(207 days)
The Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set is indicated for use in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
The 054 Aspiration Catheter and Tenzing 5 Delivery Catheter comprise the Route 92 Medical Full Length 054 Reperfusion System. The Route 92 Medical Full Length 054 Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set.
The 054 Aspiration Catheter is a single-lumen, coil-reinforced variable stiffness catheter. The Tenzing 5 Delivery Catheter is a single-lumen variable stiffness catheters are hydrophilically coated. The devices are provided sterile and non-pyrogenic and are intended for single use only.
The Route 92 Medical Aspiration Tubing Set is made from high-pressure tubing. An on/off switch is provided to control fluid flow. A suction connector allows connection to an aspiration pump canister and a Luer fitting allows connection to the aspiration catheter.
For the aspiration source, the Aspiration Catheter is used in conjunction with an aspiration pump with prespecified performance parameters that is connected using the Route 92 Medical Aspiration Tubing Set, along with a legally marketed canister and accessories kit.
The provided document is a 510(k) Premarket Notification from the FDA regarding the Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific performance acceptance criteria based on clinical outcomes or expert-adjudicated ground truth.
Therefore, many of the requested elements for describing an acceptance criteria study, especially those related to AI algorithm performance (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance), are not applicable to this type of regulatory submission. This document describes non-clinical testing to ensure the device's functional performance, safety, and compatibility.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria values for each test, but rather generally states "All samples met the pre-determined acceptance criteria." The performance is reported as "PASS" for all tests.
| Test | Test Method | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Shelf Life and Sterility | Ethylene oxide sterilization cycle verified to a sterility assurance level of 1 x 10⁻⁶ in accordance with ISO 11135. Aging studies established functional integrity for labeled expiration date. | Sterility assurance level of 1 x 10⁻⁶; functional for 6 months. | PASS |
| Biocompatibility Testing | Not performed again as materials were unchanged from reference device K223530. | None (re-use of prior assessment) | Not applicable |
| Simulated Use Testing | Deliverability, clot retrieval, device integrity, kink and aspiration resistance, lumen patency, durability and compatibility with accessory devices evaluated in a neurovascular model. | Meet pre-determined functional criteria in a neurovascular model. | PASS |
| Lumen Patency Testing | Test specimens tested for lumen patency under vacuum. | Meet pre-determined lumen patency criteria under vacuum. | PASS |
| Dimensional Verification | Device dimensions measured to confirm conformance to specifications. | Conformance to specifications. | PASS |
| Luer Integrity | Tested per ISO 80369-7:2021. | Conformance to ISO 80369-7:2021. | PASS |
| Tensile Strength | Tensile strength of catheter sections and bonds tested. | Meet pre-determined tensile strength criteria. | PASS |
| Kink Resistance | Test specimen segments formed into a defined bend diameter to evaluate kink resistance. | Meet pre-determined kink resistance criteria. | PASS |
| Torsion Resistance | Test specimens rotated to evaluate integrity after rotation. | Maintain integrity after rotation. | PASS |
| Tip Flexibility | Test specimens tested for tip flexibility. | Meet pre-determined tip flexibility criteria. | PASS |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | Conformance to ISO 10555-1:2013 Annex D. | PASS |
| Liquid Leakage | Tested per ISO 10555-1:2013 Annex C. | Conformance to ISO 10555-1:2013 Annex C. | PASS |
| Static Burst | Tested per ISO 10555-1:2013 Annex F. | Conformance to ISO 10555-1:2013 Annex F. | PASS |
| Dynamic Burst | Mechanical integrity assessed under pressure. | Maintain mechanical integrity under pressure. | PASS |
| Hydrophilic Coating Integrity | Integrity of the hydrophilic coating evaluated after multiple insertion and withdrawal cycles. | Maintain coating integrity after multiple cycles. | PASS |
| Aspiration Pressure | Vacuum pressure at the tip of the catheter assessed during aspiration. | Meet pre-determined aspiration pressure criteria. | PASS |
| Particulate | Size and quantity of particulates generated during simulated use evaluated. | Meet pre-determined particulate limits. | PASS |
2. Sample size used for the test set and the data provenance
The document states "All samples met the pre-determined acceptance criteria" for each test but does not specify the numerical sample sizes (N) for each test set. The data provenance is described as "Non-Clinical Testing" which implies in-vitro or laboratory testing, not human-derived data like images or patient records. Therefore, information like country of origin or retrospective/prospective is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests are non-clinical, mechanical, and performance-based (e.g., tensile strength, lumen patency). The "ground truth" is based on engineering specifications and adherence to international standards (like ISO) rather than expert interpretation of medical images or clinical outcomes.
4. Adjudication method for the test set
Not applicable. No expert adjudication was involved as the tests are objective, non-clinical measurements.
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
Not applicable. This is a medical device for revascularization, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the non-clinical tests is based on:
- Engineering specifications: Device dimensions, tensile strength, etc.
- International standards: ISO 11135 for sterility, ISO 80369-7:2021 for Luer integrity, ISO 10555-1:2013 for air/liquid leakage and burst strength.
- Functional performance criteria: In a simulated neurovascular model for deliverability, clot retrieval, etc.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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).