(95 days)
The Parodi Guidewire is designed to direct a catheter to the desired anatomical location during diagnostic or interventional procedures.
The Parodi Guidewire Assembly is a disposable medical device designed for single use only. It is a multi-component system which can be manipulated to vary the stiffness characteristics as required during a procedure. The device is available in 2 main configurations: 2-piece system: Comprising a 0.014" guidewire and Outer 0.035" member. 3-piece system: Comprising a 0.014" guidewire, Outer 0.035" member and an Intermediate stiffener. A 3-piece system is depicted in figure 1 below. The Intermediate Stiffener is not present in a 2-piece system. A hydrophilic coating is applied to the distal portion of the wire of the 0.014" guidewire and the 0.035" outer assembly. PTFE coating is applied to the proximal portions of these devices. The wire is packaged in a polyethylene hoop contained within a sealed pouch. A torque device is included within the pouch to assist with torquing the device if required.
The Parodi Guidewire is a medical device used to guide catheters during diagnostic or interventional procedures. The device's performance was evaluated through in vitro bench testing to ensure it met acceptance criteria and performed comparably to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Properties | Tip flexibility | (Not specified) | Met acceptance criteria |
| Lateral stiffness | (Not specified) | Met acceptance criteria | |
| Device compatibility | (Not specified) | Met acceptance criteria | |
| Biocompatibility | Biological Safety | Adherence to ISO 10993-1 | Established through biocompatibility testing |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the in vitro bench tests. The tests were performed "in vitro," indicating they were laboratory-based and not on human subjects. The data provenance is not explicitly stated in terms of country of origin, but the submitting company is Brivant Ltd. based in Galway, Ireland, suggesting the testing was likely conducted in a similar region or organized by the company. The study was a non-clinical, in-vitro study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The study involved in-vitro bench testing of physical characteristics and biocompatibility, not clinical evaluation requiring expert interpretation of results to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for in-vitro bench testing. The evaluation would have involved objective measurements and comparisons against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This was an in-vitro bench testing study of a physical device, not an AI or imaging-related study that would involve human readers or MRMC analysis.
6. Standalone Performance Study
Yes, a standalone performance evaluation was conducted for the device. The "in vitro bench testing performance evaluations demonstrated that the Parodi Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate." This indicates the device's performance was assessed independently against established criteria.
7. Type of Ground Truth Used
For the in-vitro bench tests, the "ground truth" was based on predefined technical specifications and objective measurements of the device's physical properties (e.g., tip flexibility, lateral stiffness, device compatibility) and adherence to recognized standards for biocompatibility (ISO 10993-1).
8. Sample Size for the Training Set
This information is not applicable. The Parodi Guidewire is a physical medical device, not a machine learning or AI model, thus it does not have a "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons mentioned in point 8.
§ 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.