(54 days)
The Fox Plus PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae.
This catheter is not intended for the expansion or delivery of stents.
The Fox Plus PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.035"). The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon material expands to a known diameter at specific pressures.
Here's an analysis of the provided text regarding the Fox™ Plus PTA Catheter (K080264). Unfortunately, the document does not contain the specific information requested about acceptance criteria and a study proving device performance, as it pertains to AI/ML device evaluations. This document is a traditional 510(k) premarket notification for a medical device that relies on substantial equivalence to predicate devices, rather than a performance study against specific acceptance criteria for an AI algorithm.
The request asks for details typically associated with the evaluation of AI/ML-driven medical devices, especially for topics like:
- Acceptance criteria table with reported device performance for an AI
- Sample size for a test set and data provenance for an AI
- Number and qualifications of experts for ground truth establishment for an AI
- Adjudication method for an AI test set
- MRMC comparative effectiveness study for an AI
- Standalone performance for an AI
- Type of ground truth used for an AI
- Sample size for the training set for an AI
- How ground truth for the training set was established for an AI
Since this is a conventional medical device submission (PTA Catheter), these AI/ML- specific details are not applicable and are therefore not present in the provided text.
The document focuses on:
- Device Description: What the catheter is and its components.
- Intended Use: The medical conditions and procedures for which the catheter is designed.
- Predicate Devices: Previously cleared devices to which the current device is compared for substantial equivalence.
- Technological Characteristics Comparison: How the new device is similar to or different from predicate devices (mostly identical, with minor balloon length changes).
- Substantial Equivalence Justification: Stating that in vitro bench tests, analyses, and biocompatibility testing demonstrate the safety and effectiveness, leading to substantial equivalence to predicate devices.
There is no "acceptance criteria and study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm's performance. The "acceptance" here is the FDA's determination of substantial equivalence based on the provided engineering and biocompatibility data compared to predicate devices, not specific performance metrics for an AI algorithm.
§ 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).