Two devices with recent De Novo Classifications were reported on recently in the Viz.ai HCM and Better Therapeutics devices that employ Artificial Intelligence (AI) and/or Machine Learning (ML). The Classification Order for both were recently published and present some fascinating opportunities potentially for other medical device companies that may seek to follow by using Viz.ai HCM and Better Therapeutics devices as a basis for a 510(k) submission effort (if positioned properly in 510(k) submission effort).
At a high level, the Classification Order for Viz.ai HCM includes indications for use language, generic device identification, risks and mitigations and special controls. While the indications language is specifically for detecting signs associated with hypertrophic cardiomyopathy (HCM) drawing from 12 lead ECG data, the generic device identification language for describes the device as “Cardiovascular machine learning based notification software employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up. The software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care. It is intended as the basis for further testing and is not intended to provide diagnostic quality output. It is not intended to identify or detect arrhythmias.” This device identification language is not restrictive to ECG but instead “physiological inputs”, which could be presented by any number of devices, with pulse oximetry, blood pressure, or pulse rate being only a few examples of physiological inputs. This suggests there are viable pathways for other future to be developed devices that similarly could take one or more physiological inputs as part of routine medical care to “to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up”. This is a significant development for those in the AI / ML community looking to develop innovative new products trying to aid in the identification of cardiovascular disease and considering taking a 510(k) clearance path. This opportunity may exist as long as the 510(k) submission is properly constructed to meet these Cardiovascular machine learning based notification software requirements.
The Classification Order for Better Therapeutics similarly includes indications for use language, generic device identification, risks and mitigations and special controls. The indications for use language is particularly broad in “BT-001 is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. BT-001 provides cognitive behavioral therapy as a treatment that should be used adjunctively with standard of care.” While the generic device identification and special controls have some additional limitations that must be considered, this indications for use language could open the doors for follow on industry participants to seek 510(k) clearances that could further treatment options for the type 2 diabetic population.
All in all, these are positive developments coming from the FDA de novo classification pipeline for industry, health care professionals and the patients that would be served by them. It signals FDA is embracing a wider understanding of technology as it stands today and the opportunties that could be leveraged in the future by innovative industry sponsors.
