Work

Mapping the lineage of prostate tissue ablation medical device predicates for focal therapy of prostate cancer approved via the FDA 510(k) clearance pathway

Year: 2026

Type: article

Abstract: Objective Medical devices are reviewed by the US Food and Drug Administration ( FDA ) for safety and effectiveness. Class II devices can receive 510(k) clearance if they are “substantially equivalent” to an existing predicate device. This process can be repeated iteratively, leading to a lineage of predicates for newly cleared devices. This study aims to map the predicate history of current prostate cancer focal therapies to better understand the regulatory process and the development of prostate tissue ablation devices. Methodology Four prostate tissue ablation devices—high‐intensity focused ultrasound (HIFU), focal laser ablation (FLA), irreversible electroporation (IRE) and cryotherapy—were analysed using the FDA 510(k) Premarket Notification database. Product codes, technological characteristics and indications for use were used to construct predicate trees for each device. Results The predicate trees demonstrate a branching network of predicate devices. The IRE NanoKnife traces to at least 65 predicates, HIFU to 8, FLA to 9 and cryotherapy to 14 predicates. Contemporary application of devices has diverged from initial indications of some original predicates, with IRE predicates indicated for cardiac and gynecologic use and cryotherapy predicates indicated for neurologic use. There is an integration of various functionalities from different devices, along with the absorption of one predicate tree into another. Conclusions Newer prostate tissue ablation devices used in focal therapy for prostate cancer have developed from a network of predicates. The repeated approval pathway has led to increased technological complexity and cases with predicates having initial indications for use distinct from the current‐day application. The mapping of predicates provides valuable insight into the evolution of ablation devices in the market.

Source: Surgical Practice

DOI: 10.1111/1744-1633.70074

Authors: Yiting Lin, Amir Khan, Arvin George, Mohummad Minhaj Siddiqui

Institutions: University of Maryland, Baltimore, Johns Hopkins University, Johns Hopkins Medicine, Johns Hopkins Hospital

Language: English

Topic: Healthcare Regulation

Subfield: Health Information Management

Field: Health Professions

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $2,760