Esophageal Cooling Device

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # SECTION 4: Indications for Use Statement | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120 | |-------------------------------------------------------------------------|---------------------------------------------------------------| | Indications for Use | Expiration Date: January 31, 2017<br>See 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*) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | |--------------------------------------------------------------------------------------|----------------------------------------------------------------------| |--------------------------------------------------------------------------------------|----------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (8/14) PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ # 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 1. Advanced Cooling Therapy, Inc. Esophageal Cooling Device (model #: ECD01-A); DEN140018 # 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. # 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. {4}------------------------------------------------ # 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/Hypothermia<br>System | | ECD02-A | Intended for connection to the Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-<br>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 Conductive<br>Hyper/Hypothermia System | | ECD02-A | PLC series connectors | Cincinnati Sub-Zero Blanketrol II and Blanketrol III<br>Hyper-Hypothermia System | #### Table 1: Differences between ECD models {5}------------------------------------------------ # 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 10993-10<br>demonstrated all materials used to manufacture the ECD are suitable for the<br>intended use. | | Tensile force | Tensile force testing demonstrated the ECD is suitable for insertion into and<br>removal from the esophagus. | | Burst strength | Burst strength testing demonstrated the ECD is suitable for normal operating<br>pressures. | | Ultimate<br>material strength | Ultimate material strength testing demonstrated the ECD is suitable for normal<br>operating pressures under worst-case manufacturing conditions. | | Leakage | Leakage testing demonstrated the ECD is suitable for preventing the patient's<br>stomach from filling with coolant. | | Resistance to<br>vacuum | Vacuum testing demonstrated the ECD is suitable for normal operating pressures. | | Flow rate | Flow rate testing demonstrated the ECD is suitable for maintaining thermal<br>transfer capabilities. | | Packaging<br>integrity | Package integrity testing demonstrated the ECD packaging is suitable for<br>maintaining 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.