(86 days)
The Commander Series Guide Wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. The Commander Series guide wires are not intended for use in the cerebral vasculature. Commander steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
The Commander Series guide wires are steerable guide wires. The Commander guide wire is substantially equivalent to the Phantom guide wire with respect to the design. Both wires contain a hypotube, core wire, spring segment and tip. Although the basic five segments of the Commander guide wire are similar to other currently marketed devices, the Commander guide wire contains radiopaque markers (referred to as Accumarkers).
This 510(k) summary does not contain the detailed performance data or acceptance criteria that would typically be found in a study report. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and results for the Commander Series Guide Wires.
Therefore, many of the requested sections below cannot be fully populated from the provided text. The document refers to "Appendix B in Volume II" for performance data, which is not included here.
Based on the provided text, here's what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided text. The document indicates that "Each sub-family of the Commander guide wire has been tested along with a device of similar performance characteristics" and "Performance Data Demonstrate Equivalence." However, specific numerical or qualitative acceptance criteria and the corresponding reported performance values are not present in this summary. | Not explicitly stated in the provided text. The document states "Refer to Appendix B in Volume II for the results of the in vitro testing of the Commander guide wire and the predicate devices." This appendix would contain the actual performance data. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The document states "Each sub-family of the Commander guide wire has been tested," implying multiple units were tested, but the exact number is missing.
- Data Provenance: The testing was "in vitro testing" (as stated under "7. Performance Data Demonstrate Equivalence?"). The location or country of origin is not specified, but it's likely internal testing by the manufacturer, USCI Division of C.R. Bard, Inc. (Billerica, MA, USA). The study is retrospective in the sense that it evaluates a device against existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This type of information is not applicable to the in vitro performance testing described. Ground truth established by experts is typically relevant for studies involving diagnostic image interpretation or clinical outcomes, not for mechanical performance testing of devices like guide wires.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This type of information is not applicable to the in vitro performance testing described. Adjudication methods are relevant for expert consensus in clinical studies, not for objective mechanical measurements.
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 type of study is not applicable as the device is a medical instrument (guide wire), not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This concept is not applicable as the device is a medical instrument, not an algorithm. The testing described is "standalone" in the sense that it's in vitro testing of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the in vitro performance testing, the "ground truth" would be established by objective engineering measurements based on validated test methods (e.g., measurements of forces, flexibility, radiopacity, etc., compared against specifications or predicate device performance). This is not a "ground truth" in the clinical sense with expert consensus or pathology.
8. The sample size for the training set
- This concept is not applicable as there is no "training set" for a physical medical device. Training sets are used in machine learning or AI development.
9. How the ground truth for the training set was established
- This concept is not applicable as there is no "training set" for a 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.