(90 days)
The Hot Dog Patient Warming Mattress System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Warming Mattress should be used in circumstances in which patients may not maintain a state of normothermia. The mattress includes a pressure relieving pad.
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.
The Hot Dog Patient Warming Mattress System consists of a temperature control unit that monitors and controls the temperature of a patient warming mattress. The mattress is composed of a conductive polymer coated fabric heater encased in a polymer shell. The mattress also contains a pressure relieving foam pad.
It looks like the text provided is a 510(k) Premarket Notification summary for a medical device called the "Hot Dog Patient Warming Mattress System." This type of document is for regulatory clearance by the FDA, demonstrating substantial equivalence to existing devices, rather than a clinical study proving performance against acceptance criteria in the way a new drug or high-risk device might.
Here's an analysis based on the provided text, addressing the points you requested:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the "acceptance criteria" are not reported as specific numerical targets for performance metrics (e.g., "device must maintain temperature within +/- 0.5°C for 95% of use"). Instead, the acceptance criteria are framed in terms of meeting established medical device performance standards and being "comparable" or "substantially equivalent" to predicate devices.
| Acceptance Criteria (Standards/Comparisons) | Reported Device Performance |
|---|---|
| IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance | The mattress system is designed to meet this standard. (Implied compliance through design and testing). |
| IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests | The mattress system is designed to meet this standard. (Implied compliance through design and testing). |
| IEC 60601-1-4:2000, Medical electrical equipment - Part 1: General requirements for safety - 4 - Collateral standard: Programmable electrical medical systems | The mattress system is designed to meet this standard. (Implied compliance through design and testing). |
| IEC 60601-2-35 Particular requirements for the safety of blankets, pad and mattresses intended for heating in medical use | The mattress system is designed to meet this standard. (Implied compliance through design and testing). |
| Comparison to Predicate Devices (Inditherm Patient Warming System - K051419, Hot Dog Patient Warming System - K052392, Bair Hugger Patient Warming System Model 505 - K960167, Bair Hugger Patient Warming System Model 750 - K001149) - in terms of: - Technological characteristics - Indications for Use - Design - Materials - Components - Dimensions - Temperature characteristics - Pressure relief characteristics - Safety systems | "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." "Bench testing was performed to demonstrate that the proposed warming mattress system is substantially equivalent to the predicate devices. Temperature characteristics, pressure relief characteristics and safety systems were compared and found to be comparable." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of human subject data for performance evaluation. It mentions "Bench testing" which implies laboratory or engineering tests. There is no information provided about sample sizes for this testing or data provenance (e.g., country of origin, retrospective/prospective), as it was likely internal engineering testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The evaluation presented is based on engineering principles, compliance with technical standards, and comparison to predicate devices, not on expert consensus from clinical data.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. There was no clinical test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or described. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images. The "Hot Dog Patient Warming Mattress System" is a therapeutic device, not an imaging device.
6. Standalone Performance
The "Bench testing" performed demonstrates standalone performance of the device against technical standards and in comparison to predicate devices. The summary states: "Bench testing was performed to demonstrate that the proposed warming mattress system is substantially equivalent to the predicate devices. Temperature characteristics, pressure relief characteristics and safety systems were compared and found to be comparable." However, specific numerical metrics of standalone performance are not detailed in this summary.
7. Type of Ground Truth Used
The "ground truth" for this substantial equivalence submission is based on:
- Compliance with recognized industry standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-35.
- Engineering specifications and design comparisons to legally marketed predicate devices.
- Bench test results (presumably against internal specifications and predicate device performance).
There is no mention of pathology, outcomes data, or expert consensus from clinical evaluation as ground truth.
8. Sample Size for the Training Set
This information is not applicable and not provided. The device described (a patient warming mattress) is not an AI/ML device that requires a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for an AI/ML algorithm.
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16092807
Section 5 Premarket 510k Summary
Submitter Information:
Augustine Biomedical & Design, LLC 6581 City West Parkway Eden Prairie, MN 55344 952.465.3500
DEC 10 2009
James D. Ecklein, Director RA/QA Contact: Date Prepared: December 10, 2009 Trade Name Hot Dog Patient Warming Mattress System Model Numbers: WCUB, M101, M102, M103 DWJ (21 CFR Part 870.5900) Product Code Thermal Regulating System Common Name
Inditherm Patient Warming System - K051419 Hot Dog Patient Warming System - K052392 Bair Hugger Patient Warming System Model 505 - K960167 Bair Hugger Patient Warming System Model 750 - K001149
Device Description The Hot Dog Patient Warming Mattress System consists of a temperature control unit that monitors and controls the temperature of a patient warming mattress. The mattress is composed of a conductive polymer coated fabric heater encased in a polymer shell. The mattress also contains a pressure relieving foam pad.
The Hot Dog Patient Warming Mattress System is intended to Intended Use prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Warming Mattress should be used in circumstances in which patients may not maintain a state of normothermia. The mattress includes a pressure relieving pad. 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
Non Clinical Data
Predicate Device
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.
Bench testing was performed to demonstrate that the proposed warming mattress system is substantially equivalent to the predicate devices. Temperature characteristics, pressure relief characteristics and safety systems were compared and found to be
Page 1 of 2 Updated Premarket Summary K092807 12/10/09
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Section 5 Premarket 510k Summary
comparable. The mattress 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:
IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, edition .
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
Clinical Data Conclusion
ﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
Not required
The Hot Dog Patient Warming Mattress System was found to be equivalent to the predicate devices in technological characteristics and indications for use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/17 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, depicted with three curved lines representing the wings and body.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
1
Augustine Biomedical & Design LLC c/o Mr. James D. Ecklein Director RA/QA 6581 City West Parkway Eden Prairie, MN 55344
DEC 1 0 2009
K092807 Re:
Hot Dog Patient Warming Mattress System, Model Numbers: WCUB, M101, M102, M103
Regulation Number: 21 CFR 870.5900
Regulation Name: Thermal Regulating System
Regulatory Class: Class II (two)
Product Code: DWJ
Dated: August 31, 2009
Received: September 11, 2009
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 r ou may, merelors, mans 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.
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Page 2 - Mr. James D. 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); 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/ncm115809.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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
R. h. huel.
Image /page/3/Picture/7 description: The image shows a signature or symbol that appears to be handwritten. To the right of the symbol are the words "Bra" and "Dir", stacked vertically. The symbol itself consists of a curved line that forms a loop at the top, with a more angular, wave-like line extending downwards from the loop.
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 Statement
510(k) Number (if known): K092807
Device Name: Hot Dog Patient Warming Mattress System
Indications For Use:
The Hot Dog Patient Warming Mattress System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Warming Mattress should be used in circumstances in which patients may not maintain a state of normothermia. The mattress includes a pressure relieving pad.
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)
Dma D. leliner
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number दिल्लूट रूप न
§ 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).