Search Results

The Pounce sheath is intended to introduce therapeutic devices into the vasculature.

The Pounce™ Sheath is a single-use, sterile introducer sheath intended for the introduction of therapeutic or diagnostic devices within the vasculature. The Pounce™ Sheath includes the following features:

• . Braided nitinol, self-expanding funnel at the sheath's distal end
• Handle assembly with slider button to actuate the funnel's deployment
• Hub and hemostasis valve assembly to allow for device introduction and removal .
• Aspiration assembly to include tubing, a stopcock, and connection for a 60 cc syringe .
  Additional components provided within the packaging include:
• . 0.035" guidewire compatible dilator designed for atraumatic introduction of the sheath
• . 60 cc locking syringe, compatible with the sheath's aspiration assembly
  A radiopaque marker band is located at the distal tip of the sheath during introduction and removal, when the funnel is sheathed. When the funnel is unsheathed, the radiopaque marker band is located proximally to the funnel is sheathed and unsheathed with the actuation of a slider button located on the handle assembly.
  The hemostasis valve can be actively defeated (opened), prior to device introduction or removal, by pressing down on the base of the surrounding hub. This action is designed to minimize device contact across the hemostatic valve during the introduction or removal of devices. The aspiration assembly also aids in the delivery of contrast or saline.

The provided text is a 510(k) summary for the Pounce™ Sheath, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study proving a device meets specific acceptance criteria in the context of an AI/ML algorithm or a complex diagnostic device.

Therefore, the information required to answer questions 1-9 is largely not present in this document. The 510(k) process for a device like the Pounce™ Sheath (a catheter introducer) relies heavily on bench testing (performance, biocompatibility, sterilization) to show that a new device is as safe and effective as a legally marketed predicate device. It does not involve the types of studies typically conducted for AI/ML algorithms, such as MRMC studies, expert ground truthing, or large-scale clinical trials (unless specifically mandated for a higher risk classification or novel technology).

Here's a breakdown based on the provided text, and where the requested information is absent:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document generically states, "All test results met documented acceptance criteria." It does not provide the specific numerical acceptance criteria for each bench test (e.g., minimum tensile strength, maximum insertion force).
• Reported Device Performance: Similarly, it states, "The subject device has been evaluated through the following categories of testing... All test results met documented acceptance criteria." However, the actual performance values are not reported. For example, it lists "Funnel Radial Force" as a test but doesn't provide the measured radial force.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for any of the bench tests.
• Data Provenance: Not applicable in the context of bench testing for a physical device. Data is generated in a lab setting, not from patient populations.
• Retrospective/Prospective: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is not an AI/ML algorithm or a diagnostic tool that requires expert interpretation for ground truth establishment. Bench testing relies on engineering specifications and physical measurements, not expert human assessment of images or clinical data.

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

• Not applicable. No human interpretation or adjudication is involved in the bench testing 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. This is a physical medical device (catheter introducer), not an AI algorithm for diagnostic imaging. Therefore, no MRMC study was conducted.

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

• No. This is not an algorithm. Bench tests evaluate the physical performance of the device itself.

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

• Engineering Specifications/Physical Standards: For bench tests, the "ground truth" or reference is typically defined by engineering design specifications, industry standards (e.g., ISO for biocompatibility and sterilization), and regulatory requirements. It is a measurement against a predefined acceptable range, not a "diagnosis."

8. The sample size for the training set

• Not applicable. This device does not use a training set as it's not an AI/ML algorithm or a data-driven model.

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

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

Summary regarding the device and its studies:

The document states:

• "Results of successful design verification testing demonstrate the safety and effectiveness of the Pounce Sheath and that the technological differences identified do not raise new questions of safety or effectiveness compared to the predicate device."
• "All test results met documented acceptance criteria."

The studies performed were:

• Performance Bench Testing: A long list of physical and mechanical tests (e.g., Dimensional, Funnel Radial Force, Insertion Force, Hemostasis Valve Leakage, Radiopacity, Torque Strength).
• Biocompatibility: Tests performed according to ISO 10993-1, including Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility (ASTM Hemolysis Assay, SC5b Complement Activation Assay, Partial Thromboplastin Time (PTT), Heparinized Platelet and Leukocyte Count Assay, In Vivo Thrombogenicity).
• Sterilization: Demonstrated compliance with ISO 11135.

Crucially, the document explicitly states:

• "No animal testing data was required for the Pounce Sheath."
• "No clinical data was required for the Pounce Sheath."

This indicates that the FDA deemed the bench testing sufficient to establish substantial equivalence given the nature of the device and its predicate.

Ask a specific question about this device