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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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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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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.

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