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The Instylla Microcatheter 1.2 is intended for use in super selective anatomy for peripheral diagnostic and interventional procedures. The Instylla Microcatheter 1.2 can be used for the infusion of diagnostic, embolic, or therapeutic materials into vessels.

The Instylla Microcatheter 1.2 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 ≤0.010in (0.25mm) 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 1.2Fr (0.40mm) OD with a constant flexibility along its length. The ID of the microcatheter is 0.012in (0.30mm) 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 with side-port 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 FDA 510(k) summary describes a device, the Instylla Microcatheter 1.2, which is essentially a modification of a previously cleared predicate device (Instylla Microcatheter K200744). Therefore, the acceptance criteria and performance data mainly focus on demonstrating that the modified device's performance is equivalent to or better than the predicate, especially regarding the changes made.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Instylla Microcatheter 1.2 "met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device." However, specific numerical acceptance criteria values and reported performance values are not explicitly provided in this summary for most tests. The summary lists the types of tests performed.

Note: The document explicitly states "The Instylla Microcatheter 1.2 met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device." This general statement serves as the reported performance for all the tests, even though specific numerical results are not provided in this summary.

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

The document does not explicitly state the sample sizes used for the various bench and functional tests, biocompatibility tests, sterility tests, or shelf-life studies. It only lists the types of tests performed.

Regarding data provenance: All listed tests are laboratory-based (bench testing, functional testing, biocompatibility, sterility, shelf life) and were conducted by the manufacturer, Instylla, Inc., in the United States. There is no indication of retrospective or prospective data from patient use, as clinical studies were deemed unnecessary.

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

This information is not applicable as there was no "test set" in the context of clinical data requiring expert review to establish ground truth. The acceptance criteria for this device relied on engineering performance specifications, biocompatibility standards, and sterility validations.

4. Adjudication Method for the Test Set

This information is not applicable. Since no clinical test set requiring expert adjudication was conducted, there was no adjudication method used. The evaluation centered on technical specifications and regulatory standards.

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

No, a multi-reader, multi-case comparative effectiveness study was not done. The document explicitly states: "The fundamental technological characteristics, indications for use, material, manufacturing and sterilization processes are the same as the predicate devices and therefore, no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device." This means there was no study comparing human readers with and without AI assistance.

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

This question is not applicable as the device is a physical medical catheter, not an AI algorithm or software. Therefore, there is no "standalone" algorithm performance to assess.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation was primarily based on:

• Engineering Specifications and Bench Test Results: Performance against predefined technical thresholds for properties like trackability, kink resistance, pushability, flow rate, tensile strength, etc.
• International Standards and Regulatory Guidance: Compliance with standards for biocompatibility (ISO 10993 series), sterilization (ISO 11135, AAMI TIR28, ISO 10993-7), and endotoxin levels.
• Prior Predicate Device Performance: The underlying assumption is that the predicate device (Instylla Microcatheter K200744) was safe and effective, and the modified device's equivalence to the predicate (or improvement where specified, e.g., smaller OD/ID) served as its "ground truth" for safety and effectiveness.

8. The Sample Size for the Training Set

This question is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The development and testing of the device rely on engineering principles, materials science, and physical testing, not data training.

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

This question is not applicable for the same reasons mentioned in point 8.

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