The article provides an overview of the applicable regulatory requirements and describes the policy the authority intends to apply.
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 510(k) premarket notification submissions for ultrasonic diathermy devices. The document provides additional clarifications regarding the regulatory requirements set forth under the current framework, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, it is important to mention that 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 underlying legislation and has been agreed with the authority in advance. The present document constitutes a revised version of the guidance initially published by the authority earlier in April 2018.
The scope of the present guidance covers the regulatory requirements for the submissions under the 510(k) pathway related to ultrasonic diathermy devices, also referred to as physiotherapy devices. Under the general rule, these products are regulated under section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act. The present document provides, inter alia, recommendations based on the International Electrotechnical Commission (IEC) standards to be taken into consideration when collecting information for the respective submission. As it is mentioned by the authority, the present document should be interpreted in conjunction with other guidance documents dedicated to the 510(k) framework.
The document also contains references to the FDA-recognized voluntary consensus standards the medical device manufacturers may refer to when demonstrating compliance with the applicable regulatory requirements. Specific aspects are also covered in the FDA guidance documents dedicated to the various 510(k) submission types (e.g., Traditional or Abbreviated).
The products covered by the scope of the present guidance are subject to regulation under 21 CFR 890.5300(a) with the product codes IMI and PFW. In accordance with the existing risk-based classification, they are Class II medical devices.
As outlined in the document, this guidance is applicable to ultrasonic diathermy (physiotherapy) devices for use in applying therapeutic deep heat for selected medical conditions such as relief of pain, muscle spasms, and joint conjectures; this guidance only relates to equipment employing ultrasonic energy at a frequency beyond 20 kilohertz, using a single plane circular transducer per treatment head, and producing non-convergent beams perpendicular to the face of the treatment head. The authority explicitly states that other medical devices utilizing ultrasound are falling outside of the scope of the present guidance – for instance, the ones intended to destroy conglomerates or tools driven by ultrasound.
The document provides detailed recommendations to be taken into consideration by the applicant in order to ensure completeness of the submission in terms of information contained therein for the purpose of facilitating the review and streamlining the related regulatory procedures. In particular, the document outlines specific aspects to be addressed in the submission and highlights the key points to be covered.
Medical Device Description
First of all, the document provides additional clarifications regarding the description of a medical device to be provided. As defined in the applicable regulation, an ultrasonic diathermy device for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures. When used for its intended purpose, an ultrasonic diathermy device produces high-frequency sound waves creating a mild therapeutic effect. For this purpose, a sustained local temperature increase should be achieved.
As further explained by the FDA, there are three general beam types for ultrasonic devices: convergent (of focusing), collimated, and divergent. In the case of diathermy devices, the two last types should apply.
The authority expects the applicant to provide a general description of the product subject to review. The key points to be covered by such a description should include, inter alia, model designation, design, patient contact materials, and control panel and system operation. Specific aspects should also be addressed in case of a declaration of conformity based on the applicable IEC standards. According to the guidance, such a description should include, inter alia, the details related to:
- Quantitative indicators used;
- A proper description of the spatial distribution of the ultrasonic radiation;
- Generators operating in the pulse mode and applicable controls;
- Time the device is equipped with.
In summary, the present FDA guidance describes the regulatory requirements to be applied in the case of 510(k) premarket notification submissions for ultrasonic medical devices. The document outlines the aspects to be addressed in the device description the authority expects to be included in the submission.
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