(60 days)
Model #ECD01-A:
The EnsoETM 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.
Model # ECD02-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,
· 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 modulate a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage, thereby maintaining the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the EnsoETM to an external heat exchanger. Two lumens connect to the external heat exchanger. A third central lumen connects to wall suction and is used for standard gastric decompression. The EnsoETM is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less.
The provided document is a 510(k) summary for the EnsoETM device, focusing on an increase in the intended duration of use from 36 hours to 72 hours. This is an important distinction. The core function and safety of the device for its initial duration have already been established in previous 510(k) submissions (K170009 and K152450).
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are specifically related to the extended duration of use, rather than the initial performance of the device as a thermal regulating and gastric decompression tool.
Based on the provided text, here is the information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for safety and effectiveness related to the extended duration of use. Instead, it refers to demonstrating that the device is "safe and effective" for 72 hours through a retrospective analysis of real-world human use data.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device remains safe and effective for an intended duration of use of 72 hours. | A retrospective analysis of real-world human use data was conducted to demonstrate the subject devices are safe and effective for an intended duration of use of 72 hours. |
| No significant adverse events or device malfunctions attributable to extended use were observed. | (Implicit; the conclusion states the device is "safe and effective," which implies no unacceptable safety issues were found in the analyzed data.) |
| Device maintains its thermal regulating and gastric decompression functionalities throughout the extended use period. | (Implicit; the conclusion states the device is "safe and effective," which implies functionality was maintained.) |
2. Sample size used for the test set and the data provenance
- Sample Size: 18 patients
- Data Provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Retrospective analysis of real-world human use data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications used to establish ground truth for this retrospective analysis. Given it's a safety and effectiveness assessment for extended use, the "ground truth" would likely be based on clinical outcomes observed in the patients (e.g., lack of adverse events, continued functionality). This is not explicitly defined in terms of expert consensus for image or data interpretation, as might be the case for an AI-based diagnostic device.
4. Adjudication method for the test set
Not applicable/not specified. This type of study (retrospective analysis of real-world use) for device duration extension doesn't typically involve an "adjudication method" in the sense of reconciling expert opinions on specific data points, as would be common in diagnostic imaging studies. The "ground truth" is derived directly from the observed clinical data.
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
No. This study is not an MRMC comparative effectiveness study. The device is a physical medical device (esophageal thermal regulation device), not an imaging AI or diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant. The device operates with human connection to an external heat exchanger and human placement.
7. The type of ground truth used
The ground truth was based on real-world human use data, likely encompassing clinical outcomes, adverse event reporting, and potentially device performance metrics (e.g., sustained temperature control, continued gastric decompression) collected during the extended use period in those 18 patients. It is not expert consensus, pathology, or specific outcomes data in the sense of a disease diagnosis, but rather the observed clinical reality of the device's performance over an extended duration.
8. The sample size for the training set
Not applicable. This is a physical device, and the study described is a retrospective analysis for an extended duration of use. There is no "training set" in the context of machine learning or AI algorithm development. The "training" of the device itself would have occurred during its prior development and manufacturing, and its initial clearance was based on different studies.
9. How the ground truth for the training set was established
Not applicable. As explained above, there is no "training set" in the context of this 510(k) submission.
§ 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.