Background

A medical device company was looking to understand the FDA classification and regulatory framework that is needed to be considered for an Automated Breast Ultrasound (ABUS). The company wanted to engage a qualified and skilled team to help them with various problems that they were facing in getting ABUS to the market, and hence they contacted Elexes. The medical device company was earlier authorized to produce Ultrasound Bronchoscopes. The two happen to be very diverse with respect to the site of diagnosis, but they share a common imaging technique in usage i.e “Ultrasound”. The key principle of ultrasound is based on the high-frequency sound waves that are used to get the real-time visualization of internal organs, and other soft tissues within the body without making any incisions.

Problem Statement 

1. Unsure of the Medical Device Classification
   The manufacturer was confused about the classification of the ABUS device, as it differs in terms of the associated risks, intended use, and indications for use from that of the ultrasound bronchoscope. 
2. Regulatory Framework and the pathway to the market

The manufacturer struggled to assess the regulatory requirements and the type of regulatory submission or the pathway to be pursued for getting a US FDA approval stamp.

Solution

Elexes investigated the problem and realized that some of the issues arose because certain core product technical people were common between the two different devices that the manufacturer was developing. Elexes first helped ensure that the indications for use for both the devices, Ultrasound Bronchoscope vs. ABUS were very clear amongst the engineering and development teams, as that one was one deriving factor for the regulatory framework. 

The differences: 

The ultrasound Bronchoscope was intended to guide the needle aspiration within the airways. It helped in gathering the ultrasonic visualization of the pulmonary tract, nasal passage, pharynx, larynx, bronchial tract, and underlying areas detecting different types of lung disorders, infections, inflammations, and cancers.

ABUS was intended to be used as an adjunct to mammography for B-mode ultrasonic imaging of a patient’s breast with improved lesion detection. The device is considered to increase the screening of breast cancer detection in asymptomatic females or the ones having dense breast parenchyma.

1. Due diligence and risk-based approach for identification of classification 

Elexes assessed the information about the product diligently, in consonance with the general and technical characteristics of the device such as definition, site of application, technology in use, intended use, indications for use, and risk associated with the device. The associated risks were conceptualized to arrive at a conclusion about the risk classification of the device. Although the Ultrasound Bronchoscope was classified as a Class 2 device, Elexes differentiated the risks of ABUS from that of the Ultrasound Bronchoscope and provided a justification for ABUS being classified under a Class III category. Elexes adopted a risk-based approach for classification. 

For ABUS the risks were identified to be: 

• Technique inadequacy (inability to access the axilla, operator dependency)
• Artifacts (induced by the use of ultrasound gel, probe motion artifacts, skip artifact so on)
• False-Positive Results (complicated cysts mimicking complex cystic lesions)
• False-Negative Results (small lesions, circumscribed edges, or peripheral localization of the mass may be sources of false-negative results)

2. Unique approaches and insights to determine the regulatory framework and pathway to be pursued

After determining the class of the new ABUS device, Elexes investigated and observed that there have been 12 PreMarket Approvals (PMAs) in the past several years for Automated Breast Ultrasound. Due to the FDA risk profile of the device, PMA was determined to be the right regulatory pathway. On further analysis, Elexes could see that ABUS lacked the support of clinical and scientific evidence which is essential while pursuing a PMA submission. Elexes also foresaw the need for strong non-clinical evidence. Elexes continued with their review and identified gaps that need to be addressed to get approval from the US FDA. 

Elexes categorized the list of documents required for the submission and advised the manufacturer to provide scientific data (both non-clinical and clinical) to support the safety and effectiveness of the ABUS which will be then reviewed by Elexes to determine their adequacy to support the submission. For the PMA submission, once Elexes provided a detailed explanation, the manufacturer understood the importance of conducting the clinical studies and performed the necessary clinical and nonclinical studies to establish reasonable safety and effectiveness of the device and the procedure. Elexes drew a detailed project plan and paved a clear pathway to the market. This assisted the medical device company in perceiving the applicable timeline to be in compliance with the submission requirements, obtain the approvals, and accordingly plan for the marketing activities. 

Key takeaways:

Here’s a quick flowchart on what factors are important to be considered and what questions are important to be asked when getting started. 

• Classification of a medical device is the key to getting it to the market
• valid and scientifically sound data is a must for approvals
• Company must know the gaps that exist or need to be addressed to get to the market
• There should be a competent team and Advisors or Leaders who own the regulatory and quality processes and deliverables
• A thorough project plan goes a long way
• Strong teamwork (where engineering and tech teams are on the same page as that of regulatory) is critical for a timely and successful approval

For questions and comments please feel free to contact us at jennifer@elexes.com