(30 days)
The ViperCath™ XC Peripheral Exchange Catheter is intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges, and provide a conduit for the delivery of saline or diagnostic contrast agents.
The ViperCath XC Exchange Catheter is intended to be used to facilitate vascular access and guidewire exchanges during peripheral vascular intervention procedures. It is available in the following lengths with a straight tip: 65, 90, 135, and 150 cm as described in this submission. A 200 cm length is also available and was previously cleared under K183000 with a straight tip and an angled tip. There are no accessories for this device. The catheter is compatible with .035" guidewires and has radiopaque marker bands at distances of 1 cm and 5 cm from the distal tip. The ViperCath XC is supplied sterile with one catheter per box.
The provided text is a 510(k) summary for the ViperCath™ XC Peripheral Exchange Catheter. It describes the device, its intended use, and compares it to a predicate device. However, this document does not contain information on acceptance criteria for device performance, nor does it describe a study that proves the device meets such criteria in terms of clinical performance or diagnostic accuracy.
The "Functional and Safety Testing" section briefly mentions: "Dimensional checks and torque to failure testing were performed to verify the modifications are acceptable and meet specifications over the life of the device." This indicates engineering and mechanical testing, not a clinical study involving human patients or a diagnostic accuracy study.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning the elements like sample size, data provenance, ground truth, expert qualifications, or MRMC studies, as these types of studies are not described in the provided document.
The document mainly focuses on establishing substantial equivalence to a predicate device based on similar intended use, technological characteristics, and material properties, and basic functional/safety testing of the device itself rather than its performance in a diagnostic or clinical scenario.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).