(138 days)
The speX Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
The speX Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral vasculature. The device is an over the wire single lumen catheter with a proximal female hub and a distal flexible part with a radiopaque tapered tip. The distal end of the catheter has a lubricious coating. The speX Support Catheter is 0.035" guidewire compatible and has working lengths of: 50cm, 90c, 135cm and 150cm.
This document describes the speX Support Catheter, a medical device, and the testing conducted to demonstrate its substantial equivalence to predicate devices, as required for 510(k) premarket notification. The information provided focuses on various performance tests to ensure the device meets predefined criteria.
Here's an analysis of the provided text to extract the requested information:
1. A table of acceptance criteria and the reported device performance:
The document states that "The speX Support Catheter met all specified criteria and did not raise new safety or performance questions." This implies that for each test listed, there were predefined acceptance criteria, and the device successfully met them. However, the specific quantitative acceptance criteria for each test are not explicitly detailed in the provided text, nor are the precise performance results for each test (e.g., "Tensile Strength: X N met requirement of >Y N").
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Meet specified criteria for: | Met all specified criteria |
| - Simulated Use (baseline, aged) | - Passed |
| - Tensile Strength (baseline, aged) | - Passed |
| - Torque (baseline, aged) | - Passed |
| - Pressure Test (baseline, aged) | - Passed |
| - Coating verification (baseline, aged) | - Passed |
| - Corrosion Test (baseline, aged) | - Passed |
| - Luer Verification (baseline, aged) | - Passed |
| - Dimensional verification and visual inspections (baseline, aged) | - Passed |
| - Sterilization Validation | - Passed |
| - Biocompatibility (Cytotoxicity, Irritation, Sensitization, Materials Mediated Pyrogenicity, Acute Systemic Tox, Hemolysis, PTT, Complement Activation, Thrombosis) | - Passed all biocompatibility tests (did not raise new safety or performance questions) |
| Not raise new safety or performance questions | Did not raise new safety or performance questions |
2. Sample size used for the test set and the data provenance:
The document mentions that "All testing was performed on test units representative of finished devices." However, it does not specify the sample size (N) used for any of the individual tests. It also does not provide information on the data provenance such as country of origin or whether the studies were retrospective or prospective. These are typically bench or lab tests, not clinical studies with human subjects in the context of device performance evaluation for 510(k) clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the type of device performance testing described. The tests listed (e.g., tensile strength, pressure test, biocompatibility) are laboratory-based engineering and biological evaluations, not studies requiring expert interpretation of diagnostic images or clinical outcomes to establish a "ground truth." The ground truth is established by the validated test methods themselves.
4. Adjudication method for the test set:
This information is not applicable to the type of device performance testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic accuracy, which is not the case here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The speX Support Catheter is a physical medical device (a catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. As stated above, this is a physical medical device, not an algorithm.
7. The type of ground truth used:
The ground truth for the device performance tests is based on established engineering and biological standards and specifications for medical devices. For example, tensile strength would be measured against a predefined minimum force it must withstand, biocompatibility against established limits for toxicity, irritation, etc. These are objective measurements and comparisons to predefined critical values, not expert consensus, pathology, or outcomes data in the typical sense for diagnostic or prognostic devices.
8. The sample size for the training set:
This information is not applicable. The speX Support Catheter is a manufactured device, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this 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).