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The ExpanSure™ Large Access Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

The subject ExpanSure™ Large Access Transseptal Dilator represents a modification to the dilator component of the legally marketed ExpanSure™ Transseptal Dilation System (K182064). The modification was for the addition of a metallic marker coil to the dilator distal tip for increased visibility under imaging during procedures.

The subject device is comprised of a dilator (ExpanSure Dilator) and J-tip guidewire, which are single-use and supplied sterile to the user. The ExpanSure Dilator is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator consists of an inner and outer polyethylene layer containing radio-pacifier for visibility under imaging during procedures. The inner and outer shaft layers are separated by a braid material for torqueability. The dilator distal tip includes a metallic marker coil to facilitate visualization under imaging during procedures. The outer surface of the dilator is coated with a silicone lubricant. The ExpanSure Dilator is compatible with 0.032″ and 0.035″ transseptal devices/quidewires and 12.5 Fr introducer sheaths. The J-tip quidewire is comprised of stainless steel.

This document describes the ExpanSure™ Large Access Transseptal Dilator (K201288), a medical device. However, it does not describe a software-based medical device or AI system. Therefore, the provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of AI/software performance.

Instead, this document is a 510(k) Premarket Notification summary for a traditional medical device (a vessel dilator). The "acceptance criteria" and "study" described herein refer to non-clinical performance testing (mechanical, physical, pyrogen, biocompatibility, packaging, and sterilization verification) to demonstrate substantial equivalence to a predicate device, not performance against clinical metrics for an AI algorithm.

Therefore, I cannot provide the requested information in the format of AI/software performance as the input document does not pertain to such a device.

Here's why the provided input doesn't fit the request about AI/software performance:

• Device Type: The device is a "vessel dilator for percutaneous catheterization," a physical, sterile, single-use medical instrument, not a software system.
• Performance Testing: The "Performance Testing" section lists mechanical tests, general physical tests, pyrogen testing, benchtop validation (for intended use), biocompatibility, packaging verification, and sterilization verification. These are standard tests for physical medical devices, not for evaluating AI model performance.
• Substantial Equivalence: The entire submission focuses on demonstrating "substantial equivalence" to a predicate physical device (K182064) based on shared intended use, technology, and similar materials, with modifications (a metallic marker coil) validated through the non-clinical tests listed.
• Absence of AI/Software Specifics: There is no mention of algorithms, data sets (training, validation, test), ground truth, expert readers, or performance metrics like sensitivity, specificity, or AUC, which would be expected for an AI/software device.

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