(236 days)
The sheath is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
The sheath curve can be visualized when used with impedance-based electroanatomical mapping systems.
The proposed SureFlex HD Steerable Sheath and VersaCross HD Steerable Sheath subject devices are non-pyrogenic, single use devices that are supplied sterile to the UD Steerable Sheath families are comprised of the following components that are packaged together:
- . One Steerable Sheath
- . One Transseptal Dilator
- . One J-tip Mechanical Guidewire
The SureFlex and VersaCross HD Steerable Sheaths are intended for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum. The sheath curve can be visualized when used with separately cleared impedancebased electroanatomical mapping (EAM) systems. The steerable sheath component used in conjunction with a compatible transseptal dilator can facilitate transseptal puncture using separately cleared compatible needle or wire-based puncture devices. The steerable sheath component is connected to the impedance-based EAM system via a compatible legally marketed accessory cable. The subject device is used in a sterile environment where facilities are appropriately equipped and staffed to perform transseptal procedures.
The steerable sheath component is 8.5 Fr with a 63 cm or 73 cm useable length and is available in three curve options (small, medium, large). It is flexible and bi-directionally deflectable at the distal end (180 degrees clockwise and counterclockwise). The radiopaque tip (containing a platinum/iridium marker band) maximizes visualization of the sheath during manipulation. The sheath contains 4 electrodes equi-spaced along the shaft to enable shaft visualization. The sheath has two distal sideports and the proximal end includes a hemostasis valve and a 3-way stopcock to facilitate the injection or fluids. A silicone lubricant is applied to the outer surface of the shaft for smoother device manipulation. The sheath handle allows the user to control the deflection of the sheath tip through rotation of the knob in the direction of desired distal deflection.
The compatible dilator component is 8.5F with a 95cm usable length and is comprised of HDPE material with a tungsten radiopaque marker coil at the tip for visualization. The dilator has a tapered distal tip that provides support for the sheath. The compatible mechanical guidewire (0.032″ or 0.035″) component is J-tipped, 180 cm in length and is comprised of a stainless-steel core mandrel with a PTFE coating.
The provided document is a 510(k) Premarket Notification for medical devices, specifically steerable sheaths (SureFlex HD Steerable Sheath and VersaCross HD Steerable Sheath). It details the substantial equivalence determination made by the FDA.
Crucially, this document does NOT describe the acceptance criteria and study proving a device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product. The medical devices in question are physical catheters/sheaths, and the performance testing summarized refers to mechanical, electrical, biocompatibility, sterilization, pyrogen, and packaging testing, as well as a simulated-use animal study. These are typical validation activities for a physical medical device.
The only mention of "visualization" or "mapping systems" is in the context of the sheath's curve being visualized when used with impedance-based electroanatomical mapping systems, and the predicate device's compatibility with CARTO® 3 EP Navigation Systems. This refers to the ability of the physical sheath to be seen on separate, compatible systems, not an AI or SaMD performing a diagnostic or therapeutic function itself.
Therefore, I cannot provide the requested information regarding acceptance criteria and study proving a device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product based on the provided text, as this information is not present. The document focuses on the substantial equivalence of a physical medical device.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).