(86 days)
Not Found
No
The description focuses on the mechanical and thermal properties of the device and its connection to external temperature management systems. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a "thermal regulating device, intended to control patient temperature," which is a therapeutic function. Additionally, it provides "gastric decompression and suctioning," which are also therapeutic interventions.
No
The device is described as a thermal regulating device used to control a patient's temperature and provide gastric decompression and suctioning. Its function is therapeutic, not diagnostic (i.e., it does not identify, monitor, or detect a medical condition or disease).
No
The device description clearly states it is a multi-lumen silicone tube and describes its physical components and function as a hardware device for thermal regulation and gastric decompression. There is no mention of software as the primary or sole component.
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. This involves direct interaction with the patient's body for therapeutic and supportive purposes.
- Device Description: The device is a physical tube placed in the esophagus and stomach. It works by circulating fluid for temperature control and providing a lumen for suction.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health status. This device does not perform any such analysis of biological samples.
The device is a therapeutic and supportive medical device, not an in vitro diagnostic.
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 or Stryker Altrix Precision Temperature Management 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 performance testing was conducted to demonstrate the compatibility of the device with the Stryker Altrix Precision Temperature Management System. The following tests were performed: Flow rate testing demonstrated the Esophageal Cooling Device is suitable for maintaining thermal transfer capabilities. The results of all performance testing showed the subject device to be substantially equivalent to the predicate device.
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.
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.
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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.
1
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
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.
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.
4
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 maintaining |
| thermal transfer capabilities. |
Conclusion
The results of all performance testing showed the subject device to be substantially equivalent to the predicate device.