(30 days)
Model # ECD03-A:
The EnsoETM is a thermal regulating device, intended to:
· connect to a Gaymar Medi-Therm III Conductive HyperHypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature,
· allow enteral administration of fluids,
· and provide gastric decompression and suctioning.
Model # ECD04-A:
The EnsoETM is a thermal regulating device, intended to:
· connect to a Cincinnati Sub-Zero Blanketrol III Hyper-Hypothermia System to control patient temperature.
· allow enteral administration of fluids,
· and provide gastric decompression and suctioning.
The EnsoETM is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression, drainage, and enteral administration of fluids, thereby maintaining the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the device to an external heat exchanger. Two lumens connect to the external heat exchanger. A third central lumen connects to wall suction to allow standard gastric decompression or an enteral administration system to allow enteral administration of fluids. The device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with a duration of use of 72 hours or less.
The provided text describes a 510(k) premarket notification for a medical device called EnsoETM, a thermal regulating device. The purpose of the submission (K180244) is to extend the duration of use for two models, ECD03-A and ECD04-A, from 36 hours to 72 hours.
However, the document explicitly states: "No additional performance testing was conducted." This means there is no new study described within this document that "proves the device meets the acceptance criteria" for the extended duration of use.
The submission claims substantial equivalence based on existing data and the fact that the subject devices are identical to predicate devices (K172029) except for the change in duration of use, and identical to reference devices (K172493) with the same 72-hour duration of use, except for gastric lumen connector and the indication for enteral administration of fluids.
Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets them, as the document states no new performance testing was conducted for this particular 510(k) submission.
The tables for acceptance criteria and device performance, as well as details about sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone performance, are not present because no new performance testing was performed and reported in this specific submission for the extended duration of use. The substantial equivalence is based on comparisons to previously cleared devices and their existing performance data.
§ 870.5910 Esophageal thermal regulation device.
(a)
Identification. An esophageal thermal regulation device is a prescription device used to apply a specified temperature to the endoluminal surface of the esophagus via an external controller. This device may incorporate a mechanism for gastric decompression and suctioning. The device is used to regulate patient temperature.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting materials must be demonstrated to be biocompatible.
(2) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Mechanical integrity testing.
(ii) Testing to determine temperature change rate(s).
(iii) Testing to demonstrate compatibility with the indicated external controller.
(iv) Shelf life testing.
(3) Animal testing must demonstrate that the device does not cause esophageal injury and that body temperature remains within appropriate boundaries under anticipated conditions of use.
(4) Labeling must include the following:
(i) Detailed insertion instructions.
(ii) Warning against attaching the device to unintended connections, such as external controllers for which the device is not indicated, or pressurized air outlets instead of vacuum outlets for those devices, including gastric suction.
(iii) The operating parameters, name, and model number of the indicated external controller.
(iv) The intended duration of use.