HotDog Temperature Management Controller by Augustine Temperature Management

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.

Device Description

The HotDog Temperature Management Controller is part of a System intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients could become cold. The HotDog Temperature Management Controller is designed to provide power to the HotDog warming devices and to control the devices to set temperature.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "HotDog Temperature Management Controller." This is a medical device submission, and the focus is on proving substantial equivalence to previously cleared predicate devices, rather than a clinical study establishing novel efficacy or diagnostic performance. Therefore, many of the requested categories for acceptance criteria and study details (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable in this context.

The document indicates that bench testing was performed to demonstrate substantial equivalence. The acceptance criteria for this type of submission are typically adherence to recognized performance standards and comparability to predicate devices in terms of technological characteristics and intended use.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Standards)	Reported Device Performance
IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, edition: 3.0	Assessed and found to meet this standard.
IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, edition: 3.1	Assessed and found to meet this standard.
IEC 60601-1-4:2000. Medical electrical equipment - Part 1: General requirements for safety - 4 - Collateral standard: Programmable electrical medical systems, edition 1.1.	Assessed and found to meet this standard.
IEC 80601-2-35, Particular requirements for the safety of blankets, pads and mattresses intended for heating in medical use, edition 1	Assessed and found to meet this standard.
IEC 62366, Medical Device – Application of usability engineering to medical devices	Assessed and found to meet this standard.
IEC 62304, Medical Device Software - Software Life Cycle Processes	Assessed and found to meet this standard.
Comparable Temperature Characteristics and Safety Systems to Predicate Devices	Temperature characteristics and safety systems were assessed and found to be comparable to predicate devices (HotDog Patient Warming System K052392 and HotDog Multi-Function Controller K094056).
Similar designs, materials, components, and dimensions to predicate devices.	A comparison between the new and predicate devices shows that the technological characteristics and indications for use are equivalent. The products have similar designs, materials, components, and dimensions.

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

Sample Size: Not applicable. The submission relies on "bench testing" and a comparison of technical specifications to predicate devices, not a clinical test set with human or patient data.
Data Provenance: Not applicable. The assessment is based on engineering and performance evaluations against recognized standards and comparison to existing device specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. This is not a study requiring expert-established ground truth for a test set. The evaluation is based on engineering principles and regulatory compliance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. There was no test set requiring expert adjudication.

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:

Not applicable. This device is a temperature management controller, not an AI-assisted diagnostic or interpretative system.

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

Not applicable. This is not an algorithmic device in the context of diagnostic performance. The "algorithm" here would be the control logic for temperature management, whose performance is validated through bench testing against established standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Ground Truth: For this type of submission, the "ground truth" is adherence to established engineering and safety standards (e.g., IEC 60601 series) and the documented specifications and performance of the predicate devices.

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense.

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

Not applicable. There is no training set for this device.

Summary

{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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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 PRAStaff@fda.hhs.gov

"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}------------------------------------------------

SubmitterInformation:	Augustine Temperature Management, LLC7656 West 78th StreetMinneapolis, MN 55439952.465.3539
Contact:	Temi Ogunse QA/RA Representative
Date Prepared:	06/19/2020
Trade Name	HotDog Temperature Management ControllerModel: WC7X
Product Code	DWJ (21 CFR Part 870.5900)
Common Name	Thermal Regulating System
Predicate Device	HotDog Patient Warming System K052392HotDog Multi-Function Controller K094056
Device Description	The HotDog Temperature Management Controller is part of aSystem intended to prevent or treat hypothermia and to providewarmth to patients. The System should be used in circumstancesin which patients could become cold. The HotDog TemperatureManagement Controller is designed to provide power to theHotDog warming devices and to control the devices to settemperature.
Intended Use	The Controller is intended to prevent or treat hypothermia and toprovide warmth to patients. The System should be used incircumstances in which patients may not maintain a state ofnormothermia. The System is intended primarily for use inhospitals and surgical centers including operating, recovery, andemergency rooms, on medical/surgical floors.
TechnologicalCharacteristics	A comparison between the new and predicate devices shows thatthe technological characteristics and indications for use areequivalent. The products have similar designs, materials,components, and dimensions.
Non-Clinical Data	Bench testing was performed to demonstrate that the proposedcontroller 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.

Regulation Number and Section

§ 870.5900 Thermal regulating system.

(a)
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.(b)
Classification. Class II (performance standards).