part_subject: "GENERAL AND PLASTIC SURGERY DEVICES"
subpart_code: "E"
subpart_subject: "Surgical Devices"
section_number: "878.4685"
section_subject: "Extracorporeal shock wave device for treatment of chronic wounds."
cfr_reference: "21 CFR 878.4685"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Identification. An extracorporeal shock wave device for treatment of chronic wounds is a prescription device that focuses acoustic shock waves onto the dermal tissue. The shock waves are generated inside the device and transferred to the body using an acoustic interface.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)Non-clinical performance testing must be conducted to demonstrate that the system produces anticipated and reproducible acoustic pressure shock waves.
(2)The patient-contacting components of the device must be demonstrated to be biocompatible.
(3)Performance data must demonstrate that the reusable components of the device can be reprocessed for subsequent use.
(4)Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety of the device.
(5)Software verification, validation, and hazard analysis must be performed.
(6)Performance data must support the use life of the system by demonstrating continued system functionality over the labeled use life.