(97 days)
Quick-Cross® Extreme Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The most distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter 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.
The Spectranetics Quick-Cross Extreme Support Catheters are physical medical devices, not AI/ML (Artificial Intelligence/Machine Learning) software. Therefore, the questions related to AI/ML specific criteria such as acceptance criteria for AI models, sample sizes for test/training sets, ground truth establishment by experts, and MRMC studies, do not apply to this submission.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through comparisons of material, design, construction, specifications, intended use, and performance, primarily through bench testing.
Here's an interpretation of the relevant information provided:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly list a table of "acceptance criteria" against which a device's performance is measured in a quantitative manner as one might see for an AI/ML device. Instead, the acceptance criteria are inherent in demonstrating substantial equivalence to predicate devices. The "reported device performance" is a summary statement that these criteria were met through comparative testing.
| Acceptance Criterion (Implicit for Substantial Equivalence to Predicate Devices) | Reported Device Performance |
|---|---|
| Guide and support a guidewire during vasculature access | Achieved (stated in intended use) |
| Allow for wire exchanges | Achieved (stated in intended use) |
| Provide a conduit for delivery of saline solutions or diagnostic contrast agents | Achieved (stated in intended use) |
| Equivalent physical dimensions (e.g., OD, working length, guidewire compatibility) | Quick-Cross Extreme models have the same specifications as listed (e.g., Models 518-076 to 518-083, 4Fr, 0.059" OD, 65-150cm working length, .035" guidewire comp.). "Test results show that the Spectranetics Quick-Cross Extreme Support Catheters are equivalent to the predicate devices." |
| Equivalent infusion rates | "Test results show that the Spectranetics Quick-Cross Extreme Support Catheters are equivalent to the predicate devices." |
| Equivalent burst pressure | "Test results show that the Spectranetics Quick-Cross Extreme Support Catheters are equivalent to the predicate devices." |
| Biocompatibility in conformance with ISO 10993-1:2003 | Confirmed (utilizing identical component materials as predicate devices) |
| Device integrity and functionality qualified/validated | Qualified and/or validated using samples produced under routine manufacturing conditions. |
| Sterilization in conformance with ANSI/AAMI/ISO 11135:1994 | Protocol prepared and executed for Ethylene Oxide Sterilization. |
| Meet or exceed requirements in ISO 1055-1 (Sterile, Single-use Intravascular Catheters - Part 1: General Requirements) | All models meet or exceed these requirements. |
| Package integrity validated | Initially validated in conjunction with sterilization studies. |
| Technical characteristics (e.g., stainless steel braided shaft, tapered tip, diameter) equivalent to predicate devices | "Have the same technical characteristics as the Terumo 4Fr Radifocus Optitorque (GlideCath) and the Quick-Cross Support Catheters, the predicate devices." (e.g. 0.066 inch diameter with capacity for 0.035" guidewires) |
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 mentions "comparative laboratory testing" and "samples produced under routine manufacturing conditions" for device integrity and functionality. However, specific sample sizes (e.g., number of catheters tested for burst pressure) are not provided. The data provenance (country of origin, retrospective/prospective) is also not specified, but it's implied to be internal laboratory testing conducted by Spectranetics Corporation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the submission pertains to a physical medical device. Ground truth, in the context of AI/ML, refers to annotated data. For this device, "ground truth" would more accurately be defined by established engineering and material science standards and physical measurements. No external experts are mentioned for establishing ground truth in this context; rather, internal engineering and quality control procedures would have been followed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical device submission focused on bench testing and substantial equivalence.
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 a physical support catheter, not an AI/ML diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" is fundamentally based on established engineering specifications, material properties, and performance benchmarks set by international standards (ISO and ANSI/AAMI) and comparative data against the predicate devices. This includes physical dimensions, material biocompatibility, mechanical strength (burst pressure), and flow characteristics (infusion rates).
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical medical device.
§ 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).