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.

Device Description

The Esophageal Cooling Device 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 Esophageal Cooling Device to an external heat exchanger. Two lumens connect to the exchanger. A third central lumen connects to wall suction and is used for standard gastric decompression. The Esophageal Cooling Device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 36 hours or less.

AI/ML Overview

This document is a 510(k) premarket notification for the Esophageal Cooling Device (ECD), seeking to expand its indications for use to include compatibility with an additional external heat exchanger, the Stryker Altrix Precision Temperature Management System.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, the non-clinical performance testing focuses on demonstrating an aspect suitable for maintaining thermal transfer capabilities.

Acceptance Criteria (Implied)	Reported Device Performance
Suitable for maintaining thermal transfer capabilities with the Stryker Altrix Precision Temperature Management System	Flow rate testing demonstrated the Esophageal Cooling Device is suitable for maintaining thermal transfer capabilities.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified for the "Flow rate" test. The entire document refers to a single device (Esophageal Cooling Device model ECD01-A).
Data Provenance: The testing was non-clinical performance testing. The provenance (country of origin, retrospective/prospective) is not specified, but typically non-clinical tests are conducted in a laboratory setting by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This was a non-clinical performance test, likely involving engineering or technical personnel, not medical experts establishing ground truth in a clinical context.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical performance test.

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 document describes a medical device, not an AI or imaging diagnostic tool that would typically involve human readers.

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

Not applicable. This document describes a medical device, not an algorithm. The testing focused on the device's physical performance (flow rate) in conjunction with an external system.

7. The Type of Ground Truth Used

The ground truth for the non-clinical performance testing was based on the physical properties and engineering specifications of the device and the associated external heat exchanger, specifically the objective measurement of "flow rate." It's an objective measurement rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of an algorithm or machine learning.

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

Not applicable as there is no training set for this type of device.

Summary

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

March 30, 2017

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

Re: K170009

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 30, 2016 Received: January 6, 2017

Dear Dr. 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 of medical devicerelated 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.

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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,

M.A. Hilleman
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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Indications for Use

510(k) Number (if known) K170009

Device Name Esophageal Cooling Device

Indications for Use (Describe)

The Esophageal Cooling Device 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.

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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SECTION 5: 510(k) Summary of Safety and Effectiveness (21 CFR § 807.92)

Company: Advanced Cooling Therapy, Inc. Address: 3440 S. Dearborn St. #215-South Chicago, IL 60616 Phone: +1-312-725-4756 Erik Kulstad Contact Person: President Date Prepared: December 30, 2016 Device Name & Classification Esophageal Cooling Device (ECD) Trade Name: Model Number(s): ECD01-A Esophageal Thermal Regulation Device (21 CFR 870.5910) Classification Name: Product Code: PLA ll Class:

Submitter / 510(k) Holder

Predicate Device

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

Device Description

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 or Stryker Altrix Precision Temperature Management System to control patient temperature, and
provide gastric decompression and suctioning.

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Technological Characteristics

The indications for use have been expanded to include the Stryker Altrix Precision Temperature Management System as a compatible external heat exchanger. All other technological characteristics (including principles of operation, materials, and design) remain identical. The Stryker Altrix Precision Temperature Management System provides functionality and safety features comparable to the Gaymar Medi-Therm III Conductive Hyper/Hypothermia System.

Non-Clinical Performance Testing

Non-clinical performance testing was conducted to demonstrate the compatibility of the device with the Stryker Altrix Precision Temperature Management System. The following tests were performed:

Test performed	Discussion
Flow rate	Flow rate testing demonstrated the Esophageal Cooling Device is suitable for maintainingthermal transfer capabilities.

Conclusion

The results of all performance testing showed the subject device to be 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.