(27 days)
This Hi-Torque Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA) in arteries such as the femoral, popliteal, and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.
The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
The Abbott Vascular Hi-Torque (HT) Command 18 Guide Wire with hydrophilic coating is a guide wire with a maximum diameter of 0.0180'' and is provided in 210 cm and 300 cm lengths.
The Abbott Vascular HT Command 18 Guide Wire consists of a 304V stainless steel proximal core and a nitinol distal core. The distal core is attached to the stainless steel proximal core using a dissimilar metal solid-state resistance weld. The core wire at the tip is processed to optimize flexibility, steering, and tip shaping. There are four nitinol lengths of the HT Command 18 family, each having multiple tip load options. HT Command 18 has a straight (shapeable) tip.
The distal portion of the wire is coated with a polyurethane jacket and a hydrophilic coating. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE) and a single coat of a silicone-based hydrophobic coating. Brachial and femoral markers are located on the proximal segment of the 210 cm and 300 cm guide wires.
A Torque Device and Guide Wire Introducer are supplied with the wire to facilitate the procedures as physician's aids, if desired.
The provided text describes a 510(k) premarket notification for a medical device, the Hi-Torque Command 18 Guide Wire. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive details about a complete clinical study with detailed acceptance criteria and performance metrics for an AI/algorithm-based device.
Therefore, much of the requested information regarding AI/algorithm performance, such as sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, and standalone performance, is not applicable or available in this document. This document details the engineering and safety performance of a physical medical device.
Here's what can be extracted and inferred from the provided text regarding acceptance criteria and performance, as appropriate for this type of device submission:
Acceptance Criteria and Device Performance for Hi-Torque Command 18 Guide Wire
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Bench Testing | Met all acceptance criteria for: |
| Catheter Compatibility | Successfully completed |
| Radiopacity | Successfully completed |
| Tip Tensile Strength | Successfully completed |
| Torsional Wire Strength | Successfully completed |
| Dissimilar Metal Weld Strength | Successfully completed |
| Rotary Bend Strength | Successfully completed |
| Tip Load | Successfully completed |
| Rotational Accuracy | Successfully completed |
| Coating Adherence & Integrity (Particulate Testing) | Successfully completed |
| Friction Testing | Successfully completed |
| Biocompatibility Testing | Met all acceptance criteria for: |
| Cytotoxicity | Successfully completed |
| Sensitization | Successfully completed |
| Acute Systemic Toxicity | Successfully completed |
| Material-Mediated Pyrogen | Successfully completed |
| Hemolysis | Successfully completed |
| Coagulation | Successfully completed |
| Complement Activation | Successfully completed |
| Substantial Equivalence | Demonstrated substantial equivalence to the predicate device in regards to indications for use, materials, fundamental technology, design, performance, biocompatibility, sterilization, and packaging. |
Additional Information based on the Provided Text:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified for individual bench and biocompatibility tests. It would typically be a specific number of guide wire units tested under controlled laboratory conditions, not a "test set" of patient data as implied for AI.
- Data Provenance: The tests are described as "In vitro functional bench testing" and "Biocompatibility testing." This indicates lab-based, controlled testing of the physical device components and assembled product. No patient-derived data (e.g., country of origin, retrospective/prospective) is involved for these types of tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For mechanical and material properties of a guide wire, "ground truth" is established by physical measurements and standardized test methods, not by expert interpretation of medical images or clinical data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this pertains to expert review of clinical data, which is not relevant for this device's performance testing described.
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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 physical guide wire, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the functional bench tests, the "ground truth" is determined by established engineering specifications, mechanical test standards (e.g., ASTM, ISO), and predefined physical or chemical property thresholds.
- For biocompatibility, the "ground truth" is determined by compliance with biological safety standards (e.g., ISO 10993 series) and specific observable biological reactions (or lack thereof) in laboratory models.
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The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established:
- Not Applicable. Not an AI device.
In summary, the provided document details the testing of a physical medical device (a guide wire) for its engineering performance and biocompatibility. The acceptance criteria and performance data reflect these aspects, not those typically associated with the validation of an AI-powered 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.