(327 days)
Not Found
No
The device description focuses on the physical and electrical principles of capacitive coupling for electrosurgical return electrodes. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No.
This device is a return electrode mattress used to conduct electrosurgical energy back to a generator, completing an electrical circuit during monopolar surgery. It does not provide any therapeutic effect itself but rather facilitates the function of a separate therapeutic device (the electrosurgical unit).
No
The device, a "HotDog Return Electrode Mattress," is described as a return electrode for electrosurgery, intended to conduct electrosurgical energy back to a generator to complete a circuit. Its function is therapeutic (enabling electrosurgical procedures), not diagnostic (identifying a disease or condition).
No
The device description clearly outlines a physical "Return Electrode Mattress" and a "Return Electrode Cable," which are hardware components. The mechanism of action described (capacitive method with conductive plates and an insulator) is also based on physical principles and hardware design.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to conduct monopolar electrosurgical energy from a patient back to an electrosurgical unit during surgery. This is a therapeutic/surgical function, not a diagnostic one.
- Device Description: The description details how the device works to complete an electrical circuit for electrosurgery. It does not involve analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic results.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is entirely within the realm of surgical energy management.
N/A
Intended Use / Indications for 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.
Product codes
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients only.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The results demonstrated the subject device can perform the intended use as safely and effectively as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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)
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Submitter
Information: | Augustine Temperature Management, LLC
7656 West 78th Street
Minneapolis, MN 55439
952.465.3539 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Temi Ogunse RA/QA Representative |
| Date Prepared: | 01/25/2022 |
| Trade Name | Return Electrode Mattress
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
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. |
| Indication for 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. |
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Premarket 510k Summary
| Technological
Characteristics | The proposed subject device is found to possess similar
technological characteristics under the premise of sharing the
same intended use, warning, contraindications, area of use,
frequency, cut power, COAG power, electrical safety standards,
and conductor. Further detailed information is listed in the
Substantial Equivalence Comparison table. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| | The proposed subject device uses foam for pressure relief under
the patient, while the predicate device uses a gel for pressure
relief under the patient. The proposed subject device has a
polyurethane layer that serves as a dielectric material, whereas the
predicate device has a gel layer the serves as a dielectric material
in separating the two conductive layers. The analysis of the
differences between the subject and predicate device does not
raise questions regarding safety and effectiveness. |
| Non-Clinical Data | 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. The
results demonstrated the subject device can perform the intended
use as safely and effectively as the predicate device. |
| | HotDog Return Electrode Mattress has conducted extensive
testing to ensure conformance to the following standards: |
| | IEC 60601-1 Medical Electrical Equipment - Part 1: General
Requirements for Basic Safety and Essential Performance,
edition: 3.1 |
| | IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General
Requirements for Safety - Collateral standard: Electromagnetic
Compatibility - Requirements and Tests, edition: 4.0 |
| | 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 |
| | ISO 14971 Medical Device - Application of Risk Analysis to
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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