(28 days)
The ANGIOGUARD™ XP Emboli Capture Guidewire is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.
The ANGIOGUARD™ RX Emboli Capture Guidewire is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.
Both subject and predicate ANGIOGUARD XP and RX devices consist of a guidewire with integrated emboli filter basket at the distal end. The devices function as an interventional guidewire and distal protection device during delivery and placement of stents and interventional devices in carotid procedures. The guidewire is delivered via an OTW (over-the-wire) or RX (rapid-exchange) deployment sheath and is captured via an OTW or RX capture sheath. ANGIOGUARD devices have a fitter basket at the distal end that is deployed prior to the stenting procedure. When deployed, the filter basket opens in an umbrella-like fashion, allowing passive hemo-filtration with subsequent emboli capture. At the end of the procedure, the filter is collapsed and retrieved.
The Cordis Corporation ANGIOGUARD XP & RX Emboli Capture Guidewires are embolic protection guidewires used during carotid artery angioplasty and stenting procedures. The device's primary function is to contain and remove embolic material (thrombus/debris). This 510(k) notification is for a special 510(k) due to a change in the adhesive material used to adhere radiopaque markers to the filter basket struts.
Here's an analysis of the acceptance criteria and study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Design Outputs meet Device Inputs | "Results demonstrated that design outputs continue to meet device inputs." |
| Biocompatibility | Met per ISO 10993-1. |
| Sterility Assurance Level (SAL) | Unchanged from predicate device. |
| Material Composition (except adhesive) | Unchanged from predicate device. |
| Intended Use | Unchanged from predicate device. |
| Indication for Use | Unchanged from predicate device. |
| Design & Dimensions | Unchanged from predicate device. |
| Size Range | Unchanged from predicate device. |
| Fundamental Technology and Operating Principle | Unchanged from predicate device. |
| Manufacturing Site and Methods | Unchanged from predicate device. |
| Sterilization Site, Method, Parameters | Unchanged from predicate device. |
| Packaging | Unchanged from predicate device. |
| Labeling / Instructions for use | Unchanged from predicate device. |
| Shelf Life | Unchanged from predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "Design verification activities" rather than a clinical human trial needing a test set with specific sample sizes. The testing involved:
- Deployment and Capture Testing: This would likely involve in vitro or bench testing. No specific sample size is provided.
- Visual Inspections: No specific sample size is provided.
- Bioburden Testing: No specific sample size is provided.
- Endotoxin Testing: No specific sample size is provided.
- EtO Residual Testing: No specific sample size is provided.
- Biocompatibility Testing: Conducted per ISO 10993-1. This is a series of tests, and the "sample size" would relate to the number of test articles and controls used in each specific biological evaluation (e.g., cytotoxicity, sensitization, irritation). No specific detailed numbers are given in this summary.
The data provenance is not explicitly stated as retrospective or prospective in the context of human data. Given the "Special 510(k)" for a material change, the focus is on bench testing and laboratory evaluations to confirm the new adhesive does not alter the device's fundamental performance or safety.
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 material change to an already cleared device, relying on design verification activities (bench testing, lab tests) rather than a clinical test set requiring expert ground truth establishment for a diagnostic or imaging device.
4. Adjudication Method for the Test Set:
Not applicable. Since the evaluation consists of design verification activities (bench and lab testing), there is no "adjudication method" in the sense of expert review for clinical data.
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 an embolic protection guidewire, a physical medical device, not an AI software. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm or AI software.
7. The Type of Ground Truth Used:
For the design verification activities:
- Technical Specifications/Device Inputs: The "ground truth" for the tests described (Deployment and Capture Testing, Visual Inspections, Bioburden, Endotoxin, EtO residual testing, biocompatibility testing) is adherence to predefined engineering specifications, performance standards, and regulatory standards (e.g., ISO 10993-1). The summary states "Results demonstrated that design outputs continue to meet device inputs."
8. The Sample Size for the Training Set:
Not applicable. This is a change to a physical medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set was used.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).