Friday, August 10, 2018

Do I need to File a 510(k) for my PACS?

Over the past several months many of our clients have asked us questions about whether their future products need a 510(k). Initially, PACS devices were generally treated as accessories to the imaging modalities with which they were used. For example, medical image digitizers, image viewing workstation or medical image printer were considered by FDA to be accessories to stationary x-ray, MRI or CT systems. However, with the significant expansion in the functionality of medical image management products, FDA realized that the identification of many of these products as accessories to specific radiological imaging modalities was no longer appropriate.

This realization led FDA to publish the “Guidance for the Submission of Pre-market Notifications for Medical Image Management Devices” in July 2000. This guidance is applicable to medical devices that provide functions related to the management of medical images after acquisition, of which PACS (as defined by the FDA), is only one of five classifications. By the way, the guidance does not address image-processing devices that utilize artificial intelligence (AI) or other techniques to identify abnormalities in medical images or assist in diagnosis. AI is currently being addressed under the FDA Guidance; Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions Document issued on: July 3, 2012.(more on that in a later blog post).

The “Classifications for Medical Image Management Devices” are;
1)     Medical Image Storage Device (892.2010) - is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory. This device type is Class I and exempt from 510(k) requirements. 
2)     Medical Image Communications Device (892.2020) – is a device that provides electronic transfer of medical image data between medical devices. It may include physical communications medium, modems, interfaces, and communications protocols. This device is also Class I and exempt from 510(k) requirements.
3)     Medical Image Digitizer (892.2030) - is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners that use lasers or charge-coupled devices. This is a Class II device and a 510(k) must be submitted to FDA.
4)     Medical Image Hardcopy Device (892.2040) - produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers. These are Class II devices and a 510(k) must be submitted to FDA.
5)     Picture Archiving and Communications System (892.2050) - provide one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. Software components may provide functions for performing operations related to image manipulation, enhancement, compression, or quantification. This is a Class II device and a 510(k) must be submitted to FDA.

Classifications 892.2010 and 892.2020 are intended to include all medical image management devices whose principal functions are communications or storage. Classification 892.2050 is intended to cover devices that have not been included in the other Medical Image Management device classifications (i.e. 892.2010-2040).

The confusion regarding the applicability of 892.2050 has occurred because the term "PACS" has commonly been used by industry to refer to all types of medical image management devices. However, the FDA classification in 892.2050 is not intended to include products whose principal function is only medical image communications and/or storage. These devices are classified Class I under 892.2010 and 892.2020.

In many cases it is not clear cut if a device should be classified as a Medical Image Communications Device, a Medical Image Storage Device, or as a Picture Archiving and Communications System. In these cases, the classification is determined by reviewing the additional functions performed by the product. Simple manipulations that do not alter the image data, such as window and level, pan and zoom, and image annotation are considered to be within the scope of the communications and storage functions and no 510(k) is required. A typical image viewing workstation falls within this classification. However, image-processing functions, which are intended to alter the image data (e.g. filtering, multiplanar reconstruction, and 3D reconstruction), are considered to be outside the scope of the storage and communications functions and fall into the PACS classification where a 510(k) must be submitted.  Also, complex quantitative functions (e.g. measurements, arterial stenosis evaluation, ventricular volume calculations, and calcium scoring) are not considered to be communications and storage functions and these types of functions are treated as PACS, requiring a 510(k).

Hopefully, I have reduced some of the confusion but if you have any questions or need assistance for product classification and/or FDA clearance, don’t hesitate to contact us.

Also, there is a comprehensive white paper available with more details, references, and which provides a decision chart for you to decide on what action to take.

The author of this article is Carl Alletto, OTech Senior regulatory consultant. OTech filed more than 100 PACS related 510(k)'s for both US and international based companies, see list here.