
| ISO 11607-2 Part 2 | Met ISO 11607-1 and ISO 11607-2 requirements | PASS |
Biocompatibility Testing:
| Test | Conclusions (Reported Performance) |
|---|---|
| Cytotoxicity - ISO MEM Elution | The test article is non-cytotoxic. (Met requirements, grade |
§ 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).