(94 days)
TransGate™ Guide Catheters are intended to facilitate the placement of interventional devices into the coronary, peripheral, and neuro vasculature.
Stryker Neurovascular's TransGate Guide Catheters are constructed with polytetrafluoroethylene (PTFE) on the inner lumen for lubricity, stainless steel wire reinforcement within the wall for trackability. torque transmission and strength, and polymer materials along the length of the catheter for support and flexibility. The catheter has an atraumatic tip, a hub for device connectivity and device handling, and a strain relief at the hub for kink resistance. The distal segment of the device shaft is radiopacified and. in addition, a radiopaque marker is embedded at the distal tip of the device to aid visualization under fluoroscopy. .
The Stryker Neurovascular TransGate Guide Catheter has straight (ST) and pre-shaped distal tips, available in 40 (40), and Multipurpose (MP) shapes. The TransGate Guide Catheters are offered in both 90 and 100 cm lengths and 5 and 6 French diameters.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Stryker Neurovascular TransGate™ Guide Catheter.
Important Note: The provided document is a 510(k) Summary for a medical device – a guide catheter specifically. These types of devices do not typically involve AI components or software algorithms that would require the typical "AI/ML acceptance criteria" found in software as a medical device (SaMD) clearances. Therefore, many of your requested points regarding AI/ML studies (like standalone algorithm performance, MRMC studies, training set details, ground truth for training) are not applicable to this particular device and document.
The "acceptance criteria" here refer to meeting performance standards for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Kink Distance | Established criteria | Met established criteria |
| Torque Degrees Rotation to Kink | Established criteria | Met established criteria |
| Tip Shape Retention | Established criteria | Met established criteria |
| Distal Shaft Flexibility | Established criteria | Met established criteria |
| Pushability | Established criteria | Met established criteria |
| Tensile Strength | Established criteria | Met established criteria |
| Chemical Compatibility | Established criteria | Met established criteria |
| Corrosion Resistance | Established criteria | Met established criteria |
| Particulate | Established criteria | Met established criteria |
| Liquid Leakage | Established criteria | Met established criteria |
| Air Leakage | Established criteria | Met established criteria |
| Unscrewing Torque | Established criteria | Met established criteria |
| Resistance to Overriding | Established criteria | Met established criteria |
| Stress Cracking | Established criteria | Met established criteria |
| Ease of Assembly | Established criteria | Met established criteria |
| Luer Gauging | Established criteria | Met established criteria |
| Luer Separation Force | Established criteria | Met established criteria |
| Freedom from leakage and damage under high static pressure | Established criteria | Met established criteria |
| Radiopacity | Established criteria | Met established criteria |
| Shelf Life Testing (Product and Packaging) | Established criteria | Met established criteria |
| Distribution / Shipping Challenge Conditioning and Testing | Established criteria | Met established criteria |
| Packaging Verification (sterile barrier, protection) | EN ISO 11607-1 and -2 requirements | Complies and met established criteria |
| Biocompatibility (Hemolysis, Sensitization, etc.) | EN ISO 10993-1, relevant sub-parts | Successfully passed all tests |
| Sterilization (EO and ECH residuals) | EN ISO 10993-7:2008 limits | Meets limits |
| Sterility Assurance Level (SAL) | 10^-6 | Demonstrated 10^-6 |
Note on "Established Criteria": For physical medical devices, "established criteria" typically refer to internal design specifications, industry standards (like ISO standards), and recognized test methods that demonstrate the device is safe and effective for its intended use. The document explicitly mentions adherence to international standards like EN ISO 10555-1, EN ISO 10555-2, EN 1707, EN ISO 11607-1 and -2, EN ISO 10993-1, EN ISO 10993-7, EN ISO 11135-1, and EN 556-1. These standards define many of the specific acceptance criteria for these types of tests.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific performance test (e.g., how many catheters were tested for kink distance, tensile strength, etc.). It generally states that "Testing was conducted" and "Test samples consisted of 2X EtO sterilized devices (entire device)" for the SAL measurement.
Data Provenance: This is a physical device testing, not a clinical data study. The "provenance" would be from laboratory testing conducted by Stryker Neurovascular. There is no mention of country of origin for data beyond the company's location (Fremont, CA, USA) and adherence to international (EN ISO) standards. The testing is prospective for the device's design verification and validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is not an AI/ML device that generates diagnostic outputs requiring expert ground truth for a test set. The "ground truth" for these tests is defined by the physical or chemical properties measured against predefined scientific and engineering standards and specifications.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation or diagnostic performance evaluation, which is not relevant to the design verification and validation of a guide catheter.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
N/A. MRMC studies are specific to evaluating diagnostic technologies, often AI-powered, where human readers interpret cases. This is not applicable to a physical medical device like a guide catheter. There is no AI component in this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for this device's safety and performance studies is based on:
- Engineering and Design Specifications: The device must meet its own internal specifications for physical properties.
- International Standards: Adherence to recognized international standards (e.g., EN ISO 10555 for catheters, EN ISO 10993 for biocompatibility, EN ISO 11135 for sterilization). These standards define acceptable ranges and methodologies.
- Scientific Principles: Basic principles of material science, mechanics, and biology for biocompatibility.
8. The Sample Size for the Training Set
N/A. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set, there is no ground truth to establish for it.
§ 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).