Search Results

The VizaraMed Multiflex Steerable Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The VizaraMed Multiflex Steerable Sheath is a deflectable, sterile, single-use, percutaneous steerable sheath with dilator used to facilitate placement of various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The sheath is available in two sizes and consists of a steerable shaft capable of threedimensional shapes, a handle with lockable steering controls, a Tuohy-Borst adapter with a hemostasis valve, a side port, and atraumatic soft distal tip. The shaft is radiopaque for visualization under fluoroscopy. The accompanying dilator is packaged with the sheath in a pouch for removal.

The 12.5F sheath can accommodate devices of 3F(0.039") - 12.5F (0.162"). The 15.5F sheath can accommodate devices sized 3F (0.039") - 15.5F (0.203").

The provided document describes the VizaraMed Multiflex Steerable Sheath (K221655), a "Catheter introducer" device. However, it does not contain the detailed acceptance criteria for a device-specific performance study, nor does it present the results of such a study in a manner that would allow filling out the requested table for performance metrics.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (St. Jude Medical Agilis Steerable Introducer [K081645]) through various tests. These tests are described at a high level, but the specific acceptance criteria and the quantitative results are not provided.

Here's a breakdown of what is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Missing. The document lists types of tests performed (Mechanical properties, Sterilization, Usability, Biocompatibility) but does not provide specific numerical acceptance criteria or the reported device performance against those criteria. For example, for "Tensile Testing," it doesn't state "tensile strength > X MPa" or the actual measured value.

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

• Missing for most tests.
  • For "Sterilization validation," it mentions "appropriate sample size of final preconditioned, packaged product," but doesn't specify the number.
  • No information on the country of origin or whether the data was retrospective or prospective.

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

• Not applicable. This question typically pertains to studies involving image analysis or diagnostic performance where human experts establish a "ground truth" (e.g., presence/absence of a disease). The studies described here are primarily engineering and safety evaluations of a physical medical device.
• For "Usability Assessment," it mentions "physicians" but doesn't specify the number or their qualifications.

4. Adjudication Method for the Test Set:

• Not applicable. As above, this is for studies where expert disagreement on ground truth needs to be resolved.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

• No. An MRMC study is not mentioned. The "Usability Assessment" involved "physicians" evaluating the device, but it wasn't a comparative effectiveness study comparing human readers with and without AI assistance, as the device itself is not an AI diagnostic tool.

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

• Not applicable. This device is a physical medical instrument, not an algorithm or AI.

7. The type of ground truth used:

• Varies by test, but not explicitly detailed as "ground truth" in the diagnostic sense.
  • For mechanical testing, the "ground truth" would be engineering specifications and standards.
  • For sterilization, established protocols and biological indicators.
  • For biocompatibility, standard toxicology and material science criteria.
  • For usability, physician feedback based on simulated use.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

• Not applicable. As above.

In summary, the provided FDA 510(k) clearance letter and summary discuss the physical and functional characteristics of a medical device (Multiflex Steerable Sheath) and the types of engineering, safety, and performance tests conducted to demonstrate its substantial equivalence to a predicate device. However, it does not provide the detailed quantitative acceptance criteria and results typically found in a clinical performance study for diagnostic AI/ML devices, which the posed questions relate to.

Ask a specific question about this device