(73 days)
Not Found
No
The summary describes a temperature management system with a controller and warming devices, focusing on preventing/treating hypothermia. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices. The performance studies focus on temperature characteristics and safety systems, not AI/ML performance metrics.
Yes
The device is intended to prevent or treat hypothermia and provide warmth to patients, which are therapeutic actions to maintain or restore health.
No
Explanation: The device is intended to prevent or treat hypothermia and provide warmth to patients, which is a therapeutic function, not a diagnostic one. It controls temperature, but does not diagnose or identify medical conditions.
No
The device description explicitly states it is a "Controller" that provides power to "warming devices" and controls their temperature. This indicates the device includes hardware components beyond just software.
Based on the provided information, the HotDog Patient Warming System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to prevent or treat hypothermia and provide warmth to patients. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The device description focuses on providing power and controlling temperature for warming devices. This aligns with a patient warming system, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information about a patient's condition based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The HotDog Patient Warming System does not fit this definition.
N/A
Intended Use / Indications for Use
The HotDog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The HotDog Temperature Management Controller should be used in circumstances in which patients may not maintain a state of normothermia. The System is intended primarily for use in hospitals and surgical centers including, without limitation, operating, recovery, and emergency rooms and on medical/surgical floors.
The Controller 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 is intended primarily for use in hospitals and surgical centers including operating, recovery, and emergency rooms, on medical/surgical floors.
Product codes (comma separated list FDA assigned to the subject device)
DWJ
Device Description
The HotDog Temperature Management Controller is part of a System intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients could become cold. The HotDog Temperature Management Controller is designed to provide power to the HotDog warming devices and to control the devices to set temperature.
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
Not Found
Intended User / Care Setting
hospitals and surgical centers including, without limitation, operating, recovery, and emergency rooms and on 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 controller is substantially equivalent to the predicate devices.
Temperature characteristics and safety systems were assessed and found to be comparable.
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.
HotDog Patient Warming System K052392, HotDog Multi-Function Controller K094056
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.
Not Found
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).
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September 11, 2020
Augustine Temperature Management Temi Ogunse QA/RA Representative 7656 West 78th Street Minneapolis, Minnesota 55439
Re: K201779
Trade/Device Name: HotDog Temperature Management Controller Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: June 24, 2020 Received: June 30, 2020
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/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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
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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 medical devices and radiation-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.
Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201779
Device Name HotDog Temperature Management Controller
Indications for Use (Describe)
The HotDog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The HotDog Temperature Management Controller should be used in circumstances in which patients may not maintain a state of normothermia. The System is intended primarily for use in hospitals and surgical centers including, without limitation, operating, recovery, and emergency rooms and on medical/surgical floors.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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 QA/RA Representative |
| Date Prepared: | 06/19/2020 |
| Trade Name | HotDog Temperature Management Controller
Model: WC7X |
| Product Code | DWJ (21 CFR Part 870.5900) |
| Common Name | Thermal Regulating System |
| Predicate Device | HotDog Patient Warming System K052392
HotDog Multi-Function Controller K094056 |
| Device Description | The HotDog Temperature Management Controller is part of a
System intended to prevent or treat hypothermia and to provide
warmth to patients. The System should be used in circumstances
in which patients could become cold. The HotDog Temperature
Management Controller is designed to provide power to the
HotDog warming devices and to control the devices to set
temperature. |
| Intended Use | The Controller 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 is intended primarily for use in
hospitals and surgical centers including operating, recovery, and
emergency rooms, on medical/surgical floors. |
| Technological
Characteristics | A comparison between the new and predicate devices shows that
the technological characteristics and indications for use are
equivalent. The products have similar designs, materials,
components, and dimensions. |
| Non-Clinical Data | Bench testing was performed to demonstrate that the proposed
controller is substantially equivalent to the predicate devices. |
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SECTION 5 Premarket 510k Summary 510(k) Number: K201779
Temperature characteristics and safety systems were assessed and found to be comparable.
The Controller is designed to meet the following performance standards:
IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, edition: 3.0
IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, edition: 3.1
IEC 60601-1-4:2000. Medical electrical equipment - Part 1: General requirements for safety - 4 - Collateral standard: Programmable electrical medical systems, edition 1.1.
IEC 80601-2-35, Particular requirements for the safety of blankets, pads and mattresses intended for heating in medical use, edition 1
IEC 62366, Medical Device – Application of usability engineering to medical devices
IEC 62304, Medical Device Software - Software Life Cycle Processes
Clinical Data Not required
Conclusion
The HotDog Temperature Management Controller was found to be equivalent to the predicate devices in technological characteristics and indications for use.