Who is the manufacturer of HotDog Warming Mattress + Return Electrode?

Augustine Temperature Management, LLC filed the 510(k) submission for HotDog Warming Mattress + Return Electrode (K232627).

What is the FDA product code for HotDog Warming Mattress + Return Electrode?

DWJ. It is classified under 21 CFR 870.5900 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for HotDog Warming Mattress + Return Electrode?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like HotDog Warming Mattress + Return Electrode?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HotDog Warming Mattress + Return Electrode

Q: What are the predicate devices for HotDog Warming Mattress + Return Electrode?

HotDog Warming Mattress + Return Electrode (K230866).

K232627 · Augustine Temperature Management, LLC · DWJ · Apr 18, 2024 · Cardiovascular

Device Facts

Record ID	K232627
Device Name	HotDog Warming Mattress + Return Electrode
Applicant	Augustine Temperature Management, LLC
Product Code	DWJ · Cardiovascular
Decision Date	Apr 18, 2024
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.5900
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

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 Story

HotDog Warming Mattress + Return Electrode is a thermal regulating system for adult patients. Device uses flexible semi-conductive polymer fabric in urethane shells; powered by low-voltage floating isolated DC current via controller/sensor feedback loop. Mattress functions as capacitive return electrode for monopolar electrosurgery. Operated in hospitals/surgical centers by clinical staff. Device connects to one or two electrosurgical units (ESU) via specialized cable. Output is controlled warming and safe return path for electrosurgical energy. Benefits include normothermia maintenance and integrated electrosurgical return functionality. Healthcare providers use device to manage patient temperature and facilitate surgery; output informs clinical management of patient thermal state.

Clinical Evidence

Bench testing only. Evaluated electrical safety (ANSI AAMI ES60601-1), EMC (IEC 60601-1-2), and performance standards (IEC 80601-2-35, IEC 60601-2-2). Testing confirmed temperature rise performance and patient leakage safety under worst-case dual-generator conditions.

Technological Characteristics

Flexible semi-conductive polymer fabric; urethane shell; low-voltage floating isolated DC power; capacitive return electrode; supports 1 or 2 ESUs. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 80601-2-35, IEC 60601-2-2.

Indications for Use

Indicated for adult patients to prevent or treat hypothermia and provide warmth in clinical settings (OR, recovery, ER, burn units). Also indicated to conduct monopolar electrosurgical energy back to one or two isolated electrosurgical generators.

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 Warming Mattress + Return Electrode (K230866)

Reference Devices

Mega 2000 Soft Dual Cord Patient Return Electrode Pad (K031285)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration". 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). {1}------------------------------------------------ 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K232627 Device Name HotDog Warming Mattress + Return Electrode #### Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |----------------------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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}------------------------------------------------ ### SECTION 5 Premarket 510k Summary | Submitter Information: | Augustine Temperature Management, LLC 15305 Minnetonka Blvd Minnetonka, MN 55345 952.465.3529 | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 and Accessories (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") 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. | | Indication for Use | 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 maintain 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. | | Technological Characteristics | The subject and predicate devices are identical in every respect but one. While the predicate device can function as a return electrode for a single ESU, the subject device can function as a return electrode for one or two ESUs, using a “Y” version of the predicate's cable. This technological characteristic – one or two ESU's -- is well established in the FDA-cleared devices in the capacitive-style return electrode category going back to May of 2003. Megadyne (K031285), which functions in a substantially equivalent manner to the submission device, indicates for one or two ESU's. | | | The reference Megadyne device, from their 510(k) summary, supports scientific methodology / standard reference values as it relates to the expanded technology of this Special 510(k) submission. Their summary defines temperature rise with two ESUs and impedance performance as bench testing to establish substantial equivalence. For Megadyne, in K031285 both of these values were found to be within acceptable limits to the standard, and substantially equivalent to their | | Performance Data | Bench testing was performed to demonstrate that the proposed Warming Mattress + Return Electrode is compliant with FDA recognized consensus standards for use with one ESU. These tests were underwritten by Intertek, using pass/fail criteria. | | | Electrical safety and electromagnetic compatibility (EMC) The HotDog Warming Mattress + Return Electrode 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 & A2:2010/(R)2012 FDA recognition #19-4 | | | 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 | | | Particular Standards | | | The HotDog Warming Mattress + Return Electrode 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 | | | 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 | | | Risk Management & Human Factors | | | Risk management was applied throughout the development process of the device. Risks related to use with two ESUs compared to one were analyzed. Risk mitigations were verified. Residual risks were assessed and an overall benefit-risk was established. The benefits of the warming mattress + return electrode outweigh the risks. | | SECTION 5 | | | Premarket 510k Summary | | | | ISO 14971, Medical Device - Application of Risk Analysis to Medical Devices, third edition FDA recognition # 5-125 | | | Human factors and usability engineering was applied to the HotDog Warming Mattress + Return Electrode, on the design side, and throughout risk management. | | | IEC 62366-1, Medical Device - Application of usability engineering to medical devices, Edition: 1.0 FDA recognition # 5-114 | | Further Bench Testing | Additional bench testing was completed to assess the impact on performance or safety of use of two generators vs one. Utilizing the reference device to support well established methodology, the temperature rise performance of the HotDog Warming Mattress + Return Electrode is substantially equivalent to the predicate device when utilizing two or one electrosurgical generators. Impedance results are theoretically unaffected by one or two generators, and therefore additional bench testing on impedance was not necessary. Patient Leakage testing was conducted under worst case conditions, demonstrating safety in dual generator use. | | Summary | Bench testing was performed to demonstrate that the proposed HotDog Warming Mattress + Return Electrode is compliant with FDA recognized consensus standards related to this submission. This and further bench testing demonstrate that the device is substantially equivalent to the predicate device. No substantial new risks exist from the ability to use one or two generators in electrosurgery with this device. | | Clinical Data | Not required | | Conclusion | The HotDog Warming Mattress + Return Electrode was found to be substantially equivalent to the predicate HotDog Warming Mattress + Return Electrode. Reference device Mega 2000 Soft Dual Cord Patien Return Electrode Pad presents clear methodology for addressing differences in technology. The expanded technology of this submission, when considering the reference device capabilities and testing to FDA recognized consensus standards, demonstrate substantial equivalence to the predicate. The overall intended use of the device is identical to the predicate. In sum, the Warming Mattress + Return Electrode this submission is as safe, as effective, and | {4}------------------------------------------------ # SECTION 5 SECTION 5 Premarket 510k Summary {5}------------------------------------------------ # SECTION 5 SECTION 5 Premarket 510k Summary {6}------------------------------------------------

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Device Facts

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Reference Devices

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