(91 days)
The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in percutaneous interventions in native coronary and peripheral arteries with total occlusions. The device is not to be used in the carotid arteries.
The Safe-Cross® Radio Frequency Total Occlusion Crossing System provides Optical Coherence Reflectometry for navigation through vessels allowing visualization of the Safe-Cross Crossing Wire tip. Radio Frequency energy is provided to the wire's distal tip in order to ablate tissue to create a passage for wire advancement through difficult sections of arterial occlusions. The System was modified to add a High Dynamic Range Console to the product line, which allows more light to penetrate and reflect off tissue improving the overall range of the system; and to modify the Crossing Wires to reinforce the distal tip.
The Safe-Cross Crossing Wires are provided EtO sterile for single use in the following sizes:
- .014" x 275 cm, straight or angled tip packaged with Safe Torquer and tip shaping tool; Coronary . and Peripheral use.
- .035" x 275 cm, straight or angled tip packaged with Safe-Cross Torquer; Peripheral use only. .
The provided text describes a 510(k) summary for the Safe-Cross® Radio Frequency Total Occlusion Crossing System. This submission focuses on modifications to an existing device, specifically adding a High Dynamic Range Console and reinforcing the distal tip of the crossing wires.
Based on the information provided, here's a description of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria or a direct comparison table as would be typical for an AI/ML device. Instead, the "acceptance criteria" are implied by the types of non-clinical tests performed to demonstrate the safety and effectiveness of the modifications to an already legally marketed predicate device. The "reported device performance" refers to the successful completion of these tests, demonstrating substantial equivalence to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Console optics module verification: Functionality and performance of the new High Dynamic Range Console. | Verification of Console optics module completed successfully. |
| Software validation: Functionality and safety of the updated software. | Software validation completed successfully. |
| Crossing Wire biocompatibility: Safety of materials in contact with body tissues. | Biocompatibility testing of crossing wires completed successfully. |
| Crossing Wire tensile strength: Ability of the wire to withstand pulling forces. | Tensile strength testing of crossing wires completed successfully. |
| Crossing Wire friction: Smoothness of wire movement within vessels. | Friction testing of crossing wires completed successfully. |
| Crossing Wire torque response/strength: Ability of the wire to transmit rotational forces and resist breakage. | Torque response and strength testing of crossing wires completed successfully. |
| Crossing Wire package integrity: Assurance of sterility and product protection until use. | Package integrity testing completed successfully. |
| Overall safety and effectiveness: The modifications do not negatively impact the device's ability to facilitate placement of percutaneous intervention devices in total occlusions. | Testing provides reasonable assurance of safety and effectiveness for its intended use, maintaining substantial equivalence to the predicate. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided text describes non-clinical testing (e.g., bench testing, material characterization). It does not mention a "test set" in the context of patient data or clinical studies. Therefore, there is no information on sample size for a test set or data provenance (country of origin, retrospective/prospective) related to patient data. The tests were performed presumably in a laboratory setting.
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 as the submission describes non-clinical engineering and material tests, not clinical studies requiring expert ground truth for patient data.
4. Adjudication Method for the Test Set
This information is not applicable as the submission describes non-clinical engineering and material tests, not clinical studies requiring adjudication of patient data.
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 done. The submission focuses on non-clinical testing for device modifications and substantial equivalence to a predicate device, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study as described for an AI algorithm was not done. The device in question is a physical medical device (catheter/guidewire system), not an AI algorithm. Its "navigation" capabilities involving "Optical Coherence Reflectometry" are physical and optical, not AI-driven.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests would have been established by engineering specifications, validated test methods, and industry standards for material properties and device performance. For example, a tensile strength test would have a specified breaking point or load capacity as a "ground truth" to meet.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI/ML system that utilizes a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for an AI/ML algorithm mentioned in the submission. The "ground truth" for the non-clinical tests would have been based on established engineering principles and benchmarks, as mentioned in point 7.
§ 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.