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The AGILTRAC™ .035 Peripheral Dilatation Catheter is intended to:

• dilate stenoses in peripheral arteries
• treat obstructive lesions of native or synthetic A-V fistulae
• secure the attachment systems in the iliac arteries, and
• to expand vascular prosthesis limbs

The AGILTRAC™ .035 Peripheral Dilatation Catheter is an over the wire catheter with an XCELON™ (nylon blend) balloon bonded at the distal end. The shaft is a dual lumen design. The smaller lumen provides for inflation of the balloon with contrast medium and the larger lumen permits use of a 0.035" quide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The distal 20 cm of the dual lumen tubing and the entire length of the balloon are coated with Microglide®, a silicone based material used to reduce friction by providing a suface film over the dual lumen tubing.
The balloon, which has two (2) radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of known diameter and length at specific pressures.
The proximal end of the catheter has a sidearm adaptor that provides access to the inflation lumen and guidewire lumen. It is designed with a luer-lock fitting for connection with an inflation device.

This document describes the AGILTRAC™ .035 Peripheral Dilatation Catheter (K023320), a balloon catheter for dilating stenoses in peripheral arteries, treating obstructive lesions in A-V fistulae, securing attachment systems in iliac arteries, and expanding vascular prosthesis limbs.

Acceptance Criteria and Device Performance:

The submission explicitly states that "The safety and effectiveness of the AGILTRAC™ .035 Peripheral Dilatation Catheter has been demonstrated through data collected from in vitro bench tests and analyses." However, no specific quantitative acceptance criteria or detailed performance data are provided in the excerpt. The device's clearance is based on its substantial equivalence to a predicate device, the Guidant's Ancure® Iliac Balloon Catheter, in terms of design, materials, method of delivery, and intended use. This implies that the performance of the AGILTRAC™ device is expected to meet the established safety and effectiveness profile of the predicate device, although specific metrics are not detailed.

Given the information provided, a table of acceptance criteria and reported device performance cannot be fully constructed with quantitative data.

Detailed Study Information:

1. Sample size used for the test set and the data provenance:

   • The study relied on "in vitro bench tests and analyses." The specific sample sizes for these tests are not provided in the given text.
   • The data provenance is in vitro (laboratory-based), implying controlled experimental conditions rather than human or animal studies. The country of origin for the data is not explicitly stated but is implicitly associated with Guidant Corporation, a U.S. company.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not applicable as the clearance is based on in vitro bench tests and a comparison of technological characteristics to a predicate device, not on clinical data requiring expert review for ground truth establishment.

3. Adjudication method for the test set:

   • This information is not applicable as the clearance is based on in vitro bench tests and a comparison of technological characteristics, not on clinical data requiring adjudication.

4. 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, an MRMC comparative effectiveness study was not conducted. This device is a medical instrument (catheter), not an AI-powered diagnostic or assistive technology.

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

   • No, a standalone algorithm-only performance study was not done. This device is a physical medical device, not an algorithm or software.

6. The type of ground truth used:

   • For the in vitro bench tests, the "ground truth" would be objective measurements and established engineering specifications for performance parameters (e.g., material properties, dimensional accuracy, burst pressure, force resistance, biocompatibility standards). These are typically defined by industry standards, internal company specifications, and regulatory guidelines for similar devices. There is no clinical ground truth (like pathology or outcomes data) mentioned for this submission.

7. The sample size for the training set:

   • This information is not applicable. This is a physical device, not an AI model, so there is no "training set."

8. How the ground truth for the training set was established:

   • This information is not applicable as there is no training set for an AI model.

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The AGILTRACTM .035 Peripheral Dilatation Catheter is intended:

• To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries); and
• . For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The AGILTRAC™ . 035 Peripheral Dilatation Catheter is an over the wire catheter with an XCELON™ (nylon blend) balloon bonded at the distal end. The shaft is a dual lumen design. The smaller lumen provides for inflation of the balloon with contrast medium and the larger lumen permits use of a 0.035" guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The distal 20 cm of the catheter shaft and the entire length of the balloon are coated with Microglide®, a silicone based material used to reduce friction by providing a surface film over the catheter shaft.

The balloon, which has two (2) radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of known diameter and length at specific pressures.

The proximal end of the catheter has a sidearm adaptor that provides access to the inflation lumen and guidewire lumen. It is designed with a luer-lock fitting for connection with an inflation device.

The provided text describes a 510(k) submission for the AGILTRAC™ .035 Peripheral Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria based on clinical performance.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies, tailored to your request:

Acceptance Criteria and Device Performance

The submission does not define specific quantitative performance acceptance criteria (e.g., accuracy, sensitivity, specificity, or specific physical measurements with thresholds) and then report how the device met those for a clinical outcome. Instead, the "Performance Data" section states:

"The safety and effectiveness of the AGILTRACTM .035 Peripheral Dilatation Catheter has been demonstrated through data collected from in vitro bench tests and analyses."

This indicates that the safety and effectiveness were assessed through bench testing, likely comparing physical and mechanical characteristics to the predicate device, rather than patient outcomes. The primary "acceptance criterion" appears to be substantial equivalence to the predicate device, the AGILTRAC™ .018 Peripheral Dilatation Catheter, in terms of design, materials, method of delivery, intended use, technological characteristics, biocompatibility, mode of operation, performance properties (presumably physical/mechanical), sterilization, and packaging.

Since no specific performance metrics are given for the new device and accepted as meeting criteria, the table below will reflect this.

Study Details:

Given that this is a 510(k) for substantial equivalence based on bench testing, many of the requested details about clinical studies, expert-based ground truth, and reader studies are not applicable or not provided.

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

   • Sample Size: Not specified in terms of patient numbers or specific clinical cases. The "test set" consisted of in vitro bench tests and analyses.
   • Data Provenance: Not applicable in the context of clinical data provenance as the data is from bench tests.

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. Ground truth for bench tests typically refers to engineering specifications, validated test methods, and reference standards, not expert clinical consensus.

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

   • Not applicable as no clinical test set requiring adjudication is 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 MRMC study was done, as this is a medical device (catheter) and not an AI or imaging diagnostic device.

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

   • Not applicable as this is a medical device (catheter), not an algorithm or AI system.

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

   • For in vitro bench tests, the "ground truth" would be established by engineering specifications, validated physical measurements (e.g., balloon diameter at specified pressure, shaft flexibility, burst pressure), and adherence to material standards, rather than clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set

   • Not applicable. This device is not an AI/ML algorithm that requires a "training set." The development process would involve iteration and testing, but not in the sense of an ML training set.

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

   • Not applicable. No training set in the context of AI/ML.

Summary of the Document's Scope:

The provided 510(k) documentation focuses on establishing substantial equivalence for a peripheral dilatation catheter to an already marketed predicate device. This process primarily relies on demonstrating that the new device has "technological characteristics such as materials, biocompatibility, mode of operation, performance properties, sterilization and packaging" that are substantially equivalent, supported by in vitro bench tests and analyses. It does not describe clinical studies with human subjects that measure specific clinical outcomes against predefined acceptance criteria, nor does it involve AI or imaging algorithms.

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