(92 days)
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 hospital 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 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.
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.
The provided document is a 510(k) Premarket Notification summary for the HotDog Warming Mattress + Return Electrode. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical performance acceptance criteria through the kind of studies typically discussed for AI/ML-based diagnostic devices (e.g., MRMC studies for image analysis).
Therefore, the requested information, particularly points 1, 2, 3, 4, 5, 6, 7, 8, and 9, which are standard for evaluating AI/ML algorithm performance for diagnostic purposes, are not applicable to this document. This submission primarily relies on bench testing, adherence to recognized consensus standards, and risk management to demonstrate safety and effectiveness.
Here's why many of your specific questions are not directly answered by this document:
- No AI/ML Algorithm: The device described is a physical warming mattress with an integrated return electrode. It's not an AI/ML diagnostic or predictive algorithm. Therefore, concepts like "test set," "training set," "ground truth experts," "adjudication," or "human readers improve with AI vs without AI assistance" are not relevant.
- Focus on Substantial Equivalence: The 510(k) pathway requires demonstrating that a new device is as safe and effective as a legally marketed predicate device. This is often achieved through comparative testing of physical characteristics and performance against established standards, rather than clinical efficacy trials involving "ground truth" derived from expert consensus on images or pathology.
However, I can extract the relevant information regarding the performance claims and the studies/testing cited to support them, reframing the acceptance criteria in terms of the standards and tests performed.
Acceptance Criteria and Device Performance for HotDog Warming Mattress + Return Electrode
The "acceptance criteria" for this device are primarily defined by its compliance with recognized consensus standards for medical electrical equipment and specific standards for warming blankets/pads and high-frequency surgical accessories. The "study that proves the device meets the acceptance criteria" refers to the bench testing and risk management activities conducted.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined by Standards & Equivalence) | Reported Device Performance (Summary of Testing) |
|---|---|
| Electrical Safety and Electromagnetic Compatibility (EMC): The device must meet general safety and EMC requirements for medical electrical equipment. (Referenced Standards: ANSI AAMI ES60601-1, IEC 60601-1-2) | The HotDog Warming Mattress + Return Electrode is designed and verified to meet ANSI AAMI ES60601-1 and IEC 60601-1-2. Bench testing, underwritten by Intertek, confirmed compliance with these standards using pass/fail criteria. |
| Warming Function Safety and Performance: The device must meet specific safety and performance requirements for heating in medical use. (Referenced Standard: IEC 80601-2-35) | The HotDog Warming Mattress + Return Electrode is designed and verified to meet IEC 80601-2-35. Further bench testing demonstrated that the warming functions as intended during use as a return electrode and that the warming control at the WC77 controller is unaffected by electrosurgical use. Warming performance and safety were found to be equivalent to the predicate device. |
| Return Electrode Function Safety and Performance: The device must meet specific safety and performance requirements for high-frequency surgical accessories. It must also safely and effectively conduct monopolar electrosurgical energy. (Referenced Standard: IEC 60601-2-2) | The HotDog Warming Mattress + Return Electrode is designed and verified to meet IEC 60601-2-2. Further bench testing showed that cut performance/safety of electrosurgery is unaffected whether or not warming is engaged in the mattress. Return electrode performance and safety were found to be equivalent to the reference device (HotDog Return Electrode Mattress K210727), which provides clear methodology for addressing differences in technology and supports scientific methodology/standard reference values related to HF electrosurgical accessories. |
| Integrated Functionality Safety: The combination of warming and return electrode functions must not introduce new or increased risks, or negatively impact the safety or performance of either function. | Additional bench testing was completed to assess the impact on performance or safety of the integrated mattress. Testing shows that warming and return electrode functions do not affect the safety or performance of one another, and do not create a substantial new risk that is not inherent to the standalone pads. No substantial new risks exist from the integration of the two features. Risk management applied throughout development, assessing risks particular to interacting functions, with mitigations verified and residual risks assessed. Overall benefit-risk was established, concluding benefits outweigh risks. Longevity/shelf life are also unaffected. |
| Human Factors/Usability: The device design incorporates human factors principles to ensure usability and safety. (Referenced Standard: IEC 62366-1) | Human factors and usability engineering was applied to the HotDog Warming Mattress + Return Electrode, on the design side and throughout risk management. |
| Biocompatibility/Safety with Living Tissue (if applicable): While not explicitly an "acceptance criterion" table entry, the document notes validation on tissue. | The device was validated on porcine tissue in a real operating room environment at the University of Minnesota's Visible Heart Laboratory. |
For points 2-9, as this is a traditional medical device (not AI/ML software), these concepts are not applicable in the way they relate to AI model validation. However, I will address them where analogous information can be inferred from the document.
2. Sample Size Used for the Test Set and Data Provenance:
* "Test Set" Analogue: For this device, the "test set" is the actual device (or representative samples) subjected to various bench tests. The document doesn't specify a numerical sample size for each test (e.g., how many warming mattresses were tested for electromagnetic compatibility).
* Data Provenance: The testing was conducted by Intertek, a recognized third-party testing laboratory. The document indicates validation on porcine tissue at the University of Minnesota's Visible Heart Laboratory. This suggests prospective, controlled laboratory/animal testing, rather than retrospective human clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
* This question is not applicable. The "ground truth" for a physical device like this is dictated by established engineering standards (e.g., specific voltage limits, temperature accuracy, current flow parameters) and material properties, rather than human expert interpretation of images or clinical outcomes that require medical consensus.
4. Adjudication Method for the Test Set:
* This is not applicable. Testing against engineering standards involves objective measurements and pass/fail criteria, not subjective human judgment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:
* This is not applicable. This device is not an AI/ML diagnostic tool, and thus no MRMC study with human readers assisting AI was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* This is not applicable. There is no AI algorithm to test in a standalone fashion. The "standalone" performance here refers to the device's functional tests (warming, electrosurgical return) in isolation and in combination. The testing confirmed that warming and return electrode functions perform as intended both independently and when integrated.
7. The Type of Ground Truth Used:
* The "ground truth" for this device's performance is objective measurement against industry-recognized consensus standards (e.g., IEC 60601 series, ISO 14971, IEC 62366-1) and internal design specifications, supplemented by animal model validation (porcine tissue) for the combined functionality. It's not based on expert clinical consensus or patient outcomes data in the way an AI diagnostic model would be.
8. The Sample Size for the Training Set:
* This is not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
* This is not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.
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June 29, 2023
Augustine Temperature Management, LLC % Garrett Augustine VP R&d Augustine Temperature Management 6581 City West Parkway Eden Prairie, Minnesota 55344
Re: K230866
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, ODR Dated: March 29, 2023 Received: March 29, 2023
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 (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/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.
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
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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 (OS) 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 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,
Kathleen M. Grunder -S for 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
Enclosure
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Indications for Use
510(k) Number (if known) K230866
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 maintain a state of normothermia. The System can be used with adult patients.
The System is intended primarily for use in hospital 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 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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Premarket 510k Summary
| SubmitterInformation: | Augustine Temperature Management, LLC7656 West 78th StreetMinneapolis, MN 55439952.465.3529 |
|---|---|
| Contact: | Garrett Augustine, VP R&D |
| Date Prepared: | 03/29/2023 |
| 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 andAccessories (21 CFR § 878.4400) |
| Common Name | Warming Mattress + Return Electrode |
| Predicate Device | HotDog Temperature Management System (K220941) |
| Reference Device | HotDog Return Electrode Mattress (K210727) |
| Related Submission | Q-Submission (Q222939) |
| Device Description | The HotDog Warming Mattress + Return Electrode (“Mattress”) ispart of a thermal regulating system, indicated for controlling patienttemperature in adult patients.Mattresses utilize a flexible semi-conductive polymer fabric whichwarms the patient effectively within safe limits (controlledtemperature, low watt density, low thermal mass) from a controllerand sensor feedback loop. They are RF sealed in durable urethaneshells 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 tofunction 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 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. |
| TechnologicalCharacteristics | Active warming of patients with semi-conductive mattresses with a temperature sensor and controller is the technological principle for both the subject and predicate devices. The subject and predicate devices share the following same technological characteristics:Heater conductor material Shell material Output voltage Controller Port Power supply The subject and predicate devices are in every other respect identical in their construction, with one exception: for the subject device, a proprietary green cable enables the mattress to function as a return electrode. This functionality represents the technological difference between the subject and predicate devices.The reference device contains the functionality of return electrode mattress. Its use is the same, and -- aside from the warming function -- the construction is identical. The reference device supports scientific methodology / standard reference values as it relates to the expanded technology of this submission (ie use of |
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SECTION 5 Premarket 510k Summary
FDA recognized consensus standards IEC 60601-2-2 [HF electrosurgical accessories]).
Bench testing was performed to demonstrate that the proposed Performance Data Warming Mattress + Return Electrode is compliant with FDA recognized consensus standards related to this submission. 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 a warming mattress + return electrode were assessed, particularly in how the functions might interact with each others' safety and performance, as compared to the known risks of a standalone warming mattress or standalone return electrode. 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.
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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 an integrated mattress (warming + return electrode) as compared to a standalone warming mattress or return electrode mattress. Testing shows that warming functions as intended during use as a return electrode. In addition, the warming control at the WC77 controller is unaffected by electrosurgical use. Testing also shows that cut performance/safety of electrosurgery is unaffected whether or not warming is engaged in the mattress. Testing also show that warming and return electrode functions do not have some deleterious effect on longevity or shelf life. In sum, testing shows that warming and return electrode functions do not affect the safety or performance of one another, and do not create a substantial new risk that is not inherent to the standalone pads.
Validation
HotDog Warming Mattress + Return Electrode was validated on porcine tissue in a real operating room environment at the University of Minnesota's Visible Heart Laboratory.
Summary
Bench testing was performed to demonstrate that the proposed 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. Warming performance and safety is equivalent. Return electrode performance and safety is equivalent. No substantial new risks exist from the integration of the two features.
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| Clinical Data | Not required |
|---|---|
| Conclusion | The HotDog Warming Mattress + Return Electrode was found to besubstantially equivalent to the predicate HotDog TemperatureManagement System. Reference device HotDog Return ElectrodeMattress presents clear methodology for addressing differences intechnology. The expanded technology of this submission, whenconsidering the reference device capabilities and tested to FDArecognized consensus standards, demonstrate substantialequivalence to the predicate. The overall intended use of thedevice, achieving normothermia, is identical to the predicate. Insum, the Warming Mattress + Return Electrode this submission isas safe, as effective, and performs as well as the legally marketedpredicate device. |
§ 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).