HOTDOG PATIENT WARMING SYSTEM

K112488 · Augustine Biomedical & Design, LLC · DWJ · Nov 23, 2011 · Cardiovascular

Device Facts

• Record ID: K112488
• Device Name: HOTDOG PATIENT WARMING SYSTEM
• Applicant: Augustine Biomedical & Design, LLC
• Product Code: DWJ · Cardiovascular
• Decision Date: Nov 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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 patient warming system can be used with adult and pediatric patients. 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.

Device Story

HotDog Patient Warming System consists of temperature control unit, warming blankets, and mattresses. Blankets/mattresses utilize conductive polymer-coated fabric heaters encased in polymer shells; mattress includes pressure-relieving foam. System monitors and regulates temperature to prevent/treat hypothermia. Used in hospitals, surgical centers, ORs, recovery rooms, emergency rooms, and medical/surgical floors by clinicians. Provides warmth to patients unable to maintain normothermia. Output is controlled thermal energy; healthcare providers use system to maintain patient body temperature during clinical procedures.

Clinical Evidence

No clinical data. Bench testing only. System verified against IEC 60601-1 (General Safety), IEC 60601-1-2 (EMC), IEC 60601-1-4 (Programmable electrical medical systems), and IEC 60601-2-35 (Safety of heating blankets/pads/mattresses).

Technological Characteristics

Conductive polymer-coated fabric heater; polymer shell; pressure-relieving foam (mattress). Temperature control unit monitors/regulates heat. Standards: IEC 60601-1 (Ed 2), IEC 60601-1-2 (Ed 2), IEC 60601-1-4 (Ed 1.1), IEC 60601-2-35 (Ed 1).

Indications for Use

Indicated for adult and pediatric patients to prevent or treat hypothermia and maintain normothermia in hospital and surgical settings.

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

• HotDog Patient Warming System (K052392)

Submission Summary (Full Text)

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K112488

## Section 5 510k Summary

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NOV 2 3 2011

| Submitter<br>Information: | Augustine Biomedical & Design, LLC<br>6581 City West Parkway<br>Eden Prairie, MN 55344<br>952.465.3500 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Wendy J. Nelson, Director RA/QA |
| Date Prepared: | 8/10/2011 |
| Trade Name | HotDog Patient Warming System<br>Model Numbers: WC0X, WC5X, BXXX, UXXX |
| Product Code | DWJ (21 CFR Part 870.5900), |
| Common Name | Thermal Regulating System |
| Predicate Device | HotDog Patient Warming System K052392 |
| Device<br>Description | The HotDog Patient Warming System consists of a temperature control<br>unit that monitors and controls the temperature of a patient warming<br>blanket or mattress. The blankets and mattresses are composed of a<br>conductive polymer coated fabric heater encased in a polymer shell.<br>The mattress also contains a pressure relieving foam pad. |
| 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<br>may not maintain a state of normothermia. The patient warming system<br>can be used with adult and pediatric patients.<br>The System is intended primarily for use in hospitals and surgical<br>centers including without limitation operating, recovery and emergency<br>rooms and on medical/surgical floors. |
| Technological<br>Characteristics | A comparison between the new and predicate device shows that the<br>technological characteristics and indications for use are equivalent. The<br>products have similar designs, materials, components and dimensions. |

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### Section 5 510k Summary

Non Clinical Data Bench testing was performed to demonstrate that the proposed warming system is substantially equivalent to the predicate devices. Temperature characteristics and safety systems were compared and found to be comparable. The system 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. 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 60601-2-35 Particular requirements for the safety of blankets, pad and mattresses intended for heating in medical use, edition 1. Clinical Data Not required Conclusion The HotDog Patient Warming System was found to be equivalent to the predicate device in technological characteristics and indications for use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Augustine Biomedical & Design LLC. c/o Ms. Wendy Nelson Director of Regulatory Affairs 6851 City West Parkway Eden Prairie, MN 55344

NOV 213 2011

Re: K112488 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: August 22, 2011 Received: August 29, 2011

Dear Ms. Nelson:

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 - Ms. Wendy Nelson

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,

M. G. Hillemann

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): K112488

Device Name: HotDog Patient Warming System

Indications For Use:

The HotDog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The HotDoq Patient Warming System should be used in circumstances in which patients may not maintain a state of normothermia. The patient warming system can be used with adult and pediatric patients.

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 X (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)

M. A. Wilhelm

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ K 11 2 4 88