(246 days)
Not Found
No
The summary describes a microprocessor-based temperature controller for a patient warming system. There is no mention of AI, ML, or any algorithms that would suggest learning or adaptive capabilities. The performance studies focus on temperature control and safety, not on AI/ML performance metrics.
Yes
The device is intended to prevent or treat hypothermia, which is a medical condition. Therefore, it is a therapeutic device.
No
The device is described as a patient warming system intended to treat and prevent hypothermia, not to diagnose medical conditions.
No
The device description explicitly lists hardware components: Warming Blanket, Warming Pad, Connecting Cable, and Temperature Controller.
Based on the provided information, the Hot Dog Patient Warming System is not an IVD (In Vitro Diagnostic) 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 consists of components that physically interact with the patient's body (warming blanket, warming pad) and a controller to regulate temperature.
- 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 Patient Warming System does not perform any such analysis of biological specimens.
Therefore, the Hot Dog Patient Warming System falls under the category of a therapeutic or supportive medical device, not an In Vitro Diagnostic device.
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 Warming System should be used in circumstances in which patients could become cold.
The System is intended for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms, burn units and on medical/surgical floors
Product codes
DWJ
Device Description
The Hot Dog Patient Warming System is designed to compensate for body heat loss before, during and after surgery and in other situations in which a patient could become cold.
The device consists of four primary components, the outer Warming Blanket (disposable), the Warming Pad, Connecting, Cable and the Temperature Controller.
The outer Warming Blanket is placed atop the patient, and the Warming Pad is placed over the outer Warming Blanket.
The microprocessor based Temperature Controller uses 110-240 VAC line voltage and is connected to the Warming Pad via a cable. The Controller output to the Warming Pad is 48 VDC or less.
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
The System is intended for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms, burn units 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)
The System was evaluated in terms of achieved surface temperatures under Functional and normal operating conditions and in conditions of possible single fault failures Safety Testing: to determine if an unacceptable risk of thermal injury existed. Functional temperature testing shows that the warming system does not result in simulated skin temperatures that would cause thermal injury. Safety system validation testing shows that all systems operate as intended. The primary and secondary over-temperature protection systems shut down power to the warming pad before pad surface temperatures reached unsafe temperatures. Side-by-side testing of the electrically powered warming pads and the Bair Hugger™ Temperature management system showed similar performance for both devices. The average contact surface temperature for both devices falls into the 39 - 42 °C range in steady state testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bair Hugger Model 750 – Arizant Medical, Inc. (K001149), Chillbuster – Microtek Medical, Inc. (K022903)
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
Premarket (510k) Summary
Image /page/0/Picture/1 description: The image contains a sequence of alphanumeric characters, specifically "Kos2392". The characters are handwritten in a bold, black font against a white background. The letters 'K', 'o', and 's' are followed by the numbers '2', '3', '9', and '2'.
| Submitter
Information: | Augustine Biomedical & Design, LLC
6581 City West Parkway
Eden Prairie, MN 55344
952.465.3500 | MAY 04 2006 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | James D. Ecklein, Director RA/QA | |
| Summary Date: | January 13, 2006 | |
| Device
Information: | Hot Dog Patient Warming System
DWJ 21 CFR Part 870.5900
Class II without exemption | |
| Common Name: | Patient Warming System | |
| Predicate Devices: | Bair Hugger Model 750 – Arizant Medical, Inc. (K001149)
Chillbuster – Microtek Medical, Inc. (K022903) | |
| Device
Description: | The Hot Dog Patient Warming System is designed to compensate for body
heat loss before, during and after surgery and in other situations in which a
patient could become cold.
The device consists of four primary components, the outer Warming Blanket
(disposable), the Warming Pad, Connecting, Cable and the Temperature
Controller.
The outer Warming Blanket is placed atop the patient, and the Warming Pad
is placed over the outer Warming Blanket.
The microprocessor based Temperature Controller uses 110-240 VAC line
voltage and is connected to the Warming Pad via a cable. The Controller
output to the Warming Pad is 48 VDC or less. | |
| 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 could
become cold.
The System is intended for use in hospitals and surgical centers including
without limitation operating, recovery and emergency rooms, burn units and
on medical/surgical floors | |
1
Premarket (510k) Summary
The System was evaluated in terms of achieved surface temperatures under Functional and normal operating conditions and in conditions of possible single fault failures Safety Testing: to determine if an unacceptable risk of thermal injury existed. Functional temperature testing shows that the warming system does not result in simulated skin temperatures that would cause thermal injury. Safety system validation testing shows that all systems operate as intended. The primary and secondary over-temperature protection systems shut down power to the warming pad before pad surface temperatures reached unsafe temperatures. Side-by-side testing of the electrically powered warming pads and the Bair Hugger™ Temperature management system showed similar performance for both devices. The average contact surface temperature for both devices falls into the 39 - 42 °C range in steady state testing. Based on the testing the "Hot Dog Patient Warm System™ is substantially Conclusion: equivalent to the Bair Hugger Model 750 Temperature Management System. The Hot Dog Patient Warming System exhibits satisfactory temperature uniformity and responds satisfactorily in normal and single fault conditions
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2006
Augustine Biomedical & Design, LLC c/o Mr. James Dr. Ecklein Director of RA/OA 6581 City West Parkway Eden Prairie, MN 55344
Re: K052392
Hot Dog Patient Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (Two) Product Code: DWJ Dated: February 27, 2006 Received: March 2, 2006
Dear Mr. Ecklein:
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. 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 such 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. James Dr. Ecklein
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Vachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
Device Name: Hot Dog Patient Warming System
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 Warming System should be used in circumstances in which patients could become cold.
The system in intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms, burn units and on medical/surgical floors.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. Ladner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K05239