(233 days)
Mega 2000 Soft Dual Cord Patient Return Electrode Pad (K031285)
No
The document describes a temperature management system and return electrode mattress that uses a sensor feedback loop and semi-conductive fabric for warming. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as a "Temperature Management System" intended to "prevent or treat hypothermia and to provide warmth to patients," which falls under the definition of a therapeutic intervention.
No
The device is intended to prevent or treat hypothermia, provide warmth to patients, and function as a return electrode for electrosurgery. It is a therapeutic device and not designed for diagnostic purposes.
No
The device description explicitly details hardware components like a flexible semi-conductive polymer fabric, cables, and a controller, indicating it is not software-only.
Based on the provided text, the HotDog Temperature Management System and the HotDog Warming Mattress + Return Electrode are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves testing blood, urine, tissue, or other bodily fluids to diagnose diseases, monitor health, or screen for conditions.
- The HotDog system's intended use is to manage patient temperature and function as a return electrode for electrosurgery. These are direct patient care functions performed on the patient's body, not on specimens taken from the body.
The description clearly outlines the device's purpose in warming the patient and conducting electrosurgical energy, which falls outside the scope of in vitro diagnostics.
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 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 or two electrosurgical units (ESU) or generators 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
DWJ, GEI
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
Hospitals and surgical 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
Bench testing was performed to demonstrate that the proposed Warming Mattress + Return Electrode is compliant with FDA recognized consensus standards for use with one ESU. 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 use with two ESUs compared to one were analyzed. 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 use of two generators vs one. Utilizing the reference device to support well established methodology, the temperature rise performance of the HotDog Warming Mattress + Return Electrode is substantially equivalent to the predicate device when utilizing two or one electrosurgical generators. Impedance results are theoretically unaffected by one or two generators, and therefore additional bench testing on impedance was not necessary. Patient Leakage testing was conducted under worst case conditions, demonstrating safety in dual generator use.
Summary
Bench testing was performed to demonstrate that the proposed HotDog 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. No substantial new risks exist from the ability to use one or two generators in electrosurgery with this device.
Clinical Data Not required
Key Metrics
Not Found
Predicate Device(s)
HotDog Warming Mattress + Return Electrode (K230866)
Reference Device(s)
Mega 2000 Soft Dual Cord Patient Return Electrode Pad (K031285)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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April 18, 2024
Augustine Temperature Management, LLC Garrett Augustine VP R&D 6581 City West Parkway Eden Prairie, Minnesota 55344
Re: K232627
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, GEI Dated: March 19, 2024 Received: March 19, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Nicole M. Gillette -S
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
2
Indications for Use
510(k) Number (if known) K232627
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 mantain 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 or two electrosurgical units (ESU) or generators 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
SECTION 5 Premarket 510k Summary
| Submitter
Information: | Augustine Temperature Management, LLC
15305 Minnetonka Blvd
Minnetonka, MN 55345
952.465.3529 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Garrett Augustine, VP R&D |
| Date Prepared: | 03/19/2024 |
| 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 Warming Mattress + Return Electrode (K230866) |
| Reference Device | Mega 2000 Soft Dual Cord Patient Return Electrode Pad (K031285) |
| 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 or two electrosurgical units (ESU) or generators 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 | The subject and predicate devices are identical in every respect but
one. While the predicate device can function as a return electrode for a
single ESU, the subject device can function as a return electrode for
one or two ESUs, using a “Y” version of the predicate's cable.
This technological characteristic – one or two ESU's -- is well
established in the FDA-cleared devices in the capacitive-style return
electrode category going back to May of 2003. Megadyne (K031285),
which functions in a substantially equivalent manner to the submission
device, indicates for one or two ESU's. |
| | The reference Megadyne device, from their 510(k) summary, supports
scientific methodology / standard reference values as it relates to the
expanded technology of this Special 510(k) submission. Their
summary defines temperature rise with two ESUs and impedance
performance as bench testing to establish substantial equivalence. For
Megadyne, in K031285 both of these values were found to be within
acceptable limits to the standard, and substantially equivalent to their |
| Performance Data | Bench testing was performed to demonstrate that the proposed
Warming Mattress + Return Electrode is compliant with FDA
recognized consensus standards for use with one ESU. 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 use with two ESUs compared to one were
analyzed. 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. |
| 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 use of two generators
vs one. Utilizing the reference device to support well
established methodology, the temperature rise performance
of the HotDog Warming Mattress + Return Electrode is
substantially equivalent to the predicate device when
utilizing two or one electrosurgical generators. Impedance
results are theoretically unaffected by one or two
generators, and therefore additional bench testing on
impedance was not necessary. Patient Leakage testing was
conducted under worst case conditions, demonstrating
safety in dual generator use. |
| Summary | Bench testing was performed to demonstrate that the
proposed HotDog 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. No substantial new risks exist from the
ability to use one or two generators in electrosurgery with
this device. |
| Clinical Data | Not required |
| Conclusion | The HotDog Warming Mattress + Return Electrode was found to be
substantially equivalent to the predicate HotDog Warming Mattress +
Return Electrode. Reference device Mega 2000 Soft Dual Cord Patien
Return Electrode Pad presents clear methodology for addressing
differences in technology. The expanded technology of this
submission, when considering the reference device capabilities and
testing to FDA recognized consensus standards, demonstrate
substantial equivalence to the predicate. The overall intended use of
the device is identical to the predicate. In sum, the Warming Mattress
- Return Electrode this submission is as safe, as effective, and |
4
SECTION 5 SECTION 5
Premarket 510k Summary
5
SECTION 5 SECTION 5
Premarket 510k Summary
6