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The TracStar LDP Large Distal Platform is indicated for the introduction of interventional devices into the peripheral. coronary, and neuro vasculature.

The Zoom 88 Large Distal Platform and Zoom 88 Large Distal Platform Support are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Imperative Care Large Distal Platform™ (LDP) Catheters include the Zoom™ 88 Large Distal Platform™, Zoom™ 88 Large Distal Platform™ Support, and TracStar™ LDP Large Distal Platform. The LDP Catheters are 0.038" diameter or smaller guidewire compatible single lumen guide catheters that provide access to peripheral, coronary and neuro vasculature. The catheters are comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. An angled distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. The LDP Catheters have an inner diameter (ID) of 0.088" (6F compatible), and a maximum outer diameter (OD) of 0.110". The LDP guide catheters are packaged with a rotating hemostasis valve (RHV) that is attached to the proximal luer to help maintain hemostasis.

This document describes the acceptance criteria and the study conducted to demonstrate that the TracStar™ LDP Large Distal Platform, Zoom™ 88 Large Distal Platform, and Zoom™ 88 Large Distal Platform Support devices meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The device is a medical catheter, and the performance evaluation involved a series of bench and laboratory (in-vitro) tests to ensure its safety and effectiveness. The acceptance criteria are "Pass" for all tested attributes, meaning the device met the specified performance requirements.

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

The document does not specify the exact sample sizes for each test attribute. The study relies on bench and laboratory (in-vitro) testing, which typically involves testing a defined number of device units or components to statistical significance or to demonstrate compliance with a specification. The data provenance is prospective as the testing was conducted specifically for this submission to evaluate the subject devices. The country of origin of the data is not explicitly stated but is implied to be where Imperative Care, Inc. conducts its R&D and testing.

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

This information is not applicable as the study involves bench and laboratory (in-vitro) testing of physical device properties against established engineering and performance specifications, not human interpretation of medical data. Therefore, there is no "ground truth" established by medical experts in this context.

4. Adjudication Method for the Test Set

Not applicable, as this was not a human-reader study requiring adjudication of expert opinions. The adjudication for bench testing is typically based on whether the test results meet or exceed the predefined pass/fail criteria.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems where human readers interpret medical images. The current submission pertains to the substantial equivalence of a medical catheter based on physical and mechanical performance.

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

This question is not applicable to the device described. The device is a physical medical catheter, not a software algorithm. The "standalone" performance refers to the physical and mechanical performance of the catheter itself, which was evaluated through bench and laboratory testing without human "in-the-loop" performance in the context of interpretation or decision-making.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is defined by established engineering and performance specifications based on standards such as ISO 10555-1, as well as internal design requirements. These specifications act as the objective criteria against which the device's performance is measured.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical catheter, not a machine learning or AI algorithm that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

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The TracStar LDP Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Zoom 88 Large Distal Platform and Zoom 88 Large Distal Platform Support are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Imperative Care Large Distal Platform (LDP) Catheters include the Zoom™ 88 Large Distal Platform, Zoom™ 88 Large Distal Platform Support, and TracStar™ LDP Large Distal Platform. The LDP Catheters are 0.038" diameter or smaller guidewire compatible single lumen guide catheters that provide access to peripheral, coronary and neuro vasculature. The catheters are comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. An angled distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. LDP Catheters have an inner diameter of 0.088" (6F compatible), and a maximum outer diameter of 0.110". The LDP guide catheters are packaged with a rotating hemostasis valve (RHV) that is attached to the proximal luer to help maintain hemostasis.

This FDA 510(k) Summary describes a device (TracStar LDP Large Distal Platform, Zoom 88 Large Distal Platform, Zoom 88 Large Distal Platform Support) intended for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The submission is for a line extension and manufacturing process improvements, referencing a predicate device (K212224). Therefore, the study details provided are focused on demonstrating substantial equivalence to the predicate device, rather than a de novo clinical trial for a new product with absolute performance metrics against a disease state.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are based on the performance of the device against a set of predefined specifications derived from an existing standard (ISO 10555-1 for catheter performance) and internal engineering requirements. The reported device performance is simply "Pass" for all tested attributes, indicating that the subject device met these specifications.

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

The document does not specify the exact sample sizes used for each bench and laboratory test. It states that "Bench and laboratory (in-vitro) testing was completed" and references "simulated neurological model" and "simulated use testing," indicating an in-vitro experimental setting.

Data Provenance: The data is generated from in-vitro bench and laboratory testing conducted by the manufacturer, Imperative Care, Inc. The country of origin of this data is not explicitly stated, but it is implied to be internal testing. The data is retrospective in the sense that it evaluates the performance of the manufactured devices against pre-established specifications.

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

This type of information is not applicable to this 510(k) submission. "Ground truth" established by experts (e.g., radiologists) is typically relevant for studies validating diagnostic or AI-driven devices against clinical outcomes or expert interpretation, such as in an MRMC study. This submission focuses on the physical and mechanical performance of a medical device (catheter) through bench testing.

4. Adjudication Method for the Test Set

Since the evaluation is based on objective measurements and predefined specifications in bench testing (e.g., absence of kinking, passage through a simulated model), there is no adjudication method as typically understood in clinical or expert-reviewed studies. The "Pass/Fail" results are determined by whether the device meets the quantitative and qualitative requirements of the test specifications.

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, an MRMC comparative effectiveness study was not done. This submission is for a percutaneous catheter, not an AI-driven or diagnostic device that involves human reader interpretation. Consequently, there is no discussion of human reader improvement with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument (catheter), not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context refers to the pre-established physical and mechanical performance specifications laid out in the test attributes and derived from standards like ISO 10555-1 and internal engineering requirements. It is a benchmark of expected functional performance, rather than a clinical or pathological diagnosis.

8. The Sample Size for the Training Set

This question is not applicable as this is not a machine learning or AI-driven device. There is no concept of a "training set" for physical device performance testing.

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

This question is not applicable as this is not a machine learning or AI-driven device.

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The TracStar LDP Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Zoom 88 Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Imperative Care Large Distal Platform (LDP) Catheters include the TracStar™ LDP Large Distal Platform and Zoom™ 88 Large Distal Platform. The LDP Catheters are 0.038" diameter or smaller guidewire compatible single lumen guide catheters that provide access to peripheral, coronary and neuro vasculature. The catheters are comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. An angled distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. LDP Catheters have an inner diameter of 0.088" (6F compatible), and a maximum outer diameter of 0.110". The LDP guide catheters are packaged with a rotating hemostasis valve (RHV) that is attached to the proximal luer to help maintain hemostasis.

This document describes the premarket notification for the Imperative Care TracStar LDP Large Distal Platform and Zoom 88 Large Distal Platform, which are guide catheters. The submission is based on substantial equivalence to predicate devices, meaning extensive new studies were not required. The provided text details the acceptance criteria and study findings for this medical device.

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 specific sample sizes (number of units tested) for each individual bench and laboratory test. It generally refers to "bench and laboratory (in-vitro) testing." The data provenance is in-vitro, conducted in a laboratory setting. There is no information regarding country of origin of the data or if it was retrospective or prospective, as these terms typically apply to clinical studies with human participants.

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

This information is not provided. For performance testing of a medical device like a catheter, "ground truth" is typically established by physical measurements, engineering specifications, and adherence to recognized standards (like ISO 10555-1), rather than expert consensus on interpretive data.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data (e.g., imaging) by multiple readers to resolve discrepancies. The performance tests described here are objective, pass/fail engineering tests.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission is for a medical device (catheter) and relies on bench and laboratory testing for substantial equivalence, not comparative clinical effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the device described. The TracStar LDP Large Distal Platform and Zoom 88 Large Distal Platform are physical guide catheters, not algorithms or AI software. Therefore, there is no "algorithm only" or "human-in-the-loop" performance to report.

7. The Type of Ground Truth Used

For the bench and laboratory tests, the "ground truth" is based on pre-defined engineering specifications and performance standards, particularly ISO 10555-1 for catheters. The results are objective measurements against these established criteria, leading to a "Pass" or "Fail" outcome.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical catheter, not an AI/ML algorithm that requires a training set. The substantial equivalence pathway relies on demonstrating that the new device performs similarly to a predicate device through bench testing, not on learning from a dataset.

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

This information is not applicable, as there is no training set for a physical medical device.

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