(135 days)
The Runthrouh NS are used to facilitate placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
The Runthrough NS is a coil-type guide wire. The main components of the wire include a core wire, a tip coil, a tip coil marker, and surface coating. The core wire is constructed of a Ni/Ti alloy wire and a stainless steel wire joined together. The tip coil marker, a Pt/Ni alloy, is radiopaque. The tip coil has lubricous coating (silicone coating) and/or hydrophilic coating on the surface depending on product code. The shaft is surfacecoated with silicone and PTFE. Tip flexibility can be selected among three types, Extra Floppy, Floppy, and Intermediate, flexibility decreasing in the named order. The wire is also available in a hyper-coating type which is more lubricous than the standard wire. The device may be accompanied by a torque device, inserter, and stylet accessories.
The provided 510(k) summary for the Terumo Runthrough NS guide wire describes a device intended to facilitate placement of balloon dilatation catheters. It's important to note that this submission focuses on demonstrating substantial equivalence to a predicate device (Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil, K961445), rather than proving the device meets a set of clinical performance acceptance criteria in the way an AI/software device would.
Therefore, many of the requested categories related to AI performance, such as sample size for training/test sets, ground truth establishment for AI, expert consensus, MRMC studies, and standalone AI performance, are not applicable to this type of device submission. The "acceptance criteria" here are defined by demonstrating equivalence through a series of engineering/physical tests.
Here's the information that can be extracted or inferred from the provided text, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating that the Runthrough NS performs equivalently to the predicate device across a range of physical and mechanical characteristics. The "performance" is reported as "substantial equivalence" based on the results of the verification tests.
| Acceptance Criteria (Implicitly, Equivalence to Predicate) | Reported Device Performance (Runthrough NS) |
|---|---|
| Dimensional Accuracy | Performed Dimensional Inspection |
| Resistance to Tip Sliding | Performed Tip sliding resistance test |
| Tip Tensile Strength | Performed Tensile strength of tip |
| Tip Butting Load | Performed Tip butting load |
| Shaft Tensile Strength | Performed Tensile strength of shaft |
| Wire Stability in Holder Loop | Performed Wire stability in holder loop |
| Bend Strength | Performed Bend strength |
| Seal Strength of Packaging | Performed Seal strength of packaging |
| Reshapability | Performed Reshapability |
| Torque Strength | Performed Torque Strength |
| Torqueability | Performed Torqueability |
| Tip Flexibility | Performed Tip Flexibility |
| Coating Adherence/Integrity | Performed Coating Adherence/Integrity |
| Biocompatibility | Tested according to ISO-10993 |
| Sterility Assurance Level (SAL) | Validated to SAL of 10-6 per ANSI/AAMI/ISO 11135 |
The document states: "None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness. Therefore the performance of the modified Runthrough NS is substantially equivalent to the performance of the predicate device..."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in terms of clinical or imaging data. The "test set" refers to physical samples of the device undergoing engineering verification tests. The number of physical units tested for each criterion is not disclosed.
- Data Provenance: Not applicable in the context of clinical data. The performance data comes from internal laboratory testing of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth in the context of AI refers to labels or diagnoses provided by experts. For this medical device, "ground truth" would be the known physical properties and performance of the predicate device, against which the modified device's performance is compared through engineering tests. The "experts" involved would be the engineers and technicians performing and assessing these tests.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to human readers reviewing clinical cases for ground truth establishment. Here, the "adjudication" is based on comparing engineering test results of the new device against established benchmarks or the predicate device's performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a physical medical device like a guide wire.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a physical guide wire, not a software algorithm.
7. Type of Ground Truth Used
- For the engineering performance tests, the "ground truth" is implicitly the known and acceptable performance specifications for a guide wire of this type, often derived from prior knowledge of the predicate device and relevant industry standards. For biocompatibility, the ground truth is established by the specified ISO-10993 standards. For sterility, it's defined by ANSI / AAMI / ISO 11135-1994.
8. Sample Size for the Training Set
- Not applicable. This refers to AI/machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This refers to AI/machine learning.
§ 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.