(118 days)
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.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).