Search Results

The Instylla Microcatheter is intended for use in small vessel or 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 device is 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 ≤ 0.014 in (0.36 mm) in diameter. Once the target region has been accessed, the microcatheter can be used to deliver diagnostic, embolic, or therapeutic materials into vessels.

The Instylla Microcatheter has a 1.7Fr (0.56mm) OD with a constant flexibility along its length. The ID of the microcatheter is 0.016 in (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 allow for flexibility and securement inside a Tuohy-Borst adapter, for maintaining position inside a guiding catheter as needed. The Instylla Microcatheter has a radiopaque marker at the distal tip to aid in fluoroscopic visualization. A 4Fr Tuohy-Borst with side-port adapter, a short catheter extension and a long catheter extension adapter are also included. The Instylla Microcatheter is available in 122, 142 and 162 cm usable lengths.

The provided text describes Instylla, Inc.'s K191731 510(k) submission for their Instylla Microcatheter. The document outlines the device's characteristics, its comparison to predicate devices, and the performance and safety studies conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, while noting limitations in the information for certain requested points:

Acceptance Criteria and Device Performance for Instylla Microcatheter (K191731)

The acceptance criteria for the Instylla Microcatheter revolved around demonstrating substantial equivalence to a predicate device (CrossCath Support Catheter, K093052) through various performance benchmarks and safety assessments. Since this is a 510(k) submission, the "acceptance criteria" are implied by the comprehensive pre-clinical testing conducted to show that the device performs as safely and effectively as the predicate, and does not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly list numerical "acceptance criteria" values for each test, but it clearly states that the Instylla Microcatheter "met the predetermined acceptance criteria" for all tests and that "No new safety or performance issues were raised during testing."

Given the context of a 510(k), the implied acceptance criterion for each test is that the Instylla Microcatheter performs comparably to the predicate device or within recognized safety and effectiveness standards for such devices.

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

The document does not explicitly state the specific sample sizes for each individual bench test (e.g., how many catheters were tested for kink resistance). It broadly mentions "bench testing and functional testing to verify specifications" and "testing was also conducted to demonstrate the subject device is substantially equivalent to the predicate device."

• Test Set Sample Size: Not explicitly stated for specific tests. It implies a sufficient number of devices were tested to meet statistical significance for product verification and validation.
• Data Provenance: The studies were pre-clinical bench and lab-based testing performed by the manufacturer, Instylla, Inc. The country of origin for the data is not specified beyond being generated by a US-based company (Waltham, MA). The data is prospective in the sense that it was generated specifically for this 510(k) submission, not retrospectively analyzed from existing patient data.

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

• This question is not applicable to this type of submission. The "ground truth" for device performance in a 510(k) pre-clinical bench testing context is established by engineering specifications, recognized industry standards, and comparison to the predicate device's known performance characteristics, not by expert consensus on clinical data. The tests themselves are designed to objectively measure physical and chemical properties and performance.

4. Adjudication Method for the Test Set

• This question is not applicable as there were no subjective clinical interpretations requiring adjudication. Performance against predetermined specifications and predicate device equivalence are evaluated based on objective test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The fundamental technological characteristics, indications for use, marker 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."

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

• This question is not applicable as the Instylla Microcatheter is a physical medical device, not an artificial intelligence (AI) algorithm. Therefore, "algorithm only" or "human-in-the-loop" performance does not apply.

7. The Type of Ground Truth Used

• For the performance testing, the "ground truth" was based on:
  • Engineering Specifications: Predetermined design and performance requirements for the microcatheter.
  • Industry Standards: Adherence to relevant international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135 for sterilization).
  • Predicate Device Equivalence: The performance of the Instylla Microcatheter was evaluated against the known characteristics and performance of the legally marketed predicate device (CrossCath Support Catheter).

8. The Sample Size for the Training Set

• This question is not applicable as the Instylla Microcatheter is a physical medical device, not an AI algorithm that requires a "training set" of data.

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

• This question is not applicable for the same reason as point 8.

Ask a specific question about this device