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The EsoCool catheter is a thermal regulating device intended to connect to a Gentherm Blanketrol III Hyper-Hypothermia System to control the patient temperature.

The EsoCool Thermal Regulation Catheter is a dual lumen tube that is placed in the esophagus. The two lumens are connected to an external heater cooler to allow for circulation of cold or warm fluid in a closed loop system. Heater cooler control is used to modulate the fluid temperature and control of patient's temperature. The EsoCool catheter is made of polyurethane with barium sulfate for radiopacity. The EsoCool catheter is a single-use, disposable, non-implantable device with an intended duration of use of 24 hours or less.

The provided text describes the regulatory clearance of a medical device, the EsoCool Thermal Regulation Catheter, and mentions non-clinical testing performed. However, it does not detail specific acceptance criteria, reported device performance metrics in a tabular format, or information about separate test sets, experts, or ground truth establishment as typically associated with AI/ML device evaluations. The device appears to be a hardware device, not an AI/ML algorithm requiring such specific performance validation.

Therefore, many of the requested fields cannot be populated from the provided document.

Here's a breakdown of what can be gleaned:

1. A table of acceptance criteria and the reported device performance

The document lists types of bench and animal testing performed but does not provide specific quantitative acceptance criteria or corresponding reported device performance values. It only states that testing was done to "confirm conformance to the special controls per 21 CFR 870.5910" and that "non-clinical testing demonstrate that the device is safe and as effective as the legally marked predicate device."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample size for bench testing: Not specified.
• Sample size for animal testing: Not specified, only refers to a "porcine animal model."
• Data provenance: The testing was "non-clinical," involving bench and animal studies. No information about country of origin is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable, as this is a hardware device undergoing non-clinical bench and animal testing, not an AI/ML algorithm requiring expert ground truth for interpretation tasks.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable for this type of non-clinical device testing.

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, as this is a hardware device, not an AI/ML system designed to assist human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable, as this is a hardware device, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the animal studies, the "ground truth" would be established through direct physiological measurements (temperature profiles) and histological analysis ("Gross and light microscopy assessment of the esophagus") to determine esophageal injury.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI/ML device that requires a training set.

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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.

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