HotDog Warming Mattress + Return Electrode

K210727 · Augustine Temperature Management, LLC · GEI · Feb 1, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K210727
• Device Name: HotDog Warming Mattress + Return Electrode
• Applicant: Augustine Temperature Management, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 1, 2022
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

HotDog Return Electrode Mattress functions as a capacitive return electrode for monopolar electrosurgery. Device completes electrical circuit between patient and electrosurgical generator via capacitive coupling; conductive plates separated by polyurethane dielectric layer. Input is electrosurgical energy from patient tissue; output is return path to generator. Used in surgical settings; operated by surgical staff. Provides alternative to traditional adhesive return electrodes; benefits patient by eliminating adhesive-related skin injuries and providing pressure relief via foam construction. Requires thin barrier between patient and device surface.

Clinical Evidence

No clinical data. Bench and functional testing performed, including porcine model testing per FDA guidance for electrosurgical devices. Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and ISO 14971 standards.

Technological Characteristics

Capacitive return electrode; polyurethane dielectric layer; foam pressure relief material. Dimensions/form factor: Mattress. Connectivity: Wired via 4m cable (A136) to isolated monopolar ESU. Non-sterile. Electrical safety: IEC 60601-1 (3.1), IEC 60601-1-2 (4.0), IEC 60601-2-2 (6.0).

Indications for Use

Indicated for adult patients undergoing monopolar surgery requiring return of electrosurgical energy to an isolated monopolar electrosurgical generator.

Regulatory Classification

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.

Predicate Devices

• MegaSoft Universal Patient Return Electrode - K133726

Submission Summary (Full Text)

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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 [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#

| Submitter<br>Information: | Augustine Temperature Management, LLC<br>7656 West 78th Street<br>Minneapolis, MN 55439<br>952.465.3539 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Temi Ogunse RA/QA Representative |
| Date Prepared: | 01/25/2022 |
| Trade Name | Return Electrode Mattress<br>Model: 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 Return<br>Electrode Cable, 4m (A136) that enables connection to one<br>electrosurgical generator. The HotDog Return Electrode Mattress<br>completes the circuit required for electrosurgery through<br>Capacitive method. A capacitor is created when two conductive<br>plates are separated by an insulator. The separation of two<br>conductive plates by an insulator creates a capacitor. The insulator<br>prevents current from flowing directly between the two plates,<br>thereby avoiding the resistance which creates heat. With<br>capacitive grounding, current from the active electrode produces a<br>charge on the first conductive plate. This causes an equal (but<br>opposite) charge to form on the second conductive plate. Current<br>produced by the charge on the second plate produces electrical<br>returns to the generator and completes the circuit. |
| Indication for Use | The HotDog Return Electrode Mattress is intended to conduct<br>monopolar electrosurgical energy from the target tissue of a<br>patient back to one electrosurgical unit (ESU) or generator in<br>monopolar surgery. The HotDog Return Electrode Mattress is<br>restricted to use with isolated monopolar electrosurgical<br>generators. The Hotdog Return Electrode Mattress is intended for<br>use with adult patients only. |

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K210727

# Premarket 510k Summary

| Technological<br>Characteristics | The proposed subject device is found to possess similar<br>technological characteristics under the premise of sharing the<br>same intended use, warning, contraindications, area of use,<br>frequency, cut power, COAG power, electrical safety standards,<br>and conductor. Further detailed information is listed in the<br>Substantial Equivalence Comparison table. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| | The proposed subject device uses foam for pressure relief under<br>the patient, while the predicate device uses a gel for pressure<br>relief under the patient. The proposed subject device has a<br>polyurethane layer that serves as a dielectric material, whereas the<br>predicate device has a gel layer the serves as a dielectric material<br>in separating the two conductive layers. The analysis of the<br>differences between the subject and predicate device does not<br>raise questions regarding safety and effectiveness. |
| Non-Clinical Data | Designed bench and functional use testing in a porcine model as<br>recommended by the FDA guidance Premarket Notification<br>510(k) Submission for Electrosurgical Devices for General<br>Surgery to support substantial equivalence to the Predicate. The<br>results demonstrated the subject device can perform the intended<br>use as safely and effectively as the predicate device. |
| | HotDog Return Electrode Mattress has conducted extensive<br>testing to ensure conformance to the following standards: |
| | IEC 60601-1 Medical Electrical Equipment - Part 1: General<br>Requirements for Basic Safety and Essential Performance,<br>edition: 3.1 |
| | IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General<br>Requirements for Safety - Collateral standard: Electromagnetic<br>Compatibility - Requirements and Tests, edition: 4.0 |
| | IEC 60601-2-2, Medical electrical equipment - Part 2-2: Particular<br>requirements for the basic safety and essential performance of<br>high frequency surgical equipment and high frequency surgical<br>accessories edition 6.0 |
| | ISO 14971 Medical Device - Application of Risk Analysis to<br>Medical 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

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# Premarket 510k Summary