(90 days)
The intended use of the ACS HI-TORQUE WIGGLE™ Guide Wire with MICROGLIDE® Coating is to facilitate the placement of the catheter by orienting the catheter tip during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) and other interventional diagnostic or therapeutic procedures.
The ACS HI-TORQUE WIGGLE™ Guide Wire with MICROGLIDE® Coating is a guide wire with a nominal diameter of 0.014″ and available in two lengths: a 190 cm extendable length and a 300 cm exchange length. The proximal end of the 190 cm models are tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension.
The wire is constructed from stainless steel, the distal end of this guide wire has a radiopaque tip that is available either as a straight, shapeable configuration or as a preshaped J. The distal end of the wire has sinusoidal waves manufactured approximately 4.5 cm - 6.5 cm from to the distal tip. The guide wire has proximal markers at 90 and 100 cm from the distal tip. MICROGLIDE® Coating is applied to the distal section of the guide wire, the proximal shaft is coated with polytetrafluoroethylene.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative acceptance criteria. Instead, it describes a comparative approach where the new device's performance is expected to be "similar to" or "substantially equivalent" to the predicate device. The performance data section lists the types of tests performed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Distal Tip Pull Strength/Integrity similar to predicate | Bench testing performed (Distal Tip Pull Test). Results showed new device is "substantially equivalent to the predicate wires and performs as intended." |
| Distal Tip Durability ("Turns-to-Failure") similar to predicate | Bench testing performed (Distal Tip Turns-to-Failure Test). Results showed new device is "substantially equivalent to the predicate wires and performs as intended." |
| Rotational Accuracy similar to predicate | Bench testing performed (Rotational Accuracy Test). Results showed new device is "substantially equivalent to the predicate wires and performs as intended." |
| Tip Flexibility similar to predicate | Bench testing performed (Tip Flexibility Test). Results showed new device is "substantially equivalent to the predicate wires and performs as intended." |
| Performs as intended for facilitating catheter placement & orientation | In vitro heart model studies were performed to substantiate the intended use. "The results of the heart model study demonstrated that the new wire performs as intended." This implies it successfully facilitated catheter placement and orientation in the model. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the numerical sample sizes for the bench tests (e.g., number of wires tested for each bench test) or the in vitro heart model studies.
- Data Provenance: The studies were described as "Bench testing" and "in vitro heart model studies," indicating laboratory-based testing. There is no information about the country of origin of the data provided in the 510(k) summary. The studies are prospective in nature as they involve testing of the device for submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the studies described. The performance assessment was based on objective bench tests and in vitro model studies, not on expert interpretation of diagnostic images or clinical outcomes that would require a "ground truth" established by experts in that context. The "ground truth" here is the physical performance measurement and functional demonstration in a model.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements (e.g., pull strength, turns-to-failure) that do not typically require expert adjudication in the way clinical studies or image interpretation studies do.
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
Not applicable. This device is a guide wire, not a diagnostic AI device requiring human reader interaction or interpretation. Therefore, an MRMC study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm. The "standalone" performance refers to the device's physical and functional characteristics.
7. The type of ground truth used
The ground truth used for these studies was based on the physical performance measurements of the device against predefined engineering specifications (implied by "acceptance criteria" and "similar to predicate") and the functional demonstration of its intended use in an in vitro model. It's essentially a form of empirical measurement and functional validation.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set. The "training" for a physical device is its design and manufacturing process.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this physical medical 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.