Who is the manufacturer of HOTDOG MULTI FUNCTION CONTROLLER?

Augustine Biomedical & Design, LLC filed the 510(k) submission for HOTDOG MULTI FUNCTION CONTROLLER (K094056).

What is the FDA product code for HOTDOG MULTI FUNCTION CONTROLLER?

DWJ. It is classified under 21 CFR 870.5900 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for HOTDOG MULTI FUNCTION CONTROLLER?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HOTDOG MULTI FUNCTION CONTROLLER?

Hot Dog Patient Warming System (K052392); Hot Dog Patient Warming Mattress System (K092807).

Who can help prepare an FDA 510(k) submission like HOTDOG MULTI FUNCTION CONTROLLER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HOTDOG MULTI FUNCTION CONTROLLER

K094056 · Augustine Biomedical & Design, LLC · DWJ · Jun 3, 2010 · Cardiovascular

Device Facts

Record ID	K094056
Device Name	HOTDOG MULTI FUNCTION CONTROLLER
Applicant	Augustine Biomedical & Design, LLC
Product Code	DWJ · Cardiovascular
Decision Date	Jun 3, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.5900
Device Class	Class 2
Attributes	Therapeutic, 3rd-Party Reviewed

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.

Device Story

Hot Dog Multifunction Controller (Model WC52) is a temperature control unit for patient warming blankets and mattresses. Device monitors and regulates thermal output to prevent or treat hypothermia. Used in hospitals and surgical centers (OR, recovery, ER, medical/surgical floors) by healthcare professionals. Controller ensures patient normothermia through active thermal management. Bench testing confirmed safety and performance equivalence to predicate systems.

Clinical Evidence

No clinical data required; substantial equivalence established via bench testing comparing temperature characteristics and safety systems against predicate devices.

Technological Characteristics

Thermal regulating system; temperature control unit for warming blankets/mattresses. Complies with IEC 60601-1 (General Safety), IEC 60601-1-2 (EMC), and IEC 60601-1-4 (Programmable electrical medical systems).

Indications for Use

Indicated for patients at risk of or experiencing hypothermia requiring active warming to maintain normothermia in clinical settings including operating, recovery, and emergency rooms, 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

Hot Dog Patient Warming System (K052392)
Hot Dog Patient Warming Mattress System (K092807)

Related Devices

K201779 — HotDog Temperature Management Controller · Augustine Temperature Management · Sep 11, 2020
K112488 — HOTDOG PATIENT WARMING SYSTEM · Augustine Biomedical & Design, LLC · Nov 23, 2011
K052392 — HOT DOG PATIENT WARMING SYSTEM · Augustine Biomedical & Design, LLC · May 4, 2006
K092807 — HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 · Augustine Biomedical & Design, LLC · Dec 10, 2009
K123946 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS · Cincinnati Sub-Zero Products, Inc. · Jan 17, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ יין איי " KOSYSSO ، 。・ ### Section 5 Premarket 510k Summary . ・す | 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. | ﺔ. {1}------------------------------------------------ ## Section 5 Premarket 510k Summary r : という。・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ . • ﭘﺮ .~ . مستعمار سرع {2}------------------------------------------------ #### 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 {4}------------------------------------------------ ### 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 . .