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The Instylla Microcatheter is intended for use in super selective anatomy for peripheral diagnostic and interventional procedures. The Instylla Microcatheter can be used for the infusion of diagnostic, embolic, or therapeutic materials into vessels.

The Instylla Microcatheter includes a single lumen, multipurpose catheter intended for use in the peripheral vasculature. The basic operating principle is to advance the microcatheter through an outer guiding catheter and track coaxially over a steerable guidewire in order to access the treatment site. The microcatheter lumen is able to accommodate steerable guidewires that are ≤0.014in (0.36mm) in diameter. Once the target region has been accessed, the microcatheter can be used to deliver diagnostic, embolic, or therapeutic materials into vessels.

The microcatheter has a 1.7Fr (0.56mm) OD with a constant flexibility along its length. The ID of the microcatheter is 0.016in (0.41mm) along its length. The proximal end of the microcatheter incorporates a standard luer hub to enable the attachment of accessories, and a strain relief with a feature that allows for flexibility and securement inside a Tuohy-Borst adapter, for maintaining position inside a guiding catheter as needed. The microcatheter has a radiopaque marker at the distal tip to aid in fluoroscopic visualization. A 4Fr Tuohy-Borst with side-port adapter, a short extension adaptor, a long extension adapter and a duckbill check-valve are also included. The Instylla Microcatheter is available in 122cm, 142cm and 162cm usable lengths.

This document describes the Instylla Microcatheter with check-valve connector and asserts its substantial equivalence to a previously cleared predicate device (Instylla Microcatheter, K191731). As such, the study focuses on verifying that the modified device meets the same performance criteria as the predicate, rather than establishing entirely new acceptance criteria or conducting a clinical effectiveness study.

Here's an analysis of the provided information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific bench and functional test. It refers to these as "testing" and "evaluation." Given the nature of a 510(k) submission focusing on substantial equivalence for a minor modification (addition of a duckbill check-valve connector), these tests are typically conducted on a representative sample of devices.

• Provenance: This is a retrospective comparison to the predicate device. The tests are performed "in-house" by the manufacturer (Instylla, Inc.) to demonstrate that the modified device performs comparably to the previously-cleared device. The data provenance is effectively manufacturer-generated test data. No specific country of origin for test data is mentioned beyond the company's US location.

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

Not applicable to this type of submission. This is a bench and functional testing report for a device modification, not a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" for these tests is based on established engineering and biological standards (e.g., ISO for sterility, defined limits for endotoxins/biocompatibility observations).

4. Adjudication Method for the Test Set

Not applicable. As described above, this is laboratory-based testing against predefined specifications, not judgmental classification requiring adjudication.

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 applicable. This is not an AI/Software as a Medical Device (SaMD) submission. It concerns a physical medical device (microcatheter).

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests described (functional, biocompatibility, sterility, shelf life) is based on:

• Engineering Specifications: For functional tests like accessory compatibility, the ground truth is whether the device meets its design specifications and operates as intended.
• International Standards: For biocompatibility (ISO 10993-1) and sterility (ISO 11135), the ground truth is adherence to the validated methods and acceptable limits defined by these standards.
• Predetermined Acceptance Criteria: The document mentions "predetermined acceptance criteria" for functional testing, implying a comparison to established benchmarks, likely derived from the predicate device's performance or industry best practices.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning/AI device.

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

Not applicable. This is not a machine learning/AI device.

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