HOT DOG PATIENT WARMING SYSTEM

K052392 · Augustine Biomedical & Design, LLC · DWJ · May 4, 2006 · Cardiovascular

Device Facts

• Record ID: K052392
• Device Name: HOT DOG PATIENT WARMING SYSTEM
• Applicant: Augustine Biomedical & Design, LLC
• Product Code: DWJ · Cardiovascular
• Decision Date: May 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Hot Dog Patient Warming System prevents/treats hypothermia in clinical settings. System components: disposable outer warming blanket, warming pad, connecting cable, microprocessor-based temperature controller. Controller uses 110-240 VAC input, outputs 48 VDC or less to warming pad. Used in hospitals/surgical centers (OR, recovery, ER, burn units, medical/surgical floors) by healthcare staff. Controller monitors surface temperature; primary/secondary over-temperature protection systems automatically shut down power if unsafe temperatures detected. Provides consistent surface warming (39-42 °C) to maintain patient normothermia during/after surgery.

Clinical Evidence

Bench testing only. Evaluated surface temperatures under normal and single-fault conditions. Compared contact surface temperatures against Bair Hugger system; both maintained steady-state temperatures in the 39-42 °C range. Safety validation confirmed primary and secondary over-temperature protection systems effectively prevent unsafe thermal levels.

Technological Characteristics

Microprocessor-controlled thermal regulation system. Components: disposable warming blanket, warming pad, connecting cable, temperature controller. Power: 110-240 VAC input, 48 VDC output to pad. Features primary and secondary over-temperature protection circuits. Steady-state surface temperature range: 39-42 °C.

Indications for Use

Indicated for patients at risk of or experiencing hypothermia requiring supplemental warmth in clinical settings including hospitals, surgical centers, operating rooms, recovery rooms, emergency rooms, burn units, and medical/surgical floors.

Regulatory Classification

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.

Predicate Devices

• Bair Hugger Model 750 – Arizant Medical, Inc. (K001149)
• Chillbuster – Microtek Medical, Inc. (K022903)

Submission Summary (Full Text)

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## Premarket (510k) Summary

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| Submitter<br>Information: | Augustine Biomedical & Design, LLC<br>6581 City West Parkway<br>Eden Prairie, MN 55344<br>952.465.3500 | MAY 04 2006 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | James D. Ecklein, Director RA/QA | |
| Summary Date: | January 13, 2006 | |
| Device<br>Information: | Hot Dog Patient Warming System<br>DWJ 21 CFR Part 870.5900<br>Class II without exemption | |
| Common Name: | Patient Warming System | |
| Predicate Devices: | Bair Hugger Model 750 – Arizant Medical, Inc. (K001149)<br>Chillbuster – Microtek Medical, Inc. (K022903) | |
| Device<br>Description: | The Hot Dog Patient Warming System is designed to compensate for body<br>heat loss before, during and after surgery and in other situations in which a<br>patient could become cold.<br><br>The device consists of four primary components, the outer Warming Blanket<br>(disposable), the Warming Pad, Connecting, Cable and the Temperature<br>Controller.<br><br>The outer Warming Blanket is placed atop the patient, and the Warming Pad<br>is placed over the outer Warming Blanket.<br><br>The microprocessor based Temperature Controller uses 110-240 VAC line<br>voltage and is connected to the Warming Pad via a cable. The Controller<br>output to the Warming Pad is 48 VDC or less. | |
| Intended Use: | The Hot Dog Patient Warming System is intended to prevent or treat<br>hypothermia and to provide warmth to patients. The Hot Dog Patient<br>Warming System should be used in circumstances in which patients could<br>become cold.<br><br>The System is intended for use in hospitals and surgical centers including<br>without limitation operating, recovery and emergency rooms, burn units and<br>on medical/surgical floors | |

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## 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

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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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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