The HotDog Temperature Management System 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 mantain a state of normothermia. The System can be used with adult patients.

The System is intended primarily for use in hospitals and surgical centers including, without limitation, operating rooms, recovery rooms, emergency rooms, burn units and on other medical/surgical floors.

The HotDog Return Electrode Mattress is intended to conduct monopolar electrosurgical energy from the target tissue of a patient back to one or two electrosurgical units (ESU) or generators in monopolar surgery. The HotDog Return Electrode Mattress is restricted to use with isolated monopolar electrosurgical generators. The HotDog Return Electrode Mattress is intended for use with adult patients only.

Device Description

The HotDog Warming Mattress + Return Electrode (“Mattress") is part of a thermal regulating system, indicated for controlling patient temperature in adult patients.

Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings.

Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "HotDog Warming Mattress + Return Electrode." This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than performance data derived from an AI/ML-based device that would require a study with acceptance criteria, a test set, and human expert adjudication.

Therefore, the requested information, specifically regarding "AI vs without AI assistance," "standalone performance," "human readers," "ground truth," training/test sets, and expert consensus, is not applicable to this document as it pertains to a physical medical device (warming mattress and return electrode) and not an AI/ML diagnostic or therapeutic device.

The document discusses bench testing to demonstrate compliance with FDA-recognized consensus standards and to show substantial equivalence to the predicate device.

Here's a summary of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific acceptance criteria with quantifiable metrics for a "device performance" in the way one would for an AI/ML diagnostic. Instead, it describes compliance with recognized consensus standards and general safety/performance characteristics.

Acceptance Criteria (Compliance with Standards/Characteristics)	Reported Device Performance (Demonstrated through Bench Testing)
Electrical safety and electromagnetic compatibility (EMC):	The device is designed and verified to meet the following performance standards:
- ANSI AAMI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, A1:2012, C1:2009/(R)2012 (FDA recognition #19-4)	Compliant
- IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, edition: 4.0 (FDA recognition # 19-8)	Compliant
Particular Standards for Warming Mattresses and Electrosurgery:	The device is designed and verified to meet the following particular standards:
- IEC 80601-2-35, Particular requirements for the safety of blankets, pad and mattresses intended for heating in medical use, edition: 2.1 (FDA recognition # 6-390)	Compliant
- IEC 60601-2-2, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories, edition 6.0 (FDA recognition # 6-389)	Compliant
Risk Management:	Risk management was applied, risks related to use with two ESUs were analyzed, mitigations verified, and residual risks assessed. Overall benefit-risk was established.
- ISO 14971, Medical Device - Application of Risk Analysis to Medical Devices, third edition (FDA recognition # 5-125)	Compliant (Benefits outweigh risks)
Human Factors & Usability Engineering:	Applied to the device design and throughout risk management.
- IEC 62366-1, Medical Device - Application of usability engineering to medical devices, Edition: 1.0 (FDA recognition # 5-114)	Compliant
Performance with one vs. two ESUs:	Demonstrated substantial equivalence to the predicate device.
- Temperature rise performance	Substantially equivalent to predicate (when utilizing two or one ESUs, supported by reference device methodology).
- Impedance	Theoretically unaffected by one or two generators; no additional bench testing deemed necessary.
- Patient Leakage	Conducted under worst-case conditions; demonstrated safety in dual generator use.

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

Sample Size: Not applicable in the context of clinical data or AI/ML testing. The "tests" here refer to bench tests on the physical device. The document does not specify the number of devices or test conditions for the bench testing beyond stating "bench testing was performed."
Data Provenance: The bench testing was "underwritten by Intertek." This implies a third-party laboratory conducted the tests. The document does not specify the country of origin of the data beyond this. It's a retrospective assessment of the device's characteristics against predefined standards.

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

Not applicable. "Ground truth" in the AI/ML sense (e.g., expert labels on medical images) is not relevant for this physical device's regulatory review. The "truth" is established by compliance with engineering and safety standards.

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

Not applicable. This is a bench test evaluation, not a clinical study involving reader performance and 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 does not involve AI or human reader assistance.

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

Not applicable. This is not an algorithm-based device.

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

The "ground truth" for this device's evaluation is adherence to recognized consensus standards for medical electrical equipment safety, electromagnetic compatibility, thermal regulation, and electrosurgical accessories. This is established through established engineering and testing methodologies, not clinical expert consensus on specific cases.

8. The sample size for the training set:

Not applicable. There is no AI/ML model being trained.

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

Not applicable. There is no AI/ML model being trained.

Summary

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April 18, 2024

Augustine Temperature Management, LLC Garrett Augustine VP R&D 6581 City West Parkway Eden Prairie, Minnesota 55344

Re: K232627

Trade/Device Name: HotDog Warming Mattress + Return Electrode Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ, GEI Dated: March 19, 2024 Received: March 19, 2024

Dear Garrett Augustine:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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,

Nicole M. Gillette -S

Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K232627

Device Name HotDog Warming Mattress + Return Electrode

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION 5 Premarket 510k Summary

SubmitterInformation:	Augustine Temperature Management, LLC15305 Minnetonka BlvdMinnetonka, MN 55345952.465.3529
Contact:	Garrett Augustine, VP R&D
Date Prepared:	03/19/2024
Trade Name	HotDog Warming Mattress + Return Electrode
Primary Code	DWJ -- Thermal Regulating System (21 CFR §870.5900)
Reference Code	GEI -- Electrosurgical Cutting and Coagulation Device andAccessories (21 CFR § 878.4400)
Common Name	Warming Mattress + Return Electrode
Predicate Device	HotDog Warming Mattress + Return Electrode (K230866)
Reference Device	Mega 2000 Soft Dual Cord Patient Return Electrode Pad (K031285)
Device Description	The HotDog Warming Mattress + Return Electrode (“Mattress") ispart of a thermal regulating system, indicated for controlling patienttemperature in adult patients.Mattresses utilize a flexible semi-conductive polymer fabric whichwarms the patient effectively within safe limits (controlledtemperature, low watt density, low thermal mass) from a controller andsensor feedback loop. They are RF sealed in durable urethane shellsdesigned to eliminate uncleanable crevices. Via a blue cable, they arepowered with a low voltage floating isolated DC current, designed tosafely operate in the most demanding clinical settings.Mattresses contain a green cable which enables the mattress to functionas a capacitive return electrode for electrosurgery.
Indication for Use	The HotDog Temperature Management System is intended to preventor treat hypothermia and to provide warmth to patients. The Systemshould be used in circumstances in which patients may not maintain astate of normothermia. The System can be used with adult patients.
	The System is intended primarily for use in hospitals and surgicalcenters including, without limitation, operating rooms, recoveryrooms, emergency rooms, burn units and on other medical/surgicalfloors.
	The HotDog Return Electrode Mattress is intended to conductmonopolar electrosurgical energy from the target tissue of a patientback to one or two electrosurgical units (ESU) or generators inmonopolar surgery. The HotDog Return Electrode Mattress isrestricted to use with isolated monopolar electrosurgical generators.The Hotdog Return Electrode Mattress is intended for use with adultpatients only.
TechnologicalCharacteristics	The subject and predicate devices are identical in every respect butone. While the predicate device can function as a return electrode for asingle ESU, the subject device can function as a return electrode forone or two ESUs, using a “Y” version of the predicate's cable.This technological characteristic – one or two ESU's -- is wellestablished in the FDA-cleared devices in the capacitive-style returnelectrode category going back to May of 2003. Megadyne (K031285),which functions in a substantially equivalent manner to the submissiondevice, indicates for one or two ESU's.
	The reference Megadyne device, from their 510(k) summary, supportsscientific methodology / standard reference values as it relates to theexpanded technology of this Special 510(k) submission. Theirsummary defines temperature rise with two ESUs and impedanceperformance as bench testing to establish substantial equivalence. ForMegadyne, in K031285 both of these values were found to be withinacceptable limits to the standard, and substantially equivalent to their
Performance Data	Bench testing was performed to demonstrate that the proposedWarming Mattress + Return Electrode is compliant with FDArecognized consensus standards for use with one ESU. These testswere underwritten by Intertek, using pass/fail criteria.
	Electrical safety and electromagnetic compatibility (EMC)The HotDog Warming Mattress + Return Electrode is designed andverified to meet the following performance standards:
	ANSI AAMI ES60601-1, Medical Electrical Equipment - Part 1:General Requirements for Basic Safety and Essential Performance,A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 FDA recognition#19-4
	IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: GeneralRequirements for Safety - Collateral standard: ElectromagneticCompatibility - Requirements and Tests, edition: 4.0 FDA recognition# 19-8
	Particular Standards
	The HotDog Warming Mattress + Return Electrode is designed andverified to meet the following particular standards:
	IEC 80601-2-35, Particular requirements for the safety of blankets, padand mattresses intended for heating in medical use, edition: 2.1 FDArecognition # 6-390
	IEC 60601-2-2, Medical electrical equipment - Part 2-2: Particularrequirements for the basic safety and essential performance of highfrequency surgical equipment and high frequency surgical accessoriesedition 6.0, FDA recognition # 6-389
	Risk Management & Human Factors
	Risk management was applied throughout the development process ofthe device. Risks related to use with two ESUs compared to one wereanalyzed. Risk mitigations were verified. Residual risks wereassessed and an overall benefit-risk was established. The benefits ofthe warming mattress + return electrode outweigh the risks.
SECTION 5
Premarket 510k Summary
	ISO 14971, Medical Device - Application of Risk Analysis toMedical Devices, third edition FDA recognition # 5-125
	Human factors and usability engineering was applied to theHotDog Warming Mattress + Return Electrode, on the designside, and throughout risk management.
	IEC 62366-1, Medical Device - Application of usabilityengineering to medical devices, Edition: 1.0 FDArecognition # 5-114
Further Bench Testing	Additional bench testing was completed to assess theimpact on performance or safety of use of two generatorsvs one. Utilizing the reference device to support wellestablished methodology, the temperature rise performanceof the HotDog Warming Mattress + Return Electrode issubstantially equivalent to the predicate device whenutilizing two or one electrosurgical generators. Impedanceresults are theoretically unaffected by one or twogenerators, and therefore additional bench testing onimpedance was not necessary. Patient Leakage testing wasconducted under worst case conditions, demonstratingsafety in dual generator use.
Summary	Bench testing was performed to demonstrate that theproposed HotDog Warming Mattress + Return Electrode iscompliant with FDA recognized consensus standards relatedto this submission. This and further bench testingdemonstrate that the device is substantially equivalent to thepredicate device. No substantial new risks exist from theability to use one or two generators in electrosurgery withthis device.
Clinical Data	Not required
Conclusion	The HotDog Warming Mattress + Return Electrode was found to besubstantially equivalent to the predicate HotDog Warming Mattress +Return Electrode. Reference device Mega 2000 Soft Dual Cord PatienReturn Electrode Pad presents clear methodology for addressingdifferences in technology. The expanded technology of thissubmission, when considering the reference device capabilities andtesting to FDA recognized consensus standards, demonstratesubstantial equivalence to the predicate. The overall intended use ofthe device is identical to the predicate. In sum, the Warming Mattress+ Return Electrode this submission is as safe, as effective, and

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SECTION 5 SECTION 5

Premarket 510k Summary

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SECTION 5 SECTION 5

Premarket 510k Summary

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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).