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The AGILITY® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the neuro and peripheral vasculature.

The NEUROSCOUT® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the neuro and peripheral vasculature.

The hydrophilically coated AGILITY® and NEUROSCOUT® Steerable Guidewires consist of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. The basic principle of the guidewires is to act as a monorail that catheters can track over to reach a particular area of the neuro and peripheral vasculature. They have a nominal outside diameter range of 0.012 to 0.016 inches and overall length of up to 350 cm. Guidewire length, diameter, and distal tip configuration are indicated on the product label. A steering/torquing device and a guidewire introducer are packaged with the guidewires.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided 510(k) summary:

This 510(k) summary describes a modification to existing AGILITY® and NEUROSCOUT® Steerable Guidewires, specifically material changes and related manufacturing process changes. The submission asserts substantial equivalence to predicate devices, meaning that clinical testing was not required. Therefore, the acceptance criteria and studies are focused on non-clinical (bench and biocompatibility) performance rather than clinical outcomes or human reader performance.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes various tests conducted to verify the modified design. The acceptance criteria for these tests are generally implied to be meeting the performance of the predicate devices or established engineering specifications, but explicit numerical acceptance criteria are not provided in this summary. The reported device performance is stated as "performed according to their description, intended use and the established performance characteristics" and "meet all the same biocompatibility requirements as the predicate devices."

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

The document does not specify the exact sample sizes used for each individual bench test (e.g., number of guidewires tested for tensile strength, number of samples for coating adherence). It indicates "Design Verification testing" was conducted.

The data provenance is internal laboratory testing conducted by Codman & Shurtleff, Inc. "Bench testing data demonstrated..." and "Full biocompatibility testing... was conducted." This is not clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in this context.

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

Not applicable. This submission is for a medical device (guidewire) and relies on objective, quantifiable engineering and biological tests rather than expert interpretation of medical images or records. The "ground truth" for the bench tests is defined by the established test methods and specifications, often derived from industry standards (FDA Guidance for Coronary and Cerebrovascular Guidewires, 1995 and ISO 11070:1998, ISO 10993-1). No human experts are involved in establishing ground truth for these types of device performance tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers are interpreting data (e.g., medical images) to establish a consensus ground truth. For the bench and biocompatibility tests conducted here, the "adjudication" is inherent in the test method itself – a pass/fail criterion based on objective measurements or observations.

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 product is a physical medical device (guidewire), not an AI-powered diagnostic or assistive tool. Clinical studies involving human reader performance or AI assistance are not relevant to its regulatory pathway or the provided testing summary.

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

Not applicable. This product is a physical guidewire, not an algorithm or software. "Standalone performance" in this context refers to the device's inherent physical and biological properties. The bench and biocompatibility tests assess this standalone performance against predefined standards.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the bench tests, the "ground truth" refers to the established performance specifications (e.g., minimum tensile strength, acceptable coating integrity, specific torque response values) that the guidewire must meet. These specifications are derived from:

• FDA Guidance for Coronary and Cerebrovascular Guidewires, 1995
• ISO 11070:1998 Sterile Single-Use Intravascular Catheter Introducers (though the device is a guidewire, this standard was cited, likely for relevant general requirements for intravascular devices)
• Internal engineering specifications designed to ensure the device performs as intended and is equivalent to the predicate.

For biocompatibility tests, the "ground truth" is defined by international standards and regulatory guidance:

• ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process)
• General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices

The device is deemed to meet these "ground truths" if it passes the tests within the defined acceptable parameters.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The "training set" concept does not apply to the regulatory submission for this physical medical device.

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

Not applicable. As explained above, there is no training set for this device.

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The Cordis AGILITY™ Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.

The hydrophilically coated AGILITY Steerable Guidewires consist of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. Guidewire length, diameter, and distal tip configuration are indicated on the product label. A steering/torquing device and a guidewire introducer are packaged with the AGILITY Guidewire.

The provided 510(k) summary (K991646) describes the Cordis AGILITY™ Steerable Guidewires, a Class II device intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.

However, it is important to note that this document does not contain specific acceptance criteria for performance metrics in a numerical form nor does it present a detailed study proving the device meets said criteria in the way typically expected for AI/ML medical devices.

Instead, for this type of medical device (guidewire), "acceptance criteria" are implied by the comparative testing against predicate devices to establish substantial equivalence. The "study" in this context refers to the in-vitro and animal testing performed to demonstrate that the AGILITY Guidewire performs "as well or better than" the predicate devices.

Here's an attempt to structure the information based on the provided text, acknowledging the limitations for an AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the in-vitro comparative tests (e.g., number of guidewires tested for tensile strength).
For the animal study, the sample size is not mentioned.
The data provenance (country of origin, retrospective/prospective) is not explicitly stated, but these are typically prospective laboratory and animal studies conducted by the manufacturer.

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

This information is not applicable in the context of this device and study type. Ground truth for mechanical and biological performance of a guidewire is established by standardized testing methods, not expert consensus on images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. Mechanical and biocompatibility tests have objective pass/fail or quantitative measurements, not expert adjudication.

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

No. This is a medical device (guidewire), not an AI/ML system for image interpretation, so an MRMC study is not relevant.

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

Yes, in a way relevant to this device type. The in-vitro and animal studies assess the device's inherent performance and safety characteristics independently of a human operator's specific skill set beyond standard surgical handling. The performance is of the physical device itself.

7. The Type of Ground Truth Used

• For in-vitro tests: The "ground truth" is based on objective, quantifiable measurements of physical properties (e.g., force required for tensile break, torque applied, coefficient of friction for lubricity) as defined by established engineering and material science standards and compared against predicate devices.
• For biocompatibility: Ground truth is established by adherence to recognized standards for material safety, often involving cell culture tests, sensitization tests, and toxicity tests.
• For animal study: The "ground truth" for intended function (e.g., steerability, ability to navigate vasculature, lack of adverse tissue reaction) is observed and assessed in a live biological system.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, this device does not utilize a "training set" in the context of AI/ML.

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