(234 days)
Synxess Neurovascular Guidewire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guidewire is intended for use only in the neuro vasculature.
The Synxess Neurovascular Guidewire is available in diameters of 0.014 inch (0.35 mm) and 0.010 inch (0.25 mm) and has 200 cm length. The device is comprised of a core wire, coils, and coatings, and is supplied with a shaping mandrel and a torque device. The guidewire distal tip is straight and shapeable. The device is provided sterile and is for single use.
The provided text describes a 510(k) premarket notification for a medical device, the Synxess Neurovascular Guidewire, and details the non-clinical testing performed to establish substantial equivalence to predicate devices. It does not describe an AI/ML-driven device or a study involving human readers and AI assistance. Therefore, many of the requested points in the prompt (e.g., AI performance metrics, MRMC study, expert ground truth establishment for AI, training set details) are not applicable to this document.
However, I can provide information based on the provided text regarding the device's acceptance criteria and the study that proves it meets them, focusing on the non-clinical performance testing conducted for a guidewire.
Here's the breakdown based on the provided document:
Acceptance Criteria and Device Performance for Synxess Neurovascular Guidewire
The acceptance criteria for this non-AI device are based on passing various performance bench tests and biocompatibility tests in accordance with relevant international standards and FDA guidance. The study proving the device meets these criteria is the battery of non-clinical tests performed.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are implicitly "Pass" or "Met acceptance criteria" as defined by the referenced standards and guidance documents. The reported device performance for all listed tests was successful.
| Test | Standards, Guidance, Test Method | Reported Device Performance |
|---|---|---|
| Visual Inspection | FDA Guidewire Guidance and ISO 11070 | Pass |
| Dimensional Verification | FDA Guidewire Guidance and ISO 11070 | Pass |
| Simulated Use | FDA Guidewire Guidance | Pass |
| Tensile Strength and Tip Pull | FDA Guidewire Guidance and ISO 11070 | Pass |
| Torque Strength | FDA Guidewire Guidance | Pass |
| Torqueability | FDA Guidewire Guidance | Pass |
| Coating Integrity | FDA Guidewire Guidance | Pass |
| Particulate Evaluation | FDA Guidewire Guidance | Pass |
| Lubricity | FDA Guidewire Guidance | Pass |
| Corrosion Resistance | FDA Guidewire Guidance and ISO 11070 | Pass |
| Kink Resistance | FDA Guidewire Guidance | Pass |
| Tip Flexibility | FDA Guidewire Guidance | Pass |
| Radiopacity | FDA Guidewire Guidance and ISO 11070 | Pass |
| Fracture Test | ISO 11070 | Pass |
| Flexing Test | ISO 11070 | Pass |
| Shaping Mandrel Visual and Dimensional Inspection | The shaping mandrel was examined for signs of impurities or defects. The mandrel length and outer diameter were measured. | Met acceptance criteria |
| Shaping Mandrel Corrosion Resistance | ISO 11070 | Pass |
| Shaping Mandrel Tensile Strength | The tensile strength between the shaping mandrel rod and handle was measured. | Met acceptance criteria |
| Torque Device Visual Inspection and Simulated Use | The torque device was examined for signs of impurities or defects. Simulated use evaluated the torque device compatibility and performance. | Met acceptance criteria |
| Biocompatibility Tests | ||
| Cytotoxicity Study Using MTT Method | ISO 10993-5 | Pass |
| Sensitization Study Guinea Pig Maximization Test | ISO 10993-10 | Pass |
| Intracutaneous Reactivity Test In Rabbits | ISO 10993-23 | Pass |
| Acute Systemic Toxicity Study In Mice | ISO 10993-11 | Pass |
| Pyrogen Test In Rabbits | ISO 10993-11 / USP | Pass |
| Hemolysis Assay-Direct Contact And Extract Methods | ISO 10993-4 / ASTM F756-17 | Pass |
| Complement Activation SC5b-9 Assay | ISO 10993-4 | Pass |
| Thromboresistance Evaluation In Dogs | ISO 10993-4 | Pass |
| Sterilization Validation | ||
| EO Sterilization Process Validation | ISO 11135:2014 | Validated |
| Sterilant Residuals | ISO 10993-7:2008 | Met acceptance criteria |
| Shelf-Life Validation | ||
| Shelf-Life (3 years) | Testing of accelerated aged devices | Validated |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (e.g., number of guidewires) used for each individual performance bench test or biocompatibility test. It only states that the device "passed all performance bench testing." For biocompatibility, some tests specify animal models (e.g., guinea pig, rabbits, mice, dogs), but the specific number of animals is not provided.
- Data Provenance: The document generally indicates that the tests were performed in accordance with "internal requirements, referenced guidance and international standards." The country of origin for the data is implied to be from the manufacturer, Enlight Medical Technologies (Shenzhen) Co., Ltd., located in China. The data would be considered prospective as it was generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This question is not applicable as this is a physical medical device (guidewire), not an AI/ML-driven diagnostic device requiring expert clinical interpretation for ground truth. The "ground truth" for these tests is defined by the physical and chemical properties measured against established engineering and biological standards.
4. Adjudication Method for the Test Set
- This question is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation of medical images or patient data requires consensus, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study was not performed because this is a physical medical device, not an AI/ML-driven system that assists human readers in diagnostic tasks. The document explicitly states: "No clinical testing was deemed necessary to support the substantial equivalence of the subject device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-only device.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by engineering standards (e.g., measurements of tensile strength, torqueability, flexibility, dimensions) and biological/chemical standards for biocompatibility (e.g., cytotoxicity assays, pyrogen tests, hemolysis assays). These are objective, quantifiable measures against predefined acceptance criteria from international standards (e.g., ISO 11070, ISO 10993 series) and FDA guidance.
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is a physical device, not an AI/ML model.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.