(92 days)
No
The summary describes a temperature management system and return electrode mattress with a controller and sensor feedback loop, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended to treat hypothermia and provide warmth to patients, which are therapeutic actions to restore and maintain a normal physiological state. Additionally, it functions as a return electrode for electrosurgery, which is a therapeutic surgical procedure.
No
Explanation: The device is intended to prevent or treat hypothermia and provide warmth to patients, and to conduct electrosurgical energy. These are therapeutic and functional purposes, not diagnostic ones.
No
The device description explicitly details hardware components, including a flexible semi-conductive polymer fabric, cables, and a controller, which are integral to its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent or treat hypothermia, provide warmth, and function as a return electrode for electrosurgery. These are all direct therapeutic or procedural functions performed on the patient's body.
- Device Description: The description details a thermal regulating system and a return electrode function, both of which interact directly with the patient's body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly interact with or treat the body itself. This device falls under the category of a therapeutic or procedural medical device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DWJ, ODR
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.
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
Intended User / Care Setting
hospital centers including, without limitation, operating rooms, recovery rooms, emergency rooms, burn units and on other medical/surgical floors.
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)
Bench testing was performed to demonstrate that the proposed 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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
1
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
2
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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3
Premarket 510k Summary
| Submitter
Information: | Augustine Temperature Management, LLC
7656 West 78th Street
Minneapolis, MN 55439
952.465.3529 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 and
Accessories (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”) 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 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. |
| Technological
Characteristics | 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 |
4
5
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.
6
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.
7
| Clinical Data | Not required |
|---|---|
| Conclusion | The HotDog Warming Mattress + Return Electrode was found to be |
| substantially equivalent to the predicate HotDog Temperature | |
| Management System. Reference device HotDog Return Electrode | |
| Mattress presents clear methodology for addressing differences in | |
| technology. The expanded technology of this submission, when | |
| considering the reference device capabilities and tested to FDA | |
| recognized consensus standards, demonstrate substantial | |
| equivalence to the predicate. The overall intended use of the | |
| device, achieving normothermia, is identical to the predicate. In | |
| sum, the Warming Mattress + Return Electrode this submission is | |
| as safe, as effective, and performs as well as the legally marketed | |
| predicate device. |