(158 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 (RF) Total Occlusion (TO) Crossing System consists of a 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-Steer™ Optical Coherence Reflectometry (OCR) Unit with . Display Monitor
- Safe-Cross RF Generator with Footswitch and Interface Cable .
The Safe-Cross RF Crossing Wires are similar to the predicate guidewires in construction and intended use. 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 Unit to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF Generator. 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 sterilized by ethylene oxide gas. The packaged RF Crossing Wire is provided "STERILE" and Non-pyrogenic, and is intended for single use only.
The provided text describes the Safe-Cross Radio Frequency Total Occlusion Crossing System, but it does not contain acceptance criteria for the device or a dedicated clinical study report outlining specific performance metrics against such criteria.
The document primarily focuses on:
- Device Identification: Trade name, common name, classification, and predicate devices.
- Device Description: Components of the system (crossing wires, OCR Unit, RF Generator) and their function.
- Intended Use: Facilitating placement of devices in vascular interventions for total occlusions in native iliac and superficial femoral arteries.
- Technological Characteristics: Similarity to predicate devices.
- Biocompatibility and Performance Data: Mentions that biocompatibility testing, in vitro bench testing, and in vivo animal studies were conducted, and that results "satisfy safety and performance requirements of the device specifications" and "do not raise unanticipated safety issues."
- Clinical Studies: States that human clinical studies were conducted to "verify the safety and performance characteristics..." and concluded that the device "performs as intended and does not involve unacceptable risk to the patient."
- Conclusion: The system is "substantially equivalent" to predicate devices.
- FDA K031842 Clearance Letter: Confirms clearance and reclassification.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I provide specific details about a study that proves the device meets those criteria, as this information is not present in the provided text.
The document implies that general safety and performance criteria were met through bench, animal, and human clinical studies, but it does not quantify these criteria or provide the results in a comparative format.
Based on the provided text, the following sections cannot be answered with specific details:
- 1. A table of acceptance criteria and the reported device performance (Not provided).
- 2. Sample sized used for the test set and the data provenance (Not provided, beyond "human clinical studies" in general).
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not provided).
- 4. Adjudication method (Not provided).
- 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 provided; this device is a guidewire system, not an AI diagnostic tool involving human readers).
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not provided; this device is a guidewire system, not an algorithm).
- 7. The type of ground truth used (Not specified beyond "safety and performance in human subjects").
- 8. The sample size for the training set (Not provided).
- 9. How the ground truth for the training set was established (Not provided).
§ 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).