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

Model #: ECD02-A:
The Esophageal Cooling Device is a thermal regulating device, intended to:

connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient
temperature, and
provide gastric decompression and suctioning.

Device Description

The Esophageal Cooling Device (ECD) 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 ECD 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 ECD is made of standard medical-grade silicone. It is a single-use, disposable, nonimplantable device.

AI/ML Overview

The provided text is a 510(k) summary for the Esophageal Cooling Device (ECD). It details the device's characteristics, indications for use, and a comparison to a predicate device, along with a list of non-clinical performance tests. However, this document does not describe acceptance criteria for a device's performance in terms of metrics like sensitivity, specificity, accuracy, or any performance targets against a ground truth.

Instead, the "acceptance criteria" can be inferred as the successful completion of various engineering and safety tests, and the "study" is the non-clinical performance testing conducted by the manufacturer. These tests are primarily to demonstrate that the device is safe, functions as intended, and is substantially equivalent to a previously cleared device.

Therefore, many of the requested fields cannot be directly answered from the given input, as the document focuses on regulatory clearance for a physical medical device, not a diagnostic or AI-driven system that would typically undergo studies with performance metrics against a ground truth.

Here's an attempt to answer the questions based on the provided text, while acknowledging its limitations for certain categories:

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

Since this document describes a physical medical device (Esophageal Cooling Device) and the "studies" are non-clinical engineering and safety tests, the acceptance criteria are generalized to "suitability for intended use" rather than specific numerical performance metrics typically seen for diagnostic devices or AI systems.

Acceptance Criteria (Inferred from Test Objective)	Reported Device Performance
Biocompatibility: Materials suitable for intended use	"All materials used to manufacture the ECD are suitable for the intended use."
Tensile Force: Suitable for insertion/removal	"ECD is suitable for insertion into and removal from the esophagus."
Burst Strength: Suitable for normal operating pressures	"ECD is suitable for normal operating pressures."
Ultimate Material Strength: Suitable for specified operating conditions	"ECD is suitable for normal operating pressures under worst-case manufacturing conditions."
Leakage: Prevention of stomach filling with coolant	"ECD is suitable for preventing the patient's stomach from filling with coolant."
Resistance to Vacuum: Suitable for normal operating pressures	"ECD is suitable for normal operating pressures."
Flow Rate: Maintenance of thermal transfer capabilities	"ECD is suitable for maintaining thermal transfer capabilities."
Packaging Integrity: Maintenance of cleanliness	"ECD packaging is suitable for maintaining the cleanliness of the ECD."
Overall: No new questions of safety or effectiveness (compared to predicate)	"The ECD01-A and ECD02-A have technological characteristics that do not raise new questions of safety or effectiveness when compared to the predicate device."
Shelf Life: Increased from 1 year to 3 years	"Non-clinical performance testing was also conducted to show the technological characteristics of the subject devices are suitable to increase the shelf life from 1 year to 3 years."

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

The document does not specify sample sizes (e.g., number of devices tested) for the non-clinical performance tests. These are typically engineering tests, likely involving a small number of physical samples from manufacturing lots. Data provenance in terms of country of origin or retrospective/prospective is not applicable as these are laboratory/benchtop tests, not human studies.

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. This device is not an imaging or diagnostic device that requires expert ground truth establishment for a test set. The "ground truth" here is based on engineering specifications and existing regulatory standards for medical device safety and performance.

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

Not applicable. This concept applies to studies where expert opinions (e.g., medical image interpretations) are being adjudicated. For engineering tests of a physical device, results are typically determined by measurement against established standards, not expert consensus or adjudication.

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 is not an AI-assisted diagnostic device, nor is it a device that involves "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.

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

For biocompatibility, the ground truth is established by ISO 10993 standards (e.g., cell viability for cytotoxicity, irritation scores for irritation). For mechanical tests (tensile, burst, strength, leakage, vacuum, flow rate), the ground truth is established by industry-accepted engineering standards and internal specifications derived from the device's intended use and comparison to the predicate device. The ultimate "ground truth" for regulatory clearance is "substantial equivalence" to the predicate device in terms of safety and effectiveness.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on established engineering principles and prior device models.

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

Not applicable, as there is no "training set." The design and testing are based on engineering principles and regulatory guidances relevant to medical devices.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 15, 2016

Advanced Cooling Therapy, LLC Erik Kulstad President /CEO 3440 S Dearborn St. # 215-South Chicago, Illinois 60616

Re: K152450

Trade/Device Name: Esophageal Cooling Device Regulation Number: 21 CFR 870.5910 Regulation Name: Esophageal Thermal Regulation Device Regulatory Class: Class II Product Code: PLA Dated: December 15, 2015 Received: December 16, 2015

Dear Erik Kulstad:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrand

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4: Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120
Indications for Use	Expiration Date: January 31, 2017See PRA Statement below.

510(k) Number (if known)	TBD
Device Name	Esophageal Cooling Device

Indications for Use (Describe)

Model #: ECD01-A:
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.

Model #: ECD02-A:
The Esophageal Cooling Device is a thermal regulating device, intended to:

connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient
temperature, and
provide gastric decompression and suctioning.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
--------------------------------------------------------------------------------------	----------------------------------------------------------------------

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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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510(k) Summary of Safety and Effectiveness

Submitter / 510(k) Holder

Company:	Advanced Cooling Therapy, Inc.
Address:	3440 S. Dearborn St.
	#215-South
	Chicago, IL 60616
Phone:	+1-312-725-4756
Contact Person:	Erik Kulstad
	President
Date Prepared:	August 26, 2015
Device Name & Classification
Trade Name:	Esophageal Cooling Device (ECD)
Model Number(s):	ECD01-A, ECD02-A
Classification Name:	Esophageal Thermal Regulation Device (21 CFR 870.5910)
Product Code:	PLA
Class:	II

Predicate Device

Advanced Cooling Therapy, Inc. Esophageal Cooling Device (model #: ECD01-A); DEN140018

Device Description

Indications for Use (Subject Device 1; Model #: ECD01-A)

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.

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Indications for Use (Subject Device 2; Model #: ECD02-A)

The Esophageal Cooling Device 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.

Technological Characteristics

The ECD is available in two models based on the intended external heat exchanger.

Model #	Description
ECD01-A	Intended for connection to the Gaymar Medi-Therm III Conductive Hyper/HypothermiaSystem
ECD02-A	Intended for connection to the Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System.

The ECD01-A model has the identical indications for use, patient population, principles of operation, materials, and design as the predicate device.

The ECD02-B model has similar indications for use, an identical patient population, identical principles of operation, similar materials, and a substantially equivalent design as the predicate device. The ECD02-A is intended to connect to a different external heat exchanger than the predicate device and is therefore supplied with the appropriate connectors for connection to the Cincinnati Sub-Zero Blanketrol II and Blanketrol III external heat exchangers. The external heat exchanger connectors are the only difference between the ECD02-A and the predicate device. The Cincinnati Sub-Zero Blanketrol III Hyper-Hypothermia System provide functionality and safety features similar to the Gaymar Medi-Therm III Conductive Hyper/Hypothermia System.

Table 1 shows the difference between the two models. All other technological characteristics are identical for both models.

Model #	Fittings	Intended external heat exchanger
ECD01-A	Clik-Tite connectors	Gaymar Medi-Therm III ConductiveHyper/Hypothermia System
ECD02-A	PLC series connectors	Cincinnati Sub-Zero Blanketrol II and Blanketrol IIIHyper-Hypothermia System

Table 1: Differences between ECD models

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Non-Clinical Performance Testing

Non-clinical performance testing was conducted to demonstrate the technological characteristics of Device 2 are substantially equivalent to the predicate device. Furthermore, non-clinical performance testing was also conducted to show the technological characteristics of the subject devices are suitable to increase the shelf life from 1 year to 3 years. The following tests were performed:

Test performed	Discussion
Biocompatibility	Biocompatibility testing in accordance with ISO 10993-5 and ISO 10993-10demonstrated all materials used to manufacture the ECD are suitable for theintended use.
Tensile force	Tensile force testing demonstrated the ECD is suitable for insertion into andremoval from the esophagus.
Burst strength	Burst strength testing demonstrated the ECD is suitable for normal operatingpressures.
Ultimatematerial strength	Ultimate material strength testing demonstrated the ECD is suitable for normaloperating pressures under worst-case manufacturing conditions.
Leakage	Leakage testing demonstrated the ECD is suitable for preventing the patient'sstomach from filling with coolant.
Resistance tovacuum	Vacuum testing demonstrated the ECD is suitable for normal operating pressures.
Flow rate	Flow rate testing demonstrated the ECD is suitable for maintaining thermaltransfer capabilities.
Packagingintegrity	Package integrity testing demonstrated the ECD packaging is suitable formaintaining the cleanliness of the ECD.

Conclusion

The results of all performance testing demonstrate the ECD01-A and ECD02-A have technological characteristics that do not raise new questions of safety or effectiveness when compared to the predicate device. Therefore, the subject devices are substantially equivalent to the predicate device.

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.