EnsoETM

K172493 · Attune Medical · PLA · Oct 17, 2017 · Cardiovascular

Device Facts

• Record ID: K172493
• Device Name: EnsoETM
• Applicant: Attune Medical
• Product Code: PLA · Cardiovascular
• Decision Date: Oct 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5910
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

EnsoETM is a multi-lumen silicone tube placed in the esophagus; functions as an orogastric tube. Two lumens connect to an external heat exchanger (Gaymar Medi-Therm III, Stryker Altrix, or Cincinnati Sub-Zero Blanketrol III) to modulate patient temperature; third central lumen connects to wall suction for gastric decompression and drainage. Used in clinical settings; single-use, disposable, non-implantable. Duration of use up to 72 hours. Device allows simultaneous temperature control and gastric access; benefits patient by providing non-invasive thermal regulation while maintaining standard gastric functionality.

Clinical Evidence

Retrospective analysis of real-world human clinical data from 18 patients. Data used to demonstrate safety and effectiveness for an intended duration of use of 72 hours.

Technological Characteristics

Multi-lumen tube; material: medical-grade silicone. Principle: heat exchange via circulating fluid through esophageal interface. Dimensions/form factor: orogastric tube. Connectivity: connects to external hyper/hypothermia systems via specific fittings (Clik-Tite or Colder PLC series). Single-use, non-implantable.

Indications for Use

Indicated for patients requiring temperature management and gastric decompression/suctioning via an esophageal thermal regulation device.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the Esophageal Cooling Device is subject to the following special controls:

*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.

Predicate Devices

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

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: | [phone] |
| 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 | |

1. Attune Medical EnsoETM (model #: ECD01-A); K170009

2. Attune Medical EnsoETM (model #: ECD02-A); K152450

## 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.

## 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 | Intended<br>Duration of Use |
|---------------------------------|---------------------------------|--------------------------------------------------------|-----------------------------|
| ECD01-A (Predicate<br>Device 1) | Clik-Tite connectors | Stryker/Gaymar Medi-Therm III or<br>Stryker Altrix | 36 hours |
| ECD02-A (Predicate<br>Device 2) | Colder PLC series<br>connectors | Cincinnati Sub-Zero Blanketrol II or<br>Blanketrol III | 36 hours |
| ECD01-A (Subject<br>Device 1) | Clik-Tite connectors | Stryker/Gaymar Medi-Therm III or<br>Stryker Altrix | 72 hours |
| ECD02-A (Subject<br>Device 2) | Colder PLC series<br>connectors | Cincinnati Sub-Zero Blanketrol II or<br>Blanketrol 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.