(100 days)
Quantum Perfusion Dual Lumen Cannula 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.
All medical devices pertaining to Quantum Perfusion Dual Lumen Cannula product family are single use devices intended to be used in medical procedures providing cardiac and/or respiratory support up to 6 hours. Devices are characterized by two coaxial catheters and are designed to be coupled with an extracorporeal circuit for artificial oxygenation of the blood and carbon dioxide removal.
Devices exploit a single site insertion which reduces the invasiveness 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.
Devices feature multiple inflow openings in the outer catheter limiting the circulation of unoxygenated blood.
Devices are non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch. All the devices' surfaces in contact with blood are coated with a phosphorylcholinebased biocompatible material.
The provided text describes a 510(k) premarket notification for Qura's Quantum Perfusion Dual Lumen Cannula, which introduces new REF codes (different sizes) and a warning in the Instruction for Use. It does not describe acceptance criteria for an AI/ML powered device or a study involving human readers or sophisticated ground truth establishment.
Therefore, most of the requested information (related to AI/ML device performance, reader studies, type of ground truth, training sets, etc.) cannot be extracted from this document, as it pertains to a medical device's physical and mechanical performance rather than an AI/ML algorithm.
However, I can extract the relevant information regarding the non-clinical testing for this specific medical device submission.
Here's what can be extracted based on the provided text:
Study and Acceptance Criteria Information (as per the provided document's scope):
The document describes the performance data and conclusions for new variants of a Quantum Perfusion Dual Lumen Cannula. The "study" here refers to the non-clinical bench testing conducted to demonstrate product safety and effectiveness for these new variants.
1. A table of acceptance criteria and the reported device performance:
The document mentions "Performance tests for new REF codes introduced in the portfolio, according to applicable Recognized Consensus Standard ISO 18193:2021" specifically, "Evaluation of devices' Pressure Drop." However, the specific acceptance criteria values (e.g., "Pressure drop must be less than X mmHg at Y flow rate") and the reported device performance values are not detailed in this summary. It only states that testing was performed "as per same internal applicable standards/protocols applied for predicate devices (K203067)."
| Acceptance Criteria (Specific Values) | Reported Device Performance (Specific Values) |
|---|---|
| Not specified in the document. (e.g., Pressure Drop |
§ 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).