(56 days)
Not Found
No
The summary describes a physical device for thermal regulation and gastric access, with no mention of AI or ML in its function or intended use.
Yes.
The device's intended use is to "raise or maintain a patient's temperature," which is a therapeutic action aimed at treating or managing a patient's physiological state.
No
The device is described as a "thermal regulating device" intended to raise or maintain a patient's temperature, allow enteral fluid administration, and provide gastric decompression and suctioning. Its function is therapeutic and supportive, not to diagnose a condition.
No
The device description clearly describes a physical, multi-lumen silicone tube and its connection to external hardware (heat exchanger, gastric decompression system). There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The EnsoETM is a thermal regulating device that is placed in the esophagus to control a patient's body temperature. It also allows for gastric decompression, suctioning, and enteral administration of fluids.
- Lack of Sample Analysis: The device does not analyze any samples taken from the body. Its function is entirely external to the analysis of biological specimens.
Therefore, the EnsoETM falls under the category of a therapeutic or supportive medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Model # ECD05-A:
The EnsoETM is a thermal regulating device, intended to:
- · connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient's temperature,
- · allow enteral administration of fluids, and
- · provide gastric decompression and suctioning.
Model # ECD06-A
The EnsoETM is a thermal regulating device, intended to:
- · connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient's temperature, and
- · provide gastric decompression and suctioning.
Product codes (comma separated list FDA assigned to the subject device)
PLA
Device Description
The EnsoETM is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to raise or maintain a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression, drainage, and enteral administration of fluids, thereby maintaining the functionality of the standard orogastric tube. Raising or maintaining patient temperature is achieved by connecting the device to an external heat exchanger. Two lumens connect to the exchanger. A third central lumen connects to wall standard gastric decompression or, in some models, an enteral administration system to allow enteral administration of fluids. The device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with a duration of use of 72 hours or less.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus, stomach
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 Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System. The following tests were performed:
Coolant lumen flow rate: Coolant lumen flow rate testing demonstrated the EnsoETM is suitable for maintaining thermal transfer capabilities.
The results of all performance testing demonstrated the subject devices are substantially equivalent to the predicate devices.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 17, 2018
Advanced Cooling Therapy, Inc. d/b/a Attune Medical Erik Kulstad Chief Medical Officer 3440 S. Dearborn St. #215-South Chicago, Illinois 60616
Re: K180742
Trade/Device Name: EnsoETM Regulation Number: 21 CFR 870.5910 Regulation Name: Esophageal Thermal Regulation Device Regulatory Class: Class II Product Code: PLA Dated: March 20, 2018 Received: March 22, 2018
Dear Erik Kulstad:
We have reviewed vour 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 device-related adverse events) (21 CFR 803); good
1
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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole G. Ibrahim -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180742
Device Name EnsoETM
Indications for Use (Describe)
Model # ECD05-A:
The EnsoETM is a thermal regulating device, intended to:
- · connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient's temperature,
· allow enteral administration of fluids, and
· provide gastric decompression and suctioning.
Model # ECD06-A
The EnsoETM is a thermal regulating device, intended to:
· connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient's temperature, and
· provide gastric decompression and suctioning.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Company: Advanced Cooling Therapy, Inc. d/b/a Attune Medical Address: 3440 S. Dearborn St. #215-South Chicago, IL 60616 Phone: +1-312-725-4756 Contact Person: Erik Kulstad Chief Medical Officer Date Prepared: March 20, 2018 Device Name & Classification Trade Name: EnsoETM Model Number(s): ECD05-A, ECD06-A Esophageal Thermal Regulation Device (21 CFR 870.5910) Classification Name: Product Code: PLA
SECTION 5: 510(k) Summary of Safety and Effectiveness (21 CFR § 807.92)
Submitter / 510(k) Holder
Predicate Device
Class:
- Attune Medical EnsoETM (model #: ECD04-A); K180244
ll
- Attune Medical EnsoETM (model #: ECD02-A); K172493
Device Description
The EnsoETM is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to raise or maintain a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression, drainage, and enteral administration of fluids, thereby maintaining the functionality of the standard orogastric tube. Raising or maintaining patient temperature is achieved by connecting the device to an external heat exchanger. Two lumens connect to the exchanger. A third central lumen connects to wall standard gastric decompression or, in some models, an enteral administration system to allow enteral administration of fluids. The device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with a duration of use of 72 hours or less.
Indications for Use (Subject Device 1; Model #: ECD05-A)
The EnsoETM is a thermal regulating device, intended to:
- connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient's temperature,
- . allow enteral administration of fluids, and
- . provide gastric decompression and suctioning.
4
Indications for Use (Subject Device 2; Model #: ECD06-A)
The EnsoETM is a thermal regulating device, intended to:
- connect to Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient's temperature, and
- provide gastric decompression and suctioning.
Technological Characteristics
The indications for use have been modified to (1) list the Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System as a compatible external heat exchanger instead of the Cincinnati Sub-Zero Blanketrol III Hyper-Hypothermia System, and (2) state that the device can only raise or maintain a patient's temperature instead of controlling (i.e. raising, maintaining, or lowering) it.
All other technological characteristics (including principles of operation, materials, and design) remain identical. The Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System provides functionality and safety features comparable to the Cincinnati Sub-Zero Blanketrol III Hyper-Hypothermia System.
Non-Clinical Performance Testing
Non-clinical performance testing was conducted to demonstrate the compatibility of the device with the Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System. The following tests were performed:
| Test performed | Discussion |
|---|---|
| Coolant lumen | |
| flow rate | Coolant lumen flow rate testing demonstrated the EnsoETM is suitable for maintaining thermal transfer capabilities. |
Conclusion
The results of all performance testing demonstrated the subject devices are substantially equivalent to the predicate devices.