(86 days)
Not Found
No
The summary describes a temperature control unit and warming blankets/mattresses, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions. Performance studies focus on temperature characteristics and safety systems, not algorithmic performance.
Yes
The device is intended to treat hypothermia and provide warmth to patients, which aligns with the definition of a therapeutic device as it provides treatment for a medical condition.
No
The device is a patient warming system intended to prevent or treat hypothermia and provide warmth. It does not perform any diagnostic functions like detecting, monitoring, or analyzing medical conditions or disease states.
No
The device description explicitly states that the system consists of a temperature control unit, blankets, and mattresses, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- HotDog Patient Warming System Function: The description clearly states the device's purpose is to "prevent or treat hypothermia and to provide warmth to patients." It works by directly warming the patient's body using blankets or mattresses.
- No Sample Analysis: There is no mention of the device analyzing any biological samples from the patient.
Therefore, the HotDog 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 HotDog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Doq 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.
Product codes
DWJ
Device Description
The HotDog Patient Warming System consists of a temperature control unit that monitors and controls the temperature of a patient warming blanket or mattress. The blankets and mattresses are composed of a conductive polymer coated fabric heater encased in a polymer shell. The mattress also contains a pressure relieving foam pad.
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
adult and pediatric patients
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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
Section 5 510k Summary
.
NOV 2 3 2011
| Submitter
Information: | Augustine Biomedical & Design, LLC
6581 City West Parkway
Eden Prairie, MN 55344
952.465.3500 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Wendy J. Nelson, Director RA/QA |
| Date Prepared: | 8/10/2011 |
| Trade Name | HotDog Patient Warming System
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
Description | The HotDog Patient Warming System consists of a temperature control
unit that monitors and controls the temperature of a patient warming
blanket or mattress. The blankets and mattresses are composed of a
conductive polymer coated fabric heater encased in a polymer shell.
The mattress also contains a pressure relieving foam pad. |
| 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. |
| Technological
Characteristics | A comparison between the new and predicate device shows that the
technological characteristics and indications for use are equivalent. The
products have similar designs, materials, components and dimensions. |
:
1
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.
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 stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
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.
3
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 (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 (240) 276-3150 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
4
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