(76 days)
The Route 92 Medical Full Length 054 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 054 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 devices are provided sterile and non-pyrogenic and are intended for single use only.
The provided text describes the 510(k) premarket notification for the "Route 92 Medical Full Length 054 Access System." This document focuses primarily on the comparison of the new device to a predicate device and the results of non-clinical performance testing, rather than a study proving the device meets acceptance criteria through clinical or user-based performance.
Therefore, many of the requested details, particularly those related to AI-based device performance, human reader studies, and ground truth establishment for patient data, are not present in this document. The document focuses on physical properties and mechanical performance of the device itself.
Based on the provided text, here's the information that can be extracted about the acceptance criteria and the "study" (non-clinical performance testing):
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test were "pre-determined" and the performance was reported as "PASS" for all samples, indicating they met these criteria. The specific numerical values or ranges for the acceptance criteria are not provided in this summary.
| Test | Acceptance Criteria (Not Explicitly Stated, Implied "Pre-determined") | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Conformance to specifications | PASS |
| Luer Integrity | Per ISO 80369-7:2016 | PASS |
| Tensile Strength | Maintain integrity of catheter sections and bonds | PASS |
| Kink Resistance | No kinking in defined bend diameter | PASS |
| Torsion Resistance | Maintain integrity after rotation | PASS |
| Tip Flexibility | Met flexibility requirements | PASS |
| Air Leakage | Per ISO 10555-1:2013 Annex D | PASS |
| Liquid Leakage | Per ISO 10555-1:2013 Annex C | PASS |
| Static Burst | Per ISO 10555-1:2013 Annex F | PASS |
| Dynamic Burst | Mechanical integrity maintained up to specified pressures | PASS |
| Hydrophilic Coating Integrity | Coating integrity maintained after multiple cycles | PASS |
| Simulated Use Testing | Deliverability and compatibility in neurovascular model | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document states "All samples met the pre-determined acceptance criteria" for each test. However, the specific number of samples used for each non-clinical test is not provided. The data provenance is laboratory testing of the device itself, not human or patient data. It is a non-clinical, bench-top study.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
Not applicable for this type of non-clinical device testing. The "ground truth" here is adherence to engineering specifications and ISO standards, evaluated through physical measurements and mechanical tests, not expert interpretation of patient data.
4. Adjudication Method for the Test Set
Not applicable. This was not a study involving human interpretation or adjudication. The results were based on physical measurements and performance against established engineering and ISO standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not conducted. This is a non-clinical device clearance, not an AI or diagnostic imaging study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, this is purely a mechanical/physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was based on pre-determined acceptance criteria derived from engineering specifications and international standards (e.g., ISO 80369-7:2016, ISO 10555-1:2013).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no corresponding ground truth establishment process.
Summary of what the document does describe related to acceptance and proof:
The document demonstrates that the "Route 92 Medical Full Length 054 Access System" meets its non-clinical performance and safety requirements by successfully passing a series of mechanical and physical tests. These tests are conducted to ensure the device performs as intended and is equivalent to the predicate device in terms of function and safety, given its similar design and materials but different dimensions. The "acceptance criteria" are implied to be the specific thresholds or ranges for each test (e.g., tensile strength, leak rate) that the device must meet to be considered safe and effective, and all samples passed these "pre-determined" criteria.
§ 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).