(151 days)
The CenterCross Ultra Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.
The CenterCross Ultra Catheter is a sterile, single-use, single lumen over-the-wire support catheter to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature to facilitate exchange of guidewires and other interventional devices.
The CenterCross Ultra Catheter consists of an outer shaft and a removable handle/inner shaft assembly that allows for manual device manipulation. A kev element of the device is an expandable and retractable nitinol structure, which, when deployed by the physician, expands to the artery wall to aid interventionalists in establishing greater support near the treatment site.
Subsequent to conventional guidewire placement, atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The CenterCross Ultra Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire and device support. The CenterCross Ultra Catheter is similar in its design and achieves its intended use by means of the same mechanisms as the predicate device.
The provided text describes a 510(k) premarket notification for the CenterCross Ultra Catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the CenterCross Catheter (K140910). The information provided is primarily focused on non-clinical bench testing to show that the new device performs to specifications and is comparable to the predicate.
Here's an analysis based on the categories requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide specific quantitative acceptance criteria or detailed numerical performance results for the CenterCross Ultra Catheter. Instead, it states that "All testing was performed in accordance with recognized standards" and "The collective results of the non-clinical testing demonstrate that the CenterCross Ultra Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device."
Summary of Tested Aspects:
| Test Aspect | Reported Device Performance |
|---|---|
| Dimensional Inspection | Meets established specifications for consistent performance. |
| Hydrophilic Coating | Meets established specifications for consistent performance. |
| Simulated Use | Meets established specifications for consistent performance. |
| Contrast Flush Injection | Meets established specifications for consistent performance. |
| Leak | Meets established specifications for consistent performance. |
| Torque Strength | Meets established specifications for consistent performance. |
| Tip Flexibility & Kink Resistance | Meets established specifications for consistent performance. |
| Pressurized Flow Rate | Meets established specifications for consistent performance. |
| Tensile Strength | Meets established specifications for consistent performance. |
| Particulate | Meets established specifications for consistent performance. |
| Shelf-life | Meets established specifications for consistent performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document only mentions "Extensive bench testing" but does not specify the sample sizes (n) for each of the non-clinical tests conducted.
The data provenance is non-clinical bench testing, meaning it was performed in a laboratory setting. There is no information regarding country of origin or whether the data is retrospective or prospective, as these terms are typically relevant for clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the document describes non-clinical bench testing, not a study involving human subjects or expert assessment for ground truth determination. The "ground truth" for these tests would be the established engineering specifications and recognized standards themselves.
4. Adjudication Method for the Test Set
This section is not applicable as the document describes non-clinical bench testing. Adjudication methods are typically used in clinical studies for resolving discrepancies in expert opinions or outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The submission focuses on non-clinical bench testing to demonstrate substantial equivalence, not a clinical study involving human readers and AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a medical catheter, not an algorithm or AI. The testing described is bench testing of the physical device.
7. The Type of Ground Truth Used
For the non-clinical bench tests, the "ground truth" is implicitly the established engineering specifications and recognized industry standards that the device was tested against. The document states, "All testing was performed in accordance with recognized standards."
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical medical catheter, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reason as above; it is a physical device, not an AI model.
§ 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).