(81 days)
The Access & Support Catheter is intended for use during coronary and peripheral interventional procedures to guide and support guidewires, traverse discrete portions of the vasculature, allow for guidewire exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents.
The Access & Support Catheter is an over-the-wire (OTW) single-lumen catheter with an atraumatic tapered tip. The catheter is offered in twelve (12) size models as outlined in the following table. The catheter shaft consists of high density polyethylene (HDPE) with distal platinum/iridium markerbands. The distal 40 cm outer portion of all catheters have a hydrophilic coating. The proximal portion includes a PEBA strain relief with a HDPE manifold which incorporates a female luer connection which communicates with the catheter lumen. The catheter through lumen is used to pass the catheter over the appropriate guidewire or for infusion. When used for infusion, the maximum infusion pressure should not exceed 300 psi. The catheter guidewire compatibility size and length are printed on the strain relief. All models are compatible with 5 Fr introducer sheaths and 6 Fr guiding catheters. All devices are provided sterile and intended for single use only.
The provided text is a 510(k) Summary for a medical device called the "Access & Support Catheter." It outlines the device's design, intended use, and a comparison to predicate devices, primarily focusing on non-clinical performance data. It explicitly states that "All tests demonstrated the materials, manufacturing processes, and design of the Access & Support Catheter met the established performance criteria and will perform as intended." However, the document does not contain information about a study proving the device meets acceptance criteria in the context of clinical performance or algorithm-based diagnostics.
Instead, it describes the results of non-clinical bench testing and biocompatibility tests to demonstrate substantial equivalence to predicate devices, focusing on physical properties and material safety.
Therefore, many of the requested categories for a study proving acceptance criteria (especially those related to human readers, ground truth establishment for a test set, and multi-reader multi-case studies) are not applicable to the information provided.
Here's a summary based on the provided text, highlighting the absence of information for certain criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various non-clinical tests conducted and states that performance criteria were met. It does not provide specific numerical acceptance criteria or detailed quantitative performance results for each test in a table format. Instead, it offers a qualitative statement of compliance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Visual inspections | Met established criteria |
| Dimensional evaluations | Met established criteria |
| Luer syringe compatibility | Met established criteria |
| Guidewire compatibility | Met established criteria |
| Sheath compatibility | Met established criteria |
| Guidewire support | Met established criteria |
| Catheter stiffness & flexibility, guidewire retraction & re-insertion | Met established criteria |
| Catheter fatigue | Met established criteria |
| Catheter kink resistance | Met established criteria |
| Markerband retention | Met established criteria |
| Leakage/burst (Pressure & Vacuum) | Met established criteria |
| Torque testing | Met established criteria |
| Tensile testing | Met established criteria |
| Corrosion testing | Met established criteria |
| Simulated Use | Met established criteria |
| Coating Adherence | Met established criteria |
| Particulate Evaluations | Met established criteria |
| Shelf life | Met established criteria |
| Package Integrity | Met established criteria |
| Biocompatibility | |
| Cytotoxicity | Met established criteria |
| Sensitization | Met established criteria |
| Irritation / Intracutaneous Reactivity | Met established criteria |
| Systemic Toxicity (Acute) | Met established criteria |
| Genotoxicity | Met established criteria |
| Hemolysis | Met established criteria |
| Immunology (Compliment Activation) | Met established criteria |
| In Vivo Thromboresistance | Met established criteria |
| Pyrogenicity (material mediated) | Met established criteria |
| Physicochemical Tests | Met established criteria |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for individual non-clinical tests. The text indicates that "The Access & Support Catheter has been evaluated using the following in vitro bench testing." This implies testing of device units, but the number of units tested for each criterion is not provided.
- Data Provenance: The tests are described as "in vitro bench testing" and "Biocompatibility tests," indicating laboratory-based, non-clinical data. No country of origin is mentioned for data, but the submitter is QXMédical, LLC, based in White Bear Lake, MN, USA. The data is retrospective in the sense that it was generated prior to submission for regulatory review.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this device is based on objective measurements and established standards for mechanical and biocompatibility performance, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. See explanation for point 3.
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-enabled diagnostic device, and no MRMC study was conducted or mentioned.
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 a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for non-clinical performance (mechanical, material, and biocompatibility) is based on established engineering specifications, material standards, and biological safety standards (e.g., ISO standards for biocompatibility). The tests objectively demonstrate that the device meets these predefined physical and biological requirements.
8. The sample size for the training set:
- Not applicable. As a physical medical device submission, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not applicable. See explanation for point 8.
§ 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).