Search Results

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 arteries with total occlusions.

The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following:

• 175cm Working Length 0.014" Safe-Cross RF Crossing Wire Straight and . Angled Tip (with Torquer and Tip Shaping Tool)
• 275cm Working Length 0.014" Safe-Cross RF Crossing Wire Straight and . Angled Tip (with Torquer and Tip Shaping Tool)
• Safe-Cross RF System Console with Display and Footswitch ●
  The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The proximal end of the RF 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 with the Tip Shaping Tool. A Torquer is provided in a separate peel pouch. The packaged RF Crossing Wire is provided "STERILE" (ethylene oxide) and non-pyrogenic, and is intended for single use only.

Acceptance Criteria and Device Performance

This 510(k) summary focuses on modifications to a previously cleared device. Therefore, the acceptance criteria are primarily demonstrated through verification that the modified device maintains the safety and performance of the predicate device and meets established design specifications. Specific numerical performance metrics or acceptance criteria are not explicitly detailed in the provided text as they would be in a submission for a novel device.

Study Details

The provided document describes studies conducted to support the substantial equivalence claim for the modified Safe-Cross® Radio Frequency Total Occlusion Crossing System.

2. Sample sizes used for the test set and the data provenance:

• Test Set (Bench Testing): Not explicitly stated. The document mentions "Benchtop performance test results indicate that the modified RF Crossing Wires satisfy safety and performance requirements of the device specifications." This implies a set of tests were conducted, but the number of devices or iterations tested is not provided.
• Test Set (In Vivo Animal Studies): Not explicitly stated. The document mentions "In vivo animal studies have shown that the components of the system function properly together and satisfy intravascular performance requirements in an animal model." The number of animals or specific experimental design details are not given.
• Data Provenance: The studies were conducted by IntraLuminal Therapeutics, Inc., likely at their facilities or through contracted labs. The data would be prospective, as it was generated specifically for this 510(k) submission. No country of origin for the data is specified beyond the company's location in Carlsbad, CA, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not explicitly stated. For biocompatibility, bench testing, and animal studies, "ground truth" is typically established by objective measurements, scientific standards, and observation by qualified scientific personnel (e.g., toxicologists, engineers, veterinarians, or principal investigators) according to established protocols. The document does not specify the number or qualifications of experts beyond the company's internal R&D and QA teams.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable/Not explicitly stated. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for human interpretation of data (e.g., image reading). For the types of studies described (biocompatibility, bench, animal), results are generally objective and determined by predefined pass/fail criteria or statistical analysis, not by human adjudication of nuanced findings in the same way.

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:

• No. An MRMC comparative effectiveness study was not performed. This device is a medical instrument (catheter guide wire system), not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in data interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No. This device is a medical instrument, not an algorithm or software-only device. Its function intrinsically requires human operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Biocompatibility: Ground truth is established by adherence to recognized standards (e.g., ISO 10993 series) and biological safety assessments based on specific tests (e.g., cytotoxicity, sensitization, irritation).
• Bench Testing: Ground truth is established by design specifications, engineering tolerances, and mechanical/electrical performance standards. Measurements are compared against these predefined criteria.
• In Vivo Animal Studies: Ground truth is established through direct observation of device function, physiological responses, and potentially histological examination in animal models, evaluated against expected normal biological function and safety parameters.

8. The sample size for the training set:

• Not applicable. The devices described are hardware medical devices, not AI models that require a "training set" in the computational sense. The "training" of the device is through design, manufacturing, and quality control processes.

9. How the ground truth for the training set was established:

• Not applicable, as there is no "training set" in the context of an AI model for this hardware medical device.

Ask a specific question about this device