(a) Identification. An esophageal tissue characterization system is a device intended for obtaining measurements of electrical properties within esophageal tissue.

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

(1) All patient contacting components of the device must be demonstrated to be biocompatible.

(2) Performance testing must demonstrate the device can accurately measure the designated electrical characteristics.

(3) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.

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

(5) Electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety of the device must be performed.

(6) Performance data must validate the reprocessing instructions for any reusable components of the device.

(7) Labeling must include:

(i) Specific instructions regarding the proper placement and use of the device;

(ii) Instructions for reprocessing of any reusable components; and

(iii) An expiration date for single use components.

[86 FR 68399, Dec. 2, 2021]