510(k) Approval for AI Imaging Analytics Device

On July 16, 2020, FDA issued 510(k) Approval for AI Imaging Analytics Device HealthMammo, a device manufactured by Zebra Medical Vision Ltd. As reported in the New York Times, HealthMammo is an artificial intelligence (AI) product that analyzes mammograms for suspicious lesions. Radiologists can use the HealthMammo results to prioritize which mammogram images need attention first.

The HealthMammo AI Imaging Analytics Device device was approved after a 510(k) submission, and the FDA found that the Class II device was substantially equivalent to a predicate device: Access Data FDA. The FDA defined the software-only device as “Radiological Computer-Assisted Prioritization Software for Lesions.”  The key thing to understand about qualifying for this device definition is that the software “does not provide information from the image analysis other than triage and notification.” The AI used in the device is only establishing “effective triage within a specialists queue.”

The triage functionality of HealthMammo comes at an opportune time, with many radiologists facing backlogs of scans that were postponed due to COVID-19. Zebra Medical has proven to be quite capable of creating AI products that can analyze images and assist healthcare professionals in quick identification of scans that need attention – the company has four previous 510(k) approvals from the FDA for similar AI products. AI manufacturers are likely to be encouraged by this signal of potential Class II eligibility for certain AI software.

Read our other AI posts: FDA Regulation of AIFDA Public Workshop – Artificial Intelligence in Radiological Imaging

A good reference is the IMDRF SaMD Risk Categorization Framework:  IMDrf Finalizes SaMD Document

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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