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510(k) Data Aggregation
(115 days)
This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
The VASSALLO GT 018 Hybrid consists of a hybrid NiTi alloy and stainlesssteel core wire and a coil assembly on the distal end of the device. The coil assembly is soldered to the NiTi alloy portion of the core. The coil is radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy. Coatings are applied on the surface of the VASSALLO GT 018 Hybrid. The proximal portion is coated with PTFE. The distal section is coated with a hydrophilic coating and polyurethane coating. When wet, the hydrophilic coating increases the lubricity of the quidewire surface. The middle portion of the device is coated with PFA and silicone coatings. The VASSALLO GT 018 Hybrid has an outer diameter of 0.018 inches (0.45 mm) and is available in 190cm and 300cm lengths. About 2cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the quide wire with a length of less than 300 cm. A Torque device is included in the same package.
This document describes the VASSALLO® GT 018 Hybrid, a peripheral guide wire. It focuses on non-clinical and biocompatibility testing to establish substantial equivalence to predicate devices, rather than a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested fields are not applicable (N/A) in this context.
Here's an analysis of the provided text:
1. A table of acceptance criteria and the reported device performance:
The document states, "The in vitro bench tests demonstrated that the VASSALLO GT 018 Hybrid met all acceptance criteria and performed similarly to the predicate and reference devices." However, it does not explicitly list the quantitative acceptance criteria for each test or detailed performance metrics. It only lists the tests performed.
| Test Type | Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance |
|---|---|---|
| Dimensional Verification | N/A (Not explicitly stated) | Met all acceptance criteria and performed similarly to predicate and reference devices. |
| Visual Inspection | N/A (Not explicitly stated) | Met all acceptance criteria and performed similarly to predicate and reference devices. |
| Tensile Strength / Tip Pull | N/A (Not explicitly stated) | Met all acceptance criteria and performed similarly to predicate and reference devices. |
| Torque Strength | N/A (Not explicitly stated) | Met all acceptance criteria and performed similarly to predicate and reference devices. |
| Torqueability | N/A (Not explicitly stated) | Met all acceptance criteria and performed similarly to predicate and reference devices. |
| Coating Adhesion | N/A (Not explicitly stated) | Met all acceptance criteria and performed similarly to predicate and reference devices. |
| Catheter Compatibility / Lubricity | N/A (Not explicitly stated) | Met all acceptance criteria and performed similarly to predicate and reference devices. |
| Corrosion Resistance | N/A (Not explicitly stated) | Met all acceptance criteria and performed similarly to predicate and reference devices. |
| Kink Resistance | N/A (Not explicitly stated) | Met all acceptance criteria and performed similarly to predicate and reference devices. |
| Tip Flexibility | N/A (Not explicitly stated) | Met all acceptance criteria and performed similarly to predicate and reference devices. |
| Radiopacity | N/A (Not explicitly stated) | Met all acceptance criteria and performed similarly to predicate and reference devices. |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity, Hemolysis, Partial Thromboplastin Time, In Vivo Thromboresistance, SC5b-9 Complement Activation, Material Mediated Pyrogenicity) | N/A (Not explicitly stated) | Shown to be biocompatible. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. The document only mentions "Non-clinical laboratory testing" and "in vitro bench tests."
- Data provenance: The applicant is FILMECC CO., LTD. located in Japan. The tests are non-clinical, so "retrospective or prospective" as generally understood in clinical trials is not applicable. The tests are likely performed in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a non-clinical device submission based on bench testing and biocompatibility. There is no mention of human-expert-established ground truth in the context of radiology or similar fields. The "ground truth" would be the objective results of the engineering and biological tests conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. This concept is not applicable for non-clinical bench testing.
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
N/A. This document is for a medical device (guide wire), not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This document is for a medical device (guide wire), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission would be defined by the pre-established engineering specifications and industry standards for guide wire performance and safety (e.g., ISO standards for medical devices, ASTM standards for material properties). The tests measure if the device meets these objective standards.
8. The sample size for the training set
N/A. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
N/A. Not an AI/machine learning device.
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