MEM Discussion, page-436

Here it is again, because you can't handle the truth lol

The Memphasys Felix™ device is an automated electrophoretic system designed for sperm separation, using a proprietary process that combines electrophoresis and size-exclusion membranes to isolate sperm from raw semen. It consists of a console supplying electrical power and a sterile disposable cartridge for sperm isolation.

To determine whether the Felix device would be classified as Class I or Class II in Brazil, you need to consider ANVISA’s classification criteria, which are based on risk and complexity:

• Class I: Low-risk devices, typically simple in design, non-invasive, and not requiring significant regulatory oversight beyond general controls. Examples include adhesive bandages or manual stethoscopes.
  
• Class II: Medium-risk devices, often more complex, that may pose moderate risks if they fail but are unlikely to cause immediate serious injury or death. These devices require special controls, such as specific labeling or performance standards. Examples include syringes or endoscopes.
  

The Felix device is a specialized, automated system involving electrical components and a sterile disposable cartridge, used in a clinical setting for assisted reproductive technology (ART). Its function and complexity suggest it is more than a simple, low-risk device. Additionally, the device’s intended use in sperm separation for fertility treatments involves a controlled process with potential implications for patient outcomes, which likely elevates its risk profile above Class I. Supporting evidence comes from the U.S. FDA classification, where the Felix device is being registered as a Class II medical device, requiring special controls and traceability of materials due to its complexity and clinical application. While Brazil’s classification system differs from the FDA’s (Brazil uses a rules-based system rather than the FDA’s predicate-based approach), the FDA’s Class II designation aligns with medium-risk devices, suggesting a similar classification in Brazil.