(77 days)
The Verrata PLUS pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. It can also be used to guide the positioning of a balloon dilatation cather interventional devices. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
The Verrata PLUS pressure guide wire (hereafter referred to as the "pressure guide wire") is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata PLUS guide wire measures pressure when used with the SmartMap, ComboMap, s5 Series, CORE , and IntraSight series of systems. This pressure guide wire will not operate if connected to any other imaging system. The pressure guide wire has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm and in straight or pre-shaped tips. The pressure guide wire is packaged attached to the connector with a torque device to facilitate navigation through the vasculature.
The provided document does not contain all the requested information for acceptance criteria and the study that proves the device meets them. This document is a 510(k) summary for the Verrata PLUS Pressure Guide Wire and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed report of a clinical study with specific acceptance criteria and detailed performance statistics.
Here is the information that can be extracted or inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "All device acceptance criteria were met" and that the device "meets its intended use." However, it does not provide a specific table of quantitative acceptance criteria values or the corresponding reported device performance values. It lists types of performance testing completed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| EMC and Electrical Safety | Met (implied) |
| Design Verification | Met (implied) |
| Shelf Life | Met (implied) |
| Drift Performance | Met (implied) |
| System Verification | Met (implied) |
| Sensor Accuracy | SAME as predicate (K161887) |
| Sensor Drift | SAME as predicate (K161887) |
| Sensor Operating Range | SAME as predicate (K161887) |
The comparison table on page 4-5 explicitly states that for "Sensor" attributes, the "Accuracy," "Drift," and "Operating Range" are "SAME" as the predicate device (Verrata PLUS Pressure Guide Wire, K161887). This implies that the acceptance criteria for these sensor-related performance metrics are identical to those established for the predicate device, and the subject device achieved performance equivalent to the predicate.
2. Sample Size for Test Set and Data Provenance:
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be primarily bench and laboratory-based design verification and system verification, not human clinical trials.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The document describes performance testing, likely against established engineering and technical standards, rather than expert-established ground truth from clinical data.
4. Adjudication Method for Test Set:
Not applicable. There is no indication of an adjudication method for a test set, as no clinical study or expert review for ground truth establishment is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study is not mentioned or implied. The device is a pressure guide wire, not an imaging or diagnostic algorithm that would typically involve human readers.
6. Standalone (Algorithm Only) Performance:
Not applicable. The device is a physical medical instrument (pressure guide wire) meant for use in conjunction with other systems and interventional procedures, not a standalone algorithm.
7. Type of Ground Truth Used:
The "ground truth" for the performance testing cited would be based on established engineering specifications, calibration standards, and industry-recognized testing methodologies for medical devices, particularly pressure sensors and guide wires. This is not explicitly stated but is inferred from the types of tests listed (EMC, Electrical Safety, Design Verification, Shelf Life, Drift, System Verification).
8. Sample Size for Training Set:
Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set was Established:
Not applicable, as there is no training set for this device.
§ 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.