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FDA guidance addresses ultrasonic prostate ablation submissions

Posted 15 July 2020 | By Kari Oakes 

FDA guidance addresses ultrasonic prostate ablation submissions

A new final guidance from the US Food and Drug Administration (FDA) addresses clinical testing and clinical data collection to support marketing authorizations for high intensity ultrasound systems to ablate prostate tissue.
The agency clarified in the guidance that the scope is limited to clinical investigations that support authorization to market the devices for “general indications of prostate tissue ablation systems,” including those regulated under the PLP product code. “Regardless of the energy type used for ablation, these devices may receive marketing authorization for a general indication for ablation of prostatic tissue, said FDA in announcing the guidance. “This guidance does not address intended uses for the treatment of a specific disease (e.g., prostate cancer or benign prostatic hyperplasia).”
FDA recommends that clinical studies should be conducted that comply with the clinical testing special control for new high intensity ultrasound systems for prostate tissue ablation as provided in 21 CFE 876.4340(b)(8). The guidance also applies to systems whose ablation output energy characteristics differ from the 510(k)-cleared version.
“Generally, we believe prostate tissue ablation devices addressed by this guidance document are significant risk devices subject to all requirements of the Investigational Device Exemptions (IDE) regulation, 21 CFR 812, for studies conducted in the United States (US),” clarified FDA in the guidance. This categorization triggers the need for US-conducted trials to comply with regulations relating to institutional review boards and informed consent, and to review compliance requirements for out-of-US clinical trials under 21 CFR 812.28.
Clinical studies should also be conducted to support marketing submissions for ablation devices that all outside the scope of 21 CFR 876.4340, according to the guidance. However, real-world data may also be used to support this type of submission in some cases; in this event, said FDA, the individual facts of the situation will dictate whether an IDE will be required. Cases where the cleared device is already in usein the normal course of medical practice, said the agency, would “likely not” require an IDE.
The specifics of clinical investigations should be direct3d to demonstrating the safety and effectiveness of the device as a general surgical tool for the ablation of prostate tissue; safety can be addressed with outcomes that look at whether tissue outside the targeted volume is damaged, and effectiveness can be assessed by determining if the targeted tissue is, in fact, ablated.
The guidance also lays out recommendations regarding a study design and size that can “adequately estimate the adverse event profile with clinically meaningful precision,” citing a participant number of 100 as a minimum target.
Ablation effectiveness can be measured indirectly by means of prostate biopsy, prostate-specific antigen levels and prostate volume in the same study population, says the guidance. If a separate population is used, the size should be “scientifically justified,” said FDA.
The guidance also makes recommendations about the study duration, inclusion and exclusion criteria for participants, treatment protocol, safety and effectiveness endpoints, and data and statistical analyses.
The guidance follows a draft guidance issued in June 2019.

Tags: Devices, FDA, Medical, US

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