· 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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called EnsoETM, a thermal regulating device. The purpose of the submission (K180244) is to extend the duration of use for two models, ECD03-A and ECD04-A, from 36 hours to 72 hours.

However, the document explicitly states: "No additional performance testing was conducted." This means there is no new study described within this document that "proves the device meets the acceptance criteria" for the extended duration of use.

The submission claims substantial equivalence based on existing data and the fact that the subject devices are identical to predicate devices (K172029) except for the change in duration of use, and identical to reference devices (K172493) with the same 72-hour duration of use, except for gastric lumen connector and the indication for enteral administration of fluids.

Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets them, as the document states no new performance testing was conducted for this particular 510(k) submission.

The tables for acceptance criteria and device performance, as well as details about sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone performance, are not present because no new performance testing was performed and reported in this specific submission for the extended duration of use. The substantial equivalence is based on comparisons to previously cleared devices and their existing performance data.

Summary

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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

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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

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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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Company:	Advanced Cooling Therapy, Inc. d/b/a Attune Medical
Address:	3440 S. Dearborn St.#215-SouthChicago, IL 60616
Phone:	+1-708-651-0736
Contact Person:	Erik KulstadChief 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

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

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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 #	CoolantLumenFittings	Gastric LumenFittings	Intended heat exchanger	Enteraladministrationof fluids?	Duration ofuse
ECD03-A(PredicateDevice 1)	Clik-Titeconnectors	Male ENFitconnector	Stryker/Gaymar Medi-Therm III or Stryker Altrix	Yes	36 hours
ECD04-A(PredicateDevice 2)	Colder PLCseriesconnectors	Male ENFitconnector	Cincinnati Sub-ZeroBlanketrol II or BlanketrolIII	Yes	36 hours
ECD01-A(ReferenceDevice 1)	Clik-Titeconnectors	5° siliconetaper	Stryker/Gaymar Medi-Therm III or Stryker Altrix	No	72 hours
ECD02-A(ReferenceDevice 2)	Colder PLCseriesconnectors	5° siliconetaper	Cincinnati Sub-ZeroBlanketrol II or BlanketrolIII	No	72 hours

Table 1: Differences Between EnsoETM Models

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Model #	CoolantLumenFittings	Gastric LumenFittings	Intended heat exchanger	Enteraladministrationof fluids?	Duration ofuse
ECD03-A(SubjectDevice 1)	Clik-Titeconnectors	Male ENFitconnector	Stryker/Gaymar Medi-Therm III or Stryker Altrix	Yes	72 hours
ECD04-A(SubjectDevice 2)	Colder PLCseriesconnectors	Male ENFitconnector	Cincinnati Sub-ZeroBlanketrol II or BlanketrolIII	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.

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.