(86 days)
The Esophageal Cooling Device is a thermal regulating device, intended to:
- connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature, and
- provide gastric decompression and suctioning.
The Esophageal Cooling Device is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to modulate a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage and maintain the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the Esophageal Cooling Device to an external heat exchanger. Two lumens connect to the exchanger. A third central lumen connects to wall suction and is used for standard gastric decompression. The Esophageal Cooling Device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 36 hours or less.
This document is a 510(k) premarket notification for the Esophageal Cooling Device (ECD), seeking to expand its indications for use to include compatibility with an additional external heat exchanger, the Stryker Altrix Precision Temperature Management System.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria with numerical targets. Instead, the non-clinical performance testing focuses on demonstrating an aspect suitable for maintaining thermal transfer capabilities.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Suitable for maintaining thermal transfer capabilities with the Stryker Altrix Precision Temperature Management System | Flow rate testing demonstrated the Esophageal Cooling Device is suitable for maintaining thermal transfer capabilities. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for the "Flow rate" test. The entire document refers to a single device (Esophageal Cooling Device model ECD01-A).
- Data Provenance: The testing was non-clinical performance testing. The provenance (country of origin, retrospective/prospective) is not specified, but typically non-clinical tests are conducted in a laboratory setting by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a non-clinical performance test, likely involving engineering or technical personnel, not medical experts establishing ground truth in a clinical context.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical performance test.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document describes a medical device, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was Done
Not applicable. This document describes a medical device, not an algorithm. The testing focused on the device's physical performance (flow rate) in conjunction with an external system.
7. The Type of Ground Truth Used
The ground truth for the non-clinical performance testing was based on the physical properties and engineering specifications of the device and the associated external heat exchanger, specifically the objective measurement of "flow rate." It's an objective measurement rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of an algorithm or machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for this type of device.
§ 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.