(133 days)
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
| Performance Metric (Implied Acceptance Criteria: Perform "as well or better than predicate devices") | Reported Device Performance (Summary) |
|---|---|
| Tensile Strength | Performed "as well or better than predicate devices" |
| Torque Strength | Performed "as well or better than predicate devices" |
| Torque Response | Performed "as well or better than predicate devices" |
| Tip Flexibility | Performed "as well or better than predicate devices" |
| Lubricity | Performed "as well or better than predicate devices" |
| Kink Resistance | Performed "as well or better than predicate devices" |
| Biocompatibility (materials) | All appropriate tests successfully performed |
| Functionality in-vivo (animal study) | Device works as intended |
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.
§ 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.