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The Zenith Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The InNeuroCo Zenith Support product consists of a catheter, a hemostasis valve, and a split sheath introducer. The Zenith Support catheter is a single lumen, variable stiffness catheter that has an outer polymer shaft and is reinforced with a Stainless Steel cross coil. The Zenith Support catheter has a radiopaque Platinum/Iridium marker band on the distal end. The Zenith Support is available with an internal diameter of 0.074 inches and a nominal outer diameter of 0.086 inches. There are three working lengths available: 95 cm, 105 cm, and 115 cm in either diameter. The Zenith Support catheter has a PTFE-lined lumen throughout the catheter shaft. The catheter is flexible and has a hydrophilic coating. The Zenith Support catheter is inserted through a guide catheter or vascular sheath, provides access to the target site, and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a split sheath introducer. The Zenith product line is supplied sterile, non-pyrogenic, and intended for single use only.

This request concerns the InNeuroCo Zenith Support Catheter, a percutaneous catheter used for introducing interventional devices into the peripheral and neuro vasculature. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study for novel device acceptance criteria.

The information primarily revolves around non-clinical data and justifications for not re-testing certain parameters due to the device's similarity to its predicate. Therefore, detailed information on ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not available as this type of submission typically relies on a comparison to an already approved device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a "SUMMARY OF NON-CLINICAL DATA" (page 8, "Table 1: Non-Clinical Testing Analysis") which serves this purpose. Many tests were not re-tested for the Zenith Support Catheter because no material changes were made from the predicate device (Zenith 074) and manufacturing processes were identical or within the predicate's tolerance.

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

Due to the nature of a 510(k) summary relying on substantial equivalence, specific sample sizes for re-tested parameters (like Simulated Use - Bench) are not explicitly stated. For most tests, the data provenance is essentially inherited from the predicate device (Zenith 074) and another reference device (InNeuroCo SDA) because the new device's materials and manufacturing are identical or within tolerance. The document indicates these are non-clinical studies (benchtop and animal models for predicate devices). The geographical origin of the data is not specified beyond the manufacturer being based in Florida, USA. All studies are retrospective in relation to the current device's testing, as they refer to data from predicate devices.

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

This information is not provided. For non-clinical tests, "ground truth" is typically established by laboratory procedures and measurements against defined standards (e.g., ISO, ASTM). For the "Simulated Use - Bench" test, it states it was conducted "by a physician," implying at least one expert, but qualifications and number are not detailed.

4. Adjudication Method for the Test Set

Not applicable/not provided. This type of detail (e.g., 2+1, 3+1 consensus) is typical for clinical studies, especially those involving expert interpretation of medical images, which is not the focus of this non-clinical submission.

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 a medical device (catheter), not an AI/Software as a Medical Device (SaMD) product. Therefore, MRMC studies and AI-assisted performance metrics are not relevant or performed for this submission.

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

Not applicable. The device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

For the majority of the non-clinical tests not re-performed, the "ground truth" (or accepted performance) is based on:

• Established performance of the predicate device (Zenith 074): This implies that the predicate device previously met these standards.
• International Standards (ISO 10993, ISO 10555-1, ISO 594-1, ISO 594-2, ISO 11135) and ASTM standards (ASTM F1929-12, ASTM F88-09, ASTM F1980): These standards define methodologies and acceptable ranges for material properties, biocompatibility, and device functionality.
• USP 788: For particulates.

For the re-tested "Simulated Use - Bench" test, the ground truth was "predetermined user needs," likely established through design validation or clinical input.

8. The Sample Size for the Training Set

Not applicable. The Zenith Support Catheter is a physical medical device. The concept of "training set" is relevant for AI/machine learning models, which this device is not.

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

Not applicable as there is no "training set" for this physical device.

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The 091 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasulature.

The InNeuroCo, Inc. 091 Long Sheath is a variable stiffness catheter that has a catheter shaft reinforced with a stainless steel double coil. It has a radiopaque Platinum/lridium marker band on the distal end. The distal 10 cm of the 091 Long Sheath Catheter has a hydrophilic coating. The catheter has a nominal outer diameter of 0.109 inches and a nominal inner diameter of 0.091 inches. It is available in three working lengths: 70 cm, and 90 cm. The 091 Long Sheath has a PTFE-lined lumen. The 091 Long Sheath is inserted at a vascular access point to provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and a Vessel Dilator. The 091 Long Sheath is supplied sterile, non-pyrogenic, and intended for single use only.

The provided text is a 510(k) summary for the InNeuroCo 091 Long Sheath peripheral, coronary, and neuro vasculature catheter. It outlines the device's characteristics and its comparison to a predicate device, along with the results of performance testing to demonstrate substantial equivalence.

Based on the provided document, here's a description of the acceptance criteria and the study proving the device meets these criteria:

This document describes the validation of a medical device, the InNeuroCo 091 Long Sheath, for regulatory approval. It is not an AI/ML device, and therefore several of the requested sections (e.g., number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable as they relate to the validation of AI/ML algorithms, not traditional medical devices like catheters.

Acceptance Criteria and Device Performance Study for the InNeuroCo 091 Long Sheath

The InNeuroCo 091 Long Sheath is a percutaneous catheter intended for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The study conducted was a series of non-clinical (bench and animal) tests to demonstrate substantial equivalence to a legally marketed predicate device (Stryker AXS Infinity LS, K152876).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The exact sample sizes for each specific test are not explicitly enumerated in the provided summary table. The statements typically indicate "Test samples" or "All samples," implying that a sufficient number were tested according to the referenced ISO or ASTM standards.
• Data Provenance: The data is a mix of:
  • Direct testing: For many bench tests (e.g., Visual Inspection, Leaks, Particulates, Simulated Use, Catheter Burst, Tensile, Kink Resistance, Torque, PTFE Liner inspection, Hydrophilic Coating Integrity, Labeling Legibility, Barcode, Sterilization, Bacterial Endotoxin, Shelf Life). These tests were conducted on the 091 Long Sheath.
  • Leveraged data: For all biocompatibility tests, Chemical Compatibility, Hub compatibility, and Corrosion, data was leveraged from previously approved InNeuroCo devices (Super Distal Access K161262, Zenith Catheter K171672, and Intermediate Catheter K152202). This leveraging is justified by stating that the materials and manufacturing processes are equivalent.
  • Animal Testing: Product evaluated within a porcine model for angiographic evaluation.
• Retrospective/Prospective: All described testing appears to be prospective (new tests conducted for this device and leveraged results from other devices), not retrospective analysis of existing clinical data.
• Country of Origin: Not specified in the document, but given the FDA 510(k) submission, it would be expected to follow US or internationally recognized standards. The company address is in Florida, USA.

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

• Not Applicable. This is a traditional medical device (catheter) validation, not an AI/ML algorithm. Ground truth for device performance is established through standardized physical, chemical, biological, and animal testing, not human expert interpretation of data.
• For "Simulated Use" testing, it mentions "by a physician," indicating one or more physicians were involved in that specific assessment, but their number and specific qualifications are not detailed beyond "physician."

4. Adjudication Method for the Test Set

• Not Applicable. As this is not an AI/ML study, there is no need for adjudication of conflicting expert opinions on a dataset. Test results are objective measurements against defined acceptance criteria.

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

• No. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not relevant for the validation of a physical medical device like a catheter.

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

• Not Applicable. There is no AI algorithm being validated in this submission. The "device" is a physical catheter.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by:
  • Standardized Test Methods: Adherence to established international (ISO, ASTM, USP) and industry standards for material properties, mechanical performance, biocompatibility, and sterility.
  • Physical Measurements: Objective measurements of dimensions, burst pressure, tensile strength, etc.
  • Chemical/Biological Assays: Results from biocompatibility tests (e.g., cytotoxicity, hemolysis, pyrogenicity, sensitization) and bacterial endotoxin tests.
  • Functional Demonstrations: Successful performance in simulated use environments and in an animal model (porcine model for angiographic evaluation, showing no vessel injury).
  • Predetermined Specifications: Comparison against established product specifications and the performance of the predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. As there is no AI/ML training set, this question is not relevant.

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