(410 days)
Not Found
No
The description details a mechanical device for temperature control and gastric suctioning, controlled by a microprocessor in an external system. There is no mention of AI or ML in the device's function or the external system's control logic.
Yes
The device is intended to control patient temperature, which is a therapeutic intervention for various medical conditions, and also provides gastric decompression and suctioning, another therapeutic function.
No
The device is described as a "thermal regulating device" and is intended to "control patient temperature" and "provide gastric decompression and suctioning." It does not detect, monitor, or identify a disease or condition.
No
The device is a physical, single-use, disposable silicone tube with multiple lumens intended for insertion into the esophagus. It is a hardware device that connects to an external heat exchanger and wall suction. The summary describes extensive hardware testing (tensile force, burst strength, leakage, etc.) and animal/clinical studies involving physical insertion and function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control patient temperature and provide gastric decompression and suctioning. These are therapeutic and supportive functions, not diagnostic ones.
- Device Description: The device is a thermal regulating device that circulates fluid to control temperature and has a lumen for gastric suctioning. It does not analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Performance Studies: The performance studies focus on safety (biocompatibility, tissue integrity) and functional performance (flow rate, strength, etc.) related to its intended therapeutic and supportive uses. There are no studies related to diagnostic accuracy or the analysis of biological samples.
- Key Metrics: The absence of metrics like Sensitivity, Specificity, PPV, and NPV further indicates that this is not a diagnostic device. These metrics are used to evaluate the performance of diagnostic tests.
In summary, the Esophageal Cooling Device is a therapeutic and supportive medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Esophageal Cooling Device is a thermal regulating device, intended to:
- · connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control patient temperature, and
- · provide gastric decompression and suctioning.
Product codes (comma separated list FDA assigned to the subject device)
PLA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Esophagus
Indicated Patient Age Range
The safety and effectiveness of the Esophageal Cooling Device have not been evaluated in patients with less than 40 kg of body mass.
Intended User / Care Setting
The Esophageal Cooling Device should only be used by healthcare professionals with training in the use of orogastric tubes and the use of the Gaymar Medi-Therm III Conductive Hyper/Hypothermia System.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical/bench studies were conducted, and an animal study titled "Induction, Maintenance, and Reversal of Therapeutic Hypothermia with an Esophageal Heat Transfer Device" (Kulstad et al., Resuscitation 2013; 8; p. 1619-1624) was performed.
For the animal study:
- Study Type: Animal study
- Sample Size: Five female domestic D(4) swine (range 61-70 kg)
- Data Source: Kulstad et al. "Induction, Maintenance, and Reversal of Therapeutic Hypothermia with an Esophageal Heat Transfer Device" (Resuscitation 2013; 8; p. 1619-1624).
- Key Results:
- The primary aim was to evaluate esophageal mucosa tissue and adjacent organ integrity after experimental temperature modification.
- 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.
- All five swine were cooled successfully, with an average rate of temperature decrease of 1.3 °C/hour.
- Warming rates averaged 0.4℃/hour.
- The average deviation from goal temperature was 0.2℃ during the maintenance phase.
- Thermogenic shivering did not occur.
- One animal died due to tracheal edema and tissue damage from the endotracheal tube, not the Esophageal Cooling Device.
Clinical data summaries for 16 patients were supplied from centers outside the United States where the device is commercially available.
- Study Type: Clinical data summaries (not a formal clinical study)
- Sample Size: 16 patients
- Data Source: Centers outside the United States where the Esophageal Cooling Device is commercially available.
- Key Results:
- All data summaries described therapeutic cooling, maintenance of target temperature, and eventual rewarming.
- Ten reports included patient body temperature charts, which showed adequate device performance at achieving and maintaining goal temperatures.
- Target temperatures were 33℃ - 36.5℃.
- The device was primarily used to cool and re-warm post-cardiac arrest patients.
- Duration of temperature management ranged from 24 to 36 hours.
- No adverse events or device malfunctions were reported.
- Gastric suctioning worked as intended without additional tube insertion.
- No evaluation of whether hypothermia improved cardiac arrest outcomes was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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DE NOVO CLASSIFICATION REQUEST FOR ESOPHAGEAL COOLING DEVICE
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Esophageal thermal regulation device. 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.
NEW REGULATION NUMBER: 21 CFR 870.5910
CLASSIFICATION: II
PRODUCT CODE: PLA
BACKGROUND
DEVICE NAME: Esophageal Cooling Device
DE NOVO REQUEST: DEN140018
DATE OF DE NOVO REQUEST: May 9, 2014
| REQUESTOR CONTACT: | Advanced Cooling Therapy, LLC
3440 S. Dearborn St. #215-South
Chicago, IL 60616 |
| -------------------- | --------------------------------------------------------------------------------------- |
|---|
REQUESTOR'S RECOMMENDED CLASSIFICATION: II
INDICATIONS FOR USE
The Esophageal Cooling Device is a thermal regulating device, intended to:
- · connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control patient temperature, and
- · provide gastric decompression and suctioning.
LIMITATIONS
Prescription use only: Federal (USA) law restricts this device to sale by or on the order of a physician.
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The Esophageal Cooling Device may cause or exacerbate esophageal tissue damage in patients with esophageal deformity or evidence of esophageal trauma, or in patients who have ingested acidic or caustic poisons within the prior 24 hours.
The safety and effectiveness of the Esophageal Cooling Device have not been evaluated in patients with less than 40 kg of body mass.
The Esophageal Cooling Device should only be used by healthcare professionals with training in the use of orogastric tubes and the use of the Gaymar Medi-Therm III Conductive Hyper/Hypothermia System.
The Esophageal Cooling Device is intended for esophageal placement. Inserting the Esophageal Cooling Device in the trachea, bronchi or lungs can result in serious patient harm.
Attachment of the Esophageal Cooling Device to unapproved or unintended comnections can result in serious patient harm.
The presence of the Esophageal Cooling Device may interfere with other devices in the esophagus or mouth. Dual placement of other devices in the esophagus with the Esophageal Cooling Device in place, such as an enteral feeding tube, may result in patient harm.
Large patients with a body mass greater than 120 kg may exhibit slower responses to intended temperature changes. Small patients with a body mass less than 60 kg may exhibit faster cooling than anticipated, and may exhibit slower rewarming than anticipated.
For a full list of warnings and precautions, refer to the Esophageal Cooling Device Instructions for Use.
2
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.
Image /page/2/Picture/2 description: The image shows a medical device with several tubes and connectors. The tubes are transparent with a blue tint, and they are connected to various white plastic components. One end of the device has a white connector with a small opening, while another end has a larger white connector with a more complex design. The device appears to be designed for fluid transfer or suction in a medical setting.
Figure 1: Esophageal Cooling Device
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.
3
SUMMARY OF NONCLINICAL/BENCH STUDIES
Non-clinical/bench studies conducted on the Esophageal Cooling Device to demonstrate a reasonable assurance of safety and effectiveness of the device are summarized in the sections below.
BIOCOMPATIBILITY/MATERIALS
The Esophageal Cooling Device contacts the lining of the patient's esophagus for up to 36 hours. The Esophageal Cooling Device is categorized as a surface-contacting device that is in contact with an intact mucosal membrane for a prolonged exposure time. In accordance with ISO 10993-1: Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a Risk Management Process, the following biocompatibility testing was conducted on the Esophageal Cooling Device. The biocompatibility assessment was deemed adequate.
| Test | Purpose | Results |
|---|---|---|
| Cytotoxicity Evaluation – | ||
| L929 MEM Elution | ||
| Test/L929 Neutral Red | ||
| Uptake Test | To assess the biological activity of L-929 | |
| mouse fibroblast cells (grown in culture) | ||
| after exposure to extracts prepared from | ||
| the completed Esophageal Cooling Device | Non-cytotoxic | |
| Kligman Maximization | ||
| Test | To estimate the potential for sensitization | |
| of the Esophageal Cooling Device extract | ||
| using the guinea pig as an animal model | Sensitization rate = | |
| 0%, Sensitization | ||
| grade = “Weak” | ||
| Intracutaneous Injection | ||
| Test | To assess the irritating potential of extracts | |
| of the Esophageal Cooling Device to cause | ||
| irritation to the exposed part of the body | No difference | |
| between mean test | ||
| article score and | ||
| mean control score | ||
| Test | Purpose | Results |
| Tensile force | To ensure all components and joints in the | |
| Esophageal Cooling Device assembly are | ||
| capable of withstanding tensile forces | ||
| experienced during insertion, use, and removal | Passed; ≥15 N | |
| acceptance criteria | ||
| Burst strength | To ensure the Esophageal Cooling Device can | |
| withstand the operating pressures supplied by | ||
| the external heat exchanger | Passed; ≥15 psi | |
| Ultimate material strength | To determine the ultimate strength of the | |
| material used to manufacture the Esophageal | ||
| Cooling Device extruded tube and evaluate the | ||
| device's ability to withstand pressures | ||
| experienced during a worst-case scenario | Passed; ≥5 MPa | |
| Leakage | To ensure the Esophageal Cooling Device | |
| does not allow a potentially hazardous amount | ||
| of coolant into the esophagus or stomach | Passed; no visible | |
| evidence of leakage | ||
| Flow rate | To ensure the thermal transfer capacity of the | |
| Esophageal Cooling Device is not adversely | ||
| affected by an insufficient flow rate from the | ||
| external heat exchanger | Passed; ≥31 L/h | |
| Resistance to vacuum | To ensure the Esophageal Cooling Device | |
| does not collapse and prevent suctioning when | ||
| placed under vacuum | Passed; no visible | |
| evidence of occlusion | ||
| End cap axial deflection | ||
| testing | To ensure the Esophageal Cooling Device | |
| does not puncture or irritate the esophageal | ||
| mucosa during tube insertion | Passed; ≤ mean force | |
| required to cause end | ||
| cap axial deflection for | ||
| a currently marketed | ||
| enteral feeding | ||
| connector | ||
| Hardware verification | ||
| (temperature control and | ||
| safety) | To ensure the external heat exchanger can | |
| accurately monitor coolant temperature when | ||
| connected to the Esophageal Cooling Device |
To ensure the external heat exchanger can,
adjust coolant temperature when connected to
the Esophageal Cooling Device
To ensure the safety features of the external
heat exchanger operate properly when
connected to the Esophageal Cooling Device
(high/low temperature alarms, coolant flow
occlusion alarm) | Passed; temperature
probe accurate to
within ± 1.0°C
Passed; coolant
temperature at lowest
setting reached 4.5°C
within 30 minutes
Passed; all alarms and
indicators sounded
appropriately |
| Transportation simulation | To ensure the finished device packaging is
capable of withstanding the rigors of shipping
without damaging the product | Passed in accordance
with ISTA 2A 2011 |
| Packaging integrity | To ensure the finished device packaging is
capable of preventing contamination of the
device from outside sources | Passed in accordance
with ASTM F2096-11 |
Table 1: Esophageal Cooling Device Biocompatibility Testing
SHELF LIFE/STERILITY
The Esophageal Cooling Device is provided non-sterile, is not intended to be sterilized. and is for single use. The Esophageal Cooling Device has a shelf life of one year, which was assessed by repeating bench performance testing after one year of accelerated aging.
PERFORMANCE TESTING - BENCH
The Esophageal Cooling Device was subjected to a series of bench tests to assess its functional performance. These tests were performed on final manufactured product that had been pre-conditioned to simulate exposure to worst-case acidic gastric conditions. This conditioning consisted of exposure to simulated gastric contents (pH ~ 1.2), waterbased lubricants, and coolant containing the maximum recommended concentration of algaecide/cleaner provided by the external heat exchanger manufacturer for at least 36 hours. Heated coolant (40°C) was circulated through the device to increase the reactivity of the chemicals.
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Table 2: Esophageal Cooling Device Bench Testing
5
Compatibility with the Gaymar System was assessed via the burst strength, flow rate, and hardware verification testing described above.
PERFORMANCE TESTING - ANIMAL
The following animal study was used to support the in vivo evaluation of the safety and effectiveness of the Esophageal Cooling Device:
Kulstad et al. "Induction, Maintenance, and Reversal of Therapeutic Hypothermia with an Esophageal Heat Transfer Device" (Resuscitation 2013; 8; p. 1619-1624). The primary aim of this study conducted in five female domestic D(4) swine (range 61-70 kg) was to evaluate the integrity of esophageal mucosa tissue and adjacent organs after experimental temperature modification, as determined by gross pathological and histological analysis at necropsy.
Study Protocol
Thirty minutes after anesthesia and insertion of the Esophageal Cooling Device, the baseline body temperatures of the swine were monitored for 15-60 minutes and then reduced by b(4) Celsius and maintained for approximately 24 hours. b(4)
After the 24-hour period, the swine were rewarmed at a rate of approximately b(4) by setting the external heat exchanger (Gaymar Medi-Therm III) to warming mode. The swine were allowed to recover from anesthesia and kept under surveillance for 3 to 14 days prior to sacrifice and necropsy.
After device placement, low-intermittent wall suction was connected to the Esophageal Cooling Device gastric outlet to provide gastric decompression and suctioning for the full duration of treatment. The total gastric fluids suctioned for each swine were measured and recorded. Arterial blood pressure, heart rate, electrocardiograms, end tidal CO2 and O2 saturation were monitored and recorded every 30 minutes to 1 hour while the animals were anesthetized. Arterial blood gases were measured at intervals throughout the treatment duration.
Study Outcomes
All swine were recovered from anesthesia successfully and transferred to cages while spontaneously breathing. One animal expired approximately 4 hours after completion of the protocol. This death was determined by the veterinary pathologist to be due to tracheal edema and tissue damage induced by the prolonged pressure of the inflated endotracheal tube balloon and not the Esophageal Cooling Device. With the exception of that swine, all animals recovered successfully from anesthesia and returned to normal behavioral, eating, and drinking habits.
Multiple sections of each esophagus were taken (cranial, mid-cranial, mid-caudal,
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caudal, and gastroesophageal junction). As reported by the veterinary pathologist, no adverse effects from the Esophageal Cooling Device were identified in gross or histological (sections were stained with hematoxylin and eosin) analyses, demonstrating that the device did not cause harm to the esophageal lining following use.
Between 300 and 825 mL of gastric fluids were collected from each animal. All five swine were cooled successfully, with an average rate of temperature decrease of 1.3 °C/hour b(4) Warming rates averaged 0.4℃/hour b(4) b(4) . The average deviation from goal temperature was 0.2℃ during the maintenance phase of the study. Thermogenic shivering did not occur in any of the animals.
SUMMARY OF CLINICAL INFORMATION
Clinical data summaries for 16 patients were supplied to support a determination of a reasonable assurance of the safety and effectiveness of the Esophageal Cooling Device. These data were obtained from centers outside the United States, from locations where the Esophageal Cooling Device is commercially available. All of the data summaries describe therapeutic cooling. maintenance of the target temperature, and eventual rewarming. Ten reports included a patient body temperature chart plotted over time. Target temperatures were set from 33℃ - 36.5℃, and each of the ten temperature charts showed adequate device performance at achieving and maintaining goal temperatures.
In the majority of the clinical cases, the Esophageal Cooling Device was used to cool and eventually re-warm patients that had been resuscitated from cardiac arrest. Some of the patients had a fever at baseline, while others were at normal or below-normal body temperatures prior to placement of the device. The duration of temperature management ranged from 24 to 36 hours. No adverse events or device malfunctions were reported, and the gastric suctioning was reported by the centers to have worked as intended without the need for additional tube insertion.
While the majority of the submitted clinical data was obtained from post-cardiac arrest patients. the Esophageal Cooling Device was only evaluated according to its ability to modulate patient temperature. No evaluation of whether hypothermia improved cardiac arrest outcomes was performed.
LABELING
The Esophageal Cooling Device labeling consists of Instructions for Use and packaging labels. The Instructions for Use include the indications for use, warnings, precautions, and instructions for the safe use of the device. The labeling satisfies the requirements of 21 CFR 801.109.
Please see the Limitations section above for important warnings and precautions presented in the device labeling.
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RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of esophageal thermal regulation devices and the measures necessary to mitigate these risks.
| Identified Risk | Mitigation Measures |
|---|---|
| Adverse Tissue Reaction | Biocompatibility Testing |
| Gastric Distension | Non-clinical Performance Evaluation |
| Gastric Distension | Labeling |
| Injury to the Esophagus | Non-clinical Performance Evaluation |
| Injury to the Esophagus | Animal Testing |
| Injury to the Esophagus | Labeling |
| Harmful Hypo/Hyperthermia | Non-clinical Performance Evaluation |
| Harmful Hypo/Hyperthermia | Animal Testing |
| Harmful Hypo/Hyperthermia | Labeling |
| Injury to the Trachea | Labeling |
SPECIAL CONTROLS:
In combination with the general controls of the FD&C Act, the Esophageal Cooling Device is subject to the following special controls:
-
- The patient contacting materials must be demonstrated to be biocompatible.
-
- Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
- a. Mechanical integrity testing
- b. Testing to determine temperature change rate(s)
- Testing to demonstrate compatibility with indicated external controller C.
- d. Shelf life testing
-
- 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.
-
- Labeling must include the following:
- a. Detailed insertion instructions
- b. Warning against attaching 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
- c. The operating parameters, name, and model number of the indicated external controller
- The intended duration of use. d.
BENEFIT/RISK DETERMINATION
While 16 clinical use summaries were provided, no formal clinical study was provided, requested, or deemed necessary for the Esophageal Cooling Device based on the risks. The
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probable risks of the device are based on the nonclinical data and the animal study described above. Potential device-related adverse events include adverse tissue reactions, gastric distension, injury to the esophagus, injury to the trachea, and inappropriate patient temperature. Based on the nonclinical information provided, the probability of each of these potential adverse events is low.
The probable benefits of the device are also based on nonclinical data and the animal study, as well as the clinical data summaries and clinical literature surrounding patient temperature management. The Esophageal Cooling Device lowers, maintains, or raises patient temperature as desired by the physician. The gastric suctioning feature precludes the need for additional gastric tube insertion. It should be noted that the clinical data were only reviewed in the context of the indications for use; that is, the device's ability to control patient temperature and provide gastric suctioning. Consequently, a demonstration of an improvement in clinical outcomes was not required.
Additional factors considered in determining probable risks and benefits for the Esophageal Cooling Device include:
- . alternative methods of patient temperature management have different risks and difficulties associated with their use; intravascular cooling carries risk of vascular injury and infection, surface methods may be slower, and gastric lavage has risks of volume overload and electrolyte imbalance
- in some clinical case reports, the device more effectively lowered patient temperature . after conventional methods had failed to achieve the target temperature
- the clinical data is limited for all temperature management methods and devices ●
- feedback from centers using the device outside of the United States has been positive in . terms of ease of use and degree of temperature control
In conclusion, given the available information above, the data support that for controlling patient temperature the probable benefits outweigh the probable risks for the Esophageal Cooling Device. The device provides benefits and the risks can be mitigated by the use of general and the identified special controls.
CONCLUSION
The de novo for the Esophageal Cooling Device is granted and the device is classified under the following:
Product Code: PLA Device Type: Esophageal thermal regulation device Class: II Regulation: 21 CFR 870.5910