(89 days)
The Docking-Extension Wire is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.
The SCHNEIDER Docking-Extension Wire is used to elongate the working length of compatible SCHNEIDER extendable guide wires. The stainless-steel Docking-Extension Wire has an outer diameter of 0.014" (0.36 mm) and a length of 130 cm. Its distal end bears a preformed superelastic connecting hypotube. This superelastic property allows the proximal end of the quide wire to be fixed in the hypotube to such an extent. that axial forces can easily be transmitted. A docking aid enables easy introduction of the extendable end of the guide wire into the hypotube. The device is compatible with the SCHNEIDER extendable guide wires (C-Thru, Hannibal and Clyde). The currently marketed guide wires had been slightly modified at the proximal end to create a tapered end in order to be accommodated into the hypotube of the Docking-Extension Wire. This modification does not in any way affect the safety or performance of the guide wire.
This is a 510(k) premarket notification for a medical device (Docking-Extension Wire), not a study evaluating an AI device. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
Instead, the document details the equivalence testing performed to demonstrate that the new device is substantially equivalent to a predicate device.
Here's an analysis based on the provided text, addressing the applicable categories:
1. A table of acceptance criteria and the reported device performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Docking Joint Tensile Strength | Equivalent to predicate device (ACS DOC™ Extension Wire) | Substantial equivalence demonstrated through comparative performance testing. |
| Docking Junction Fatigue | Equivalent to predicate device (ACS DOC™ Extension Wire) | Substantial equivalence demonstrated through comparative performance testing. |
| Glued Bond Break Load | Equivalent to predicate device (ACS DOC™ Extension Wire) | Substantial equivalence demonstrated through comparative performance testing. |
| Compatibility with Interventional Devices | Functionally compatible with interventional devices (as predicate) | Substantial equivalence demonstrated through comparative performance testing. |
| Biocompatibility: Cytotoxicity | Non-cytotoxic (as per established biocompatibility standards) | Passed biocompatibility testing. |
| Biocompatibility: Coagulation | Compatible with blood coagulation (as per established standards) | Passed biocompatibility testing. |
| Biocompatibility: Indirect Hemolysis | Non-hemolytic (as per established biocompatibility standards) | Passed biocompatibility testing. |
| Biocompatibility: Intracutaneous Reactivity | Non-reactive (as per established biocompatibility standards) | Passed biocompatibility testing. |
| Biocompatibility: Systemic Toxicity | Non-systemically toxic (as per established biocompatibility standards) | Passed biocompatibility testing. |
| Biocompatibility: Sensitization | Non-sensitizing (as per established biocompatibility standards) | Passed biocompatibility testing. |
2. Sample sizes used for the test set and the data provenance
- The document does not specify the sample sizes (number of devices tested) for the comparative performance testing or the biocompatibility testing.
- The data provenance is from testing conducted by SCHNEIDER (Europe) GmbH in Switzerland. This is prospective testing specifically for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device equivalence study, not an AI study relying on expert-established ground truth for medical image interpretation or diagnosis. The "ground truth" here is the performance of the predicate device and established biocompatibility standards.
4. Adjudication method for the test set
- Not Applicable. There was no human adjudication process involved in comparing the device's technical performance. The evaluation was based on objective physical and chemical tests against the predicate device and recognized standards.
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 device, and therefore no MRMC study was conducted or is relevant.
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 or AI system.
7. The type of ground truth used
- The "ground truth" for the performance testing was the performance characteristics of the legally marketed predicate device (ACS DOC™ Extension Wire) and established international standards for biocompatibility testing. The goal was to prove "equivalence in technological characteristics."
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI model, this question is not relevant.
§ 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.