CDRH Drafts Clinical Recommendations for Prostate Tissue Ablation Devices
Posted 25 June 2019 | By
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) issued draft guidance Tuesday to support clinical testing of high-intensity ultrasound systems for prostate tissue ablation devices.
The 10-page draft guidance outlines clinical investigation recommendations for the devices and includes benefit-risk determinations in premarket regulatory decisions that are “flexible in some cases” and “tailored to the type and intended use of the device.” The release of the guidance comes as CDRH previously granted SonaCare Medical’s de novo classification request in 2015 for its high intensity ultrasound system for prostate tissue ablation.
The guidance’s scope is limited to clinical investigations to support the marketing authorization for general indications for prosthetic tissue ablation systems and does not address the clinical investigations for specific disease treatments.
Data “should collectively provide evidence of the extent to which the intended region of tissue is ablated to support marketing authorization,” CDRH says. Device safety “should be assessed in a separate cohort of patients who are similarly treated with the ablation device and prospectively followed for one year post-ablation” if a “treat and resect” study is used to assess effectiveness.
CDRH recommends sponsors conduct a clinical study for both new high-intensity ultrasound systems for prostate tissue ablation and systems with changes to ablation energy output characteristics to comply with the special control and for new prostate tissue ablation devices not covered by the 2015 regulation to support 510(k)s of such devices. FDA generally believes such prostate tissue ablation devices are subject to all requirements of the Investigational Device Exemptions regulation.
The draft guidance specifies elements to format the clinical study protocol and complete test reports. CDRH recommends the objective of the clinical investigation is to demonstrate the device’s safety and effectiveness “as a general surgical tool for the ablation of prostate tissue.” with a one-year minimum of scheduled follow-up for studies to support 510(k)s. Draft recommendations also address patient demographics and treatment parameters, among other study design elements.
“To adequately estimate the adverse event profile with clinically meaningful precision, including the incidence of infrequent device- or procedure-related complications, FDA recommends that the dataset include a minimum of 100 patients treated with the subject device and who were clinically followed,” FDA says.
In a study published
in September 2018, CDRH officials concluded that “the lack of long-term high-intensity focused ultrasound oncological data in an American population has brought new challenges to prostate cancer stakeholders, including clinicians, patients and FDA.” They added that “patient preference information from future patient studies on high-intensity focused ultrasound could provide additional information to patients, clinicians and current and prospective device developers” and be used by regulators to support benefit-risk evaluations of the device class.
Clinical Investigations for Prostate Tissue Ablation Devices: Draft Guidance for Industry and Food and Drug Administration Staff