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 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 consists of the following:

• 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) (175cm Working Length)
• 0.018" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (275cm Working Length)
• 0.035" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) ◆ (275cm Working Length)
• Safe-Cross RF System Console with Display and Footswitch .

The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The The modified Bate-Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connector is connected to the OCR input on the console to allow the medical practitioner to visualize structures within the mible on the console to anow and more connector is connected to the RF output on the vessel for navigation purposes. al 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.

The provided text describes the Safe-Cross® Radio Frequency Total Occlusion Crossing System (K050916), a catheter guide wire system. The summary focuses on its substantial equivalence to a predicate device and safety testing, rather than a clinical study with detailed acceptance criteria and performance metrics typically seen for AI/ML device evaluations.

Therefore, much of the requested information regarding acceptance criteria, study sizes, expert involvement, and ground truth types for AI performance evaluation is not available in the provided document, as it pertains to a mechanical medical device rather than an AI/ML system.

However, I can extract the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a mechanical device, the "acceptance criteria" are related to safety and performance requirements rather than statistical metrics against a benchmark. The document states:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified for biocompatibility, bench testing, or animal studies. The text only mentions "modified 0.014" RF Crossing Wires" for biocompatibility and "an animal model" for in vivo.
• Data Provenance: Not specified (e.g., country of origin). Both bench and animal studies are mentioned as "in vitro" and "in vivo," respectively, but whether they are retrospective or prospective is not stated, though animal studies are typically prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable/Not specified. This information is typically relevant for AI/ML studies where human experts establish ground truth. For this mechanical device, "ground truth" would be the direct measurement of physical properties or biological response in laboratory or animal settings, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert ground truth labeling in AI/ML studies. For device testing involving physical and biological measures, standard scientific protocols for data collection and analysis would be followed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic technologies, particularly AI systems, with human readers. The Safe-Cross® system is an interventional device, not a diagnostic one.

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

• Not applicable. The device is a physical, interventional medical device and does not involve an AI algorithm operating "standalone."

7. The Type of Ground Truth Used:

• Bench Testing: Engineering specifications and physical measurements are the "ground truth" for bench testing.
• Biocompatibility: Standardized biological tests (e.g., cytotoxicity, sensitization, irritation) results compared against acceptance criteria for biological safety.
• Animal Studies: Observed physiological and pathological responses in an animal model—e.g., successful crossing of occlusions, lack of vessel damage, proper system function.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As above, there is no training set.

Ask a specific question about this device

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

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 (RF) Total Occlusion (TO) Crossing System consists of a the following:

• 0.014" 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 Wire is similar to the prodicate guidewire 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, a medical device, and its regulatory submission. It mentions human clinical studies were conducted to verify the device's safety and performance, but it does not provide specific acceptance criteria or detailed results of those studies in a quantifiable manner.

Therefore, I cannot populate the table or answer all of your questions directly from the provided text.

However, I can extract the information that is present and indicate where information is missing.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states a general conclusion that the device performs as intended and does not pose unacceptable risks, but it does not provide the specific numerical acceptance criteria (e.g., "successful crossing of occlusion in X% of cases") or the achieved performance metrics (e.g., "successful crossing in Y% of cases").

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document only states "Human clinical studies have been conduct to verify the safety and performance characteristics of the Safe-Cross System."
• Data Provenance: Prospective human clinical studies. The country of origin is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The document does not detail how the outcomes of the clinical studies were assessed or by whom.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• MRMC Study Done?: Not applicable. This device is a guidewire system, not an imaging or diagnostic AI requiring human reader comparison. The "clinical studies" mentioned are likely efficacy and safety trials demonstrating the device's ability to cross occlusions.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Study Done?: Not applicable in the context of an "algorithm only" study. This is a physical medical device (guidewire system) operated by a human, not a standalone AI algorithm. The device's performance inherently involves human interaction.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for performance and safety would be established through clinical outcomes observed during the human clinical studies, likely including successful occlusion crossing, procedural success rates, and the incidence of adverse events, as assessed by the treating physicians and study investigators.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set" in the machine learning sense. The development and testing would involve bench testing and animal studies prior to human clinical trials.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable as there is no "training set" in the AI sense. For the development and pre-clinical stages, "ground truth" for design and performance would be established through engineering specifications, bench testing results (e.g., force required to cross simulated occlusions, RF power output, durability), and animal study observations (e.g., successful crossing in animal models, tissue effects). These would typically be compared against predetermined design requirements and safety parameters.

Ask a specific question about this device

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).

Ask a specific question about this device