The new article highlights the aspects related to biocompatibility, electrical safety, electromagnetic compatibility, and the use of wireless technologies.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to premarket notification submissions under 510(k) framework for ultrasonic diathermy devices. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance.
The scope of the guidance covers, inter alia, the aspects related to biocompatibility, electrical safety, electromagnetic compatibility (EMC), and the use of wireless technology in medical devices of the said type.
First of all, the authority mentions that ultrasonic diathermy devices by default contain elements that are intended to be in contact with the patient when the device is used for its purpose, hence, a rigorous assessment of biocompatibility-related matters associated with patient-contacting materials is required in order to mitigate the risks associated with a potential harmful biological response. In particular, a party responsible for a medical device should assess biocompatibility for any and all patient-contacting materials the device contains. It is also important to mention that in order to demonstrate compliance with the applicable regulatory requirements, a comparison to a similar medical device already placed on the market and references to the respective testing or literature review could be provided.
The authority also mentions that in case medical device manufacturer is unable to identify a legally marketed predicate device with a similar location/duration of contact and intended use that uses the same materials as used in … device, the authority encourages to conduct and provide with the 510(k) submission a biocompatibility risk assessment; the said assessment should explain the relationship between the identified biocompatibility risks, the information available to mitigate the identified risks, and any knowledge gaps that remain. Apart from the above, a party responsible for a medical device subject to review will also have to submit information about any biocompatibility testing performed in order to assess the remaining risks. In this respect, the authority also refers to a separate guidance document dedicated to biocompatibility-related matters published earlier by the FDA. The said guidance describes in detail the applicable types of biocompatibility assessments and outlines the key points to be taken into consideration in order to ensure the respective procedures are duly followed, and the applicable regulatory requirements are duly fulfilled.
Since ultrasonic diathermy devices described in the guidance are considered “surface device”, “intact skin”, and “A – limited contact duration”, the scope of biocompatibility assessment should include the following endpoints:
- Skin sensitization;
- Irritation testing.
The authority additionally emphasises that any differences in comparison to a predicate, that could potentially affect biocompatibility, should be subject to a separate assessment.
The submission associated with an ultrasonic diathermy device should also contain information about the transmission media used.
Electrical Safety and EMC
As it was mentioned before, the scope of the guidance also covers the aspects related to electrical safety and electromagnetic compatibility, since the medical devices in question are considered to be medical electrical equipment and, consequently, should operate properly in the environment where electromagnetic disturbance is present. Thus, according to the guidance, such devices should be subject to testing demonstrating the safety and proper operations in the intended use environment. As further explained by the FDA, the said testing should be carried out as prescribed by the applicable standards recognized by the authority, including:
- ANSI/AAMI ES60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance;
- IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests.
Once the medical device manufacturer submits a declaration of conformity to the abovementioned standards, such a declaration should be accompanied by the respective supporting documentation (e.g., the assessment of results, description of methods used, applicable acceptance criteria, etc.). The authority also refers to a separate guidance document where the aspects related to electromagnetic compatibility are addressed in detail.
In case an ultrasonic diathermy device subject to review incorporates a radiofrequency wireless technology, the appropriate testing should be conducted in accordance with the relevant standards in order to demonstrate that the respective functions operate as intended when the device is used in the intended use environment. The authority additionally emphasizes the importance of proper operations of wireless functions for ensuring the safety of patients and overall effectiveness of use. According to the guidance, special attention should be paid to coexistence with other devices using wireless technologies that could be present in the intended use environment. For instance, the authority mentions that in case the device subject to review is expected to have two or more like devices operating wirelessly in close proximity to one another (e.g., mobile or body-worn devices located in a waiting room or the same room of a home), the ability to so operate should be also tested. Additional recommendations to be considered in this respect are provided in the guidance document dedicated to the use of wireless technologies in medical devices.
In summary, the present FDA guidance addresses certain specific aspects associated with ultrasonic diathermy medical devices, including the ones related to biocompatibility, electrical safety, and the use of wireless technologies. With respect to the above, the authority highlights the key points to be considered and provides additional recommendations to be followed.
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