(30 days)
No
The summary describes a mechanical device for temperature regulation and gastric access, with no mention of AI or ML in its function or description.
Yes
The device is intended to control patient temperature, which is a therapeutic intervention for regulating physiological conditions. It also provides gastric decompression and allows enteral administration of fluids, which are direct medical treatments.
No
The device description, intended use, and indications for use all describe the EnsoETM as a "thermal regulating device" that controls patient temperature, allows fluid administration, and provides gastric decompression and suctioning. None of these functions involve diagnosing a condition or disease.
No
The device description clearly states it is a "multi-lumen silicone tube" and a "single-use, disposable, non-implantable device," indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a "thermal regulating device" used to control patient temperature, allow enteral administration, and provide gastric decompression and suctioning. These are all therapeutic and supportive functions performed on the patient, not diagnostic tests performed on samples taken from the patient.
- Device Description: The description details a multi-lumen tube placed in the esophagus and connected to external heat exchangers and suction/enteral systems. This aligns with a device used for direct patient intervention and support, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect specific analytes, or provide diagnostic information about a patient's condition based on laboratory testing.
In Vitro Diagnostics are devices used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on direct patient management and support.
N/A
Intended Use / Indications for Use
Model # ECD03-A:
The EnsoETM is a thermal regulating device, intended to:
· connect to a Gaymar Medi-Therm III Conductive HyperHypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature,
· allow enteral administration of fluids,
· and provide gastric decompression and suctioning.
Model # ECD04-A:
The EnsoETM is a thermal regulating device, intended to:
· connect to a Cincinnati Sub-Zero Blanketrol III Hyper-Hypothermia System to control patient temperature.
· allow enteral administration of fluids,
· and provide gastric decompression and suctioning.
Product codes
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 control 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. Modulation and control of patient temperature is achieved by connecting the device to an external heat exchanger. Two lumens connect to the external heat exchanger. A third central lumen connects to wall suction to allow standard gastric decompression or 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)
No additional performance testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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)
The purpose of this Special 510(k) submission is to increase the duration of use for the ECD03-A and ECD04-A models from 36 hours to 72 hours. The subject devices are identical to the predicate devices except for the change to the duration of use.
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 28, 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: K180244
Trade/Device Name: EnsoETM Regulation Number: 21 CFR 870.5910 Regulation Name: Esophageal Thermal Regulation Device Regulatory Class: Class II Product Code: PLA Dated: January 26, 2018 Received: January 29, 2018
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
1
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 manufacturing practice requirements as set forth in the quality systems (OS) 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) K180244
Device Name EnsoETM
Indications for Use (Describe)
Model # ECD03-A:
The EnsoETM is a thermal regulating device, intended to:
· connect to a Gaymar Medi-Therm III Conductive HyperHypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature,
· allow enteral administration of fluids,
· and provide gastric decompression and suctioning.
Model # ECD04-A:
The EnsoETM is a thermal regulating device, intended to:
· connect to a Cincinnati Sub-Zero Blanketrol III Hyper-Hypothermia System to control patient temperature.
· allow enteral administration of fluids,
· 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: | +1-708-651-0736 |
| Contact Person: | Erik Kulstad |
| Chief Medical Officer | |
| Date Prepared: | January 26, 2018 |
| Device Name & Classification | |
| Trade Name: | EnsoETM |
| Model Number(s): | ECD03-A, ECD04-A |
| Classification Name: | Esophageal Thermal Regulation Device (21 CFR 870.5910) |
| Product Code: | PLA |
| Class: | II |
| Predicate Devices |
SECTION 5: 510(k) Summary of Safety and Effectiveness
Submitter / 510(k) Holder
Attune Medical EnsoETM (model #s: ECD03-A & ECD04-A); K172029
Reference Devices
Attune Medical EnsoETM (model #s: ECD01-A & 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 control 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. Modulation and control of patient temperature is achieved by connecting the device to an external heat exchanger. Two lumens connect to the external heat exchanger. A third central lumen connects to wall suction to allow standard gastric decompression or 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 #: ECD03-A)
The EnsoETM 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,
- allow enteral administration of fluids, and
4
- provide gastric decompression and suctioning.
Indications for Use (Subject Device 2; Model #: ECD02-A)
The EnsoETM is a thermal regulating device, intended to:
- . connect to a Cincinnati Sub-Zero Blanketrol III or Blanketrol III Hyper-Hypothermia System to control patient temperature,
- . allow enteral administration of fluids, and
- . provide gastric decompression and suctioning.
Technological Characteristics
The EnsoETM product family currently consists of four models:
- the ECD03-A (Predicate Device 1 cleared under K172029),
- . the ECD04-A (Predicate Device 2 cleared under K172029),
- . the ECD01-A (Reference Device 1 cleared under K172493), and
- . the ECD02-A (Reference Device 2 cleared under K172493).
The purpose of this Special 510(k) submission is to increase the duration of use for the ECD03-A and ECD04-A models from 36 hours to 72 hours. The subject devices are identical to the predicate devices except for the change to the duration of use.
The subject devices have the same duration of use as the reference devices and are identical to the reference devices except for the gastric lumen connector and the inclusion of enteral administration of fluids in the indication statement.
Table 1 details the differences between the subject, predicate, and reference devices. Device characteristics not described in Table 2 are identical for all devices.
| Model # | Coolant
Lumen
Fittings | Gastric Lumen
Fittings | Intended heat exchanger | Enteral
administration
of fluids? | Duration of
use |
|------------------------------------|------------------------------------|---------------------------|-----------------------------------------------------------|-----------------------------------------|--------------------|
| ECD03-A
(Predicate
Device 1) | Clik-Tite
connectors | Male ENFit
connector | Stryker/Gaymar Medi-
Therm III or Stryker Altrix | Yes | 36 hours |
| ECD04-A
(Predicate
Device 2) | Colder PLC
series
connectors | Male ENFit
connector | Cincinnati Sub-Zero
Blanketrol II or Blanketrol
III | Yes | 36 hours |
| ECD01-A
(Reference
Device 1) | Clik-Tite
connectors | 5° silicone
taper | Stryker/Gaymar Medi-
Therm III or Stryker Altrix | No | 72 hours |
| ECD02-A
(Reference
Device 2) | Colder PLC
series
connectors | 5° silicone
taper | Cincinnati Sub-Zero
Blanketrol II or Blanketrol
III | No | 72 hours |
Table 1: Differences Between EnsoETM Models
5
| Model # | Coolant
Lumen
Fittings | Gastric Lumen
Fittings | Intended heat exchanger | Enteral
administration
of fluids? | Duration of
use |
|----------------------------------|------------------------------------|---------------------------|-----------------------------------------------------------|-----------------------------------------|--------------------|
| ECD03-A
(Subject
Device 1) | Clik-Tite
connectors | Male ENFit
connector | Stryker/Gaymar Medi-
Therm III or Stryker Altrix | Yes | 72 hours |
| ECD04-A
(Subject
Device 2) | Colder PLC
series
connectors | Male ENFit
connector | Cincinnati Sub-Zero
Blanketrol II or Blanketrol
III | Yes | 72 hours |
Performance Testing
No additional performance testing was conducted.
Conclusion
Existing data demonstrate Subject Device 1 and Subject Device 2 are substantially equivalent to Predicate Device 1 and Predicate Device 2 respectively.