(163 days)
The Fogarty® Valvulotome is intended to be used in the disruption of venous valves.
The Fogarty® Valvulotome is indicated for use in veins during in situ or autologous bypass graft procedures.
The modified Fogarty® Valvulotome, like the predicate device, consists of a flexible shaft with a cutting blade at the distal tip and a handle at the proximal end. The mode of operation for both devices is the same. The device is inserted into the vessel in an antegrade direction until the blade is located above the cusp of a venous valve. The location of the valve is visualized via an angioscope or is directly visualized through the vein wall in an open procedure. The blade is withdrawn retrograde through the cusp, thereby rendering it incompetent. After the blade disrupts one cusp, it is then rotated 180° to disrupt the adjoining cusp segment.
The Fogarty® Valvulotome, like the predicate device, contains an irrigation lumen that provides irrigation/fluid flow during the valvulotomy procedure.
The modified device is available in one size that accommodates various vessel sizes and a usable length of 81 cm.
A modification to the Fogarty® Valvulotome was implemented that enhanced the strength of the attachment of the blade holder to the stop.
The blade is on the modified Fogarty® Valvulotome is retractable whereas the blade on the predicate device was not. The size and shape of the blade have been changed to accommodate retractability.
The material used for the shaft and handle have been changed; the modified materials have been determined to be biocompatible.
The handle now includes a control button for extension and retraction of the blade and guidewire.
The provided text is a 510(k) summary for the Fogarty® Valvulotome, focusing on its substantial equivalence to a predicate device. It describes the device, its intended use, and non-clinical testing. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study details you've outlined for AI/standalone device performance.
This document predates modern AI-powered medical devices and thus does not discuss AI performance, ground truth establishment for large datasets, or MRMC studies in the context you're asking about. The "acceptance criteria" discussed are primarily related to safety, biocompatibility, and functional performance, rather than diagnostic accuracy metrics.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Found to be biocompatible and nontoxic, acceptable for intended use (per ISO 10993-1-1994 and FDA G95-1). |
| Functional/Bench Testing | Demonstrated to meet performance requirements for intended use. |
| Clinical Evaluation | Capable of disrupting venous valves during in situ saphenous vein grafting procedures. |
| Safety and Effectiveness | Safe and effective for its intended use (based on biocompatibility, functional, and clinical testing). |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not explicitly stated for any of the tests.
- Data provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by Baxter (the manufacturer). The clinical evaluation mentions in situ saphenous vein grafting procedures, implying human use, but no details on the patient cohort or study design are provided in this summary.
- Retrospective/Prospective: Not explicitly stated. The clinical evaluation would typically be prospective, but the details are missing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided in this document. The "ground truth" here relates to successful valve disruption, biocompatibility, and functional performance, which are assessed through engineering tests and clinical observations rather than expert image interpretation.
4. Adjudication method for the test set
- Not applicable/Not provided in this document. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on diagnostic imaging, which is not the subject of this 510(k). Decisions would have been made by the testing teams based on the test results.
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
- No. This device is a manual surgical instrument (valvulotome), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is a physical instrument requiring human operation, not an algorithm.
7. The type of ground truth used
- Biocompatibility testing: Ground truth was established by adherence to ISO 10993-1-1994 and FDA G95-1 guidelines, with results demonstrating non-toxicity and biocompatibility.
- Functional/Bench testing: Ground truth was based on the device meeting its predefined "performance requirements" (details of which are not specified in the summary, e.g., cutting efficacy, blade retraction reliably, shaft flexibility, irrigation flow).
- Clinical evaluation: Ground truth was the observation that the product was "capable of disrupting venous valves during in situ saphenous vein grafting procedures." This implies direct observation of the device's effect during surgery.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an algorithm is involved.
§ 870.4885 External vein stripper.
(a)
Identification. An external vein stripper is an extravascular device used to remove a section of a vein.(b)
Classification. Class II (performance standards).