§ 878.3510 Carbon dioxide gas controlled tissue expander.

(a) Identification. A carbon dioxide gas controlled tissue expander is a prescription device intended for temporary subcutaneous or submuscular implantation to stretch the skin for surgical applications, specifically to develop surgical flaps and additional tissue coverage. The device is made of an inflatable elastomer shell and is filled with carbon dioxide gas. The device utilizes a remote controller to administer doses of carbon dioxide gas from an implanted canister inside the device.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) In-vivo performance testing must be conducted to obtain the adverse event profile associated with use, and demonstrate that the device performs as intended under anticipated conditions of use.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance data must demonstrate the sterility of patient-contacting components of the device.

(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) Cycle testing of expander showing that there are no leaks or tears after repeated cycling;

(ii) Mechanical assessment of implanted carbon dioxide (CO2) canister including high impact testing;

(iii) Leak testing of expander showing that device does not leak CO2;

(iv) Assessment of gas permeability during expansion and after full expansion; and

(v) Mechanical assessment of expander (tensile set, breaking force, shell joint test, and fused or adhered joint testing).

(5) Performance data must be provided to demonstrate the electromagnetic compatibility, electrical safety, and wireless compatibility of the device.

(6) Software verification, validation, and hazard analysis must be performed.

(7) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the identified shelf life.

(8) Human factors testing and analysis must validate that the device design and labeling are sufficient for the end user.

(9) Physician labeling must include:

(i) The operating parameters, name, and model number of the indicated external dosage controller;

(ii) Information on how the device operates and the typical course of treatment;

(iii) Information on the population for which the device has been demonstrated to be effective;

(iv) A detailed summary of the device technical parameters; and

(v) Provisions for choosing an appropriate size implant that would be exchanged for the tissue expander.

(10) Patient labeling must include:

(i) Warnings, precautions, and contraindications, and adverse events/complications;

(ii) Information on how the device operates and the typical course of treatment;

(iii) The probable risks and benefits associated with the use of the device;

(iv) Post-operative care instructions; and

(v) Alternative treatments.

(11) Patient training must include instructions for device use, when it may be necessary to contact a physician, and cautionary measures to take when the device is implanted.

[87 FR 6421, Feb. 4, 2022]