Class-I: Adapter for smartphone
(Code KYT+GDPR)

* Light, Examination, Medical, Battery Powered, Regulation number 880.6350

* MDDS+Smartphone App

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Class-II: Standalone
(Code PSN, LLZ)

 

* Light Based Imaging (Surgical lamp)

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* DICOM

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Conclusions of the EU and US Regulatory Plan 2020

For Patternox Ltd’s PatScope device

Prepared by: Liat Diamant Porat, Tamar Levav-Rabkin, Duet Medical Consulting Ltd.

At this stage, the current product, PatScope scanner is intended for LD analysis of skin lesions. Since the device incorporates functions representing already available in the US 510(k)-exempt devices, the assumption is that the device should be classified as a Class I medical device for EU and US regulations.

Since the PatScope is a device which is in a continuous developmental process, in future stages, when the device will include the SGPI Algorithm, and in later stages – will include AI capabilities, we recommend that it should be submitted for a 510(k) premarket notification, as already available in the US cleared devices (Device Classification Name- Light-Based Imaging; Product Code- PSN). However, pre-submission requesting a Breakthrough Designation from the FDA is recommended. For EU, technical documentation supporting Class IIb for MDR 2017/745 should be prepared and submitted to a notified body pending on device readiness timelines.

For the future developmental stages of the PatScope device, a key consideration is whether the Agency will identify the 510(k) pathway to be appropriate for the PatScope device. In 2011 the FDA has approved in a PMA process the MelaFind (a multispectral computer vision system). A 510(k) pathway will be a viable strategy for PatScope future developmental stages, only if one can demonstrate that the device to be marketed is safe and effective by proving substantial equivalence (SE) to a legally marketed device (predicate device; such as Demetra BDEM-01 or the Vivascope System). The company will strive to provide the Agency with utmost assurance that the PatScope device does not raise new questions of safety and effectiveness. The FDA may insist on approving the PatScope under a PMA process if substantial equivalence will not be demonstrated.

Given that the PatScope device is a ‘medical device that provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions’, a pre-submission requesting a Breakthrough Designation from the FDA, is recommended.