(68 days)
The Spectranetics Quick-Cross Support2 Catheter is designed for use in the vascular system. The catheters are intended to support a guide wire during access to the vasculature, allow for exchange of guide wires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Model number 518-065 has a shaft of varying stiffness with a proximal shaft diameter of 3 Fr. Tapering to a distal shaft diameter of 1.9 Fr and is compatible with a 0.014 inch or smaller guide wire.
Model number 518-066 has a shaft of varying stiffness with a proximal shaft diameter of 4.8 Fr. Tapering to a distal shaft diameter of 3.7 Fr and is compatible with a 0.035 inch or smaller guide wire.
All models have three (3) radiopaque markers located at their tapered distal tip. A standard female luer is placed on the proximal end of each model. The distal 40 cm of each model is coated with a lubricious hydrophilic coating. Predicate devices of this type with similar intended uses have been classified into Class II. The support catheters are single-use and provided in sterile packaging.
Spectranetics Quick-Cross Support2 Catheters have the same technical characteristics as the predicate devices, the unmodified Quick-Cross Support2 Catheters. Both are constructed from HDPE extruded tubing, HDPE molded luers, and platinum/iridium bands. All support catheters have a 0.068 inch maximum diameter with the capacity to accommodate 0.014" - 0.035" diameter guide wires depending on the model (see table below).
| Model number | Wire compatibility | Sheath Compatibility | Length |
|---|---|---|---|
| 518-065 | 0.014" diameter | 5Fr | 150 cm |
| 518-066 | 0.035" diameter | 5Fr | 65 cm |
The provided text describes the Spectranetics Quick-Cross Support2 Catheter and its substantial equivalence to predicate devices, rather than a study proving a device meets specific acceptance criteria for AI/ML performance.
Therefore, I cannot extract information related to:
- A table of acceptance criteria and the reported device performance: This document does not specify performance metrics in the way an AI/ML study would (e.g., accuracy, sensitivity, specificity). Instead, it refers to "comparative laboratory testing" for physical dimensions, infusion rates, and burst pressure, stating that the device is "equivalent" in safety, effectiveness, indication, and performance to predicate devices.
- Sample sized used for the test set and the data provenance: There is no mention of a "test set" in the context of an AI/ML model or data provenance. The testing conducted was for physical characteristics, not algorithm performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no discussion of expert ground truth establishment for an AI/ML model.
- Adjudication method: Not applicable to this type of device submission.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as there is no algorithm described.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable as there is no mention of an AI/ML training set.
- How the ground truth for the training set was established: Not applicable.
The document is a 510(k) summary for a medical device (a support catheter), which focuses on demonstrating "substantial equivalence" to already-marketed predicate devices through comparative testing of physical and material properties, rather than validating an AI/ML algorithm.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).