(27 days)
The V-14 ControlWire Guidewires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures.
The V-14 ControlWire Guidewires are not intended for use in the cerebral vasculature.
The devices are provided non-pyrogenic, sterile, and intended for one procedure only.
The V-14 ControlWire Guidewire is a hydrophilic coated polymer tipped guide wire intended to facilitate the placement of balloon dilatation catheters, and/or other therapeutic devices during peripheral vascular procedures.
V-14 ControlWire core wire is constructed using 304V stainless steel wire. The distal portion of the core wire is tapered in diameter to provide added flexibility. The distal portion of the core wire is covered by a two part polymer sleeve. The polymer sleeve is coated with a hydrophilic coating to create a lubricious surface and improve wire handling. The proximal portion of the core wire is coated with polytretraflouroethylene (PTFE).
The V-14 ControlWire comes in two length configurations (182 cm and 300 cm), two distal tip configurations (Straight and Angled) and two taper lengths (Short Taper and Long Taper).
This is a 510(k) summary for a medical device (guidewire), not an AI/ML device. Therefore, the requested information regarding AI/ML device performance, such as sample sizes for test and training sets, expert consensus for ground truth, MRMC studies, or standalone algorithm performance, is not applicable and not present in the provided document.
The document describes the V-14 ControlWire Guidewire and its substantial equivalence to a predicate device based on non-clinical performance data.
Here's a breakdown of the requested information that can be extracted or noted as not applicable:
1. Table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with specific numerical targets and corresponding reported device performance values in the way you might see for an AI/ML device. Instead, it lists a series of performance tests and states that "All testing performed and data demonstrate passing results according to executed verification protocols." This implies meeting internal safety and performance standards for each test.
Performance Tests Performed (as listed in the document):
- Torqueability
- Radiopacity
- Polymer sleeve lubricity / wire movement
- Magnetic segment resiliency
- Magnetic performance
- Distal tip tensile
- Proximal tensile
- Surface Inspection
- Bends
- Corrosion resistance
- Flexing test
- Biocompatibility:
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- Materials Mediated Rabbit Pyrogen
- Hemolysis
- Direct Partial Thromboplastin Time
- In Vitro Hemocompatibility Assay
- Complement Activation
- USP Physicochemical Latex
- Tip flexibility
- Coating adherence
- Coating durability - distal
- Magnetic section kink resistance
- Magnetic section joint kink resistance / fatigue
- J-tip / angled tip retention
- Torque strength
- Polymer sleeve shear
- Overall length
- Fracture test
Reported Device Performance: "All testing performed and data demonstrate passing results according to executed verification protocols." This indicates the device successfully met the internal acceptance criteria for each listed test, supporting its safety and efficacy for the intended use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device (guidewire) submission based on non-clinical (bench) testing, not an AI/ML device with test sets of clinical data. The document does not specify sample sizes for these physical and material tests, nor does it refer to data provenance in the context of clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth, in the context of expert consensus, is typically relevant for diagnostic AI/ML devices interpreting images or other complex data. For a physical medical device, "ground truth" refers to established engineering specifications and objective test results, not expert human interpretation for establishing disease presence or absence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluation where human interpretation disagreement needs to be resolved. This document pertains to non-clinical bench testing of a physical device.
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 is not an AI/ML device, and no MRMC comparative effectiveness study was conducted. The submission specifically states, "Clinical Evaluation was not required for these devices."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the context of clinical "ground truth" as typically understood for AI/ML or diagnostic devices. For this guidewire, the "ground truth" for its performance is derived from objective engineering specifications and physical test methods designed to assess properties like torqueability, lubricity, strength, and biocompatibility, as outlined in the listed performance tests.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, and therefore no training set was used.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for one.
§ 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.