(57 days)
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."
| Acceptance Criteria Category | Specific Test | Reported Device Performance |
|---|---|---|
| Physical/Mechanical | Visual Inspection | Performed according to their description, intended use, and established performance characteristics (implied to meet visual quality standards). |
| Dimensional Inspection | Performed according to their description, intended use, and established performance characteristics (implied to meet dimensional specifications). | |
| Linear Tip Stiffness | Performed according to their description, intended use, and established performance characteristics. | |
| Torque Response | Performed according to their description, intended use, and established performance characteristics. | |
| Tensile Strength (Distal Tip) | Performed according to their description, intended use, and established performance characteristics. | |
| Tensile Strength (Middle Joint) | Performed according to their description, intended use, and established performance characteristics. | |
| Tensile Strength (Proximal Joint) | Performed according to their description, intended use, and established performance characteristics. | |
| Coating Adherence/Integrity (Particulates) | Performed according to their description, intended use, and established performance characteristics. | |
| Lubricity Testing | Performed according to their description, intended use, and established performance characteristics. | |
| Torque Strength (Rotations to Failure) | Performed according to their description, intended use, and established performance characteristics. | |
| Biocompatibility | In Vitro Cytotoxicity MEM Elution | Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass). |
| Sensitization Guinea Pig Maximization | Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass). | |
| Intracutaneous/Irritation Reactivity | Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass). | |
| Acute Systemic Toxicity | Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass). | |
| Material Mediated Rabbit Pyrogenicity | Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass). | |
| In Vitro Bacterial Mutagenicity - Ames Assay | Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass). | |
| In Vitro Mouse Lymphoma Mutagenicity Assay | Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass). | |
| In Vivo Mouse Bone Marrow Micronucleus Assay | Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass). | |
| In Vitro Hemolysis (Direct Contact & Extract) | Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass). | |
| Complement Activation (C3a Assay) | Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass). | |
| Complement Activation (SC5b-9 Assay) | Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass). | |
| Partial Thromboplastin Time (PTT) | Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass). | |
| In Vivo Dog Thrombogenicity | Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass). | |
| USP Physicochemical Tests (Aqueous) | Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass). | |
| Physicochemical Tests (Non-Aqueous) | Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass). |
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.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.