(29 days)
The Cordis 4F Infiniti™ Angiographic Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vascular system.
Cordis Nylex™ Angiography Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.
Cordis Tempo™ Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.
The 4F Infiniti™ Angiographic Catheter is a single-use device designed to deliver radiopaque contrast medium to selected sites in the vascular system. The device combines an atraumatic tip with a braided body. It is compatible with 0.038" guidewire. The Infiniti™ 4F catheter is supplied sterile and is available in various lengths and tip configurations.
The 4F & 5F Tempo "M Angiography Catheters are single-use devices designed to deliver radiopaque contrast medium to selected sites in the vascular system. The device combines an atraumatic tip with a braided body. It is compatible with 0.038" guidewire. The Tempo™ 4F & 5F catheter is supplied sterile and is available in various lengths and tip configurations.
The 4F & 5F Nylex™ Angiography Catheters are single-use devices designed to deliver radiopaque contrast medium to selected sites in the vascular system. The device combines an atraumatic tip with a non-braided body. It is compatible with 0.035" guidewire. The Nylex "10 4F & 5F catheter is supplied sterile and is available in various lengths and tip configurations.
This document is a 510(k) premarket notification for angiographic catheters and does not describe acceptance criteria or a study proving that an AI device meets acceptance criteria. Instead, it describes how the modified devices (4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters) are substantially equivalent to their predicate devices based on design, intended use, and performance testing for biocompatibility, functional performance, and sterilization. Therefore, I cannot generate the requested table and information as it pertains to AI/algorithm performance.
The document specifies the following regarding the testing conducted for the device:
Performance Data:
- Biocompatibility Testing: Conducted on finished and sterilized Tempo 4F Angiographic Catheter in compliance with ISO 10993-1:2009/Cor 1:2010 and FDA guidance.
- Tests included: In vitro cytotoxicity, Sensitization, Intracutaneous / irritation reactivity, Acute system toxicity, Material mediated pyrogenicity, Hemocompatibility (In vitro hemolysis, Partial thromboplastin time (PTT), Platelets and leukocyte counts, Complement activation (C3a & SC 5b-9), In vivo thrombogenicity).
- Device Functional Testing:
- Pull force intermediate tip-to-distal tip
- Pull force tip-to-body
- Sterilization Testing:
- Bioburden
- EO residuals
- Bacterial Endotoxin
Conclusion: The design modifications were verified and validated through a series of tests ensuring that the proposed catheter meets all the required specifications and that the performance and functionality of the proposed devices are substantially equivalent to their predicate devices.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).