(a) Identification. This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or a specific adverse event during cardiac ablation procedures. The device uses temperature regulation to control the temperature of the esophagus during cardiac ablation.

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

(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:

(i) Evaluation of reduction of the incidence of esophageal injury during cardiac ablation procedures;

(ii) Evaluation of any effects on the ablation procedure resulting in patient injury, improper catheter performance, or interruption of procedure; and

(iii) Evaluation of any esophageal or oral injury from use of the device.

(2) Animal performance testing must demonstrate that the device performs as intended under the anticipated conditions of use, including evaluation of any esophageal injury from use of the device.

(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:

(i) Mechanical integrity testing using clinically relevant forces;

(ii) Testing to determine temperature change rate(s); and

(iii) Compatibility testing with accessory devices.

(4) Performance data must demonstrate the sterility of any device components intended to be provided sterile.

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

(6) Performance data must support the shelf life of the device by demonstrating package integrity and device functionality over the identified shelf life.

(7) Labeling must include the following:

(8) A summary of clinical performance testing with the device; and

(9) A shelf life.

[91 FR 57502, Sept. 10, 2026]