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The Zenith Flex System, including the Zetheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

The Zenith Flex System consists of the Zenith Flex Catheter, the VC-701 Cliq Aspiration Pump and the Aspiration Tubing Set. The InNeuroCo Zenith Flex Catheter is a variable stiffness catheter shaft reinforced with Stainless-Steel and Nitinol to provide support. The Stainless-Steel is wound as a double coil in the proximal section and the Nitinol is a single coil in the distal section. It has a radiopaque Platinum/Iridium marker band on the distal end. The distal 25 cm of the Zenith Flex Catheter has a hydrophilic coating. The Zenith Flex Catheter is available with an internal diameter of 0.0715 inch. The outer diameter is of 0.0850 inch in the proximal section, and tapers to a nominal of 0.082 inch in the distal section. The Zenith Flex Catheter is available in three working lengths: 115 cm, 125 cm, and 132 cm. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and two peel-away Introducers and a Scout introducer. The Scout may be used to introduce the Zenith Flex Catheter into distal vasculature, thereby helping the device reach the target anatomy. The Zenith Flex Catheter is supplied sterile, nonpyrogenic, and intended for single use only. The off-the-shelf aspiration pump is provided non-sterile.

This document is a 510(k) summary for the Zenith Flex System, a medical device for revascularization in acute ischemic stroke. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench and animal) testing rather than clinical study. Thus, it does not describe a study involving an AI component or complex ground truth establishment for diagnostic output.

Here's an analysis based on the provided text, addressing your points where information is available:

1. A table of Acceptance Criteria and Reported Device Performance

The document provides extensive tables summarizing non-clinical testing. Here's a consolidated and simplified version of the information, focusing on the Zenith Flex Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump:

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

The InNeuroCo Zenith product consists of a catheter, a hemostasis valve, two split sheath introducers, and a Scout introducer. The Zenith 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 catheter has a radiopaque Platinum/lridium marker band on the distal end. The Zenith product line is available in two internal diameters: 0.065 inches and 0.074 inches. The 0.065 catheter has a tapered design and is 0.079 inches outer diameter in the distal end and a 0.081 inches outer diameter in the proximal end. The 0.074 catheter has a nominal outer diameter of 0.086 inches. There are three working lengths available: 115 cm, 125 cm, and 132 cm in either diameter. The Zenith catheter has a PTFE-lined lumen throughout the catheter shaft. The catheter is flexible and has a hydrophilic coating. The Zenith catheter is inserted through a quide 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 two split sheath introducers. There is another introducer, named Scout, which provides support to the Zenith catheter while tracking to target site. The Zenith product line is supplied sterile, nonpyrogenic, and intended for single use only.

The provided text describes the regulatory clearance (510(k)) of a medical device, the "Zenith" percutaneous catheter, and a summary of non-clinical data supporting its substantial equivalence to predicate devices. The document does not describe an AI/ML-enabled device or a study involving human readers or comparative effectiveness with AI. Therefore, several aspects of your request (e.g., sample sizes for test set/training set, number of experts, adjudication method, MRMC study, standalone performance, provenance of data) are not applicable to this document.

However, I can extract the acceptance criteria and study conclusions for the non-clinical performance and biocompatibility tests described.

Here's the information derived from the document, focusing on the available details:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the specific requested points that are relevant to this type of device clearance:

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

• The document does not explicitly state the sample sizes for each non-clinical test performed (e.g., how many catheters were burst-tested, how many animals in the angiographic evaluation). It refers to "test samples" or "units tested."
• The data provenance is from non-clinical laboratory and animal studies (e.g., ISO standards, ASTM standards, porcine model). It is not human subject data, so concepts like "country of origin" or "retrospective/prospective" as they apply to clinical studies are not applicable.
  • For biocompatibility tests, it mentions "extract human blood" for some hemolysis tests.
  • For the Angiographic Evaluation, it explicitly states it was a "porcine model."

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

• This is not applicable as the studies described are non-clinical (laboratory and animal testing). The "ground truth" for these tests comes from adherence to established scientific and regulatory standards (e.g., ISO 10993, ASTM, USP) and predefined physical/chemical limits.
• For "Simulated Use - Bench," it mentions "by a physician," implying one or more physicians were involved in the benchtop evaluation, but their number and specific qualifications are not detailed beyond "physician."

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

• Not applicable to non-clinical laboratory or animal studies. Ground truth is determined by test results against defined acceptance criteria.

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 device is a percutaneous catheter, not an AI/ML diagnostic or assistive device.

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

• Not applicable. This is not an algorithm/AI device.

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

• For non-clinical tests, the "ground truth" is determined by meeting predefined technical specifications, industry standards (e.g., ISO, ASTM), and biological safety parameters. For example, a burst pressure test's ground truth is a numerical value compared to a specification. For biocompatibility, it's the absence of adverse biological reactions per standard protocols. For the animal study, it's the absence of "clinically significant injury."

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires training data.

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

• Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

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