The HotDog Return Electrode Mattress is intended to conduct monopolar electrosurgical energy from the target tissue of a patient back to one electrosurgical unit (ESU) or generator 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 Return Electrode Mattress is sold with a Return Electrode Cable, 4m (A136) that enables connection to one electrosurgical generator. The HotDog Return Electrode Mattress completes the circuit required for electrosurgery through Capacitive method. A capacitor is created when two conductive plates are separated by an insulator. The separation of two conductive plates by an insulator creates a capacitor. The insulator prevents current from flowing directly between the two plates, thereby avoiding the resistance which creates heat. With capacitive grounding, current from the active electrode produces a charge on the first conductive plate. This causes an equal (but opposite) charge to form on the second conductive plate. Current produced by the charge on the second plate produces electrical returns to the generator and completes the circuit.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "HotDog Return Electrode Mattress". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving new clinical efficacy through a comparative effectiveness study or complex AI validation study.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria, especially concerning AI/software performance or human-in-the-loop studies.

Specifically, the document states:

Clinical Data: "Not required" (Page 5). This directly indicates that clinical studies, which would typically involve human subjects and the types of performance metrics you're asking about, were not part of this submission for substantial equivalence.
The device is an electrosurgical accessory (a return electrode mattress), not a diagnostic AI device requiring complex performance metrics like sensitivity, specificity, or AUC, nor is it subject to MRMC studies.
The "study" mentioned is "Designed bench and functional use testing in a porcine model as recommended by the FDA guidance Premarket Notification 510(k) Submission for Electrosurgical Devices for General Surgery to support substantial equivalence to the Predicate." This suggests engineering and safety testing, not a clinical performance validation against ground truth established by experts.

In summary, the provided text does not contain any of the information requested in your prompt's numbered points because the device and the nature of the 510(k) submission do not require such studies or data.

Summary

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February 1, 2022

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

Re: K210727

Trade/Device Name: HotDog Return Electrode Mattress Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: March 5, 2021 Received: December 27, 2021

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/cfpm/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.

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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 803) for 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 mediation-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,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210727

Device Name HotDog Return Electrode Mattress

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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SubmitterInformation:	Augustine Temperature Management, LLC7656 West 78th StreetMinneapolis, MN 55439952.465.3539
Contact:	Temi Ogunse RA/QA Representative
Date Prepared:	01/25/2022
Trade Name	Return Electrode MattressModel: U501, U502
Classification	21 CFR Part 878.4400 / Class II
Product Code	GEI
Common Name	Patient Return Electrode
Predicate Device	MegaSoft Universal Patient Return Electrode - K133726
Device Description	The HotDog Return Electrode Mattress is sold with a ReturnElectrode Cable, 4m (A136) that enables connection to oneelectrosurgical generator. The HotDog Return Electrode Mattresscompletes the circuit required for electrosurgery throughCapacitive method. A capacitor is created when two conductiveplates are separated by an insulator. The separation of twoconductive plates by an insulator creates a capacitor. The insulatorprevents current from flowing directly between the two plates,thereby avoiding the resistance which creates heat. Withcapacitive grounding, current from the active electrode produces acharge on the first conductive plate. This causes an equal (butopposite) charge to form on the second conductive plate. Currentproduced by the charge on the second plate produces electricalreturns to the generator and completes the circuit.
Indication for Use	The HotDog Return Electrode Mattress is intended to conductmonopolar electrosurgical energy from the target tissue of apatient back to one electrosurgical unit (ESU) or generator inmonopolar surgery. The HotDog Return Electrode Mattress isrestricted to use with isolated monopolar electrosurgicalgenerators. The Hotdog Return Electrode Mattress is intended foruse with adult patients only.

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K210727

Premarket 510k Summary

TechnologicalCharacteristics	The proposed subject device is found to possess similartechnological characteristics under the premise of sharing thesame intended use, warning, contraindications, area of use,frequency, cut power, COAG power, electrical safety standards,and conductor. Further detailed information is listed in theSubstantial Equivalence Comparison table.

	The proposed subject device uses foam for pressure relief underthe patient, while the predicate device uses a gel for pressurerelief under the patient. The proposed subject device has apolyurethane layer that serves as a dielectric material, whereas thepredicate device has a gel layer the serves as a dielectric materialin separating the two conductive layers. The analysis of thedifferences between the subject and predicate device does notraise questions regarding safety and effectiveness.
Non-Clinical Data	Designed bench and functional use testing in a porcine model asrecommended by the FDA guidance Premarket Notification510(k) Submission for Electrosurgical Devices for GeneralSurgery to support substantial equivalence to the Predicate. Theresults demonstrated the subject device can perform the intendeduse as safely and effectively as the predicate device.
	HotDog Return Electrode Mattress has conducted extensivetesting to ensure conformance to the following standards:
	IEC 60601-1 Medical Electrical Equipment - Part 1: GeneralRequirements for Basic Safety and Essential Performance,edition: 3.1
	IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: GeneralRequirements for Safety - Collateral standard: ElectromagneticCompatibility - Requirements and Tests, edition: 4.0
	IEC 60601-2-2, Medical electrical equipment - Part 2-2: Particularrequirements for the basic safety and essential performance ofhigh frequency surgical equipment and high frequency surgicalaccessories edition 6.0
	ISO 14971 Medical Device - Application of Risk Analysis toMedical Devices
Sterilization	The HotDog Return Electrode Mattress are not sterile, delivered sterile or intended to be sterilized by the end user.
Biocompatibility	The device is not intended to contact the patient. The IFU calls out a thin barrier between the patient and the shell material.
Clinical Data	Not required
Conclusion	The HotDog Patient Return Electrode Mattress was found to be as safe and effective as the predicate device as intended for use.

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K210727

Page 3/3

Premarket 510k Summary

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.