FDA 510(k) Clearance: Utilising Artificial Intelligence

Artificial intelligence (AI) is a powerful, new and evolving technology which has been proven to improve process capabilities across a significant number of industry sectors. AI utilised in Medical Devices has the potential to transform healthcare around the globe, helping doctors to make more accurate and effective diagnoses, to treat patients with improved overall patient care.

While acknowledging the above benefits of AI in Medical Devices, regulatory and data security challenges are a major concern.

Artificial Intelligence (AI) is a term applied to technology that sets out to simulate human actions or thought processes undertaken by our brains, which lead to decisions being made, whilst potentially learning from previous events and / or mistakes. Medical devices utilising AI, could, for example:

• Perform patient tasks normally undertaken by a doctor or health professional 
• Collect and analyse large amounts of data from different sources (including patient data) to identify indicated trends
• Diagnose medical conditions or disease via sensors worn by the patient 
• Identify patients who have an  increased risk for disease
• Identify patients who may have complications or the potential for negative outcomes following certain treatments based on the patients' own medical records
• Monitor and analyse patient treatment plans for efficacy and suitability of patient outcomes

At the time of writing, Medical Devices utilising AI seem to be currently focused on  three main areas of patient care. These are:

• Networked Medical Device Systems: Networked wireless remote medical devices used by healthcare professionals to manage data, keeping patients informed of their condition. These systems reduce costs due to their capability of remotely  monitoring patients at home, allowing for a  more effective and efficient treatment plan to be administered. 
• Disease Management: Medical Devices utilising AI have a capability of administering treatment plans as required by the patient. For example, AI has the potential to deliver drugs following a high blood pressure reading.
• X-Ray Replacement: Medical Devices which utilise AI have the potential to replace x-rays which will reduce the exposure level to radiation by the patient. AI seeks to improve the quality of the image provided, which in turn will provide better information for the doctor.

A Medical Device manufacturer required support with an FDA 510(k) Clearance for a new Medical Device utilising AI.

The ZES FDA experienced consultant provided expert advice and support in three main areas of concern:

• Risk Management
• Assessment of Assets, Risks, Threats, Vulnerabilities and Controls
• Software Validation and Best Practice
• Software Encryption
• Security patches and validated software updates during device lifecycle
• Determination of controls for implementation to assure software maintains integrity at source and end user

• Medical Device Self-Cleaning Rationale and Validation
• Patient Cleaning Rationale and Validation

• Validation Documentation and streamlined approaches
• The validation ‘V’ mode