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For the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal perforation / puncture.

The Thomas Medical Products Inc. Braided Guiding Introducer System(s) are designed t to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations in the heart. The sheath may be used for percutaneous entry. Each Braided Guiding Introducer System consists of the following: a sheath, a dilator, and a "J" tip guidewire. In addition, a standard 12 cc syringe, a 18 gage XTW introducer needle, and a pre-dilator may also be packaged with the Braided Guiding Introducer System.

The provided text describes a 510(k) premarket notification for a medical device, the "Braided Guiding Introducer System." However, it does not contain any information regarding acceptance criteria, device performance derived from a study, or details of a study's methodology.

The document states that the device is substantially equivalent to a legally marketed predicate device (Thomas Medical Products, Inc., 6 French Braided Guiding Introducer, K013202) because:

• Identical Intended Use/Indications for Use: The new device has the same indications for use as the predicate device, which is "For the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal perforation / puncture."
• Identical Technological Characteristics: The technological characteristics of the new device are the same as those of the predicate device.

Since this is a 510(k) submission based on substantial equivalence, the FDA typically does not require new performance studies if the device is sufficiently similar to an already cleared predicate. The focus is on demonstrating that the new device raises no new questions of safety or effectiveness compared to the predicate.

Therefore, I cannot provide the requested information, as the input text does not contain it. The sections regarding acceptance criteria, reported performance, sample size, ground truth, expert involvement, adjudication, MRMC studies, or standalone studies are not present in the provided 510(k) summary and FDA letter.

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For the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal perforation / puncture.

The Thomas Medical Products Inc. 6 French Braided Guiding Introducer(s) are designed to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations in the heart. The sheath may be used for percutaneous entry. Each 6 F Braided Guiding Introducer consists of the following: a sheath, a dilator, and a "J" tip guidewire. In addition, a standard 12 cc syringe, a 18 gage XTW introducer needle, and a pre-dilator may also be packaged with the 6 F Braided Guiding Introducer Kit.

This is a 510(k) summary for a medical device (6 French Braided Guiding Introducer) and not a study describing AI/ML device performance. Therefore, I cannot provide the requested information regarding acceptance criteria and study details as it pertains to AI/ML devices.

The document discusses the substantial equivalence of a new medical device to a legally marketed predicate device, focusing on its intended use and technological characteristics. There is no mention of AI, machine learning, or algorithms, nor does it present any performance data in the context of acceptance criteria for such technologies.

Ask a specific question about this device

Ask a specific question about this device