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The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is intended to introduce various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit consists of a 1) Steerable Sheath, 2) Dilator and 3) Guidewire, and is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. When the left side of the heart is accessed, the device is used with a compatible Transseptal Needle to puncture the interatrial septum for transseptal catheterization procedures. The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is a sterile, single use device, with asymmetrical bi-directional steerable introducer with usable length of 65cm. The Steerable Sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the Steerable Sheath tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and a radiopaque tip marker to improve fluoroscopic visualization.

The provided text describes the NaviGo 12F Steerable Intracardiac Catheter Introducer Kit and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and the Reported Device Performance

The document describes various performance tests conducted, but it does not explicitly list quantitative acceptance criteria for each test in a table format with corresponding reported performance values. Instead, it generally states that the device "met the acceptance criteria" or "demonstrated robust biocompatibility."

However, based on the descriptions, we can infer some general criteria and outcomes:

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

• Sterilization Testing: Not explicitly stated, but bioburden testing, LAL testing, and EO/ECH residual testing were performed on "the subject device."
• Shelf-Life Testing: Not explicitly stated, but accelerated aging studies and various package integrity tests were performed on "the subject device."
• Biocompatibility Testing: Not explicitly stated, but various in-vitro and in-vivo tests were conducted. The "In-Vivo Thrombogenicity Evaluation [GLP Animal Study]" refers to the animal study below. Materials were from the device itself.
• Benchtop Studies: Not explicitly stated, but various devices would have been tested for each category.
• Pre-Clinical (GLP Animal Study):
  • Sample Size: Six (6) healthy canines.
  • Data Provenance: Prospective animal study conducted in a GLP (Good Laboratory Practice) environment. The location/country of the GLP lab is not specified but it's an animal model, not human data.

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

• Pre-Clinical (GLP Animal Study):
  • Number of Experts: Two (2)
  • Qualifications: "Board Certified Electrophysiologists specializing in ablation of pulmonary veins in the management of atrial fibrillation."

4. Adjudication Method for the Test Set

• For the Pre-Clinical (GLP Animal Study), the two electrophysiologists "performed the procedures and rated the overall performance and usability of the subject device." The document does not specify a formal adjudication method (e.g., 2+1, 3+1). It states "predominant rating of Acceptable and Above Average," suggesting a consensus or combined assessment was reached, but the process is not detailed.
• For other tests (benchtop, sterilization, biocompatibility), the ground truth is based on standard test methods and established scientific criteria, not expert adjudication in the same sense.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter introducer kit), not an AI/software device that would typically involve human readers interpreting images with or without AI assistance. The study described is a pre-clinical animal study to assess safety, performance, and usability of the physical device.

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

No, a standalone algorithm performance study was not done. This is not an AI/software device.

7. The Type of Ground Truth Used

• Sterilization: Regulatory standards (ISO, ANSI/AAMI, EN ISO) for sterilization efficacy, bioburden levels, endotoxin levels, and residual limits.
• Shelf-Life: Regulatory standards (ASTM F1980-21, ASTM F2096-11(2019), ASTM F88/F88M-21) and product V&V testing.
• Biocompatibility: Regulatory standards (ISO 10993-1:2018, ISO 10993-4, -5, -7, -10, -11, -23) and FDA guidance for biological evaluation endpoints.
• Benchtop Studies: Design input acceptance criteria based on engineering specifications and industry standards relevant to catheter function (e.g., buckle force, deflection, kink resistance, leakage, bond strength).
• Pre-Clinical (GLP Animal Study): Direct observation, clinical assessment, and expert rating by Board Certified Electrophysiologists in a canine model for safety, performance, and usability. This includes observations for adverse events, device maneuverability, and overall handling, as well as thrombogenicity assessment.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. The "training set" concept is typically relevant to AI/machine learning models.

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

Not applicable, as there is no mention of a training set for an AI/ML model.

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