HotDog Temperature Management Controller

K201779 · Augustine Temperature Management · DWJ · Sep 11, 2020 · Cardiovascular

Device Facts

• Record ID: K201779
• Device Name: HotDog Temperature Management Controller
• Applicant: Augustine Temperature Management
• Product Code: DWJ · Cardiovascular
• Decision Date: Sep 11, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Controller is intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients may not maintain a state of normothermia. The System is intended primarily for use in hospitals and surgical centers including operating, recovery, and emergency rooms, on medical/surgical floors.

Device Story

HotDog Temperature Management Controller (Model WC7X) provides power and temperature control to HotDog warming devices. Used in hospitals/surgical centers (OR, recovery, emergency, medical/surgical floors) by clinicians. Device maintains patient normothermia by preventing or treating hypothermia. Operation involves controlling power output to warming blankets/pads to reach set temperatures. Benefits include thermal regulation for patients at risk of hypothermia.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing and adherence to performance standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 80601-2-35, IEC 62366, and IEC 62304.

Technological Characteristics

Thermal regulating system; provides power and temperature control to warming devices. Complies with IEC 60601-1 (General Safety), IEC 60601-1-2 (EMC), IEC 60601-1-4 (Programmable electrical medical systems), IEC 80601-2-35 (Safety of heating blankets/pads), IEC 62366 (Usability), and IEC 62304 (Software Life Cycle).

Indications for Use

Indicated for patients who may not maintain normothermia; intended to prevent or treat hypothermia and provide warmth in hospital and surgical settings.

Regulatory Classification

Identification

A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.

Predicate Devices

• HotDog Patient Warming System (K052392)
• HotDog Multi-Function Controller (K094056)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services seal, and on the right, there is the FDA acronym in a blue box, followed by the full name of the agency, "U.S. Food & Drug Administration," also in blue. The text is aligned to the left and is in a sans-serif font.

September 11, 2020

Augustine Temperature Management Temi Ogunse QA/RA Representative 7656 West 78th Street Minneapolis, Minnesota 55439

Re: K201779

Trade/Device Name: HotDog Temperature Management Controller Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: June 24, 2020 Received: June 30, 2020

Dear Temi Ogunse:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 (reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known) K201779

Device Name HotDog Temperature Management Controller

#### Indications for Use (Describe)

The HotDog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The HotDog Temperature Management Controller should be used in circumstances in which patients may not maintain a state of normothermia. The System is intended primarily for use in hospitals and surgical centers including, without limitation, operating, recovery, and emergency rooms and on medical/surgical floors.

| 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) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

#

| Submitter<br>Information: | Augustine Temperature Management, LLC<br>7656 West 78th Street<br>Minneapolis, MN 55439<br>952.465.3539 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Temi Ogunse QA/RA Representative |
| Date Prepared: | 06/19/2020 |
| Trade Name | HotDog Temperature Management Controller<br>Model: WC7X |
| Product Code | DWJ (21 CFR Part 870.5900) |
| Common Name | Thermal Regulating System |
| Predicate Device | HotDog Patient Warming System K052392<br>HotDog Multi-Function Controller K094056 |
| Device Description | The HotDog Temperature Management Controller is part of a<br>System intended to prevent or treat hypothermia and to provide<br>warmth to patients. The System should be used in circumstances<br>in which patients could become cold. The HotDog Temperature<br>Management Controller is designed to provide power to the<br>HotDog warming devices and to control the devices to set<br>temperature. |
| Intended Use | The Controller is intended to prevent or treat hypothermia and to<br>provide warmth to patients. The System should be used in<br>circumstances in which patients may not maintain a state of<br>normothermia. The System is intended primarily for use in<br>hospitals and surgical centers including operating, recovery, and<br>emergency rooms, on medical/surgical floors. |
| Technological<br>Characteristics | A comparison between the new and predicate devices shows that<br>the technological characteristics and indications for use are<br>equivalent. The products have similar designs, materials,<br>components, and dimensions. |
| Non-Clinical Data | Bench testing was performed to demonstrate that the proposed<br>controller is substantially equivalent to the predicate devices. |

{4}------------------------------------------------

## SECTION 5 Premarket 510k Summary 510(k) Number: K201779

Temperature characteristics and safety systems were assessed and found to be comparable.

The Controller is designed to meet the following performance standards:

IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, edition: 3.0

IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, edition: 3.1

IEC 60601-1-4:2000. Medical electrical equipment - Part 1: General requirements for safety - 4 - Collateral standard: Programmable electrical medical systems, edition 1.1.

IEC 80601-2-35, Particular requirements for the safety of blankets, pads and mattresses intended for heating in medical use, edition 1

IEC 62366, Medical Device – Application of usability engineering to medical devices

IEC 62304, Medical Device Software - Software Life Cycle Processes

Clinical Data Not required

Conclusion

The HotDog Temperature Management Controller was found to be equivalent to the predicate devices in technological characteristics and indications for use.