(154 days)
Not Found
No
The summary describes a temperature control unit for patient warming blankets and mattresses, with no mention of AI or ML capabilities. The performance studies focus on temperature characteristics and safety systems, not algorithmic performance.
Yes
The device is described as "intended to prevent or treat hypothermia and to provide warmth to patients," which directly points to a therapeutic function.
No
The device is described as a "patient warming system" and a "temperature control unit that monitors and controls the temperature of patient warming blankets and mattresses." Its intended use is to "prevent or treat hypothermia and to provide warmth to patients." There is no indication that it diagnoses any condition.
No
The device description explicitly states it consists of a "temperature control unit" that monitors and controls temperature, indicating a hardware component beyond just software.
Based on the provided information, the Hot Dog 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 applied directly to the patient's body.
- Device Description: The device controls the temperature of blankets and mattresses used for patient warming. This is an external, non-invasive method of temperature management.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Hot Dog system does not interact with or analyze any bodily specimens.
Therefore, the Hot Dog Patient Warming System falls under the category of a therapeutic or supportive medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Hot Dog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Multifunction 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.
Product codes
DWJ
Device Description
The Hot Dog Multifunction Controller consists of a temperature control unit that monitors and controls the temperature of patient warming blankets and mattresses.
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 compared 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: 2
IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, edition: 2.1
IEC 60601-1-4:2000, Medical electrical equipment - Part 1: General requirements for safety - 4 - Collateral standard: Programmable electrical medical systems, edition 1.1.
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
§ 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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Section 5 Premarket 510k Summary
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| Submitter
Information: | Augustine Biomedical & Design, LLC
6581 City West Parkway
Eden Prairie, MN 55344
952.465.3500. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | James D. Ecklein, Director RA/QA
JUN - 3 2010 |
| Date
Prepared: | November 20, 2009 |
| Trade Name | Hot Dog Multifunction Controller
Model Number: WC52 |
| Product Code | DWJ (21 CFR Part 870.5900) |
| Common
Name | Thermal Regulating System |
| Predicate
Device | Hot Dog Patient Warming System K052392
Hot Dog Patient Warming Mattress System K092807 |
| Device
Description | The Hot Dog Multifunction Controller consists of a temperature control
unit that monitors and controls the temperature of patient warming
blankets and mattresses. |
| Intended Use | The Hot Dog Patient Warming System is intended to prevent or treat
hypothermia and to provide warmth to patients. The Hot Dog Patient
Warming 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 without limitation operating, recovery and emergency rooms and
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. Temperature
characteristics and safety systems were compared 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: 2
IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General
Requirements for Safety - Collateral standard: Electromagnetic
Compatibility - Requirements and Tests, edition: 2.1
IEC 60601-1-4:2000, Medical electrical equipment - Part 1: General
requirements for safety - 4 - Collateral standard: Programmable electrical
medical systems, edition 1.1. |
| Clinical Data | Not required |
| Conclusion | The Hot Dog Multifunction Controller was found to be equivalent to the
predicate device in technological characteristics, safety and indications for
use. |
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Section 5 Premarket 510k Summary
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مستعمار سرع
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Regulatory Technology Services LLC c/o Mr. Mark Job Responsible Third Party Official 1394 25th Street NW Buffalo, MN 55313
JUN - 3 2010
Re: K094056
Augustine Biomedical + Design LLC Hotdog Multi-Functional Controller Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: II Product Code: DWJ Dated: May 17, 2010 Received: May 18, 2010
Dear Mr. Job:
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 Foord, Or ug, 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 . 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.
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.
3
Page 2 - Mr. Mark Job
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4 Indications For Use Statement
Indications for Use
510(k) Number (if known): Unknown
Device Name: Hot Dog Multifunction Controller
Indications for Use:
The Hot Dog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Multifunction 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.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division $1gn-Off) Division of Cardiovascular Devices 510(k) Number_K694056
11/09/09
. .