FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

· connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control patient temperature, and
· provide gastric decompression and suctioning.

Device Description

The Esophageal Cooling Device (ECD) is a silicone tube with three lumens that is placed in the esophagus (Figure 1). The intended function of the device is to control a patient's temperature. while simultaneously maintaining access to the stomach to allow gastric decompression and drainage. Modulation and control of patient temperature is intended to be achieved by connecting the ECD to an external heat exchanger and circulating temperaturecontrolled fluid (distilled water). Two lumens (the cooling lumens) connect to the external heat exchanger and are in contact with the esophageal tissues. A third central lumen connects to wall suction and is used for standard gastric decompression. A web supports the inner gastric lumen and separates the cooling lumens.

The ECD is made of standard medical-grade silicone. It is a single-use, disposable, nonimplantable device with a stated intended duration of use of 36 hours or less.

The ECD is intended to be used in conjunction with the Gaymar Medi-Therm III Conductive Hyper/Hypothermia System (cleared under K100585) with the following operating specifications:

· Dead Head Pressure: Maximum 9 psi (62 kPa)
Flow: Minimum 16 gallons/h (60.6 L/hr)
· Water Temperature Control Range: 4°C 42°C

The Gaymar System supplies temperature-controlled water through a connector hose to the ECD. An accessory probe interfaces between the Gaymar System and the patient to sense patient temperature, which is displayed on the Gavmar System's control panel. The Gaymar device controls water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control and includes a circulating pump, heater, and refrigeration system.

AI/ML Overview

Here's a summary of the acceptance criteria and the study information for the Esophageal Cooling Device, structured as requested:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Test / Characteristic	Acceptance Criteria	Reported Device Performance / Results
Biocompatibility	Cytotoxicity Evaluation	Non-cytotoxic	Non-cytotoxic
	Kligman Maximization Test (Sensitization)	Sensitization rate = 0%	Sensitization rate = 0%, Sensitization grade = “Weak”
	Intracutaneous Injection Test (Irritation)	No difference between mean test article score and mean control score	No difference between mean test article score and mean control score
Mechanical Integrity	Tensile force	≥15 N	Passed; ≥15 N
	Burst strength	≥15 psi	Passed; ≥15 psi
	Ultimate material strength	≥5 MPa	Passed; ≥5 MPa
	Leakage	No visible evidence of leakage	Passed; no visible evidence of leakage
	Resistance to vacuum	No visible evidence of occlusion	Passed; no visible evidence of occlusion
	End cap axial deflection testing (puncture/irritation)	≤ mean force required to cause end cap axial deflection for a currently marketed enteral feeding connector	Passed; ≤ mean force required to cause end cap axial deflection for a currently marketed enteral feeding connector
Thermal Performance	Flow rate (thermal transfer capacity)	≥31 L/h	Passed; ≥31 L/h
	Hardware verification (temperature probe accuracy)	Temperature probe accurate to within ± 1.0°C	Passed; temperature probe accurate to within ± 1.0°C
	Hardware verification (coolant temperature adjustment)	Coolant temperature at lowest setting reached 4.5°C within 30 minutes	Passed; coolant temperature at lowest setting reached 4.5°C within 30 minutes
	Hardware verification (safety features: alarms, indicators)	All alarms and indicators sounded appropriately (high/low temperature alarms, coolant flow occlusion alarm)	Passed; all alarms and indicators sounded appropriately
Shelf-Life/Packaging	Shelf life	Device maintains performance after 1 year accelerated aging (by repeating bench performance testing)	Passed (bench performance testing repeated after one year of accelerated aging)
	Transportation simulation	Packaging capable of withstanding shipping without product damage (in accordance with ISTA 2A 2011)	Passed in accordance with ISTA 2A 2011
	Packaging integrity	Packaging capable of preventing contamination of the device from outside sources (in accordance with ASTM F2096-11)	Passed in accordance with ASTM F2096-11
Animal Study Outcomes	Esophageal mucosa tissue integrity	No adverse effects from the Esophageal Cooling Device identified in gross or histological analyses at necropsy.	No adverse effects from the Esophageal Cooling Device were identified in gross or histological analyses, demonstrating that the device did not cause harm to the esophageal lining following use (except for one death due to endotracheal tube issues, not device related).
	Successful cooling and rewarming	Swine successfully cooled and rewarmed; average deviation from goal temperature within acceptable limits during maintenance.	All five swine were cooled successfully (average rate of temperature decrease of 1.3 °C/hour). Warming rates averaged 0.4℃/hour. Average deviation from goal temperature was 0.2℃ during the maintenance phase.
	Gastric decompression and suctioning	Gastric fluids successfully collected.	Between 300 and 825 mL of gastric fluids were collected from each animal.
Clinical Observations	Adequate device performance in achieving and maintaining goal temperatures (based on clinical summaries)	Adequate device performance at achieving and maintaining goal temperatures.	Each of the ten temperature charts showed adequate device performance at achieving and maintaining goal temperatures (target temperatures 33℃ - 36.5℃).
	Absence of adverse events or device malfunctions (based on clinical summaries)	No adverse events or device malfunctions reported.	No adverse events or device malfunctions were reported.
	Gastric suctioning worked as intended without need for additional tube insertion (based on clinical summaries)	Gastric suctioning worked as intended without the need for additional tube insertion.	The gastric suctioning was reported by the centers to have worked as intended without the need for additional tube insertion.

Study Details for Esophageal Cooling Device

1. Sample Size and Data Provenance

Test Set (Bench/Animal):
- Bench Testing: The document does not specify a precise sample size (N) for each individual bench test, but refers to "final manufactured product" exposed to worst-case conditions.
- Animal Study: 5 female domestic swine (61-70 kg).
- Data Provenance: The animal study was published in "Resuscitation 2013; 8; p. 1619-1624" by Kulstad et al. The country of origin for the animal study is not explicitly stated in the provided text, but it's a published research study. The study was prospective in nature, involving experimental temperature modification in the animals.
Test Set (Clinical Data Summaries):
- Sample Size: 16 patient summaries.
- Data Provenance: Obtained from centers outside the United States where the device is commercially available. These were summaries of therapeutic cooling, maintenance, and rewarming, making them retrospective clinical observations rather than a formal prospective clinical trial.

2. Number of Experts and Qualifications for Ground Truth (Clinical Data)

Number of Experts: Not applicable/not specified for establishing ground truth in a formal sense. The clinical data provided consists of summaries from various centers where the device was in use. The "truth" in these summaries relates to observed temperature control and absence of reported adverse events, presumably documented by the healthcare professionals at those institutions.
Qualifications of Experts: Not specified. The summaries were from "healthcare professionals with training in the use of orogastric tubes and the use of the Gaymar Medi-Therm III Conductive Hyper/Hypothermia System," as noted in the device limitations for general use.

3. Adjudication Method for the Test Set (Clinical Data)

Adjudication Method: None explicitly stated. The document refers to "clinical data summaries," "reports," and "feedback from centers," implying a collection of independently generated clinical observations rather than a centralized, adjudicated test set.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? No. This type of study is typically associated with diagnostic AI tools where human readers interpret cases with and without AI assistance to measure improvement. The Esophageal Cooling Device is a hardware device for therapeutic temperature management, not an interpretive diagnostic tool.
Effect Size of Human Readers' Improvement: Not applicable, as no such study was performed or is relevant for this device.

5. Standalone Performance Study (Algorithm only)

Was it done? Yes, a form of standalone performance was done for the device itself through the extensive bench testing and the animal study.
- Bench Testing: Demonstrated the device's functional performance (mechanical integrity, thermal transfer, compatibility with the external system, material strength, leakage, vacuum resistance, etc.) in a controlled environment without direct human intervention beyond setting up the tests.
- Animal Study: Evaluated the device's ability to induce, maintain, and reverse therapeutic hypothermia, as well as its safety profile (esophageal tissue integrity, gastric suctioning) in a physiological system. While humans operated the external heat exchanger, the performance measured was of the device itself and its interaction with the biological system.

6. Type of Ground Truth Used

Bench Testing: Engineering specifications, physical measurements, and industry standards (e.g., ISO, ASTM, pre-defined thresholds for force, pressure, temperature, flow rates).
Animal Study:
- Tissue integrity: Pathology (gross pathological and histological analysis by a veterinary pathologist at necropsy).
- Temperature control: Direct measurements of swine body temperature and external heat exchanger settings.
- Gastric suctioning: Quantifiable volume of gastric fluids collected.
Clinical Data Summaries: Physician observations, patient temperature charts, and reported adverse events/device malfunctions from clinical practice, which can be considered a form of outcomes data or reported clinical experience.

7. Sample Size for the Training Set

Training Set: Not applicable. The document describes pre-market testing and clinical observations for a new medical device, not a machine learning algorithm that requires a "training set." The device itself is not an AI/ML algorithm. The "training" for the device would be its iterative design, engineering, and manufacturing process based on established principles, not data.

8. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no algorithms with a training set for this device.

Summary

Regulation Number and Section

§ 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.