(246 days)
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.
The Hot Dog Patient Warming System is designed to compensate for body heat loss before, during and after surgery and in other situations in which a patient could become cold.
The device consists of four primary components, the outer Warming Blanket (disposable), the Warming Pad, Connecting, Cable and the Temperature Controller.
The outer Warming Blanket is placed atop the patient, and the Warming Pad is placed over the outer Warming Blanket.
The microprocessor based Temperature Controller uses 110-240 VAC line voltage and is connected to the Warming Pad via a cable. The Controller output to the Warming Pad is 48 VDC or less.
The provided text is related to a Premarket (510k) Summary for a medical device called the "Hot Dog Patient Warming System." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies like those typically conducted for AI or imaging devices.
Therefore, many of the requested categories (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance for algorithms) do not apply to this document and the type of device described. The study described here is a functional and safety testing of a physical patient warming system, not an analysis of data by an algorithm.
However, I will extract the relevant information where possible, based on the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No unacceptable risk of thermal injury from simulated skin temperatures under functional and normal operating conditions. | Functional temperature testing shows that the warming system does not result in simulated skin temperatures that would cause thermal injury. |
| All safety systems operate as intended. | 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. |
| Similar performance to the predicate device (Bair Hugger™ Temperature management system) in terms of contact surface temperature, uniformity, and response to normal and single fault conditions. | 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. The "Hot Dog Patient Warm System™ exhibits satisfactory temperature uniformity and responds satisfactorily in normal and single fault conditions. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a physical device's functional and safety testing, not a dataset analysis. Therefore, the concept of a "test set" in the context of data provenance and sample size of data points is not directly applicable. The testing was conducted on the device itself and its components. The document does not specify the number of units tested, the country of origin of the testing, or whether the testing was retrospective or prospective (though functional and safety testing is inherently prospective for the device being evaluated).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for device performance (temperature, safety shutdown) is based on physical measurements and engineering specifications, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to human interpretation of data, not physical device testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI or imaging device, and no human reader study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. The device's standalone performance was evaluated through functional and safety testing, as described in the table above.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the device's performance was established through physical measurements and engineering standards/specifications for temperature and safety features. For example, "simulated skin temperatures that would cause thermal injury" serves as a benchmark, and the target "39 - 42 °C range" for contact temperature is a performance benchmark.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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Premarket (510k) Summary
Image /page/0/Picture/1 description: The image contains a sequence of alphanumeric characters, specifically "Kos2392". The characters are handwritten in a bold, black font against a white background. The letters 'K', 'o', and 's' are followed by the numbers '2', '3', '9', and '2'.
| SubmitterInformation: | Augustine Biomedical & Design, LLC6581 City West ParkwayEden Prairie, MN 55344952.465.3500 | MAY 04 2006 |
|---|---|---|
| Contact: | James D. Ecklein, Director RA/QA | |
| Summary Date: | January 13, 2006 | |
| DeviceInformation: | Hot Dog Patient Warming SystemDWJ 21 CFR Part 870.5900Class II without exemption | |
| Common Name: | Patient Warming System | |
| Predicate Devices: | Bair Hugger Model 750 – Arizant Medical, Inc. (K001149)Chillbuster – Microtek Medical, Inc. (K022903) | |
| DeviceDescription: | The Hot Dog Patient Warming System is designed to compensate for bodyheat loss before, during and after surgery and in other situations in which apatient could become cold.The device consists of four primary components, the outer Warming Blanket(disposable), the Warming Pad, Connecting, Cable and the TemperatureController.The outer Warming Blanket is placed atop the patient, and the Warming Padis placed over the outer Warming Blanket.The microprocessor based Temperature Controller uses 110-240 VAC linevoltage and is connected to the Warming Pad via a cable. The Controlleroutput to the Warming Pad is 48 VDC or less. | |
| Intended Use: | The Hot Dog Patient Warming System is intended to prevent or treathypothermia and to provide warmth to patients. The Hot Dog PatientWarming System should be used in circumstances in which patients couldbecome cold.The System is intended for use in hospitals and surgical centers includingwithout limitation operating, recovery and emergency rooms, burn units andon 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 (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 (301) 443-6597 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
§ 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).