(395 days)
The Quantum Perfusion Single Lumen Cannula 22F is designed to drain blood from the patient through the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.
The Quantum Perfusion Dual Lumen Cannula 24F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.
The Quantum Perfusion Dual Lumen Cannula 27F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.
The Quantum Perfusion Dual Lumen Cannula 31F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.
Quantum Perfusion Single Lumen Cannula:
Quantum Perfusion Single Lumen Cannula is a single use device intended to be used in medical procedures providing cardiac and respiratory support up to 6 hours. The device is characterized by a single lumen drainage catheter and is designed to be coupled with an extracorporeal circuit, allowing for blood oxygenation and carbon dioxide removal.
The device exploits a percutaneous insertion procedure, which reduces the invasiveness of extracorporeal procedures. It is intended to be inserted in the right internal jugular vein.
The device features multiple inflow openings, allowing to drain blood from the vena cava., providing drainage during extra-corporeal medical procedures.
The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch. Blood contact surfaces of the device are coated with a stable biocompatible surface.
Quantum Perfusion Dual Lumen Cannula:
Quantum Perfusion Dual Lumen Cannula is a single use device intended to be used in medical procedures providing cardiac and/or respiratory support up to 6 hours. The device is characterized by two coaxial catheters and is designed to be coupled with an extracorporeal circuit for artificial oxygenation of the blood and carbon dioxide removal.
The device exploits a single site insertion which reduces of extracorporeal procedures. It can be inserted via a percutaneous approach through the right internal jugular vein. Blood is drained through the lumen of the outer catheter, and returned through the lumen of the inner catheter.
The device features multiple inflow openings in the outer catheter limiting the circulation of unoxygenated blood.
The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch. All the device surfaces in contact with blood are coated with a phosphorylcholine-based biocompatible material.
The provided text describes a medical device submission (K203067) for several Quantum Perfusion Cannulas. This document is a 510(k) summary, which outlines the device's characteristics and demonstrates substantial equivalence to predicate devices, rather than establishing acceptance criteria or performing a study to prove performance against those criteria in the context of an AI/ML device.
The entire submission focuses on non-clinical testing to establish substantial equivalence for physical medical cannulas, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/ML device cannot be extracted from this document.
The document explicitly states:
- "No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate and reference devices." (Page 10)
- "In-vitro performance tests have been performed in order to substantial equivalence determining that proposed devices do not raise any new issues in terms of product's safety or effectiveness if compared to currently cleared predicate and reference products." (Page 9)
The non-clinical testing performed includes evaluations of: Device Pressure Drop, Mechanical Integrity, Kinking resistance, Dynamic Blood Damage, Infusion/drainage recirculation, Air aspiration, Marker radiopacity, Pad printing resistance, product shelf life, EtO Sterilization process validation, Packaging Validation tests, and Biocompatibility. These are typical engineering and material tests for physical medical devices.
Therefore, I cannot provide the requested information for an AI/ML device based on this document because it is not about an AI/ML device.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).