(140 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 Peripheral Guide Wires in this submission are steerable guide wires with a maximum diameter of 0.014 inches (0.36mm) and available in 190cm and 300cm lengths. These devices have a solid core with a hydrophilic coil-type distal end. When wet, the hydrophilic coating increases the lubricity of the quidewire surface. Some models also include silicone coating on the distal tip. The coil is partly or entirely radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). 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 is a 510(k) summary for the VASSALLO® GT Guide Wire. It details the device's characteristics, intended use, and substantial equivalence to predicate devices, based on non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The in vitro bench tests demonstrated that the VASSALLO GT met all acceptance criteria". However, it does not provide a specific table of acceptance criteria with corresponding performance values. It only lists the types of tests performed.
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Not specified in document | Met acceptance criteria |
| Visual Inspection | Not specified in document | Met acceptance criteria |
| Simulated Use | Not specified in document | Met acceptance criteria |
| Tensile Strength / Tip Pull | Not specified in document | Met acceptance criteria |
| Torque Strength | Not specified in document | Met acceptance criteria |
| Torqueability | Not specified in document | Met acceptance criteria |
| Coating Integrity | Not specified in document | Met acceptance criteria |
| Coating Adhesion | Not specified in document | Met acceptance criteria |
| Catheter Compatibility / Lubricity | Not specified in document | Met acceptance criteria |
| Corrosion Resistance | Not specified in document | Met acceptance criteria |
| Kink Resistance | Not specified in document | Met acceptance criteria |
| Tip Flexibility | Not specified in document | Met acceptance criteria |
| Radiopacity | Not specified in document | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for each non-clinical test.
The data provenance is from non-clinical laboratory testing performed on the VASSALLO® GT. The country of origin for the manufacturing company (Filmecc Co., Ltd.) is Japan. The type of study is bench testing (in vitro), not human subject testing (prospective or retrospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable as the study described is non-clinical bench testing, not a clinical study involving expert interpretation of data or images. Ground truth for non-clinical tests is established by adhering to testing standards and specifications.
4. Adjudication Method for the Test Set
This question is not applicable as the study described is non-clinical bench testing. Adjudication methods are typically relevant for clinical studies where human interpretation or consensus is required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document focuses on non-clinical bench testing of a guide wire, not an AI-assisted diagnostic device. Therefore, there is no discussion of human readers, AI assistance, or effect sizes in that context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a medical guide wire, not an algorithm or software requiring standalone performance evaluation.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" or reference for evaluating performance would be predefined engineering specifications, international standards, and performance characteristics of predicate devices. The document states that the device "met all acceptance criteria" and "performed similarly to the predicate and reference devices," implying comparison against these types of benchmarks.
8. The Sample Size for the Training Set
This question is not applicable. There is no mention of a "training set" as this is a physical medical device undergoing bench testing, not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for a guide wire.
§ 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.