|
(a) Identification. A manual percutaneous surgical set assembled in the abdomen is a prescription device consisting of a percutaneous surgical set used as a means to penetrate soft tissue to access certain areas of the abdomen. The device's effectors or attachments are provided separately from the percutaneous shaft and are introduced to the site via a traditional conduit such as a trocar. The attachment or effectors are connected to the shaft once the tip of the shaft is inside the abdomen. Once inside the abdomen, the surgical set is used to grasp, hold, and manipulate soft tissues. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Performance data must demonstrate the sterility of patient-contacting components of the device.
(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the requested shelf life.
(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Dimensional verification testing must be conducted.
(ii) Force verification testing must be conducted. The force testing must demonstrate the forces necessary to insert and operate each component of the device during use as intended.
(iii) Functional verification testing of the device components must be conducted.
(5) Simulated use testing in an anatomically relevant animal model must demonstrate the device's ability to penetrate soft tissue, be assembled in situ, and to grasp, hold and manipulate soft tissues in the intended treatment area.
(6) The labeling must include the following:
(i) Instructions for use, including detailed instructions for instrument assembly, disassembly, and removal; and
(ii) A shelf life.
[86 FR 71569, Dec. 17, 2021]
| 
