(15 days)
The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in vascular interventions of total occlusions in native iliac and superficial femoral arteries (SFA) of the lower extremities.
The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following:
- 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) .
- 0.035" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) .
- Safe-Cross RF System Console .
The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The proximal end of the Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR input on the console to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF output on the console. This allows the medical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel.
The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray. The packaged RF Crossing Wire is provided "STERILE" (ethylene oxide) and non-pyrogenic, and is intended for single use only.
This 510(k) summary (K033708) describes a medical device, the Safe-Cross® Radio Frequency Total Occlusion Crossing System, which is a modified version of a previously cleared device. The submission focuses on demonstrating substantial equivalence to the predicate device, primarily through performance and bench testing, rather than a clinical study involving human patients.
Therefore, many of the requested categories, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance, are not directly applicable or reported in this type of submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Satisfy safety and performance requirements of device specifications | Benchtop performance test results indicate that the components of the Safe-Cross System satisfy safety and performance requirements of the device specifications. |
| Do not raise additional safety issues via modifications | Benchtop performance test results indicate that the components of the Safe-Cross System do not raise additional safety issues. |
| Substantially equivalent to predicate device | Concluded to be substantially equivalent to the predicate device based on testing. |
| Verification through software testing (for combined console) | Performance of the modified Safe-Cross System has been verified through software testing. |
| Verification through bench testing | Performance of the modified Safe-Cross System has been verified through bench testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable / Not specified for human testing. The testing was primarily in vitro bench testing and software testing.
- Data Provenance: Not applicable for human data. The testing was conducted by the manufacturer, IntraLuminal Therapeutics, Inc., likely at their facilities (Carlsbad, CA, USA). The nature of the testing (bench and software) is prospective for the device under evaluation.
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)
- Not applicable. This submission relies on in vitro bench testing and software testing, not expert-adjudicated clinical data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical adjudication method was used as this was not a human study.
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 device is a physical medical device (catheter guide wire system), not an AI/software product, and therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-only device. The performance data refers to the physical device's characteristics and functionality. The "standalone" performance here refers to the device's ability to function according to specifications in a controlled, non-human environment. The "bench testing" represents this form of standalone evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is based on the device's predetermined engineering specifications and performance requirements. The bench testing and software testing confirmed that the modified device met these specifications, which serve as the "ground truth" for its safety and performance claims in this context.
8. The sample size for the training set
- Not applicable. There is no concept of a "training set" as this is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth for a training set was used.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.