The HotDog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The HotDoq Patient Warming System should be used in circumstances in which patients may not maintain a state of normothermia. The patient warming system can be used with adult and pediatric patients.

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 Patient Warming System consists of a temperature control unit that monitors and controls the temperature of a patient warming blanket or mattress. The blankets and mattresses are composed of a conductive polymer coated fabric heater encased in a polymer shell. The mattress also contains a pressure relieving foam pad.

AI/ML Overview

The provided 510(k) summary for the HotDog Patient Warming System (K112488) does not describe a study involving an AI/Machine Learning device or an algorithm's performance against acceptance criteria in the way a typical diagnostic or image analysis AI study would.

Instead, this submission is for a medical device (a thermal regulating system) and its performance evaluation focuses on engineering benchmarks and safety standards. Therefore, many of the requested categories (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of device and submission.

Here's an analysis based on the information provided, tailored to the context of this specific device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Performance Standard)	Reported Device Performance
Safety and Performance	IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance, edition 2.	Bench testing was performed to demonstrate substantial equivalence to predicate devices. Temperature characteristics and safety systems were compared and found to be comparable. The system is designed to meet this standard.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, edition 2.	Bench testing was performed to demonstrate substantial equivalence to predicate devices. Temperature characteristics and safety systems were compared and found to be comparable. The system is designed to meet this standard.
Programmable Electrical Medical Systems	IEC 60601-1-4:2000. Medical electrical equipment - Part 1: General requirements for safety - 4 - Collateral standard: Programmable electrical medical systems, edition 1.1.	Bench testing was performed to demonstrate substantial equivalence to predicate devices. Temperature characteristics and safety systems were compared and found to be comparable. The system is designed to meet this standard.
Specific Requirements for Warming Blankets/Pads/Mattresses	IEC 60601-2-35: Particular requirements for the safety of blankets, pad and mattresses intended for heating in medical use, edition 1.	Bench testing was performed to demonstrate substantial equivalence to predicate devices. Temperature characteristics and safety systems were compared and found to be comparable. The system is designed to meet this standard.
Substantial Equivalence	Equivalence to predicate device (HotDog Patient Warming System K052392) in technological characteristics and indications for use.	Non-Clinical Data: Bench testing performed demonstrated that the proposed warming system is substantially equivalent to the predicate devices. Temperature characteristics and safety systems were compared and found to be comparable. Conclusion: The HotDog Patient Warming System was found to be equivalent to the predicate device in technological characteristics and indications for use.

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

Sample Size: Not applicable in the context of clinical or image data. The "test set" here refers to the physical device units subjected to bench testing against engineering and safety standards. The document does not specify the number of units tested.
Data Provenance: Not applicable in terms of country of origin for clinical data. The "data" comes from non-clinical bench testing conducted by the manufacturer, Augustine Biomedical & Design, LLC.

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

Number of Experts/Qualifications: Not applicable. Ground truth for this type of device (thermal regulating system) is established by conformance to recognized engineering standards and performance specifications, not often by human experts interpreting clinical data in the same way as an AI diagnostic device. The "experts" involved would be engineers and quality assurance professionals ensuring compliance with the cited IEC standards.

4. Adjudication method for the test set

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions on clinical cases. Here, the "truth" is determined by meeting objective engineering and safety standards, not by consensus on subjective interpretations.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices, not for a patient warming system.

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

Standalone Performance: Not applicable. This is not an algorithm-only device. The "device" is a physical patient warming system.

7. The type of ground truth used

Type of Ground Truth: The "ground truth" for this submission is conformance to established international medical device safety and performance standards (IEC 60601 series) and demonstrated substantial equivalence to a previously cleared predicate device (K052392) through direct comparison of engineering characteristics and safety systems.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. There is no AI model or algorithm being "trained" for this device.

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

Ground Truth for Training Set: Not applicable, as there is no training set for an AI model.

Summary

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K112488

Section 5 510k Summary

NOV 2 3 2011

SubmitterInformation:	Augustine Biomedical & Design, LLC6581 City West ParkwayEden Prairie, MN 55344952.465.3500
Contact:	Wendy J. Nelson, Director RA/QA
Date Prepared:	8/10/2011
Trade Name	HotDog Patient Warming SystemModel Numbers: WC0X, WC5X, BXXX, UXXX
Product Code	DWJ (21 CFR Part 870.5900),
Common Name	Thermal Regulating System
Predicate Device	HotDog Patient Warming System K052392
DeviceDescription	The HotDog Patient Warming System consists of a temperature controlunit that monitors and controls the temperature of a patient warmingblanket or mattress. The blankets and mattresses are composed of aconductive polymer coated fabric heater encased in a polymer shell.The mattress also contains a pressure relieving foam pad.
Intended Use	The Hot Dog Patient Warming System is intended to prevent or treathypothermia and to provide warmth to patients. The Hot Dog PatientWarming System should be used in circumstances in which patientsmay not maintain a state of normothermia. The patient warming systemcan be used with adult and pediatric patients.The System is intended primarily for use in hospitals and surgicalcenters including without limitation operating, recovery and emergencyrooms and on medical/surgical floors.
TechnologicalCharacteristics	A comparison between the new and predicate device shows that thetechnological characteristics and indications for use are equivalent. Theproducts have similar designs, materials, components and dimensions.

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Section 5 510k Summary

Non Clinical Data Bench testing was performed to demonstrate that the proposed warming system is substantially equivalent to the predicate devices. Temperature characteristics and safety systems were compared and found to be comparable. The system 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 2. IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, edition 2. 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 60601-2-35 Particular requirements for the safety of blankets, pad and mattresses intended for heating in medical use, edition 1. Clinical Data Not required Conclusion The HotDog Patient Warming System was found to be equivalent to the predicate device in technological characteristics and indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Augustine Biomedical & Design LLC. c/o Ms. Wendy Nelson Director of Regulatory Affairs 6851 City West Parkway Eden Prairie, MN 55344

NOV 213 2011

Re: K112488 Hot Dog Patient Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (two) Product Code: DWJ Dated: August 22, 2011 Received: August 29, 2011

Dear Ms. Nelson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Wendy Nelson

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M. G. Hillemann

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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Section 4 Indications For Use Statement

Indications for Use

510(k) Number (if known): K112488

Device Name: HotDog Patient Warming System

Indications For Use:

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. A. Wilhelm

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ K 11 2 4 88

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).