· 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.

Model # ECD02-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,

· 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 modulate a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage, thereby maintaining the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the EnsoETM 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 EnsoETM is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less.

AI/ML Overview

The provided document is a 510(k) summary for the EnsoETM device, focusing on an increase in the intended duration of use from 36 hours to 72 hours. This is an important distinction. The core function and safety of the device for its initial duration have already been established in previous 510(k) submissions (K170009 and K152450).

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are specifically related to the extended duration of use, rather than the initial performance of the device as a thermal regulating and gastric decompression tool.

Based on the provided text, here is the information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for safety and effectiveness related to the extended duration of use. Instead, it refers to demonstrating that the device is "safe and effective" for 72 hours through a retrospective analysis of real-world human use data.

Acceptance Criteria (Implied)	Reported Device Performance
Device remains safe and effective for an intended duration of use of 72 hours.	A retrospective analysis of real-world human use data was conducted to demonstrate the subject devices are safe and effective for an intended duration of use of 72 hours.
No significant adverse events or device malfunctions attributable to extended use were observed.	(Implicit; the conclusion states the device is "safe and effective," which implies no unacceptable safety issues were found in the analyzed data.)
Device maintains its thermal regulating and gastric decompression functionalities throughout the extended use period.	(Implicit; the conclusion states the device is "safe and effective," which implies functionality was maintained.)

2. Sample size used for the test set and the data provenance

Sample Size: 18 patients
Data Provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Retrospective analysis of real-world human use data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number of experts or their qualifications used to establish ground truth for this retrospective analysis. Given it's a safety and effectiveness assessment for extended use, the "ground truth" would likely be based on clinical outcomes observed in the patients (e.g., lack of adverse events, continued functionality). This is not explicitly defined in terms of expert consensus for image or data interpretation, as might be the case for an AI-based diagnostic device.

4. Adjudication method for the test set

Not applicable/not specified. This type of study (retrospective analysis of real-world use) for device duration extension doesn't typically involve an "adjudication method" in the sense of reconciling expert opinions on specific data points, as would be common in diagnostic imaging studies. The "ground truth" is derived directly from the observed clinical data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This study is not an MRMC comparative effectiveness study. The device is a physical medical device (esophageal thermal regulation device), not an imaging AI or diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant. The device operates with human connection to an external heat exchanger and human placement.

7. The type of ground truth used

The ground truth was based on real-world human use data, likely encompassing clinical outcomes, adverse event reporting, and potentially device performance metrics (e.g., sustained temperature control, continued gastric decompression) collected during the extended use period in those 18 patients. It is not expert consensus, pathology, or specific outcomes data in the sense of a disease diagnosis, but rather the observed clinical reality of the device's performance over an extended duration.

8. The sample size for the training set

Not applicable. This is a physical device, and the study described is a retrospective analysis for an extended duration of use. There is no "training set" in the context of machine learning or AI algorithm development. The "training" of the device itself would have occurred during its prior development and manufacturing, and its initial clearance was based on different studies.

9. How the ground truth for the training set was established

Not applicable. As explained above, there is no "training set" in the context of this 510(k) submission.

Summary

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October 17, 2017

Attune Medical Erik Kulstad President/CEO 3440 S. Dearborn St. #215-South Chicago, Illinois 60616

Re: K172493

Trade/Device Name: EnsoETM Regulation Number: 21 CFR 870.5910 Regulation Name: Esophageal Thermal Regulation Device Regulatory Class: Class II Product Code: PLA Dated: August 16, 2017 Received: August 18, 2017

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 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.

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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,

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) K172493

Device Name EnsoETM

Indications for Use (Describe)

Model #ECD01-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,

· and provide gastric decompression and suctioning.

Model # ECD02-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,

· 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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SECTION 5: 510(k) Summary of Safety and Effectiveness

Submitter / 510(k) Holder

Company:	Attune Medical
Address:	3440 S. Dearborn St.
	#215-South
	Chicago, IL 60616
Phone:	+1-312-725-4756
Contact Person:	Erik Kulstad
	CEO/President
Date Prepared:	August 16, 2017
Device Name & Classification
Trade Name:	EnsoETM
Model Number(s):	ECD01-A, ECD02-A
Classification Name:	Esophageal Thermal Regulation Device (21 CFR 870.5910)
Product Code:	PLA
Class:	II
Predicate Device

Attune Medical EnsoETM (model #: ECD01-A); K170009
Attune Medical EnsoETM (model #: ECD02-A); K152450

Device Description

Indications for Use (Subject Device 1; Model #: ECD01-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,
provide gastric decompression and suctioning.

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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 Hyper-Hypothermia System to control patient temperature, and
provide gastric decompression and suctioning.

Technological Characteristics

The EnsoETM product family currently consists of two models: the ECD01-A (Predicate Device 1 cleared under K170009) and ECD02-A (Predicate Device 2 cleared under K152450). The purpose of this 510(k) submission is to increase the intended duration of use for the EnsoETM product family from 36 hours to 72 hours. Table 1 describes the differences between the predicate and subject devices. Device characteristics not described in Table 1 are identical for all devices.

Model #	Coolant Lumen Fittings	Intended Heat Exchanger	IntendedDuration of Use
ECD01-A (PredicateDevice 1)	Clik-Tite connectors	Stryker/Gaymar Medi-Therm III orStryker Altrix	36 hours
ECD02-A (PredicateDevice 2)	Colder PLC seriesconnectors	Cincinnati Sub-Zero Blanketrol II orBlanketrol III	36 hours
ECD01-A (SubjectDevice 1)	Clik-Tite connectors	Stryker/Gaymar Medi-Therm III orStryker Altrix	72 hours
ECD02-A (SubjectDevice 2)	Colder PLC seriesconnectors	Cincinnati Sub-Zero Blanketrol II orBlanketrol III	72 hours

Table 1: Differences between EnsoETM models

Subject Device 1 has the identical technological characteristics (including indications for use, patient population, principles of operation, materials, and design) as Predicate Device 1. The only difference is the increase in the intended duration of use from 36 hours to 72 hours.

Subject Device 2 has the technological characteristics (including indications for use, patient population, principles of operation, materials, and design) as Predicate Device 2. The only difference is the increase in the intended duration of use from 36 hours to 72 hours.

Performance Testing

A retrospective analysis of real-world human use data was conducted to demonstrate the subject devices are safe and effective for an intended duration of use of 72 hours by analyzing real-world human clinical data from 18 patients.

Conclusion

The results of all testing and data analysis demonstrate 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.