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The Surefire Guiding Catheter is intended to provide a pathway through which therapeutic devices are introduced. The Surefire Guiding Catheter is intended to be used in the peripheral vascular system.

The Surefire Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system.

The Surefire Guiding Catheter is a single-lumen, braided, fixed-length 5F catheter with a soft distal tip and a proximal Luer-Lock hub and strain relief. The Pebax extruded polymer is filled with a radiopacifier to provide visibility of the Surefire Guiding Catheter under fluoroscopy.

The Surefire Guiding Catheters are 65 and 80 cm in length with a variety of pre-shaped tip designs (including but not limited to Axis, Simmons I and Cobra) to accommodate access and positioning in a range of peripheral vascular anatomies. The distal tip is rounded for atraumatic tracking.

The Surefire Guiding Catheter is compatible with standard 0.038" OD guide wires, Luer-Lock infusion syringes, rotating hemostatic valves (RHV), and 5F catheter sheath introducers.

The Surefire Guiding Catheter is provided sterile (EtO) for single patient use

This document describes the Surefire Guiding Catheter, a medical device, and its acceptance criteria as demonstrated through various studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details various tests performed to demonstrate the safety and effectiveness of the Surefire Guiding Catheter and its equivalence to a predicate device. The acceptance criteria are implicitly met by the successful completion of these tests and the determination of substantial equivalence.

Study that Proves the Device Meets the Acceptance Criteria:

The document describes a series of studies rather than a single unifying study, all aimed at demonstrating the safety, effectiveness, and substantial equivalence of the Surefire Guiding Catheter to its predicate device. This approach is typical for 510(k) submissions.

Summary of Studies:

1. Biocompatibility Testing: Performed per ISO 10993-1, leveraging data from other Surefire products with similar materials. This included various in-vitro tests for cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility.
2. Performance Testing (Bench Studies): Design verification tests including visual/dimensional inspection, particulates, kink, tensile strength, torque, trackability/device compatibility, high pressure injection, and flow/pressure generation.
3. Animal Testing (GLP): A comparative acute performance study against the predicate device.

Detailed Information Regarding the Studies:

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

• Biocompatibility Testing: The specific sample sizes for each in-vitro test (Elution, Maximization, Intracutaneous, Systemic Toxicity, Hemolysis, Complement Assays, Coagulation) are not explicitly stated in the provided text.
  • Data Provenance: The tests were performed by NAMSA (Northwood, OH). This suggests in-vitro laboratory testing. The leveraging of data from other Surefire devices implies the materials were sourced from the manufacturer for these devices.
• Performance Testing (Bench Studies): Sample sizes for the various bench tests (visual/dimensional, kink, tensile, torque, etc.) are not explicitly stated in the provided text.
  • Data Provenance: These were likely performed at a manufacturing or testing facility, but the specific location is not mentioned.
• Animal Testing: The number of animals used for the GLP animal study is not explicitly stated.
  • Data Provenance: The study was a "GLP animal study," meaning it followed Good Laboratory Practices. The location and type of animal are not specified, nor is the country of origin. This would be a prospective study.

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

• Biocompatibility Testing: Not applicable. Ground truth for these in-vitro tests is adherence to established international standards (ISO 10993) and scientific principles of toxicology and material science. The tests were performed by NAMSA.
• Performance Testing (Bench Studies): Not applicable. Ground truth for these engineering tests is meeting predefined specifications and equivalence to the predicate device's performance.
• Animal Testing: The text mentions the study assessed performance "as defined by a physician in a clinical environment." This implies at least one, and likely more, physician experts were involved in defining the performance criteria and potentially assessing the outcomes during the animal study. Their specific qualifications (e.g., years of experience, specialization) are not explicitly stated.

4. Adjudication Method for the Test Set

• Biocompatibility Testing: Not applicable in the sense of expert adjudication. The results are interpreted against established acceptance criteria defined by ISO standards.
• Performance Testing (Bench Studies): Not applicable in the sense of expert adjudication. Results are compared against specifications and predicate device performance.
• Animal Testing: The method for "defining" acceptable and comparable performance by the physician(s) is not detailed. It's possible there was an internal review panel or a sole physician's assessment, but no formal adjudication method (e.g., 2+1, 3+1) is described.

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 MRMC study was done. This device is a guiding catheter, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable.

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

• No standalone algorithm performance study was done. This device is a physical medical instrument, not an algorithm. Therefore, this question is not applicable.

7. The Type of Ground Truth Used

• Biocompatibility Testing: The ground truth is derived from established international standards (ISO 10993 series) for biological evaluation of medical devices. The "ground truth" is that the materials are not biologically reactive, cytotoxic, sensitizing, irritating, systematically toxic, or highly thrombogenic.
• Performance Testing (Bench Studies): The ground truth is based on engineering specifications and comparative performance data from the predicate device. The "ground truth" is that the device can withstand specific forces, pressures, and demonstrates appropriate mechanical behavior for its intended use, comparable to the predicate.
• Animal Testing: The ground truth is based on direct observation and assessment of the device's acute performance and safety within a living biological system (animal model), as evaluated by a physician. This is a form of outcomes data (observed physiological responses, device functionality in-vivo) within a controlled experimental setting, benchmarked against a predicate device.

8. The Sample Size for the Training Set

• Not applicable. This device is hardware and does not involve AI or machine learning models that require training sets. The "training" for this device would be its design, manufacturing, and preclinical testing phases.

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

• Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for a training set does not apply here. The "ground truth" for the device's design and manufacturing is established through quality systems, design controls, material specifications, and regulatory standards.

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