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The Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through interatrial septum.

The Steerable Guide Catheter (including a dilator) consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a dilator with a single central lumen. The device provides a conduit into the left side of the heart through the interatrial septum. The Steerable Guide Catheter is provided EtO sterile and for single use only.

This document is a 510(k) Premarket Notification from the FDA regarding a MitraClip G4 Steerable Guide Catheter. It focuses on establishing substantial equivalence to a predicate device, rather than proving the performance of a novel AI/ML-driven device against specified acceptance criteria using a study.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, and types of ground truth cannot be extracted from this document.

This document primarily discusses:

• Regulatory Classification: Class II device, product code DRA.
• Device Description: A steerable guide catheter, including a dilator, used for introducing other catheters into the left side of the heart through the interatrial septum.
• Predicate Device: K190167 Steerable Guide Catheter.
• Comparison of Technological Characteristics: Stating that the subject device has the "same technological characteristics" as the predicate device in terms of intended use, indications for use, principles of operation, fundamental technology, materials, dimensions, and sterilization. Minor design modifications and shelf-life changes are noted.
• Performance Data: Only states that "Testing was performed to support substantial equivalence, including: Performance Shelf Life." It does not provide details of these tests, specific acceptance criteria, or performance results.
• Conclusion: The device is equivalent to the predicate device, with no differences raising new safety or effectiveness questions.

In summary, this document is a regulatory approval letter based on substantial equivalence, not a study report detailing performance metrics against specific acceptance criteria for an AI/ML-driven medical device.

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The Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through the interatrial septum.

The Steerable Guide Catheter consists of a Guide and a Dilator provided EtO sterile and for single use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of 0.204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter, Dilator and accessories are packaged in a tray that is individually pouched in a Tyvek/Nylon corner peel pouch, heat-sealed one time, and the single sealed pouch is placed into a cardboard nest and top-loading box.

The provided document is a 510(k) premarket notification letter and summary for a medical device called a "Steerable Guide Catheter." It is used for introducing various catheters into the left side of the heart through the interatrial septum.

This document describes a physical medical device, not an AI/ML powered device or a software as a medical device (SaMD). Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets those criteria is not present.

The document states that the device is substantially equivalent to a legally marketed predicate device (K172394 Steerable Guide Catheter). This equivalence is based on:

• Intended use
• Indications for use
• Principles of operation
• Fundamental technology
• Similar or identical materials of composition, dimensions, and sterilization

The "Performance Data" section (number 15) lists general categories of testing performed to support substantial equivalence:

• Biocompatibility
• Sterilization
• Packaging
• Performance (general term, specific details for the physical device would be in the full submission)
• Shelf Life

Without specific details on the "Performance" testing, it's impossible to define "acceptance criteria" and "reported device performance" in the context you've requested (which implies numerical metrics for an algorithm).

Therefore, I cannot provide the requested table or answer the specific questions related to AI/ML device performance and studies, as this document pertains to a physical medical device with no mention of AI or software components.

Ask a specific question about this device