(223 days)
Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may 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 Hi-Torque Vektor Guide Wire is a 0.014" (0.36 mm) diameter steerable guide wire available in several lengths and has a shapeable distal tip. Refer to the product label for product specifications (e.g. wire length, diameter and length of tip radiopacity).
The Hi-Torque Vektor Guide Wires have a modified proximal end that permits the attachment of the DOC Guide Wire Extension. Refer to the product label for Guide Wire Extension system compatibility. Joining the guide wire extension to the guide wire facilitates the exchange of one interventional device for another, while maintaining guide wire position in the anatomy. After the interventional device exchange has been completed, the extension can be detached and the guide wire can be used in its original capacity.
Brachial and femoral markers located on the proximal segment of the 0.014" (0.36 mm) Hi-Torque Vektor guide wire aid in gauging guide wire position relative to the guiding catheter tip when using bare wire technique. These Hi-Torque Vektor guide wires are compatible with guiding catheters that are at least 90 cm (brachial) or 100 cm (femoral) long.
When wet, a hydrophilic coating increases the lubricity of the Hi-Torque Vektor guide wire surface. This coating contains highly purified hyaluronic acid (HA).
Principles of Operation: The Hi-Torque Vektor guidewire is operated manually by a manual process.
The provided document describes the predicate device comparison and performance testing for the "Hi-Torque Vektor Guidewire Family" to demonstrate substantial equivalence to its predicate devices, rather than a study proving the device meets general acceptance criteria in the context of AI/ML performance evaluation. The document is for a traditional medical device (a guidewire) and not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML performance (e.g., sample size for test set, expert qualifications for ground truth, MRMC study, effect size of AI assistance, standalone performance, training set size) are not applicable or extractable from this document.
However, I can extract information related to the acceptance criteria and performance of the device based on the provided text, focusing on the bench testing conducted to demonstrate equivalence.
Here's a summary of the applicable information:
1. A table of acceptance criteria and the reported device performance
The document states that "The results from these performance evaluations demonstrated that the Hi-Torque Vektor Guidewire range met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s)."
The acceptance criteria themselves (e.g., specific values for tensile strength, torque strength) are not explicitly detailed in the provided text. Instead, the performance is reported in relation to the predicate devices and internal product specifications. The table below outlines the tested parameters and the reported performance relative to the predicate devices.
| Acceptance Criteria (Bench Test Type) | Reported Device Performance (Hi-Torque Vektor) |
|---|---|
| Material & Biocompatibility | Stainless Steel Core: Same as predicates |
| Platinum Tungsten Alloy: Same as predicates (Pilot 50 and Fielder XT use Platinum Tungsten Coil, which is considered equivalent for this purpose) | |
| Solder: Same as predicates | |
| Polyurethane: Same as predicates | |
| PTFE Coating: Same as predicates | |
| Hydrophilic Coating: Same as predicates | |
| Biocompatibility: Established through testing in compliance with ISO 10993-1. | |
| Sterilization Status | Supplied Sterile (same as predicates) |
| Packaging | Tyvek, heat sealed to a film of PET/PE Sterile Packaging (same as assumed for predicates) |
| Overall Design & Construction | PTFE coated stainless steel core wire with tapered distal grind section, radiopaque platinum/tungsten coil soldered at distal tip, coil and core distal section encapsulated in a tungsten doped polyurethane jacket, hydrophilic coating applied to polyurethane jacket. (Similar to predicates, with minor difference in polyurethane jacket doping). |
| Core Design | Core to Tip (same as predicates) |
| Guidewire Length | 195cm, 300cm (similar range to predicates 190cm, 300cm) |
| Guidewire Nominal Diameter | 0.014" (same as predicates) |
| PTFE Coating Diameter | 0.014" maximum (same as predicates) |
| Polymer Jacket Length | 22cm (different from Pilot 50 (29cm) and Fielder XT (16cm), but acceptable within the context of substantial equivalence) |
| Polymer Jacket Diameter | 0.014" maximum (same as predicates) |
| Tensile Strength | Met product specifications and performed comparably to predicate devices (specific values not provided in this document). |
| Torque Strength | Met product specifications and performed comparably to predicate devices (specific values not provided in this document). |
| Dimensional measurement | Met product specifications and performed comparably to predicate devices (specific values not provided in this document). |
| Torque Response | Equivalent torque response to Pilot 50 and Fielder XT. |
| Catheter Compatibility | Equivalent compatibility characteristics to Hi-Torque Pilot 50 and Fielder XT. |
| Coating Adherence/Coating Integrity | Equivalent coating adherence/integrity characteristics to Hi-Torque Pilot 50 and Fielder XT when tested using this test method. |
| Coating Lubricity and Durability | Lubricity: Demonstrated higher lubricity pinch forces than Hi-Torque Pilot 50; Demonstrated lower lubricity pinch forces than Fielder XT. (This indicates performance falls between the two predicates, which is acceptable for equivalence). |
| Durability: Demonstrated superior hydrophilic coating durability to both Hi-Torque Pilot 50 and Fielder XT. | |
| Particulate Testing (Particulate Residue) | Equivalent particulate residue to Hi-Torque Pilot 50 and Fielder XT - all parts meet the specification. |
| Tip Flexibility/Stiffness | The proposed 4 models have equivalent tip stiffness characteristics to the predicate devices. Met product specifications and performed comparably to predicate devices (specific values not provided in this document). |
| Radiopacity | Radiopaque platinum/tungsten coil (same as predicates). Met product specifications and performed comparably to predicate devices (specific values not provided in this document). |
| Corrosion Resistance | Equivalent corrosion resistance properties to Hi-Torque Pilot 50 and Fielder XT. |
| Flex Resistance Test (Bending Durability) | Equivalent bending durability properties to Hi-Torque Pilot 50 and Fielder XT. |
| Guidewire Pull test | Met product specifications and performed comparably to predicate devices (specific values not provided in this document). |
| Kink Resistance | Equivalent (body) / Superior (tip) kink resistance to Hi-Torque Pilot 50; Equivalent kink resistance to Fielder XT (body & tip). |
| Extension Capability | Has extension capability and is compatible with the Abbott DOC extension system (identical to Hi-Torque Pilot 50). Demonstrated improved performance compared to Hi-Torque Pilot 50. |
| Tip Shapeability | Shapeable Tip (same as predicates) |
| Pre-Formed 'J' Tips Offered | Offered with a straight tip and an additional pre-formed J tip (same as Hi-Torque Pilot 50; Fielder XT is straight tip only). |
| Shaft Depth Markings | Has shaft depth markings/indicators (same as Hi-Torque Pilot; Fielder XT does not). |
| Proximal Wire Identifier | Has a proximal wire identifier (Hi-Torque Pilot 50 and Fielder XT do not). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes in vitro bench tests. No specific sample sizes for each test are provided, nor is information on data provenance in terms of country of origin or retrospective/prospective nature, as these are not relevant for bench testing of a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. Ground truth for these physical performance tests (e.g., tensile strength, lubricity) is established by standardized test methods and instrumentation, not by expert consensus or clinical assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable, as ground truth is based on objective physical measurements and established test methods, not subjective assessment requiring adjudication.
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
This question is not applicable. The device is a guidewire, a physical medical device, not an AI/ML-powered diagnostic or assistive tool. "Human readers" and "AI assistance" are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable, as the device is a guidewire and does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance evaluations (bench tests) is based on the results generated by standardized in vitro test methods and comparison to predefined product specifications and the performance of "legally marketed predicate devices."
8. The sample size for the training set
This question is not applicable, as the device does not involve machine learning or a training set.
9. How the ground truth for the training set was established
This question is not applicable, as the device does not involve machine learning or a training set.
§ 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.