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510(k) Data Aggregation
(63 days)
The Cultiv8 Genie MAX is intended to be inserted into the vasculature to provide a conduit for introducing intravascular devices while providing a hemostatic seal to minimize blood loss.
The Genie MAX is a large bore introducer sheath system used for providing a conduit for introduction of intravascular devices while providing a hemostatic seal. The system includes an introducer sheath, protector, dilator and a 3cc syringe.
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(131 days)
The Intri26 Introducer Sheath is indicated:
- To provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
- For the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Intri26 Introducer Sheath is an introducer sheath consisting of a short, single-lumen catheter with a hydrophilic coating, proximal hemostasis valve, and stopcock with flush port. A radiopaque marker is positioned near the distal tip of the sheath to aid fluoroscopic visualization. The Intri26 dilator is compatible with a 0.035" guidewire and has a tapered leading edge, which aids insertion and positioning of the sheath.
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(21 days)
The V•Stick™ Vascular Access Set is intended for use in the introduction and placement of guidewires and/or catheters.
The V•Stick™ Vascular Access Set consists of a 4F or 5F coaxial introducer set (with a 3F standard or 3F stiff dilator), a 21ga entry needle (with an echogenic or non-echogenic tip), and a 0.018" x 40cm Nitinol core and with Stainless Steel coil vascular access guidewire with an articulatable tip.
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(91 days)
PerQseal Introducer: The PerQseal Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature.
PerQseal Elite Introducer: The PerQseal Elite Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature.
Each PerQseal Introducer ('S', 'L', Elite 14F, and Elite 18F) includes an Introducer Sheath with a Dilator positioned within the lumen. The Introducer Sheath comprises a simple sheath that provides access to the site, while the Dilator is a component which guides the Introducer Sheath to the access site and provides a blood signal that is used to ensure proper positioning of the Introducer Sheath.
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(127 days)
The Introducer Sheath set is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.
The Introducer Sheath Set consists of a sheath and a dilator. The sheath is comprised of a sheath tube, a sheath hub, and a hemostatic valve. While the dilator comprises a dilator hub, a dilator tube and a rod cap. The sheath features a hydrophilic coating. Each set of products is equipped with a sheath and a dilator. The product is sterilized with ethylene oxide and is disposable.
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(40 days)
The Abiomed 14Fr Low Profile Introducer Kit is intended to facilitate access to the vascular system for the introduction and removal of the Impella CP Catheter and ancillary devices.
The Abiomed 14Fr Low Profile Introducer Kit is a sterile, single-use, prescription device. The 14Fr Low Profile Introducer Kit consists of an introducer sheath and a tapered sheath dilator which is compatible with an 0.035" guidewire. The 14Fr Low Profile Introducer Kit is kitted with an 0.035" access guidewire, supplemental dilators and a luer adapter for convenience to help facilitate insertion.
The Abiomed 14Fr Low Profile Introducer Sheath consists of a sheath hub with three-way stopcock and flush port at its proximal end and a sheath body at its distal end. The sheath hub features an introducer cap, hemostasis valve, side-port with three-way stopcock and flush port, a butterfly (suture pad), and connects to the dilator hub. The coil reinforced polymer sheath body has an insertion profile of 14Fr to allow the insertion and removal of the Impella CP Catheter and ancillary devices.
The Abiomed 14Fr Low Profile Dilator consists of a dilator body, a tapered tip at the distal end, and a hub at the proximal end, which connects with the sheath hub. Additionally, the 14Fr dilator has a hydrophilic coating to aid in insertion of the device into the vasculature.
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(56 days)
The Primero Safe Access System is intended to facilitate placing a catheter through the skin into a vein or artery. The introducer needle is used in facilitating entry through the skin into a vein or artery to provide a conduit for the guidewire. The guidewire is an accessory device which is used for placement of a catheter or sheath in the vein or artery.
The Primero Safe Access System (SAS) is a catheter introducer that facilitates a quick approach for placement of a guidewire during the introduction of a catheter for vascular access. The Primero SAS combines an introducer needle, guidewire, advancer, and storage tube into a single integrated device to promote ease of use and quick access by the healthcare provider. The introducer needle consists of an 18Ga stainless steel needle with an echogenic tip and terminates on the proximal end with a colored translucent standard female luer lock hub. The introducer needle has an enhanced echogenic tip, that has been slightly modified to incorporate a small bulb-like feature at the proximal end of the tip bevel to enhance ultrasonic visualization during vascular access. The introducer needle is secured to the advancer through a luer lock connector at the distal end of the advancer. The advancer is a light-weight polymer handpiece that allows the user to grip the entire setup while introducing the needle into the vessel and then advancing the guidewire through the needle by either 'thumb" or 'two-finger" advancing based on the preference of the user. A cutout in the advancer handpiece wire path exposes the guidewire and conveniently allows the user to advance the guidewire with their fingers without having to let go of the handpiece. An internal path within the handpiece feeds the guidewire from a storage tube into the introducer needle. The looped storage tube is connected to the proximal end of the advancer and holds a spooled pre-loaded guidewire ready for deployment. A back stop has been inserted into the tube at the proximal end to prevent a guidewire from being over-retracted from the advancer. The Primero SAS is pre-loaded with a commercially available guidewire (previously cleared under K142393) ready for deployment through the introducer needle once placed in the target vessel. The guidewire is comprised of an uncoated nitinol core wire that is tapered at the distal tip where a stainless-steel coil is secured over the full-length of the core. The South53 Primero Safe Access System (SAS) integrates all the necessary elements into a single device to complete the Seldinger technique as part of a vascular access procedure.
The Primero SAS is provided sterile and is intended for single patient use. The device is not intended to be re-sterilized or re-used.
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(70 days)
The Pounce™ Sheath is intended to introduce therapeutic or diagnostic devices into the vasculature.
The Pounce™ Sheath 16Fr is a single-use, sterile introducer sheath intended for the introduction of therapeutic or diagnostic devices within the vasculature. The Pounce™ Sheath 16Fr includes the following features:
- Braided nitinol, self-expanding funnel at the sheath's distal end
- Handle assembly with slider button to actuate the funnel's deployment
- Hub and hemostasis valve assembly to allow for device introduction and removal
- Aspiration assembly including tubing, a stopcock, and connection for a 60 cc syringe
Additional components provided within the packaging include:
- 0.035" guidewire compatible pre-dilator for access site preparation
- 0.035" guidewire compatible dilator designed for atraumatic introduction of the sheath
- 60 cc locking syringe, compatible with the sheath's aspiration assembly
A radiopaque marker band is located at the distal tip of the sheath during introduction and removal, when the funnel is sheathed. When the funnel is unsheathed, the radiopaque marker band is located proximally to the funnel. The funnel is sheathed and unsheathed with the actuation of a slider button located on the handle assembly. The hemostasis valve can be actively defeated (opened), during device introduction or removal, by pressing down on the base of the surrounding hub. This action is designed to minimize device contact across the hemostatic valve during the introduction or removal of devices. The aspiration assembly also aids in the delivery of contrast or saline.
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(74 days)
The Vertex™ Catheter is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.
Jupiter Endovascular's Vertex™ Catheter is a single-use catheter consisting of a multilayer shaft, a hemostatic valve, and an included locking obturator ("dilator"). The effective length of the catheter is coated to improve lubricity. The handle of the catheter includes a flush line, a fixation line for fixation control, and a hemostatic valve. The catheter shaft and obturator bodies are radiopaque. The distal tip of the catheter has a non-radiopaque region that is no more than 5 mm in length. The device is packaged as sterile and is for single use only.
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(31 days)
The Edwards eSheath Optima introducer set is indicated for the introduction and removal of compatible devices used with Edwards transcatheter heart valves.
The Edwards eSheath Optima introducer set (herein referred to as Optima set), model 14000ES16, consists of a sheath, vessel dilator, introducer, and in-sheath dilator. The Optima set is available with inner sheath diameter of 16 French and is used to facilitate introduction and removal of compatible devices used with the Edwards transcatheter heart valve (THV) systems into/from the vasculature.
The sheath shaft is composed of two layers; as devices are passed through the sheath, the inner member expands by sliding against itself while the outer jacket expands by stretching radially, temporarily expanding the shaft diameter. A radiopaque marker on the distal end indicates the location of the sheath tip in the body and a hydrophilic coating on the sheath tubing exterior facilitates introduction into the vessel. The sheath tubing mates with a housing, which holds three seals to provide hemostasis, and an extension tube with stopcock for flushing.
The vessel dilator is used to dilate the vessel prior to sheath insertion. The introducer is inserted into the sheath hub and locked prior to insertion into the body over a guidewire. The in-sheath dilator is used to expand the sheath during device use at the physician's discretion. The introducer, vessel dilator, and in-sheath dilator are radiopaque to improve fluoroscopic visibility intra-procedure.
The 29mm loader (included with the Edwards delivery system) features a disc valve within the loader cap assembly to help maintain hemostasis, and a scored perforation on the loader tube allowing the loader tubing to be "peeled away" and removed to utilize the full working length of the inserted device.
The provided text is a 510(k) clearance letter for a medical device called the Edwards eSheath Optima Introducer Set. It outlines the regulatory process and asserts the device's substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving that an AI/software device meets those criteria, as typically seen in AI/ML medical device submissions.
The document pertains to a physical medical device (catheter introducer) and its non-clinical performance testing. The "summary of non-clinical testing" section lists various engineering and biocompatibility tests performed on the device itself, not on an AI algorithm.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance for an AI/software device.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, or how training ground truth was established, because this information is not present in the provided document regarding an AI/software device.
The document is about a physical medical device and its non-clinical (engineering and biocompatibility) testing, not an AI/ML-based device.
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